PR\1343155EN.docx PE787.987v01-00
EN United in diversity EN
European Parliament
2024-2029
Committee on Public Health
2025/0404(COD)
30.06.2026
***I
DRAFT REPORT
on the proposal for a Regulation of the European Parliament and of the Council
amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards
simplifying and reducing the burden of the rules on medical devices and in
vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as
regards the support of the European Medicines Agency for the expert panels on
medical devices and Regulation (EU) 2024/1689 as regards the list of Union
harmonisation legislation referred to in its Annex I
(COM(2025)1023 – C10-0360/2025 – 2025/0404(COD))
Committee on Public Health
Rapporteur: Oliver Schenk
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PR_COD_1amCom
Symbols for procedures
* Consultation procedure
*** Consent procedure
***I Ordinary legislative procedure (first reading)
***II Ordinary legislative procedure (second reading)
***III Ordinary legislative procedure (third reading)
(The type of procedure depends on the legal basis proposed by the draft act.)
Amendments to a draft act
Amendments by Parliament set out in two columns
Deletions are indicated in bold italics in the left-hand column. Replacements
are indicated in bold italics in both columns. New text is indicated in bold
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relevant part of the draft act under consideration. If an amendment pertains to
an existing act that the draft act is seeking to amend, the amendment heading
includes a third line identifying the existing act and a fourth line identifying
the provision in that act that Parliament wishes to amend.
Amendments by Parliament in the form of a consolidated text
New text is highlighted in bold italics. Deletions are indicated using either
the ▌symbol or strikeout. Replacements are indicated by highlighting the
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By way of exception, purely technical changes made by the drafting
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CONTENTS
Page
DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION .................................5
EXPLANATORY STATEMENT ............................................................................................79
ANNEX: DECLARATION OF INPUT ...................................................................................81
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DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION
on the proposal for a Regulation of the European Parliament and of the Council
amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and
reducing the burden of the rules on medical devices and in vitro diagnostic medical
devices, and amending Regulation (EU) 2022/123 as regards the support of the
European Medicines Agency for the expert panels on medical devices and Regulation
(EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its
Annex I
(COM(2025)1023 – C10-0360/2025 – 2025/0404(COD))
(Ordinary legislative procedure: first reading)
The European Parliament,
– having regard to the Commission proposal to Parliament and the Council
(COM(2025)1023),
– having regard to Article 294(2) and Articles 168(4) and 114 of the Treaty on the
Functioning of the European Union, pursuant to which the Commission submitted the
proposal to Parliament (C10-0360/2025),
– having regard to Article 294(3) of the Treaty on the Functioning of the European Union,
– having regard to the budgetary assessment by the Committee on Budgets,
– having regard to the opinion of the European Economic and Social Committee of 29
April 20261,
– having regard to Rule 60 of its Rules of Procedure,
– having regard to the opinion of the Committee on the Internal Market and Consumer
Protection,
– having regard to the report of the Committee on Public Health (A10-0000/2026),
1. Adopts its position at first reading hereinafter set out;
2. Calls on the Commission to refer the matter to Parliament again if it replaces,
substantially amends or intends to substantially amend its proposal;
3. Instructs its President to forward its position to the Council, the Commission and the
national parliaments.
1 Not yet published in the Official Journal.
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Amendment 1
Proposal for a regulation
Recital 4 a (new)
Text proposed by the Commission Amendment
(4a) Any simplification of regulatory
procedures should safeguard a high level
of patient protection, maintain confidence
in the safety and performance of medical
devices, and ensure that streamlined
processes do not weaken requirements for
clinical evidence.
Or. en
Justification
It ensures that regulatory simplification does not compromise patient and product safety,
reduce patient protection, or undermine confidence in the safety and performance of medical
devices.
Amendment 2
Proposal for a regulation
Recital 4 b (new)
Text proposed by the Commission Amendment
(4b) Medical device software may
require regular updates to improve
functionality, usability, cybersecurity or
interoperability. Updates that do not alter
the intended purpose, clinical
functionality or risk profile of the device
should not automatically trigger a new
full conformity assessment. Where
software supports clinical decision-
making, healthcare professionals should
remain able to exercise their professional
judgement, without prejudice to the
manufacturer’s responsibility for the
safety and performance of the device.
Or. en
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Amendment 3
Proposal for a regulation
Recital 11
Text proposed by the Commission Amendment
(11) To ensure legal certainty and to
safeguard the principle of free movement
of goods, the coordination mechanism
between national competent authorities for
decisions on the regulatory status of a
product and on the classification of a
device, should be streamlined and, where
appropriate, involve external expertise
from an expert panel, supported by the
European Medicines Agency (EMA). The
decision on the regulatory status, however,
should remain with the national
authorities or, where appropriate, with the
Commission acting through implementing
acts.
(11) To ensure legal certainty and to
safeguard the principle of free movement
of goods, the coordination mechanism
between national competent authorities for
decisions on the regulatory status of a
product and on the classification of a
device, should be streamlined and, where
appropriate, involve external expertise
from an expert panel, supported by the
European Medicines Agency (EMA). The
decision on the regulatory status, however,
should remain with the competent
authority of the Member State in which
the manufacturer has its registered place
of business or, where appropriate, with the
Commission acting through implementing
acts.
Or. en
Justification
It clarifies that decisions on regulatory status are taken by the competent authority of the
Member State where the manufacturer is registered, thereby ensuring legal certainty and
reducing the risk of divergent assessments by different competent authorities.
Amendment 4
Proposal for a regulation
Recital 11 a (new)
Text proposed by the Commission Amendment
(11a) For a device which has been
subject to the conformity assessment
procedure involving the participation of a
notified body and which consequently
bears the CE marking, the coordination
mechanism should not beintended to
operate as a parallel post-certification
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review in a manner that could affect legal
certainty and the predictability of the
certification process. Accordingly, that
mechanism should be used in relation to
such devices only where there is
substantiated evidence that the device
presents an unacceptable risk, due to its
regulatory classification.
Or. en
Justification
It ensures that the functioning of the internal market and confidence in the CE marking system
are not undermined by duplicative or unnecessary layers of regulatory oversight.
Amendment 5
Proposal for a regulation
Recital 13 a (new)
Text proposed by the Commission Amendment
(13a) For the conduct of clinical trials of
medicinal products, including early-stage,
exploratory and global trials, the
requirements applicable to devices used in
such trials, in particular in vitro
diagnostic medical devices, should be
proportionate to their role in the trial.
Guidance should be developed on the
circumstances in which adapted
requirements may be warranted, in
particular where no suitable CE-marked
device is available, where a CE-marked
device is used in relation to a different but
closely related disease, condition,
population or clinical context, or where
the trial concerns a rare disease or
condition. Such guidance should
safeguard the safety, rights and well-
being of trial subjects and ensure that the
data generated are fit for purpose, while
avoiding unnecessary duplication and
delays in clinical research within the
Union.
Or. en
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Justification
It promotes a proportionate approach to the use of devices in medicinal product trials where
suitable CE-marked devices may not be available, while ensuring patient safety and
facilitating clinical research, including in early-stage, exploratory and rare disease settings.
Amendment 6
Proposal for a regulation
Recital 15
Text proposed by the Commission Amendment
(15) While it should remain the
responsibility of each Member State to
determine the language in which
information should be supplied to the users
within their territory, Member States
should consider accepting such information
in other languages of the Union that are
commonly understood in the medical field,
especially regarding devices intended for
professional users, in order to reduce costs
for translations.
(15) While it should remain the
responsibility of each Member State to
determine the language in which
information should be supplied to the lay
users within their territory, Member States
should consider accepting such information
in other languages of the Union that are
commonly understood in the medical field,
in order to reduce costs for translations.
Where a device is made available
exclusively to professional users,
information should be provided in
English.
Or. en
Justification
It reflects that English is commonly used and understood in the medical field within the
Union, in particular among professional users of medical devices.
Amendment 7
Proposal for a regulation
Recital 21
Text proposed by the Commission Amendment
(21) The Commission Report14 on the
operation of Article 17 of Regulation (EU)
2017/745 highlighted that the application
of the rules on single-use devices is
fragmented across the Union and the
relevant requirements are complex to
(21) The Commission Report14 on the
operation of Article 17 of Regulation (EU)
2017/745 highlighted that the application
of the rules on single-use devices is
fragmented across the Union and the
relevant requirements are complex to
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implement, resulting in a very limited and
unattractive market for the reprocessing of
single-use devices. To simplify the rules
regarding single-use devices and to
increase the re-use of devices for
economic and environmental reasons, it
should be the responsibility of the
manufacturer to determine whether and
how a device can be reprocessed, based on
the device’s characteristics and properties.
Unless the indication of single-use is duly
justified by the manufacturer, devices
should be subject to reprocessing, whilst
single-use devices or devices which cannot
be further reprocessed should be subject to
full refurbishing.
implement, resulting in a very limited and
unattractive market for the reprocessing of
single-use devices. Unless the indication of
single-use is duly justified by the
manufacturer, devices should be subject to
reprocessing, whilst single-use devices or
devices which cannot be further
reprocessed should be subject to full
refurbishing.
_________________ _________________
14 Report from the Commission to the
European Parliament and the Council of 29
November 2024 on the operation of Article
17 of Regulation (EU) 2017/745 of the
European Parliament and the Council on
single-use devices and their reprocessing
(COM(2024)560 final).
14 Report from the Commission to the
European Parliament and the Council of 29
November 2024 on the operation of Article
17 of Regulation (EU) 2017/745 of the
European Parliament and the Council on
single-use devices and their reprocessing
(COM(2024)560 final).
Or. en
Justification
It ensures that the classification of a device as single-use remains primarily based on patient
safety considerations and the characteristics of the device.
Amendment 8
Proposal for a regulation
Recital 31
Text proposed by the Commission Amendment
(31) To support innovation and the
development and availability of
breakthrough technology and of devices
intended for small groups of patients, the
conformity assessment procedures should
be adapted to address the specific situation
of those devices. For that purpose, criteria
for breakthrough devices and orphan
(31) To support innovation and the
development and availability of
breakthrough technology and of devices
intended for small groups of patients, the
conformity assessment procedures should
be adapted to address the specific situation
of those devices. For that purpose, criteria
for breakthrough devices and orphan
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devices should be included in Regulations
(EU) 2017/745 and (EU) 2017/746, based
on guidance developed by the Medical
Device Coordination Group. If the status as
a breakthrough device or orphan device is
confirmed by an expert panel, the review
of the device by the notified body should
be prioritised, if necessary with additional
advice from the expert panels.
devices should be included in Regulations
(EU) 2017/745 and (EU) 2017/746, based
on guidance developed by the Medical
Device Coordination Group. Where
feasible, the criteria and data
requirements under those schemes should
reflect applicable Union and international
approaches. If the status as a breakthrough
device or orphan device is confirmed by an
expert panel, the review of the device by
the notified body should be prioritised, if
necessary with additional advice from the
expert panels. Only expert panels and
notified bodies with the necessary clinical,
scientific, technical and regulatory
expertise and capabilities should be
involved in the assessment of
breakthrough or orphan devices.
Or. en
Justification
It ensures a proportionate and expertise-based framework for breakthrough and orphan
devices, facilitating innovation and timely access for small patient populations while
maintaining appropriate scientific and regulatory scrutiny.
Amendment 9
Proposal for a regulation
Recital 39
Text proposed by the Commission Amendment
(39) Clinical data are often available
for devices that are equivalent to the
device under conformity assessment. In
order to make the conditions under which
manufacturers can claim equivalence
more flexible, the requirement in
Regulation (EU) 2017/745 for a contract
with the manufacturer of the equivalent
device granting access to its technical
documentation should therefore be
removed and the equivalence criteria be
adapted.
deleted
Or. en
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Justification
It ensures that equivalence claims, particularly for high-risk implantable devices, remain
subject to robust and product-specific clinical evidence, thereby safeguarding patient safety
and maintaining incentives for manufacturers to generate their own clinical data.
Amendment 10
Proposal for a regulation
Recital 43
Text proposed by the Commission Amendment
(43) There is a growing number of
clinical studies involving, simultaneously,
a clinical trial of a medicinal product
subject to Regulation (EU) No 536/2014 of
the European Parliament and of the
Council20 , a performance study of an in
vitro diagnostic medical device subject to
Regulation (EU) 2017/746 or a clinical
investigation of a medical device subject to
Regulation (EU) 2017/745 (‘combined
studies’). To address concerns raised
regarding the complexity of applying
multiple Regulations to those combined
studies, sponsors should be enabled to
submit a single application for a combined
study leading to its coordinated assessment
under Regulation (EU) No 536/2014.
Regulations (EU) 2017/746 and Regulation
(EU) 2017/745 should not be applicable
where a single application has been
submitted.
(43) There is a growing number of
clinical studies involving, simultaneously,
a clinical trial of a medicinal product
subject to Regulation (EU) No 536/2014 of
the European Parliament and of the
Council20 , a performance study of an in
vitro diagnostic medical device subject to
Regulation (EU) 2017/746 or a clinical
investigation of a medical device subject to
Regulation (EU) 2017/745 (‘combined
studies’). To address concerns raised
regarding the complexity of applying
multiple Regulations to those combined
studies, sponsors should be enabled to
submit a single application for a combined
study leading to its coordinated assessment
under Regulation (EU) No 536/2014.
Regulations (EU) 2017/746 and Regulation
(EU) 2017/745 should not be applicable
where a single application has been
submitted. The use of a single application
for combined studies should facilitate the
conduct of clinical trials falling under
Regulation (EU) 2017/536 and
Regulation (EU) 2017/746 by reducing
procedural complexity for studies
involving diagnostic tests. To ensure its
effective application, overlaps with the
EUDAMED system for submissions
relating to clinical investigations and
performance studies should be avoided.
Experience gained from the COMBINE
programme should be taken into account
in the implementation of this Regulation.
_________________ _________________
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20 Regulation (EU) No 536/2014 of the
European Parliament and of the Council of
16 April 2014 on clinical trials on
medicinal products for human use, and
repealing Directive 2001/20/EC (OJ L 158,
27.5.2014, p.1, ELI;
http://data.europa.eu/eli/reg/2014/536/oj).
20 Regulation (EU) No 536/2014 of the
European Parliament and of the Council of
16 April 2014 on clinical trials on
medicinal products for human use, and
repealing Directive 2001/20/EC (OJ L 158,
27.5.2014, p.1, ELI;
http://data.europa.eu/eli/reg/2014/536/oj).
Or. en
Justification
It ensures a flexible implementation of the mechanism that can be refined in light of
experience gained from the COMBINE pilot project on coordinated assessment of combined
studies.
Amendment 11
Proposal for a regulation
Article 1 – paragraph 1 – point 1 a (new)
Regulation (EU) 2017/745
Article 1 – paragraph 9
Present text Amendment
(1a) Article 1(9) is replaced by the
following:
Any device which is intended to administer
a medicinal product as defined in point 2 of
Article 1 of Directive 2001/83/EC shall be
governed by this Regulation, without
prejudice to the provisions of that Directive
and of Regulation (EC) No 726/2004 with
regard to the medicinal product.
"9. Any device which is intended to
administer a medicinal product as defined
in point 2 of Article 1 of Directive
2001/83/EC shall be governed by this
Regulation, without prejudice to the
provisions of that Directive and of
Regulation (EC) No 726/2004 with regard
to the medicinal product.
However, if the device intended to
administer a medicinal product and the
medicinal product are placed on the market
in such a way that they form a single
integral product which is intended
exclusively for use in the given
combination and which is not reusable, that
single integral product shall be governed
by Directive 2001/83/EC or Regulation
(EC) No 726/2004, as applicable. In that
case, the relevant general safety and
performance requirements set out in Annex
However, if the device intended to
administer a medicinal product and the
medicinal product are placed on the market
in such a way that they form a single
integral product which is intended
exclusively for use in the given
combination and which is not reusable, that
single integral product shall be governed
by Directive 2001/83/EC or Regulation
(EC) No 726/2004, as applicable. In that
case, only the relevant general safety and
performance requirements set out in Annex
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I to this Regulation shall apply as far as the
safety and performance of the device part
of the single integral product are
concerned.
I to this Regulation shall apply as far as the
safety and performance of the device part
of the single integral product are
concerned."
Or. en
(This amendment seeks to amend a provision within the existing act – Article 1(9) – that was
not referred to in the Commission proposal.)
Justification
It avoids duplicative MDR obligations where the product is already assessed under the
pharmaceutical legislation and improves legal certainty.
Amendment 12
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point d
Regulation (EU) 2017/745
Article 2 – point 48
Text proposed by the Commission Amendment
(48) ‘clinical data’ means information
concerning safety or performance that is
generated from the use of a device and is
sourced from any of the following:
(48) ‘clinical data’ means information
concerning safety or performance that is
generated from the clinical or
investigational use of a device and is
sourced from any of the following:
Or. en
Justification
This clarifies that clinical data is information generated from clinical and/or investigational
use of a device, reflecting internationally recognised terminology.
Amendment 13
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point e
Regulation (EU) 2017/745
Article 2 – point 72 b (new)
Text proposed by the Commission Amendment
(b) it has not been associated with (b) it has a well-known safety history
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safety issues in the past; and has not been associated with safety
issues in the past;
Or. en
Amendment 14
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point e a (new)
Regulation (EU) 2017/745
Article 2 – points 77, 78 and 79 (new)
Text proposed by the Commission Amendment
(ea) The following points are added:
‘(77): 'niche devices' means a device
intended for a specific clinical use,
procedure or patient subgroup, which is
made available on the Union market only
in limited volumes due to the specific
nature of its intended purpose, and for
which no suitable alternative is available
or the absence of the device would
adversely affect patient care.
Additionally, A device shall also be
considered a niche device if an expert
panel referred to in Article 106 provides
an opinion as to whether the criteria are
fulfilled;
(78) 'breakthrough device' means a novel
medical device or in vitro diagnostic
medical device expected to provide a
significant clinical benefit through a
substantial advancement over existing
alternatives or by addressing an unmet
medical need;
(79): 'orphan devices' means a medical
device or in vitro diagnostic medical
device intended for a disease or condition
affecting not more than 12,000
individuals in the Union per year and
which fulfils an unmet medical need by
providing a diagnosis, prevention,
monitoring or treatment for which no
satisfactory alternative exists.’;
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Or. en
Justification
It ensure legal certainty for products that are essential for patient care but are not explicitly
covered by the orphan or breakthrough device pathways. Such devices may serve very small
clinical uses or patient subgroups and risk disappearing from the market due to
disproportionate regulatory burdens.
Amendment 15
Proposal for a regulation
Article 1 – paragraph 1 – point 2 a (new)
Regulation (EU) 2017/745
Article 2 – point 44
Present text Amendment
(2a) Article 2, point (44), is replaced by
the following:
(44) ‘clinical evaluation’ means a
systematic and planned process to
continuously generate, collect, analyse and
assess the clinical data pertaining to a
device in order to verify the safety and
performance, including clinical benefits, of
the device when used as intended by the
manufacturer;
"(44) ‘clinical evaluation’ means a
systematic and planned process to
continuously generate, collect, analyse and
assess the clinical data, or non-clinical
data where Article 61(10) applies,
pertaining to a device in order to verify the
safety and performance, including clinical
benefits, of the device when used as
intended by the manufacturer;"
Or. en
(This amendment seeks to amend a provision within the existing act – Article 2, point (44) –
that was not referred to in the Commission proposal.)
Amendment 16
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Regulation (EU) 2017/745
Article 3 – paragraph 2 a (new)
Text proposed by the Commission Amendment
2a. Upon a duly substantiated request
by a manufacturer or a notified body, an
expert panel referred to in Article 106
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shall provide an opinion within 30 days as
to whether a specific device or a generic
device group is a well-established
technology. The opinion shall be taken
into account by the competent authority
and the notified body in the appropriate
conformity assessment procedure.
The opinion shall be published on a
dedicated website without disclosing any
confidential information as referred to in
Article 109.
Or. en
Amendment 17
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Regulation (EU) 2017/745
Article 4 – paragraph 1
Text proposed by the Commission Amendment
1. The competent authorities of the
Member States shall coordinate their
activities when determining whether a
specific product, or category, or group of
products, falls within the definition of
‘medical device’ set out in Article 2, point
(1), or the definition of ‘accessory for a
medical device’ set out in Article 2, point
(2), or whether a product falls within the
scope of Annex XVI or is an accessory for
a product listed in that Annex.
1. The competent authorities of the
Member States shall coordinate their
activities when determining whether a
specific product, or category, or group of
products, that has been placed on the
market falls within the definition of
‘medical device’ set out in Article 2, point
(1), or the definition of ‘accessory for a
medical device’ set out in Article 2, point
(2), or whether a product falls within the
scope of Annex XVI or is an accessory for
a product listed in that Annex.
Or. en
Justification
It clarifies that the procedure applies only once products have been placed on the market. It
avoids uncertainty for products that are still under development.
Amendment 18
Proposal for a regulation
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Article 1 – paragraph 1 – point 3
Regulation (EU) 2017/745
Article 4 – paragraph 3
Text proposed by the Commission Amendment
3. Where a competent authority of a
Member State, after having performed an
evaluation in accordance with Article 94,
considers that a product that is CE marked
in accordance with Article 20, does not fall
within the scope of this Regulation, it shall
consult the competent authorities of the
other Member States regarding its
envisaged measure determining the
regulatory status of the product in question.
3. Where a competent authority of a
Member State, after having performed an
evaluation in accordance with Article 94,
has substantiated evidence that a product
that is CE marked in accordance with
Article 20, does not fall within the scope of
this Regulation, it shall consult the
competent authorities of the other Member
States regarding its envisaged measure
determining the regulatory status of the
product in question. The consulting
competent authority shall inform the
concerned manufacturer and concerned
notified body that has issued the
certificate.
Or. en
Justification
It requires substantiated evidence before re-opening the regulatory status of a CE-marked
product. It ensures early information of the manufacturer and Notified Body in order to
strengthen legal certainty.
Amendment 19
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Regulation (EU) 2017/745
Article 4 – paragraph 5
Text proposed by the Commission Amendment
5. The results of the coordination
activities of the competent authorities in
accordance with this Article and the
opinions of the expert panel delivered in
accordance with paragraph 4 of this Article
and Article 4a(2) shall be made publicly
available, without disclosing any
confidential information as referred to in
Article 109.
5. The results of the coordination
activities of the competent authorities in
accordance with this Article and the
opinions of the expert panel delivered in
accordance with paragraph 4 of this Article
shall be made publicly available, without
disclosing any confidential information as
referred to in Article 109.
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Or. en
Amendment 20
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Regulation (EU) 2017/745
Article 4 – paragraph 5 a (new)
Text proposed by the Commission Amendment
5a. Where necessary, to ensure the
uniform application of this Regulation,
and taking into account the opinion of the
expert panel referred to in paragraph 4,
the Commission may, by means of
implementing acts, determine whether a
product, CE-marked in accordance with
Article 20, falls within the scope of this
Regulation.
Or. en
Justification
It enables Union-level decision-making to ensure the consistent application of this regulation.
Amendment 21
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Regulation (EU) 2017/745
Article 4 – paragraph 6
Text proposed by the Commission Amendment
6. The Commission may, by means of
implementing acts, lay down the
procedure, including timelines, for the
application of paragraphs 1 to 4 of this
Article and of Article 4a. Those
implementing acts shall be adopted in
accordance with the examination procedure
referred to in Article 114(3).;
6. The Commission shall, by means
of implementing acts, lay down the
procedure, including timelines and
involvement of concerned stakeholders,
for the application of paragraphs 1 to 4 of
this Article and of Article 4a. Those
implementing acts shall be adopted in
accordance with the examination procedure
referred to in Article 114(3).;
Or. en
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Amendment 22
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EU) 2017/745
Article 4a – paragraph 1
Text proposed by the Commission Amendment
1. A competent authority, a notified
body, a manufacturer, a developer of a
product or the Commission may submit a
substantiated request for an opinion from
an expert panel referred to in Article 106
on the question whether a specific product,
or category or group of products, falls
within the definitions of ‘medical device’
or ‘accessory for a medical device’, or
whether a product falls within the scope of
Annex XVI or is an accessory for a product
listed in that Annex. Where, in such a
request, the requester considers that the
product in question is a device, the request
shall also specify the proposed
classification of the device in accordance
with Article 51 and Annex VIII.
1. A competent authority, may submit
a substantiated request for an opinion from
an expert panel referred to in Article 106
on the question whether a specific product,
falls within the definitions of ‘medical
device’ or ‘accessory for a medical device’,
or whether a product falls within the scope
of Annex XVI or is an accessory for a
product listed in that Annex. Where, in
such a request, the requester considers that
the product in question is a device, the
request shall also specify the proposed
classification of the device in accordance
with Article 51 and Annex VIII.
Or. en
Justification
It limits the expert panel procedure to substantiated requests by competent authorities
concerning specific products. It prevents the procedure from being used for broad or strategic
reassessments and preserves legal certainty for products already covered by Article 4.
Amendment 23
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EU) 2017/745
Article 4a – paragraph 2
Text proposed by the Commission Amendment
2. The expert panel shall provide its
opinion without undue delay. The
requester shall give utmost consideration to
2. The expert panel shall provide its
opinion within 30 days from receipt of a
complete request. The requester shall give
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the opinion of the expert panel. utmost consideration to the opinion of the
expert panel when determining the
regulatory status of the product.
Any opinion of an expert panel in relation
to the determination of the regulatory
status, shall be made publicly available,
without disclosing any confidential
information as referred to in Article 109.
Or. en
Amendment 24
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EU) 2017/745
Article 4a – paragraph 3 – subparagraph 1
Text proposed by the Commission Amendment
Having regard to the expert panel opinion
referred to in paragraph 2 or in Article
4(4), a Member State may submit a
substantiated request to the Commission
to determine whether a specific product,
or category or group of products, falls
within the definitions of ‘medical device’
or ‘accessory for a medical device’, or
whether a product falls within the scope
of Annex XVI or is an accessory for a
product listed in that Annex.
deleted
Or. en
Amendment 25
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EU) 2017/745
Article 4a – paragraph 3 – subparagraph 2
Text proposed by the Commission Amendment
The Commission shall decide on the
substantiated request of the Member State
or on its own initiative, by means of
deleted
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implementing acts, which shall be adopted
in accordance with the examination
procedure referred to in Article 114(3).
Or. en
Amendment 26
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EU) 2017/745
Article 4a – paragraph 3 – subparagraph 3
Text proposed by the Commission Amendment
The Commission may ask the expert panel
for clarifications or refer the opinion back
to the expert panel for further
consideration, including in cases where a
Member State’s substantiated request
raises new questions of a scientific or
technical nature.
deleted
Or. en
Amendment 27
Proposal for a regulation
Article 1 – paragraph 1 – point 5 a (new)
Regulation (EU) 2017/745
Article 5 – paragraph 5 – introductory part
Present text Amendment
(5a) Article 5(5) is replaced by the
following:
5. With the exception of the relevant
general safety and performance
requirements set out in Annex I, the
requirements of this Regulation shall not
apply to devices, manufactured and used
only within health institutions established
in the Union, provided that all of the
following conditions are met:
"5. With the exception of the relevant
general safety and performance
requirements set out in Annex I, applied in
a proportionate manner, having regard to
the non-commercial nature and intended
use of the device, the requirements of this
Regulation shall not apply to devices,
manufactured and used only within health
institutions established in the Union,
provided that all of the following
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conditions are met:"
Or. en
(This amendment seeks to amend a provision within the existing act – Article 5(5) – that was
not referred to in the Commission proposal.)
Justification
It ensures that in-house exemption remains, in practice, usable for health institutions.
Amendment 28
Proposal for a regulation
Article 1 – paragraph 1 – point 6 a (new)
Regulation (EU) 2017/745
Article 5 – paragraph 5 – point e
Present text Amendment
(6a) in Article 5(5), point (e) is deleted;
(e) the health institution draws up a
declaration which it shall make publicly
available, including:
""
(i) the name and address of the
manufacturing health institution;
(ii) the details necessary to identify the
devices;
Or. en
(This amendment seeks to amend a provision within the existing act – Article 5(5) – that was
not referred to in the Commission proposal.)
Justification
It removes a disproportionate publication requirement for non-commercial in-house devices,
reducing administrative burden for health institutions while preserving the purpose of the in-
house exemption.
Amendment 29
Proposal for a regulation
Article 1 – paragraph 1 – point 9 – point b
Regulation (EU) 2017/745
Article 10 – paragraph 9 – subparagraph 3 (new)
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Text proposed by the Commission Amendment
Manufacturers may rely on relevant
results from audits or certifications
carried out under internationally
recognised quality management schemes,
including ISO 13485 and the Medical
Device Single Audit Program (MDSAP),
where such results are suitable to
demonstrate compliance with the quality
management system requirements of this
Regulation.
Or. en
Justification
It allows relevant results from internationally recognised quality management audits to be
taken into account for MDR compliance, helping to avoid duplicative assessments, reducing
unnecessary administrative burden and enabling notified bodies to focus resources on risk-
relevant aspects.
Amendment 30
Proposal for a regulation
Article 1 – paragraph 1 – point 9 – point c
Regulation (EU) 2017/745
Article 10 – paragraph 10
Text proposed by the Commission Amendment
(c) paragraph 10 is deleted; deleted
Or. en
Amendment 31
Proposal for a regulation
Article 1 – paragraph 1 – point 9 – point d
Regulation (EU) 2017/745
Article 10 – paragraph 11
Text proposed by the Commission Amendment
When determining the official language of
the Union in which the information set out
When determining the official language of
the Union in which the information set out
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in Section 23 of Annex I or other
information to be provided by the
manufacturer shall be made available,
Member States shall consider accepting
another official language of the Union in
which the information is made available,
taking into consideration the technical
knowledge, experience, education or
training of the average intended user(s).;
in Section 23 of Annex I or other
information to be provided by the
manufacturer shall be made available,
Member States shall consider accepting
another official language of the Union in
which the information is made available,
taking into consideration the technical
knowledge, experience, education or
training of the average intended user(s).
Where a device is intended exclusively for
professional use, the information referred
to in Section 23 of Annex I may be
provided only in English.
Or. en
Justification
It reduces translation burden while taking account the technical expertise of the intended
users.
Amendment 32
Proposal for a regulation
Article 1 – paragraph 1 – point 9 – point e
Regulation (EU) 2017/45
Article 10 – paragraph 13
Text proposed by the Commission Amendment
(e) paragraph 13 is deleted; deleted
Or. en
Amendment 33
Proposal for a regulation
Article 1 – paragraph 1 – point 9 – point f
Regulation (EU) 2017/45
Article 10 – paragraph 14
Text proposed by the Commission Amendment
(f) paragraph 14 is amended as
follows:
deleted
(i) the third subparagraph is deleted;
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(ii) the fourth subparagraph is deleted;
Or. en
Justification
It preserves the existing safeguards on manufacturer liability and financial coverage.
Amendment 34
Proposal for a regulation
Article 1 – paragraph 1 – point 9 – point h
Regulation (EU) 2017/45
Article 10 – paragraph 16
Text proposed by the Commission Amendment
(h) paragraph 16 is deleted; deleted
Or. en
Justification
It preserves the existing safeguards on manufacturer liability and financial coverage.
Amendment 35
Proposal for a regulation
Article 1 – paragraph 1 – point 9 – point h a (new)
Regulation (EU) 2017/45
Article 10 – paragraph 16 a (new)
Text proposed by the Commission Amendment
(ha) the following paragraph 16a is
added:
16. Natural or legal persons may claim
compensation for damage caused by a
defective device in accordance with
applicable Union and national law.
Economic operators liable under Article 8
of Directive (EU) 2024/2853 shall ensure
that they have appropriate financial
coverage, including insurance or
equivalent arrangements, for their
potential liability before placing a device
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on the market, putting it into service or
making it available.The level of coverage
shall be proportionate to the risk class,
intended purpose and potential harm
associated with the device, without
prejudice to stricter protective measures
under national law.
Or. en
Justification
It strengthens patient and user protection by requiring economic operators liable for defective
devices to maintain appropriate financial coverage for potential compensation claims.
Amendment 36
Proposal for a regulation
Article 1 – paragraph 1 – point 11
Regulation (EU) 2017/745
Article 11 – paragraphs 4 and 5
Text proposed by the Commission Amendment
(11) in Article 11, paragraphs 4 and 5
are deleted;
deleted
Or. en
Justification
The original text maintains existing liability rules for authorised representatives. Where
defective devices are placed on the Union market by manufacturers established outside the
Union, patients and users must retain an effective route to compensation and accountability
within the Union.
Amendment 37
Proposal for a regulation
Article 1 – paragraph 1 – point 14 – point b
Regulation (EU) 2017/745
Article 16 – paragraph 4
Text proposed by the Commission Amendment
(b) paragraph 4 is deleted; (b) paragraph 4 is replaced by the
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following:
‘4. At least 28 days prior to making the
relabelled or repackaged device available
on the market, distributors or importers
carrying out any of the activities
mentioned in points (a) and (b) of
paragraph 2 shall inform the
manufacturer of their intention to make
the relabelled or repackaged device
available and, upon request, shall provide
the manufacturer with a sample or mock-
up of the relabelled or repackaged device,
including any translated label and
instructions for use.’
Or. en
Justification
It preserves manufacturer oversight where devices are relabeled or repackaged by importers
or distributors ensuring traceability and effective vigilance and post-market surveillance as
well as corrective actions where necessary.
Amendment 38
Proposal for a regulation
Article 1 – paragraph 1 – point 15
Regulation (EU) 2017/745
Article 17 – paragraph 1
Text proposed by the Commission Amendment
1. A device shall only be intended for
single-use where the manufacturer, in
light of the design, construction, material,
chemical, physical and biological
properties of the device, cannot ensure
that the device continues to meet the
relevant safety and performance
requirements when reused in accordance
with its intended purpose after
appropriate reprocessing. The
manufacturer’s justification of an
indication of single use shall be part of the
technical documentation referred to in
Annex II.
1. It shall be the responsibility of the
manufacturer to indicate whether a device
is intended for single-use or whether it
may be reprocessed. This indication shall
be based on the design, construction,
materials and chemical, physical and
biological properties of the device and
shall be included in the technical
documentation referred to in Annex II.
Where a device intended exclusively for
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professional use in health institutions is
designated as single-use, the
manufacturer shall include a reasoned
justification in the technical
documentation explaining why safe
reprocessing cannot be ensured.
Or. en
Justification
It ensure that a single-use decision remains with the manufacturer, who has the technical
knowledge of the device and is responsible for its safety and performance. At the same time, it
requires additional justification for devices used only in hospitals, to avoid unnecessary
single-use designation where safe reprocessing may be possible.
Amendment 39
Proposal for a regulation
Article 1 – paragraph 1 – point 15
Regulation (EU) 2017/745
Article 17 – paragraph 2
Text proposed by the Commission Amendment
2. If the device is not intended for
single-use, the manufacturer shall provide
information about the appropriate
reprocessing process for allowing reuse in
the instructions for use in accordance with
Annex I, Section 23.4, point (n).
2. If the device is not intended for
single-use, the manufacturer shall provide
information about the appropriate
reprocessing process for allowing reuse in
the instructions for use in accordance with
Annex I, Section 23.4, point (n). For any
reprocessed device, the label shall indicate
that it has been reprocessed and shall
include the name and address of the
reprocessor to ensure traceability.
Or. en
Amendment 40
Proposal for a regulation
Article 1 – paragraph 1 – point 15
Regulation (EU) 2017/745
Article 17 – paragraph 3
Text proposed by the Commission Amendment
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3. Single-use devices and devices that
cannot be further reprocessed may be
subject to full refurbishing within the
meaning of Article 2(31). The natural or
legal person that carries out the full
refurbishing shall be considered as the
manufacturer of the fully refurbished
device.
3. Single-use devices and devices that
are no longer suitable for further
reprocessing, or devices that do not
indicate whether they are single-use or
reprocessable, may be subject to full
refurbishing within the meaning of Article
2(31). The natural or legal person that
carries out the full refurbishing shall be
considered as the manufacturer of the fully
refurbished device.
Or. en
Amendment 41
Proposal for a regulation
Article 1 – paragraph 1 – point 15
Regulation (EU) 2017/745
Article 17 – paragraph 4
Text proposed by the Commission Amendment
4. The Commission may adopt, in
accordance with Article 9(1), CS on
general requirements regarding
reprocessing of devices or fully
refurbishing of single-use devices.;
4. The Commission may adopt, in
accordance with Article 9(1), CS on the
general and harmonised requirements for
the reprocessing or fully refurbishing of
devices.
Or. en
Amendment 42
Proposal for a regulation
Article 1 – paragraph 1 – point 16 – point b
Regulation (EU) 2017/745
Article 18 – paragraph 3
Text proposed by the Commission Amendment
(b) paragraph 3 is replaced by the
following:
deleted
‘3. Implants that are well-established
technology devices shall be exempted
from the obligations laid down in this
Article;’
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Or. en
Justification
Patients continue to receive essential information on implanted devices, even where the
implant is considered well-established technology.
Amendment 43
Proposal for a regulation
Article 1 – paragraph 1 – point 19 a (new)
Regulation (EU) 2017/745
Article 27 – paragraph 1 – point a i
Present text Amendment
(19a) Article 27(1), point (a)(i), is
replaced by the following:
(i) a UDI device identifier (‘UDI-DI’)
specific to a manufacturer and a device,
providing access to the information laid
down in Part B of Annex VI;
"(i) a UDI device identifier (‘UDI-DI’)
specific to a manufacturer and a device,
either originally issued by the
manufacturer or that has been lawfully
made available to the manufacturer,
providing access to the information laid
down in Part B of Annex VI;"
Or. en
(2017/745)
Amendment 44
Proposal for a regulation
Article 1 – paragraph 1 – point 22 – point a
Regulation (EU) 2017/745
Article 30 – paragraph 1
Text proposed by the Commission Amendment
1. The Commission, after consulting
the MDCG, shall set up and manage an
electronic system to create the single
registration number referred to in Article
31(2) and to collate and process
information that is necessary and
proportionate to identify the manufacturer
and, where applicable, the authorised
1. The Commission, after consulting
the MDCG, shall set up and manage an
electronic system to create the single
registration number referred to in Article
31(2) and to collate and process
information that is necessary and
proportionate to identify the manufacturer
and, where applicable, the authorised
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representative, the importer and the person
referred to in Article 22(1). The details
regarding the information to be provided to
that electronic system by the economic
operators are laid down in Part A, Section
1, of Annex VI.;
representative, the importer and the person
referred to in Article 22(1). The details
regarding the information to be provided to
that electronic system by the economic
operators are laid down in Part A, Section
1, of Annex VI. In addition to the
information referred to in Part A of
Annex VI, manufacturers and authorized
representatives shall provide the
information required to determine the size
in accordance with 2003/361/EC.
Or. en
Justification
Allows the SME status of manufacturers to be recorded directly in Eudamed. This creates a
reliable basis for SME-related measures, such as fee reductions, and reduces the need for
separate reporting.
Amendment 45
Proposal for a regulation
Article 1 – paragraph 1 – point 24 – point a
Regulation (EU) 2017/745
Article 32 – paragraph 1 – subparagraph 2
Text proposed by the Commission Amendment
The summary of safety and clinical
performance shall be written in a way that
is clear to the intended user and shall be
made available to the public via Eudamed.
The summary of safety and clinical
performance shall be written in a way that
is clear to the intended user and, if
applicable, to the patient, and shall be
made available to the public via Eudamed.
Or. en
Amendment 46
Proposal for a regulation
Article 1 – paragraph 1 – point 24 – point b
Regulation (EU) 2017/745
Article 32 – paragraph 2 – point h
Text proposed by the Commission Amendment
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(b) in paragraph 2, point (h) is
replaced by the following:
deleted
‘(h) information on any residual risks or
undesirable effects, and any warnings and
precautions.;’
Or. en
Justification
It ensures that all important information regarding health and safety is transmitted.
Amendment 47
Proposal for a regulation
Article 1 – paragraph 1 – point 30
Regulation (EU) 2017/745
Article 39 – paragraph 6
Text proposed by the Commission Amendment
Unless the application is rejected, the joint
assessment team shall plan and conduct an
on-site assessment of the applicant
conformity assessment body and, where
relevant, of any subsidiary or
subcontractor, located inside or outside the
Union, that is to be involved in the
conformity assessment process.
Unless the application is rejected, the joint
assessment team shall plan and conduct an
on-site assessment of the applicant
conformity assessment body and, where
relevant, of any subsidiary or
subcontractor, located inside or outside the
Union, that is to be involved in the
conformity assessment process within 90
days.
Or. en
Justification
It improves the predictability and efficiency of the designation procedure by introducing a
clear timeframe for the conduct of on-site assessments.
Amendment 48
Proposal for a regulation
Article 1 – paragraph 1 – point 30
Regulation (EU) 2017/745
Article 39 – paragraph 11
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Text proposed by the Commission Amendment
The joint assessment team shall submit its
final assessment report to the MCDG
without undue delay.
The joint assessment team shall submit its
final assessment report to the MCDG
within 15 days.
Or. en
Justification
It improves the predictability and efficiency of the designation procedure by introducing a
clear timeframe for the conduct joint assessments.
Amendment 49
Proposal for a regulation
Article 1 – paragraph 1 – point 30
Regulation (EU) 2017/745
Article 39 – paragraph 11
Text proposed by the Commission Amendment
Based on the findings of the final
assessment report, the authority responsible
for notified bodies shall submit to the
MDCG a draft decision on the designation
of the notified body or reject the
application.
Based on the findings of the final
assessment report, the authority responsible
for notified bodies shall submit to the
MDCG a draft decision on the designation
of the notified body or reject the
application within 15 days.
Or. en
Justification
It improves the predictability and efficiency of the designation procedure by introducing a
clear timeframe for the conduct of assessments reports.
Amendment 50
Proposal for a regulation
Article 1 – paragraph 1 – point 30
Regulation (EU) 2017/745
Article 39 – paragraph 13
Text proposed by the Commission Amendment
13. Where the authority responsible for
notified bodies does not agree with the
13. Where the authority responsible for
notified bodies does not agree with the
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recommendation of the MDCG, it shall
submit to the MDCG a duly justified
request to reconsider its recommendation.
Within 30 days of receipt of that request,
the MDCG shall either confirm its
recommendation or issue a new
recommendation.
recommendation of the MDCG, it shall
submit to the MDCG a duly justified
request to reconsider its recommendation
within this period. Within 30 days of
receipt of that request, the MDCG shall
either confirm its recommendation or issue
a new recommendation.
Or. en
Justification
It improves the predictability and efficiency of the designation procedure by introducing a
clear timeframe for the conduct of on-site assessments.
Amendment 51
Proposal for a regulation
Article 1 – paragraph 1 – point 30
Regulation (EU) 2017/745
Article 39 – paragraph 14
Text proposed by the Commission Amendment
Within 180 days of receipt of the referral,
the Commission shall, after consulting the
MDCG, the authority responsible for
notified bodies and, where necessary, the
applicant conformity assessment body
concerned, evaluate the draft decision on
the designation and decide, by means of
implementing act, whether or not the draft
designation is justified.
Within 120 days of receipt of the referral,
the Commission shall, after consulting the
MDCG, the authority responsible for
notified bodies and, where necessary, the
applicant conformity assessment body
concerned, evaluate the draft decision on
the designation and decide, by means of
implementing act, whether or not the draft
designation is justified.
Or. en
Amendment 52
Proposal for a regulation
Article 1 – paragraph 1 – point 35 – point e
Regulation (EU) 2017/745
Article 44 – paragraph 4 a – subparagraph 1
Text proposed by the Commission Amendment
At least every two years, the annual
assessment of a notified body shall be
At least every five years, the annual
assessment of a notified body shall be
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carried out by a joint assessment team
including the authority responsible for
notified bodies and two experts from the
list referred to in Article 40(2) appointed
by the Commission in consultation with the
MDCG. At least one of those experts shall
be an expert representing the Commission.
In light of the specific circumstances of the
monitoring, the Commission may appoint a
different number of experts. The joint
assessment team shall be coordinated by
the expert representing the Commission.
carried out by a joint assessment team
including the authority responsible for
notified bodies and two experts from the
list referred to in Article 40(2) appointed
by the Commission in consultation with the
MDCG. At least one of those experts shall
be an expert representing the Commission.
In light of the specific circumstances of the
monitoring, the Commission may appoint a
different number of experts. The joint
assessment team shall be coordinated by
the expert representing the Commission. In
duly justified cases and where necessary,
the joint assessment team may be involved
more frequently.
Or. en
Justification
It reduces unnecessary administrative burden by requiring full Joint Assessment Team
involvement every five years instead of every two years. More frequent involvement remains
possible where there are specific concerns, so effective oversight is preserved.
Amendment 53
Proposal for a regulation
Article 1 – paragraph 1 – point 35 – point e
Regulation (EU) 2017/745
Article 44 – paragraph 4a – subparagraph 2
Text proposed by the Commission Amendment
If, at any stage of the process, consensus
cannot be reached within the joint
assessment team on any issue, any member
of the joint assessment team may refer the
issue to the MDCG, which shall provide its
views without undue delay and at the latest
within 60 days from the referral.
Where consensus cannot be reached within
the Joint Assessment Team, any member
may refer the matter to the MDCG, which
shall provide its views without undue delay
and no later than 60 days from referral.
Or. en
Amendment 54
Proposal for a regulation
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Article 1 – paragraph 1 – point 35 – point e
Regulation (EU) 2017/745
Article 44 – paragraph 4 b
Text proposed by the Commission Amendment
At the end of any assessment carried out
pursuant to paragraph 4 or 4a, the authority
responsible for notified bodies or the joint
assessment team, as applicable, shall
inform the notified body about any non-
compliances resulting from the assessment
and summarise their assessment.
At the end of any assessment carried out
pursuant to paragraph 4 or 4a, the authority
responsible for notified bodies or the joint
assessment team, as applicable, shall
inform the notified body about any non-
compliances resulting from the assessment
and summarise their assessment within 20
days.
Or. en
Amendment 55
Proposal for a regulation
Article 1 – paragraph 1 – point 35 – point e
Regulation (EU) 2017/745
Article 44 – paragraph 4 b
Text proposed by the Commission Amendment
The authority responsible for notified
bodies or the joint assessment team, as
applicable, shall assess whether the non-
compliances identified during the
assessment have been appropriately
addressed in the plan referred to in the
second subparagraph and, where necessary,
provide any comments on the plan to the
notified body, including requests for
further clarification and modifications. The
notified body and the authority or the joint
assessment team, as applicable, shall
endeavour to agree on a final corrective
and preventive action plan in due course.
The authority responsible for notified
bodies or the joint assessment team, as
applicable, shall assess whether the non-
compliances identified during the
assessment have been appropriately
addressed in the plan referred to in the
second subparagraph and, where necessary,
provide any comments on the plan to the
notified body, including requests for
further clarification and modifications
within 30 days. The notified body and the
authority or the joint assessment team, as
applicable, shall endeavour to agree on a
final corrective and preventive action plan
in due course.
Or. en
Amendment 56
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Proposal for a regulation
Article 1 – paragraph 1 – point 35 – point e
Regulation (EU) 2017/745
Article 44 – paragraph 4 c
Text proposed by the Commission Amendment
After receipt of the final corrective and
preventive action plan, or where the
authority responsible for notified bodies or
the joint assessment team, as applicable,
have not identified non-compliances or
conclude that no agreement on a final plan
has been reached, the authority or the joint
assessment team, as applicable, shall draw
up their final monitoring report which shall
include the result of the assessment and,
where applicable, conclusions regarding
the corrective and preventive action plan
and, where applicable, any
recommendations regarding the notified
body’s designation.
After receipt of the final corrective and
preventive action plan, or where the
authority responsible for notified bodies or
the joint assessment team, as applicable,
have not identified non-compliances or
conclude that no agreement on a final plan
has been reached, the authority or the joint
assessment team, as applicable, shall draw
up their final monitoring report within 30
days which shall include the result of the
assessment and, where applicable,
conclusions regarding the corrective and
preventive action plan and, where
applicable, any recommendations
regarding the notified body’s designation.
Or. en
Amendment 57
Proposal for a regulation
Article 1 – paragraph 1 – point 35 – point e
Regulation (EU) 2017/745
Article 44 – paragraph 4 c
Text proposed by the Commission Amendment
The authority responsible for notified
bodies or the joint assessment team, as
applicable, shall submit their final
monitoring report to the MDCG without
undue delay.
The authority responsible for notified
bodies or the joint assessment team, as
applicable, shall submit their final
monitoring report to the MDCG within 10
days.
Or. en
Amendment 58
Proposal for a regulation
Article 1 – paragraph 1 – point 40
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Regulation (EU) 2017/745
Article 49 – paragraph 3
Text proposed by the Commission Amendment
3. All bodies notified under this
Regulation and under Regulation (EU)
2017/746 shall actively participate in the
work of the coordination group to support
the implementation of this Regulation and
of Regulation (EU) 2017/746 by sharing
experience and developing common
templates and technical guidance to
facilitate harmonisation and common
approaches regarding conformity
assessment activities. They shall cooperate
with each other, with the Commission,
with the relevant authorities of the Member
States, with expert panels and, where
applicable, expert laboratories or European
Union reference laboratories to ensure a
harmonised application of the requirements
set out in this Regulation and in Regulation
(EU) 2017/746.
3. All bodies notified under this
Regulation and under Regulation (EU)
2017/746 shall actively participate in the
work of the coordination group to support
the implementation of this Regulation and
of Regulation (EU) 2017/746 by sharing
experience and developing common
templates and technical guidance to
facilitate harmonisation and common
approaches regarding conformity
assessment activities. Notified bodies shall
implement the outcome of the
coordination in their practical work
without undue delay. They shall cooperate
with each other, with the Commission,
with the relevant authorities of the Member
States, with expert panels and, where
applicable, expert laboratories or European
Union reference laboratories to ensure a
harmonised application of the requirements
set out in this Regulation and in Regulation
(EU) 2017/746.
Or. en
Amendment 59
Proposal for a regulation
Article 1 – paragraph 1 – point 41 a (new)
Regulation (EU) 2017/745
Article 51 – paragraph 3 – introductory part
Present text Amendment
(41a) In Article 51(3), introductory part
is replaced by the following:
3. At the request of a Member State the
Commission shall after consulting the
MDCG, decide, by means of implementing
acts, on the following:
"3. A requester as referred in Article
51b(1), may submit a substantiated
request to the Commission, to decide, after
consulting an expert panel, referred to in
Article 106, by means of implementing
acts, on the following:"
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Or. en
(This amendment seeks to amend a provision within the existing act – Article 51(3) – that was
not referred to in the Commission proposal.)
Amendment 60
Proposal for a regulation
Article 1 – paragraph 1 – point 41 b (new)
Regulation (EU) 2017/745
Article 51 – paragraph 4
Present text Amendment
(41b) Article 51(4) is replaced by the
following:
4. The Commission may also, on its own
initiative and after consulting the MDCG,
decide, by means of implementing acts, on
the issues referred to in points (a) and (b)
of paragraph 3.
"4. The Commission may also, on its own
initiative and after consulting an expert
panel, referred to in Article 106, decide,
by means of implementing acts, on the
issues referred to in points (a) and (b) of
paragraph 3."
Or. en
(This amendment seeks to amend a provision within the existing act – Article 51(4) – that was
not referred to in the Commission proposal.)
Amendment 61
Proposal for a regulation
Article 1 – paragraph 1 – point 42
Regulation (EU) 2017/745
Article 51a – paragraph 2
Text proposed by the Commission Amendment
2. Within 30 days of receipt of the
referral referred to in paragraph 1, the
competent authority shall consult the other
Member States regarding its draft
classification decision.
2. Within 30 days of receipt of the
referral, referred to in paragraph 1, the
competent authority shall consult an expert
panel, referred to in Article 106, regarding
its draft classification decision.
Or. en
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Amendment 62
Proposal for a regulation
Article 1 – paragraph 1 – point 42
Regulation (EU) 2017/745
Article 51a – paragraph 3
Text proposed by the Commission Amendment
3. Where, within 30 days of receipt of
the consultation referred to in the
paragraph 2, no substantiated
disagreement has been raised by a
Member State, the competent authority
shall adopt its decision within 90 days of
receipt of the referral referred to in
paragraph 1.
3. The expert panel, referred to in
Article 106, shall consult the notified body
and the manufacturer concerned before
issuing its opinion.
Or. en
Amendment 63
Proposal for a regulation
Article 1 – paragraph 1 – point 42
Regulation (EU) 2017/745
Article 51a – paragraph 4
Text proposed by the Commission Amendment
4. Where, within 30 days of receipt of
the consultation referred to in paragraph
2, a substantiated disagreement has been
raised by a Member State regarding the
draft classification decision, the matter
shall be referred to an expert panel as
referred to in Article 106. That expert
panel shall deliver an opinion on the
classification of the device within 30 days.
The competent authority may ask the
expert panel for clarifications on its
opinion.
4. The expert panel, referred to in
Article 106, shall deliver an opinion on the
classification of the device within 30 days.
The competent authority may ask the
expert panel for clarifications on its
opinion.
Or. en
Amendment 64
Proposal for a regulation
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Article 1 – paragraph 1 – point 42
Regulation (EU) 2017/745
Article 51a – paragraph 5
Text proposed by the Commission Amendment
5. Within 30 days of receipt of the
expert panel opinion, or any requested
clarification, referred to in paragraph 4,
the competent authority shall adopt its
decision, giving utmost consideration to
the expert panel opinion. It shall notify the
other Member States and the Commission
of its decision without undue delay.
5. Within 30 days of receipt of the
expert panel opinion, or any requested
clarification, the competent authority shall
adopt its decision. The competent
authority shall follow the expert panel
opinion, unless it provides duly justified
reasons for departing from it. It shall
notify the other Member States and the
Commission of its decision without undue
delay.
Or. en
Amendment 65
Proposal for a regulation
Article 1 – paragraph 1 – point 42
Regulation (EU) 2017/745
Article 51a – paragraph 5 a (new)
Text proposed by the Commission Amendment
5a. Any opinion of an expert panel in
relation to classification, shall be made
publicly available, without disclosing any
confidential information as referred to in
Article 109.
Or. en
Amendment 66
Proposal for a regulation
Article 1 – paragraph 1 – point 42
Regulation (EU) 2017/745
Article 51b – paragraph 5 b (new)
Text proposed by the Commission Amendment
5b. On the basis of an expert panel
opinion issued under this Article, the
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Commission may, on its own initiative or
following a substantiated request, adopt
an implementing act to clarify the
classification of a specific product under
Annex VIII. That implementing act shall
be adopted in accordance with the
examination procedure referred to in
Article 114(3).
Or. en
Amendment 67
Proposal for a regulation
Article 1 – paragraph 1 – point 42
Regulation (EU) 2017/745
Article 51b – paragraph 4 a (new)
Text proposed by the Commission Amendment
4a. Expert panel opinions issued under
this Article shall be made publicly
available, without disclosing confidential
information as referred to in Article 109.
Or. en
Justification
This Article strengthens the role of expert panels in complex classification questions by
allowing substantiated requests for scientific and technical opinions. It improves consistency
and legal certainty while ensuring that final classification decisions remain within the
established regulatory framework.
Amendment 68
Proposal for a regulation
Article 1 – paragraph 1 – point 42
Regulation (EU) 2017/745
Article 51b – title
Text proposed by the Commission Amendment
Challenges to the classification of CE
marked devices
Challenges to the classification
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Or. en
Amendment 69
Proposal for a regulation
Article 1 – paragraph 1 – point 42
Regulation (EU) 2017/745
Article 51b – paragraph 1
Text proposed by the Commission Amendment
1. Where a competent authority, after
having performed an evaluation in
accordance with Article 94, considers that
a device that is CE marked in accordance
with Article 20, is not classified in
accordance with Annex VIII, it shall
consult the other Member States
regarding its envisaged measure on the
classification of the device.
1. In cases of uncertainty concerning
the classification of a specific product
under Annex VIII, a competent authority,
notified body, manufacturer, product
developer or the Commission may submit
a substantiated request for an opinion
from an expert panel referred to in Article
106.
Or. en
Amendment 70
Proposal for a regulation
Article 1 – paragraph 1 – point 42
Regulation (EU) 2017/745
Article 51b – paragraph 2
Text proposed by the Commission Amendment
2. Where, within 30 days of receipt of
the consultation referred to in paragraph
1, no substantiated disagreement is raised
by a Member State, the competent
authority may adopt the measure on the
classification of the device in question and
shall notify the other Member States and
the Commission of its decision giving the
reasons for the decision.
2. Where the request concerns a
device that is CE marked in accordance
with Article 20, the expert panel shall,
before issuing its opinion, consult the
competent authority of the Member State
in which the manufacturer has its
registered place of business, the
manufacturer and, where applicable, the
notified body concerned.
Or. en
Amendment 71
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Proposal for a regulation
Article 1 – paragraph 1 – point 42
Regulation (EU) 2017/745
Article 51b – paragraph 3
Text proposed by the Commission Amendment
3. Where, within 30 days of receipt of
the consultation referred to in paragraph
1, a substantiated disagreement is raised
by a Member State regarding the
envisaged measure on the classification,
the matter shall be referred to an expert
panel referred to in Article 106, which
shall deliver an opinion on the
classification of the device within 30 days.
The competent authority may ask the
expert panel for clarifications on its
opinion.
3. The expert panel shall provide its
opinion within 90 days from receipt of a
complete request. The opinion shall
include the reasons for the proposed
classification.
Or. en
Amendment 72
Proposal for a regulation
Article 1 – paragraph 1 – point 42
Regulation (EU) 2017/745
Article 51b – paragraph 4
Text proposed by the Commission Amendment
4. The competent authority shall give
utmost consideration to the expert panel
opinion. Where the competent authority
adopts a measure on the classification, it
shall notify the other Member States and
the Commission of its measure without
undue delay.;
4. The requester and the competent
authority concerned shall duly take the
expert panel opinion into account in any
subsequent classification decision or
measure.
Or. en
Amendment 73
Proposal for a regulation
Article 1 – paragraph 1 – point 43 – point e a (new)
Regulation (EU) 2017/745
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Article 52 – paragraph 7 – subparagraph 2 (new)
Text proposed by the Commission Amendment
(ea) In Article 52(7), the following
subparagraph 2 is added:
In implementing this Article, Member
States shall not require prior approval or
notification of advertising for devices.
Member States may take appropriate ex-
post measures, including prohibiting or
sanctioning advertising that does not
comply with this Article, in accordance
with Union and national law.
Or. en
Justification
It prevents divergent national prior authorisation for advertising of medical devices, which
could create barriers in the internal market but preserves the ability of Member States to act
against misleading or non-compliant advertising after publication.
Amendment 74
Proposal for a regulation
Article 1 – paragraph 1 – point 43 – point g
Regulation (EU) 2017/745
Article 52 – paragraph 14 – point b
Text proposed by the Commission Amendment
(b) the modalities of unannounced on-
site audits and sample tests to be
conducted by notified bodies in accordance
with Section 3.4 of Annex IX, taking into
account the risk-class and the type of
device,
(b) the modalities of surveillance
audits in accordance with Section 3.3 of
Annex IX, and of unannounced on-site
audits and sample tests in accordance with
Section 3.4 of Annex IX, taking into
account the manufacturer’s compliance
history, the risk class and the type of
device;
Or. en
Justification
Ensures that surveillance audits, unannounced audits and sample tests are organised in a
risk-based and proportionate way. Taking account of the manufacturer’s compliance history
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allows notified bodies to reduce burden where performance is stable while maintaining
stronger oversight where specific risks or past compliance issues exist.
Amendment 75
Proposal for a regulation
Article 1 – paragraph 1 – point 44
Regulation (EU) 2017/745
Article 52a – paragraph 1
Text proposed by the Commission Amendment
1. For the conformity assessment of
breakthrough devices and orphan devices,
for which a notified body is involved in the
conformity assessment, the procedures laid
down in Article 52 shall apply subject to
the specific arrangements set out in this
Article.
1. For the conformity assessment of
breakthrough devices, orphan devices and
niche devices, for which a notified body is
involved in the conformity assessment, the
procedures laid down in Article 52 shall
apply subject to the specific arrangements
set out in this Article.
Or. en
Amendment 76
Proposal for a regulation
Article 1 – paragraph 1 – point 44
Regulation (EU) 2017/745
Article 52a – paragraph 2
Text proposed by the Commission Amendment
(ii) fulfilling an unmet medical need
where there is an absence or insufficiency
of available alternative options for that
purpose.
(ii) fulfilling an unmet medical need as
referred to in Article 83(1) of the Directive
2001/83/EC.
Or. en
Amendment 77
Proposal for a regulation
Article 1 – paragraph 1 – point 44
Regulation (EU) 2017/745
Article 52a – paragraph 5
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Text proposed by the Commission Amendment
5. Where the opinion of the expert
panel confirms the fulfilment of the criteria
set out in paragraph 2 or 3 of this Article,
the manufacturer of a breakthrough device
or of an orphan device, as applicable, may
request advice from the expert panels
referred to in Article 106 regarding its
clinical development strategy and
appropriate preclinical or clinical data for
the clinical evaluation of the device.
5. Where the opinion of the expert
panel confirms the fulfilment of the criteria
set out in paragraph 2 or 3 of this Article,
the manufacturer of a breakthrough device,
orphan device or niche device, and the
sponsor of the relevant clinical trials, as
applicable, may request advice from the
expert panels referred to in Article 106
regarding its clinical development strategy
and appropriate preclinical or clinical data
for the clinical evaluation of the device.
Or. en
Amendment 78
Proposal for a regulation
Article 1 – paragraph 1 – point 44
Regulation (EU) 2017/745
Article 52a – paragraph 6 – subparagraph 1
Text proposed by the Commission Amendment
For a confirmed breakthrough device or an
orphan device, as applicable, the notified
body involved in the conformity
assessment procedure set out in Article 52
shall prioritise the conformity assessment
of that device and apply, where
appropriate, a rolling review with a view to
reduce assessment timelines.
For a confirmed breakthrough device,
orphan device or niche device, as
applicable, the notified body involved in
the conformity assessment procedure set
out in Article 52 shall prioritise the
conformity assessment of that device,
including relevant subsequent changes,
and apply, where appropriate, a rolling
review with a view to reducing assessment
timelines.
Or. en
Amendment 79
Proposal for a regulation
Article 1 – paragraph 1 – point 44
Regulation (EU) 2017/745
Article 52a – paragraph 6 – suparagraph 2
Text proposed by the Commission Amendment
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The notified body shall give due
consideration to an opinion or advice
provided by the expert panels in
accordance with paragraph 4 or 5 and,
where it does not follow such opinion or
advice, it shall provide duly justified
reasons. The notified body may ask the
expert panel to clarify the opinion it has
provided.
The notified body shall be able to
participate in the provision of joint advice
set out in paragraph 5 and give due
consideration to an opinion or advice
provided by the expert panels in
accordance with paragraph 4 or 5 and,
where it does not follow such opinion or
advice, it shall provide duly justified
reasons. The notified body may ask the
expert panel to clarify the opinion it has
provided.
Or. en
Amendment 80
Proposal for a regulation
Article 1 – paragraph 1 – point 44
Regulation (EU) 2017/745
Article 52a – paragraph 6 a (new)
Text proposed by the Commission Amendment
6a. For companion diagnostics and
drug-device products linked to a
medicinal product subject to an
accelerated assessment or other expedited
regulatory pathway, the notified body
shall, where appropriate, prioritise the
conformity assessment and apply a rolling
review with a view to aligning the
assessment timeline with that of the
corresponding medicinal product.
Or. en
Amendment 81
Proposal for a regulation
Article 1 – paragraph 1 – point 44
Regulation (EU) 2017/745
Article 52a – paragraph 7 – introductory part
Text proposed by the Commission Amendment
The notified body shall issue a certificate The notified body shall issue a certificate
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pursuant to Article 56 where the pre-
market clinical evidence, even if based on
limited clinical data, is deemed adequate,
provided that either of the following
conditions is fulfilled:
pursuant to Article 56 where the pre-
market clinical evidence, even if based on
limited clinical data, is deemed adequate,
provided that the following conditions are
fulfilled:
Or. en
Amendment 82
Proposal for a regulation
Article 1 – paragraph 1 – point 44
Regulation (EU) 2017/745
Article 52a – paragraph 7 – subparagraph 2
Text proposed by the Commission Amendment
Where appropriate, the notified body shall
limit the validity of the certificate and
specify any conditions for or limitations to
the certificate’s validity in accordance with
Article 56, such as a requirement for the
manufacturer to conduct specific post-
market clinical follow-up activities within
a specified period of time.
Where appropriate, the validity of the
initial certificate shall be limited to a
maximum of five years. The notified body
shall specify any conditions for the
certificate’s validity in accordance with
Article 56, including, where necessary,
specific post-market clinical follow-up
activities within a defined timeframe. The
certificate may be renewed where the
manufacturer has demonstrated
compliance with the applicable post-
market clinical follow-up requirements.
Or. en
Justification
It ensures that earlier market access based on limited clinical data is balanced by clear
safeguards. A time-limited initial certificate and binding post-market clinical follow-up
requirements ensure that additional evidence is generated after market entry.
Amendment 83
Proposal for a regulation
Article 1 – paragraph 1 – point 44
Regulation (EU) 2017/745
Article 52a – paragraph 7 – subparagraph 2 a (new)
Text proposed by the Commission Amendment
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Only expert panels and notified bodies
with appropriate clinical, scientific,
technical and regulatory expertise shall be
involved in the evaluation of
breakthrough devices, orphan devices or
niche devices.
Or. en
Amendment 84
Proposal for a regulation
Article 1 – paragraph 1 – point 44
Regulation (EU) 2017/745
Article 52a – paragraph 9
Text proposed by the Commission Amendment
9. The Commission may, by means of
implementing acts, lay down further details
of the procedure for the conformity
assessment of breakthrough devices or
orphan devices set out in this Article.
Those implementing acts shall be adopted
in accordance with the examination
procedure referred to in Article 114(3).
9. The Commission may, by means of
implementing acts, lay down further details
of the procedure for the conformity
assessment of breakthrough devices,
orphan devices or niche devices set out in
this Article, including mechanisms for
prioritisation and rolling review by
notified bodies. Those implementing acts
shall be adopted in accordance with the
examination procedure referred to in
Article 114(3).
Or. en
Amendment 85
Proposal for a regulation
Article 1 – paragraph 1 – point 46
Regulation (EU) 2017/745
Article 54 – paragraph 1 – subparagraph 1
Text proposed by the Commission Amendment
In addition to the procedures applicable
pursuant to Article 52, a notified body shall
follow the procedure regarding clinical
evaluation consultation as specified in
Section 5.1 of Annex IX or as referred to in
In addition to the procedures applicable
pursuant to Article 52, a notified body shall
follow the procedure regarding clinical
evaluation consultation as specified in
Section 5.1 of Annex IX or as referred to in
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Section 6 of Annex X, as applicable, when
performing a conformity assessment of
class III implantable devices, other than
custom-made devices.
Section 6 of Annex X, as applicable, when
performing a conformity assessment of
class III implantable devices, other than
custom-made devices, and of class IIb and
III breakthrough devices and orphan
devices and niche devices as referred to in
Article 52a of this Regulation.
Or. en
Justification
It ensures that devices with higher risk profiles remain subject to independent expert scrutiny
of their clinical evidence, particularly where market access may be based on limited clinical
data.
Amendment 86
Proposal for a regulation
Article 1 – paragraph 1 – point 47 – point b
Regulation (EU) 2017/745
Article 56 – paragraph 2a
Text proposed by the Commission Amendment
2a. During the validity of the
certificate, the notified body shall carry out
appropriate surveillance activities,
including periodic reviews taking into
consideration developments of the state of
the art. Those reviews shall be
proportionate to the risk class of the
device.;
2a. During the validity of the
certificate, the notified body shall carry out
surveillance activities in accordance with
the applicable Annex for the conformity
assessment procedure under which the
certificate was issued. Such surveillance
activities shall be proportionate to the risk
class of the device and shall not amount to
a full reassessment equivalent in scope to
the conformity assessment performed for
the issuance of the certificate.
Or. en
Justification
Surveillance during the validity of the certificate should remain proportionate and risk-based.
Amendment 87
Proposal for a regulation
Article 1 – paragraph 1 – point 49 – point a
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Regulation (EU) 2017/745
Article 59 – paragraph 1
Text proposed by the Commission Amendment
1. By way of derogation from Article
52 and on a duly justified request, any
competent authority may authorise for a
limited period of time the placing on the
market or putting into service within the
territory of the Member State concerned of
a specific device for which the applicable
conformity assessment procedures have not
been carried out, provided that the use of
that device is in the interest of public
health, patient safety or patient health.;
1. By way of derogation from Article
52 and on a duly justified request, any
competent authority may authorise for a
period not exceeding 24 months the
placing on the market or putting into
service within the territory of the Member
State concerned of a specific device for
which the applicable conformity
assessment procedures have not been
carried out, provided that the use of that
device is in the interest of public health,
patient safety or patient health.;
Or. en
Amendment 88
Proposal for a regulation
Article 1 – paragraph 1 – point 49 – point b
Regulation (EU) 2017/745
Article 59 – paragraph 1 a
Text proposed by the Commission Amendment
1a. By way of derogation from Article
6(2) and on a duly justified request, any
competent authority may authorise for a
limited period of time the provision of a
diagnostic or therapeutic service referred to
in that Article to a natural or legal person
established within the territory of the
Member State concerned using a device for
which the applicable conformity
assessment procedures set out in this
Regulation have not been carried out,
provided that the provision of that service
is in the interest of public health, patient
safety or patient health.;
1a. By way of derogation from Article
6(2) and on a duly justified request, any
competent authority may authorise for a
period not exceeding 24 months the
provision of a diagnostic or therapeutic
service referred to in that Article to a
natural or legal person established within
the territory of the Member State
concerned using a device for which the
applicable conformity assessment
procedures set out in this Regulation have
not been carried out, provided that the
provision of that service is in the interest of
public health, patient safety or patient
health.;
Or. en
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Amendment 89
Proposal for a regulation
Article 1 – paragraph 1 – point 49 – point d
Regulation (EU) 2017/745
Article 59 – paragraph 3
Text proposed by the Commission Amendment
3. Where a request pursuant to
paragraph 1 or paragraph 1a has been
submitted to competent authorities in more
than one Member State and based on an
opinion of an expert panel referred to in
Article 106, the Commission, in
exceptional cases relating to public health,
patient safety or patient health, may, by
means of implementing acts, extend for a
limited period of time the validity of an
authorisation granted by a Member State in
accordance with paragraph 1 or paragraph
1a to the territory of the Union, or provide
an authorisation referred to in paragraph 1
or paragraph 1a for the territory of the
Union. The Commission may set out the
conditions under which the device may be
placed on the market or put into service, or
under which the diagnostic or therapeutic
service may be provided. Those
implementing acts shall be adopted in
accordance with the examination procedure
referred to in Article 114(3).;
3. Where a request pursuant to
paragraph 1 or paragraph 1a has been
submitted to competent authorities in more
than one Member State and based on an
opinion of an expert panel referred to in
Article 106, the Commission, in
exceptional cases relating to public health,
patient safety or patient health, may, by
means of implementing acts, extend for a
period not exceeding 24 months the
validity of an authorisation granted by a
Member State in accordance with
paragraph 1 or paragraph 1a to the territory
of the Union, or provide an authorisation
referred to in paragraph 1 or paragraph 1a
for the territory of the Union. The
Commission may set out the conditions
under which the device may be placed on
the market or put into service, or under
which the diagnostic or therapeutic service
may be provided. Those implementing acts
shall be adopted in accordance with the
examination procedure referred to in
Article 114(3).;
Or. en
Amendment 90
Proposal for a regulation
Article 1 – paragraph 1 – point 50
Regulation (EU) 2017/745
Article 59b – paragraph 7 a (new)
Text proposed by the Commission Amendment
7a. Participation in a regulatory sandbox
shall not mean that the requirements
regarding conformity assessment under
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this Regulation are deemed to have been
fulfilled.
Or. en
Amendment 91
Proposal for a regulation
Article 1 – paragraph 1 – point 50
Regulation (EU) 2017/745
Article 59c – paragraph 5 a (new)
Text proposed by the Commission Amendment
5a. Participation in a regulatory sandbox
shall not mean that the requirements
regarding conformity assessment under
this Regulation are deemed to have been
fulfilled.
Or. en
Amendment 92
Proposal for a regulation
Article 1 – paragraph 1 – point 52 – point c
Regulation (EU) 2017/745
Article 61 – paragraph 5
Text proposed by the Commission Amendment
5. A manufacturer of a device
demonstrated to be equivalent to an already
marketed device not manufactured by it,
may also rely on paragraph 4 in order not
to perform a clinical investigation provided
that the original clinical evaluation has
been performed in compliance with the
requirements of this Regulation and the
manufacturer provides clear evidence
thereof to the notified body.;
5. A manufacturer of a device,
different from a class III implantable,
demonstrated to be equivalent to an already
marketed device not manufactured by it,
may also rely on paragraph 4 in order not
to perform a clinical investigation provided
that the original clinical evaluation,
including clinical data from a clinical
investigation of the equivalent device, has
been performed in compliance with the
requirements of this Regulation and the
manufacturer provides clear evidence
thereof to the notified body.
Or. en
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Justification
Introduces a risk-based approach to the use of equivalence. Ensures that reliance on
equivalence is only possible where the equivalent device is supported by clinical data
generated in accordance with MDR requirements. This prevents outdated or insufficiently
evidenced devices from being used as benchmarks for new products.
Amendment 93
Proposal for a regulation
Article 1 – paragraph 1 – point 52 – point f
Regulation (EU) 2017/745
Article 61 – paragraph 11
Text proposed by the Commission Amendment
11. The clinical evaluation, its
documentation and, where applicable and
needed, the summary of safety and
performance referred to in Article 32 shall
be updated throughout the life cycle of the
device concerned with data and findings
obtained from the implementation of the
manufacturer's PMCF plan in accordance
with Part B of Annex XIV and the post-
market surveillance plan referred to in
Article 84, whenever those data and
findings obtained from PMCF provide
information relevant for the confirmation
of safety and performance of the device.
11. The clinical evaluation, its
documentation and, where applicable and
needed, the summary of safety and
performance referred to in Article 32 shall
be updated throughout the life cycle of the
device concerned with data and findings
obtained from the implementation of the
manufacturer's PMCF plan in accordance
with Part B of Annex XIV and the post-
market surveillance plan referred to in
Article 84, whenever those data and
findings are relevant for the confirmation
of safety and performance of the device or
demonstrate a significant change in the
benefit-risk determination.
Or. en
Justification
Clarifies when clinical evaluation documentation must be updated.
Amendment 94
Proposal for a regulation
Article 1 – paragraph 1 – point 61 – point c a (new)
Regulation (EU) 2017/745
Article 78 – paragraph 14
Present text Amendment
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(ca) paragraph 14 is replaced by the
following:
14. The procedure set out in this Article
shall, until 27 May 2027, be applied only
by those of the Member States in which the
clinical investigation is to be conducted
which have agreed to apply it. After 27
May 2027, all Member States shall be
required to apply that procedure.
"14. The procedure set out in this Article
shall, until 27 May 2027, be applied only
by those of the Member States in which the
clinical investigation is to be conducted
which have agreed to apply it. All Member
States shall be required to apply the
procedure set out in this Article from the
date corresponding to 2 years from the
date of publication of the notice referred
to in Article 34(3), informing that the
electronic system referred to in Article
33(2), point (e), is functional and meets
the functional specifications drawn up
pursuant to Article 34(1)."
Or. en
(This amendment seeks to amend a provision within the existing act – Article 78(14) – that
was not referred to in the Commission proposal.)
Justification
The reduction of the time period and removal of the application phase will reduce
administrative burden and improve regulatory certainty.
Amendment 95
Proposal for a regulation
Article 1 – paragraph 1 – point 67 – point a – point ii
Regulation (EU) 2017/745
Article 86 – paragraph 1 – subparagraph 1 – first sentence
Text proposed by the Commission Amendment
Manufacturers of class IIb and class III
devices shall update the PSUR in the first
year after the certificate is issued and every
two years thereafter or when there is a
significant change in the benefit-risk
determination or in the acceptability of
undesirable side-effects. The PSUR shall
be part of the technical documentation as
specified in Annex III.
Manufacturers of implantable class IIb
devices and class III devices shall update
the PSUR in the first year after the
certificate is issued and every two years
thereafter, and whenever there is a
significant change in the benefit-risk
determination or in the acceptability of
undesirable side-effects. The PSUR shall
be part of the technical documentation as
specified in Annex III.
Or. en
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Amendment 96
Proposal for a regulation
Article 1 – paragraph 1 – point 67 – point a – point ii
Regulation (EU) 2017/745
Article 86 – paragraph 1 – subparagraph 3
Text proposed by the Commission Amendment
Manufacturers of class IIa devices shall
update the PSUR when necessary. The
PSURs shall be part of the technical
documentation specified in Annex III. ;
Manufacturers of class IIa devices and
non-implantable class IIb devices shall
update the PSUR at least once in the first
two years after the certificate is issued and
when necessary. The PSUR shall be part of
the technical documentation specified in
Annex III.
Or. en
Amendment 97
Proposal for a regulation
Article 1 – paragraph 1 – point 86
Regulation (EU) 2017/745
Article 106 – paragraph 2 – subparagraph 1
Text proposed by the Commission Amendment
Expert panels shall consist of experts with
proven up-to-date clinical, scientific,
technical or regulatory expertise in the
field of medical devices or in vitro
diagnostic medical devices reflecting the
diversity of scientific and clinical
approaches in the Union.
Expert panels shall consist of experts with
proven up-to-date clinical, scientific,
technical or regulatory expertise, including
experts from notified bodies, in the field of
medical devices or in vitro diagnostic
medical devices reflecting the diversity of
scientific and clinical approaches in the
Union.
Or. en
Justification
It strengthens early coordination between expert panels and notified bodies, thereby
improving regulatory predictability and reducing the risk of delays in the development of
medical devices and in vitro diagnostic medical devices.
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Amendment 98
Proposal for a regulation
Article 1 – paragraph 1 – point 86
Regulation (EU) 2017/745
Article 106 – paragraph 4
Text proposed by the Commission Amendment
4. Expert panels shall take into
account relevant information provided by
stakeholders including patients'
organisations and healthcare professionals’
associations.
4. Expert panels shall take into
account relevant information provided by
stakeholders including patients'
organisations, healthcare professionals’
associations and industry associations.
Or. en
Justification
It ensures that expert panels have access to all relevant stakeholder input in order to support
comprehensive and well-informed assessments.
Amendment 99
Proposal for a regulation
Article 1 – paragraph 1 – point 95
Regulation (EU) 2017/745
Article 120 – paragraph 14 – subparagraph 1 – introductory part
Text proposed by the Commission Amendment
By way of derogation from Article 5 and
from paragraphs 3 to 3e of this Article, a
device as referred to in paragraph 3a or 3b
of this Article that meets the criteria for an
orphan device as referred to in Article
52a(3) may be placed on the market or put
into service after the dates referred to in
paragraphs 3a and 3b of this Article if the
following conditions are met:
By way of derogation from Article 5 and
from paragraphs 3 to 3e of this Article, a
device as referred to in paragraph 3a or 3b
of this Article that meets the criteria for an
orphan device or niche device as referred
to in Article 52a(3) or a niche device may
be placed on the market or put into service
after the dates referred to in paragraphs 3a
and 3b of this Article if the following
conditions are met:
Or. en
Justification
It ensures that the derogation also covers niche devices, thereby safeguarding the continued
availability of specialised medical devices for limited patient populations.
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Amendment 100
Proposal for a regulation
Article 2 – paragraph 1 – point 5 – point a – point i – point 2
Regulation (EU) 2017/746
Article 5 – paragraph 5 – point c
Text proposed by the Commission Amendment
(c) the laboratory of the health
institution is compliant with standard EN
ISO 15189 or, where applicable, national
provisions for quality and competence in
medical laboratories, including national
provisions regarding accreditation;;
(c) the laboratory of the health
institution is compliant with standard EN
ISO 15189 or where applicable national
provisions, including national provisions
regarding accreditation or an equivalent
internationally recognised standard.
Laboratories established outside the
Union shall be accredited to EN ISO
15189 or an equivalent internationally
recognised standard by a recognised
national accreditation body or equivalent
authority.
Or. en
Justification
It ensures an equivalent level of quality and competence for laboratories, including those
located outside the Union, by recognising internationally accepted accreditation standards
and maintaining consistent safety and performance requirements.
Amendment 101
Proposal for a regulation
Article 2 – paragraph 1 – point 5 – point a – point iii
Regulation (EU) 2017/746
Article 5 – paragraph 5 – subparagraph 3
Text proposed by the Commission Amendment
This paragraph shall also apply to devices
manufactured and used within a laboratory
that is established in the Union and
provides consistent, state of the art testing
services for clinical research, provided
those devices are intended exclusively for
use in the framework of a clinical trial
subject to Regulation (EU) No 536/2014 of
This paragraph shall also apply to devices
manufactured and used within a laboratory
that provides consistent, state of the art
testing services for clinical research,
provided those devices are intended
exclusively for use in the framework of a
clinical trial subject to Regulation (EU) No
536/2014 of the European Parliament and
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the European Parliament and of the
Council*. Where, in this paragraph,
reference is made to a health institution,
such reference shall also be understood as
reference to a laboratory referred to in the
first sentence of this subparagraph.
of the Council*. Where, in this paragraph,
reference is made to a health institution,
such reference shall also be understood as
reference to a laboratory referred to in the
first sentence of this subparagraph.
Or. en
Justification
It ensures consistent application of the provision to laboratories performing testing services
for clinical research within the framework of clinical trials under Regulation (EU) No
536/2014.
Amendment 102
Proposal for a regulation
Article 2 – paragraph 1 – point 5 – point a a (new)
Regulation (EU) 2017/746
Article 5 – paragraph 5 – introductory part
Present text Amendment
(aa) in paragraph 5, the introductory
part is replaced by the following:
5. With the exception of the relevant
general safety and performance
requirements set out in Annex I, the
requirements of this Regulation shall not
apply to devices manufactured and used
only within health institutions established
in the Union, provided that all of the
following conditions are met:
"5. With the exception of the relevant
general safety and performance
requirements set out in Annex I, the
requirements of this Regulation shall not
apply to devices manufactured and used
only within health institutions established
in the Union or located outside of the
Union that are accredited by a recognised
national accreditation body or equivalent
authority, provided that all of the
following conditions are met:"
Or. en
Justification
It ensures that the exemption from regulatory requirements also applies to equivalent health
institutions outside the Union, provided that they are subject to recognised accreditation
standards ensuring an equivalent level of quality, safety and competence.
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Amendment 103
Proposal for a regulation
Article 2 – paragraph 1 – point 7 a (new)
Regulation (EU) 2017/746
Article 7 – subparagraph 3 (new)
Text proposed by the Commission Amendment
(7a) In Article 7, the following
subparagraph 3 is added:
'Member States shall not introduce or
maintain prior authorisation or similar
ex-ante administrative requirements for
the advertising of devices. Member States
may ensure enforcement of this Article
through ex-post measures, including the
prohibition or sanctioning of advertising
practices that do not comply with this
Regulation, in accordance with Union
and national law.'
Or. en
Justification
It maintains harmonised Union rules for the advertising of medical devices by preventing
national prior authorisation or notification schemes, thereby safeguarding the free movement
of goods and legal certainty, while preserving Member States’ ability to address non-
compliant advertising through market surveillance.
Amendment 104
Proposal for a regulation
Article 2 – paragraph 1 – point 9 – point b – introductory part
Regulation (EU) 2017/746
Article 10 – Paragraph 8
Text proposed by the Commission Amendment
(b) paragraph 8 is amended as
follows:
(b) deleted
Or. en
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Justification
It preserves a clear and standardised reference framework for all components, thereby
ensuring consistency across manufacturers.
Amendment 105
Proposal for a regulation
Article 2 – paragraph 1 – point 9 – point c
Regulation (EU) 2017/746
Article 10 – paragraph 9
Text proposed by the Commission Amendment
(c) paragraph 9 is deleted; (c) paragraph (9) is replaced by the
following:
'Manufacturers may use audit results
conducted under internationally
recognised quality management schemes,
including ISO 13485 certification and the
Medical Device Single Audit Program
(MDSAP), to demonstrate compliance
with the quality management system
requirements of this Regulation.';
Or. en
Justification
It enables manufacturers to rely on audits and certifications from internationally recognised
programmes for demonstrating compliance with quality management system requirements,
thereby reducing duplication and administrative burden.
Amendment 106
Proposal for a regulation
Article 2 – paragraph 1 – point 14 – point b
Regulation (EU) 2017/746
Article 16 – paragraph 4
Text proposed by the Commission Amendment
(b) paragraph 4 is deleted; (b) At least 28 days prior to making a
relabelled or repackaged device available
on the market, distributors or importers
carrying out the activities referred to in
points (a) and (b) of paragraph 2 shall
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notify the manufacturer of their intention
to place the relabelled or repackaged
device on the market and shall, upon
request, provide a sample or mock-up of
the relabelled or repackaged device,
including translated labelling and
instructions for use.
Or. en
Justification
It ensures timely and accurate information on relabelling and repackaging activities, thereby
safeguarding supply chain integrity and enabling effective product oversight throughout the
lifecycle.
Amendment 107
Proposal for a regulation
Article 2 – paragraph 1 – point 36
Regulation (EU) 2017/746
Article 54b – paragraph 7 a (new)
Text proposed by the Commission Amendment
7a. Participation in a regulatory sandbox
shall not be considered as fulfilling the
conformity assessment requirements
under this Regulation.
Or. en
Justification
It clarifies that participation in a regulatory sandbox does not affect the applicable
conformity assessment requirements and that all devices remain subject to the same
regulatory scrutiny.
Amendment 108
Proposal for a regulation
Article 2 – paragraph 1 – point 51 a (new)
Regulation (EU) 2017/746
Article 78 – paragraph 4 a (new)
Text proposed by the Commission Amendment
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(51a) in Article 78, the following
paragraph 5 is added:
'The processing of personal data within
the post-market surveillance system,
including the secondary use of personal
data initially collected during the real-
world use of a medical device, shall be
considered as processing for scientific
research purposes within the meaning of
Article 9(2), point (j), of Regulation (EU)
2016/679. ’;
Or. en
Justification
This article clarifies that post-market surveillance activities are carried out under the
safeguards of the GDPR for scientific research purposes, therefore enabling proportionate
data use for product safety and innovation while ensuring an appropriate level of data
protection.
Amendment 109
Proposal for a regulation
Article 2 – paragraph 1 a (new)
Regulation (EU) 2017/746
Article 13 – paragraph 2
Present text Amendment
1a. Article 13(2) is replaced by the
following:
2. In order to place a device on the market,
importers shall verify that:
"'2. In order to place a device on the
market, importers shall have the evidence
that:
(a) the device has been CE marked and that
the EU declaration of conformity of the
device has been drawn up;
(a) the device has been CE marked and that
the EU declaration of conformity of the
device has been drawn up;
(b) a manufacturer is identified and that an
authorised representative in accordance
with Article 11 has been designated by the
manufacturer;
(b) a manufacturer and an authorized
representative, if applicable, are identified;
(c) the device is labelled in accordance
with this Regulation and accompanied by
the required instructions for use;
(c) the device is accomplished by physical
or digital label in accordance with this
Regulation and accompanied by the
required instructions for use;
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(d) where applicable, a UDI has been
assigned by the manufacturer in
accordance with Article 24.
(d) where applicable, a UDI has been
assigned by the manufacturer.
Where an importer considers or has reason
to believe that a device is not in conformity
with the requirements of this Regulation, it
shall not place the device on the market
until it has been brought into conformity
and shall inform the manufacturer and the
manufacturer's authorised representative.
Where the importer considers or has
reason to believe that the device presents a
serious risk or is a falsified device, it shall
also inform the competent authority of the
Member State in which the importer is
established.
To verify compliance with points (a) to (d)
of the first subparagraph, importers may
rely on the documentation supplied with
the device or apply risk-based sampling
methods taking into account the risk class
of the devices they import. Where an
importer has reason to believe that a device
is not in conformity with this Regulation, it
shall not place the device on the market
until it has been brought into conformity
and shall inform the manufacturer and,
where applicable, the manufacturer’s
authorised representative. Where the
importer has reason to believe that the
device presents a serious risk or is falsified,
it shall also inform the competent authority
of the Member State in which it is
established.'"
Or. en
(This amendment seeks to amend a provision within the existing act – Article 13(2) – that was
not referred to in the Commission proposal.)
Justification
It introduces a more risk-based and proportionate approach to importer obligations, allowing
compliance to be verified through appropriate documentation and risk-based sampling rather
than full re-assessment of each product, hence reducing duplication and administrative
burden while maintaining a high level of safety and market surveillance.
Amendment 110
Proposal for a regulation
Annex I – paragraph 1 – point 1 – point d – point iii – paragraph 1
Regulation (EU) 2017/745
Annex I – Section 23.1 – point f
Text proposed by the Commission Amendment
in point (f), the reference to ‘Regulation
(EU) No 207/2012’ is replaced by the
reference to ‘Commission Implementing
Regulation (EU) 2021/2226**
Instructions for use may be provided to
the user in non-paper format such as
electronic format. Users shall have the
possibility to obtain instructions for use in
paper format upon request.
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Or. en
Justification
It facilitates the use of electronic instructions for use, while ensuring that users retain the
right to request and receive instructions in paper format to guarantee accessibility for all user
groups.
Amendment 111
Proposal for a regulation
Annex I – paragraph 1 – point 1 a (new)
Regulation (EU )2017/745
Annex I – Section 12.2
Present text Amendment
(1a) Section 12.2 is replaced by the
following:
Devices that are composed of substances or
of combinations of substances that are
intended to be introduced into the human
body, and that are absorbed by or locally
dispersed in the human body shall comply,
where applicable and in a manner limited
to the aspects not covered by this
Regulation, with the relevant
requirements laid down in Annex I to
Directive 2001/83/EC for the evaluation
of absorption, distribution, metabolism,
excretion, local tolerance, toxicity,
interaction with other devices, medicinal
products or other substances and potential
for adverse reactions, as required by the
applicable conformity assessment
procedure under this Regulation.
"Devices that are composed of substances
or of combinations of substances that are
intended to be introduced into the human
body, and that are absorbed by or locally
dispersed in the human body shall be
assessed for aspects relating to the
absorption, distribution, metabolism,
excretion, local tolerance, toxicity,
interaction with other devices, medicinal
products or other substances and potential
for adverse reactions, as required by the
applicable conformity assessment
procedure under this Regulation and
taking into account the state of the art
and the characteristics of the substances."
Or. en
(This amendment seeks to amend a provision within the existing act – Section 12.2 of Annex I
– that was not referred to in the Commission proposal.)
Justification
It clarifies that substance-based devices should be assessed in relation to relevant safety and
performance aspects in a proportionate manner within the applicable conformity assessment
procedures, while avoiding unnecessary reliance on pharmaceutical regulatory requirements
not fully adapted to medical devices.
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Amendment 112
Proposal for a regulation
Annex I – paragraph 1 – point 4 – point a
Regulation (EU) 2017/745
Annex VI – Part B – point 4
Text proposed by the Commission Amendment
4. Member States where the device is
or is to be made available,
4. deleted
Or. en
Justification
It removes the administrative requirement to indicate the Member States in which a device is
or will be made available due to its unclear added value for market surveillance or patient
safety.
Amendment 113
Proposal for a regulation
Annex I – paragraph 1 – point 5 – point c
Regulation (EU) 2017/745
Annex VII – Section 1.2.9
Text proposed by the Commission Amendment
The notified body shall have documented
procedures in place to offer and carry out
dialogues with the manufacturer before and
after an application for conformity
assessment is lodged.;
The notified body shall have documented
procedures in place to offer and carry out
dialogues with the manufacturer before and
after an application for conformity
assessment is lodged. These dialogues may
include structured and interactive
exchanges, including pre-submission
consultations, throughout the conformity
assessment procedure.
Or. en
Amendment 114
Proposal for a regulation
Annex I – paragraph 1 – point 5 – point p – point i
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Regulation (EU) 2017/745
Annex VII – Section 4.5.1 – paragraph 2 – indent 9
Text proposed by the Commission Amendment
- in the case of class IIa or class IIb
devices, assess the technical documentation
of the representative device(s);
- in the case of class IIa or class IIb
devices, assess the technical documentation
of the representative device(s), while
ensuring that issues already assessed are
not subject to re-assessment during the
conformity assessment procedure.
Or. en
Justification
Ensures that issues already resolved during the conformity assessment will not be reviewed
again at a later stage of the conformity assessment.
Amendment 115
Proposal for a regulation
Annex I – paragraph 1 – point 5 – point p – point iii
Regulation (EU) 2017/745
Annex VII – Section 4.5.1 – paragraph 2 – indent 11
Text proposed by the Commission Amendment
– leverage evidence from previous
assessments performed.
– accept evidence from previous
assessments performed by the same or
other notified body pursuant to this
Regulation.
Or. en
Justification
Recognising assessments already carried out under the MDR avoids duplication and
improves predictability while ensuring safety and compliance.
Amendment 116
Proposal for a regulation
Annex I – paragraph 1 – point 5 – point p – point iii a (new)
Regulation (EU) 2017/745
Annex VII – Section 4.5.1 – paragraph 2 – indent 11 a (new)
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Text proposed by the Commission Amendment
(iiia) the following indent 11a is added:
‘– assess the manufacturer's technical
documentation and the solutions adopted
to meet the requirements laid down in
Annex I, focusing on the critical safety
and performance elements of the device
and on the sections of the technical
documentation affected by design
changes, post-market surveillance data or
risk management updates.’
Or. en
Justification
This amendment focuses the notified body’s assessment on critical safety and performance
elements and on updated sections of the technical documentation, improving efficiency
without reducing rigour.
Amendment 117
Proposal for a regulation
Annex I – paragraph 1 – point 6 – point g
Regulation (EU) 2017/745
Annex VIII – Section 6.3 – subparagraph 1 – introductory part
Text proposed by the Commission Amendment
Software which is intended to generate an
output that confers a clinical benefit and is
used for diagnosis, treatment, prevention,
monitoring, prediction, prognosis,
compensation or alleviation of a disease or
condition is classified as class I, unless the
output is intended for a disease or
condition:
Software which is intended to generate an
output that confers a clinical benefit and is
used for diagnosis, treatment, prevention,
monitoring, prediction, prognosis,
compensation or alleviation of a disease or
condition is classified as class I, unless the
output is intended:
Or. en
Amendment 118
Proposal for a regulation
Annex I – paragraph 1 – point 6 – point g
Regulation (EU) 2017/745
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Annex VIII – Section 6.3 – subparagraph 1 – indent 1
Text proposed by the Commission Amendment
– in a critical situation with a risk of
causing death or an irreversible
deterioration of a person's state of health,
in which case it is classified as class III;
– in treat or diagnose a disease or
condition in a critical situation, in which
case it is classified as class III;
Or. en
Amendment 119
Proposal for a regulation
Annex I – paragraph 1 – point 6 – point g
Regulation (EU) 2017/745
Annex VIII – Section 6.3 – subparagraph 1 – indent 2
Text proposed by the Commission Amendment
– in a serious situation with a risk of
causing a serious deterioration of a
person's state of health or a surgical
intervention, or to drive clinical
management in a critical situation in which
cases it is classified as class IIb;
– in treat or diagnose a disease or
condition in a serious situation, or to drive
clinical management of a disease or
condition in a critical situation in which
cases it is classified as class IIb;
Or. en
Amendment 120
Proposal for a regulation
Annex I – paragraph 1 – point 6 – point g
Regulation (EU) 2017/745
Annex VIII – Section 6.3 – subparagraph 1 – indent 3
Text proposed by the Commission Amendment
– in a non-serious situation, or to
drive clinical management in a serious
situation or to inform clinical management
in a critical or serious situation in which
cases it is classified as class IIa.;
– in treat or diagnose a disease or
condition in a non-serious situation, or to
drive clinical management of a disease or
condition in a serious situation, or to
inform clinical management of a disease or
condition in a critical or serious situation,
in which case it is classified as class IIa.
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Or. en
Amendment 121
Proposal for a regulation
Annex I – paragraph 1 – point 6 – point i
Regulation (EU) 2017/745
Annex VIII – Section 7.8 – introductory part
Text proposed by the Commission Amendment
Devices that are composed of substances
or of combinations of substances that are
intended to be introduced into the human
body via a body orifice or applied to the
skin and that are absorbed by or locally
dispersed on or in the human body are
classified as:;
deleted
Or. en
Amendment 122
Proposal for a regulation
Annex I – paragraph 1 – point 6 a (new)
Regulation (EU) 2017/745
Annex VIII – Section 7.1 – subparagraph 1 – indent 1
Present text Amendment
(6a) Section 7.1 is replaced by the
following:
All devices incorporating, as an integral
part, a substance which, if used separately,
can be considered to be a medicinal
product, as defined in point 2 of Article 1
of Directive 2001/83/EC, including a
medicinal product derived from human
blood or human plasma, as defined in point
10 of Article 1 of that Directive, and that
has an action ancillary to that of the
devices, are classified as class III.
"All devices incorporating, as an integral
part, a substance which, if used separately,
can be considered to be a medicinal
product, as defined in point 2 of Article 1
of Directive 2001/83/EC, including a
medicinal product derived from human
blood or human plasma, as defined in point
10 of Article 1 of that Directive, and that
has a clinically relevant ancillary action
contributing to the intended medical
purpose of the device, are classified as
class III."
Or. en
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(This amendment seeks to amend a provision within the existing act – Annex I, Section 7.1 –
that was not referred to in the Commission proposal.)
Justification
Avoids disproportionate classification where the substance does not play a role in
contributing to the intended medical purpose of the device.
Amendment 123
Proposal for a regulation
Annex I – paragraph 1 – point 7 – point a a (new)
Regulation (EU) 2017/745
Annex IX – Section 2.4
Present text Amendment
(a a) Section 2.4 is replaced by the
following:
2.4. The manufacturer in question shall
inform the notified body which approved
the quality management system of any plan
for substantial changes to the quality
management system, or the device-range
covered. The notified body shall assess the
changes proposed, determine the need for
additional audits and verify whether after
those changes the quality management
system still meets the requirements referred
to in Section 2.2. It shall notify the
manufacturer of its decision which shall
contain the conclusions of the assessment,
and where applicable, conclusions of
additional audits. The approval of any
substantial change to the quality
management system or the device-range
covered shall take the form of a
supplement to the EU quality management
system certificate.
"2.4. The manufacturer in question shall
inform the notified body which approved
the quality management system of any plan
for substantial changes to the quality
management system or substantial
changes to the device range included in
the certificate, including the addition of a
new product category or a new generic
device group to the scope of the
certificate. The notified body shall assess
the proposed changes, determine whether
additional audits or documentary reviews
are necessary, and verify whether the
quality management system continues to
meet the requirements referred to in
Section 2.2 after those changes. It shall
notify the manufacturer of its decision
which shall contain the conclusions of the
assessment, and where applicable, the
conclusions of any additional audits or
reviews. The approval of any substantial
change to the quality management system
or to the device-range covered by the
certificate shall take the form of a
supplement to the EU quality management
system certificate."
Or. en
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(https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745)
Justification
Clarifies that additional audits or reviews are required only where necessary, reducing
unnecessary administrative burden.
Amendment 124
Proposal for a regulation
Annex I – paragraph 1 – point 7 – point c
Regulation (EU) 2017/745
Annex IX – Section 3.3 – subparagraph 2
Text proposed by the Commission Amendment
The notified body shall carry out the
surveillance audits and assessments once
every 12 months. However, where justified
in light of the results of previous
surveillance audits and assessments, and in
the absence of any concerns resulting from
data from post-market surveillance or
vigilance, the notified body shall carry out
the surveillance audits and assessments
only once every 24 months.;
The notified body shall carry out the
surveillance audits and assessments once
every 12 months. However, where justified
in light of the manufacturer compliance
history, the results of previous surveillance
audits and assessments, and in the absence
of any concerns resulting from data from
post-market surveillance or vigilance, the
notified body may consider to carry out the
surveillance audits and assessments only
once every 24 months.;
Or. en
Amendment 125
Proposal for a regulation
Annex I – paragraph 1 – point 7 – point d – point i
Regulation (EU) 2017/745
Annex IX – Section 3.4 – paragraph 1
Text proposed by the Commission Amendment
The notified body shall perform short-
notice or unannounced audits on the site of
the manufacturer and, where appropriate,
of the manufacturer's suppliers and/or
subcontractors when justified based on
concerns related to post-market
surveillance or vigilance data or at the
request of a competent authority. The
The notified body shall perform short-
notice or unannounced audits on the site of
the manufacturer and, where appropriate,
of the manufacturer’s suppliers or
subcontractors, in accordance with a risk-
based audit plan. The frequency and
scope of such audits shall take into
account the risk class and type of device,
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short-notice or unannounced audit may
be combined with the periodic surveillance
assessment referred to in Section 3.3. or be
performed in addition to that surveillance
assessment.;
the manufacturer’s compliance history
and relevant post-market surveillance or
vigilance data. Such audits may be
combined with the periodic surveillance
assessment referred to in Section 3.3 or be
performed in addition to that surveillance
assessment.
Or. en
Amendment 126
Proposal for a regulation
Annex I – paragraph 1 – point 7 b (new)
Regulation (EU) 2017/745
Annex IX – Section 5.4
Present text Amendment
(7b) Section 5.4 is replaced by the
following:
5.4 Procedure in the case of devices that
are composed of substances or of
combinations of substances that are
absorbed by or locally dispersed in the
human body
"5.4 Procedure in the case of devices that
are composed of substances or of
combinations of substances that are
absorbed by or locally dispersed in the
human body
(a) The quality and safety of devices that
are composed of substances or of
combinations of substances that are
intended to be introduced into the human
body via a body orifice or applied to the
skin and that are absorbed by, or locally
dispersed in, the human body, shall be
verified where applicable and only in
respect of the requirements not covered by
this Regulation, in accordance with the
relevant requirements laid down in Annex
I to Directive 2001/83/EC for the
evaluation of absorption, distribution,
metabolism, excretion, local tolerance,
toxicity, interaction with other devices,
medicinal products or other substances and
potential for adverse reactions.
(a) The quality and safety of devices that
are composed of substances or of
combinations of substances that are
intended to be introduced into the human
body via a body orifice or applied to the
skin and that are absorbed by, or locally
dispersed in, the human body, shall be
verified, where applicable, with regard to
absorption, distribution, metabolism,
excretion, local tolerance, toxicity,
interaction with other devices, medicinal
products or other substances, and the
potential for adverse reactions, taking into
account the state of the art and the
characteristics of the substance or
combination of substances."
Or. en
PE787.987v01-00 76/81 PR\1343155EN.docx
EN
(This amendment seeks to amend a provision within the existing act – Annex IX, Section 5.4 –
that was not referred to in the Commission proposal.)
Justification
Clarifies that substance-based medical devices must be assessed with regard to the relevant
safety aspects, while avoiding the automatic application of medicinal product requirements
where this is not appropriate.
Amendment 127
Proposal for a regulation
Annex I – paragraph 1 – point 12 – point a – point ii
Regulation (EU) 2017/745
Annex XIV – Section 1
Text proposed by the Commission Amendment
Points (b) to (e) shall not apply to devices
for which confirmation of safety and
performance based on clinical data is not
deemed appropriate in accordance with
Article 61(10).;
Points (b) to (e) may not apply to devices
for which confirmation of safety and
performance based on clinical data is not
deemed appropriate in accordance with
Article 61(10).;
Or. en
Amendment 128
Proposal for a regulation
Annex II – paragraph 1 – point 1 – point b – point v
Regulation (EU) 2017/746
Annex I – Section 20. 1 – point k
Text proposed by the Commission Amendment
(k) For devices that are used
exclusively with a medicinal product in
accordance with Article 19 of [Proposal for
a Directive on the Union code relating to
medicinal products for human use, and
repealing Directive 2011/83/EC and
Directive 2009/35/EC] and packaged
together with a medicinal product, the
instructions for use may be included,
where needed, as part of the co-packaging
of the medicinal product with the device.
Moreover, the information on the label of
(k) For devices that are used
exclusively with a medicinal product in
accordance with Article 19 of [Proposal for
a Directive on the Union code relating to
medicinal products for human use, and
repealing Directive 2011/83/EC and
Directive 2009/35/EC] and packaged
together with a medicinal product, where
instructions for use are needed, they shall
be included as part of the co-packaging of
the medicinal product with the device.
Moreover, the information on the label of
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the device may be limited to the particulars
referred to in Section 20.2., points (a) and
(c), where, following agreement of the
competent authority responsible for the
authorisation of the medicinal product, the
following conditions are met:
the device may be limited to the particulars
referred to in Section 20.2., points (a) and
(c), where, following agreement of the
competent authority responsible for the
authorisation of the medicinal product, the
following conditions are met:
Or. en
Amendment 129
Proposal for a regulation
Annex II – paragraph 1 – point 1 – point b – point v – point a (new)
Regulation (EU) 2017/746
Annex I – Section 20. 1 – point j a (new)
Text proposed by the Commission Amendment
a) (ja) The electronic instructions for
use shall provide only the current version
of the information covered by the
conformity assessment and shall be
protected against unauthorised
modification.
Or. en
Amendment 130
Proposal for a regulation
Annex II – paragraph 1 – point 6 – point c
Regulation (EU) 2017/746
Annex IX – Section 3.3 – subparagraph 2
Text proposed by the Commission Amendment
The notified body shall carry out the
surveillance audits and assessments once
every 12 months. However, where justified
in light of the results of previous
surveillance audits and assessments, and in
the absence of any concerns resulting from
data from post-market surveillance or
vigilance, the notified body shall carry out
the surveillance audits and assessments
only once every 24 months.;
The notified body shall carry out the
surveillance audits and assessments once
every 12 months. However, where justified
in light of the manufacturer’s compliance
history, the results of previous surveillance
audits and assessments, and in the absence
of any concerns resulting from data from
post-market surveillance or vigilance, the
notified body may carry out the
surveillance audits and assessments once
PE787.987v01-00 78/81 PR\1343155EN.docx
EN
every 24 months.
Or. en
Amendment 131
Proposal for a regulation
Annex II – paragraph 1 – point 6 – point d – point i
Regulation (EU) 2017/746
Annex IX – Section 3.4
Text proposed by the Commission Amendment
3.4. The notified body shall perform
audits, at short notice or unannounced, on
the site of the manufacturer and, where
appropriate, the site of the manufacturer’s
suppliers and/or subcontractors, when
justified based on concerns related to
post-market surveillance or vigilance data
or at the request of a competent authority.
The short-notice or unannounced audit
may be combined with the periodic
surveillance assessment referred to in
Section 3.3. or be performed in addition to
that surveillance assessment.;
3.4. The notified body shall perform
short-notice or unannounced audits on the
site of the manufacturer and, where
appropriate, of the manufacturer’s
suppliers or subcontractors, in accordance
with a risk-based audit plan. The
frequency and scope of such audits shall
take into account the risk class and type
of device, the manufacturer’s compliance
history and relevant post-market
surveillance or vigilance data. Such audits
may be combined with the periodic
surveillance assessment referred to in
Section 3.3 or be performed in addition to
that surveillance assessment.
Or. en
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EXPLANATORY STATEMENT
Medical devices and in vitro diagnostic medical devices are essential components of modern
healthcare systems in the Union. They support the prevention, diagnosis, monitoring and
treatment of diseases and are central to ensuring high-quality patient care, improved patient
outcomes and the overall resilience, sustainability and innovation capacity of healthcare
systems.
Regulation (EU) 2017/745 and Regulation (EU) 2017/746 were adopted to strengthen patient
safety, enhance transparency and ensure a high level of regulatory oversight. These objectives
remain fully valid. However, experience with implementation has shown that the current
framework also creates significant practical challenges, including increased administrative
burden, lengthy and complex conformity assessment procedures, regulatory uncertainty and
risks to the timely availability of certain devices on the Union market.
These challenges are particularly relevant for small and medium-sized enterprises, which
constitute the backbone of the European medical technology sector. At the same time,
healthcare providers and patients increasingly face difficulties in accessing niche and
specialised devices, including those intended for rare diseases and highly specific clinical
applications. There are also concerns that innovative technologies including breakthrough
niche and orphan devices, companion diagnostics and drug-device combinations, may reach
patients in the Union later than in other jurisdictions or may not become available at all.
The Commission proposal represents an important step towards addressing these challenges
by seeking to simplify the regulatory framework, reduce unnecessary administrative burden
and improve the efficiency of conformity assessment procedures, while maintaining the high
standards of safety and performance established under the MDR and IVDR.
The amendments in this report aim to support the Commission’s objective of simplification by
ensuring that it leads to tangible benefits for patients, healthcare providers and manufacturers.
In particular, they seek to improve regulatory predictability and promote a more proportionate
framework that facilitates innovation and the availability of medical technologies in the
Union. They also seek to strengthen legal certainty around regulatory status, classification,
well-established technology and the role of CE marking.
The report addresses breakthrough and orphan devices, which concern unmet medical needs,
including serious conditions and rare diseases affecting small patient populations. A clearer
regulatory framework including prioritised conformity assessment, rolling review where
appropriate and structured early advice, may support earlier access to innovation while
maintaining robust requirements for safety and clinical evidence, thereby contributing to
innovation across the sector, including for SMEs and research-intensive companies.
The report also addresses the functioning of the conformity assessment system. Notified
bodies play a central role in ensuring the safety and performance of medical devices, while
capacity constraints and procedural delays continue to affect certification timelines. The
amendments therefore aim to improve efficiency, predictability and resource use while
safeguarding the integrity of the system. This includes a more risk-based and proportionate
approach to surveillance activities, technical documentation assessment, sampling and
periodic reviews.
PE787.987v01-00 80/81 PR\1343155EN.docx
EN
Moreover, the report underlines the importance of greater legal clarity and consistent
application of regulatory requirements across Member States in order to ensure uniform
implementation, reduce administrative complexity and support the proper functioning of the
internal market for medical technologies.
At the same time, the rapporteur emphasizes that any simplification must not come at the
expense of patient safety. The MDR and IVDR were adopted to address serious shortcomings
in the previous regulatory framework, and their core objectives must remain fully intact.
Simplification efforts should therefore focus on reducing unnecessary duplication, improving
efficiency and ensuring proportionate regulatory requirements, while maintaining robust
standards for safety, clinical performance and post-market surveillance. The report therefore
preserves essential safeguards, including clinical evidence requirements, benefit-risk
assessment, vigilance, post-market clinical follow-up and periodic safety update reports, while
allowing proportionate adjustments where justified by the risk profile of the device.
Ultimately, the objective of this report is to contribute to a regulatory framework that ensures
a high level of patient safety while improving access to innovation, strengthening regulatory
efficiency and supporting the continued availability of essential medical technologies in the
Union. The rapporteur therefore supports a balanced revision of the MDR and IVDR that
places patients at its centre, fosters innovation and ensures a predictable, efficient and resilient
regulatory system for medical technologies.
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ANNEX: DECLARATION OF INPUT
Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteur declares that he
included in his report input on matters pertaining to the subject of the file that he received, in
the preparation of the draft report, from the following interest representatives falling within
the scope of the Interinstitutional Agreement on a mandatory transparency register1, or from
the following representatives of public authorities of third countries, including their
diplomatic missions and embassies:
1. Interest representatives falling within the scope of the Interinstitutional Agreement
on a mandatory transparency register
Association of the European Self-Medication Industry
Becton Dickinson
Bio Marin Pharmaceutical
Bundesverband Medizintechnologie
COCIR
Deutsche Krankenhausgesellschaft e. V.
Edwards Lifescience
EFPIA
European Economic and Social Committee (EESC)
European Social Insurance Platform
GAIA AG
Pharma Deutschland
Radimed
Solventum
Standing Committee of European Doctors (CPME)
Team-NB
2. Representatives of public authorities of third countries, including their diplomatic
missions and embassies
None
The list above is drawn up under the exclusive responsibility of the rapporteur.
Where natural persons are identified in the list by their name, by their function or by both, the
rapporteur declares that he has submitted to the natural persons concerned the European
Parliament’s Data Protection Notice No 484 (https://www.europarl.europa.eu/data-
protect/index.do), which sets out the conditions applicable to the processing of their personal
data and the rights linked to that processing.
1 Interinstitutional Agreement of May 2021 between the European Parliament, the Council of the European
Union and the European Commission on a mandatory transparency register (OJ L 207, 11.6.2021, p. 1,
ELI:http://data.europa.eu/eli/agree_interinstit/2021/611/oj).
https://www.europarl.europa.eu/data-protect/index.do
https://www.europarl.europa.eu/data-protect/index.do
http://data.europa.eu/eli/agree_interinstit/2021/611/oj
02.07.2026
Datei
PD
Der Ausschuss für öffentliche Gesundheit (SANT) des Europäischen Parlaments wurde als federführender Ausschuss für die Überarbeitung der Medizinprodukte-Verordnung (MDR) benannt. Der Berichterstatter, Oliver Schenk (EVP), hat seinen Berichtsentwurf am 2. Juli 2026 vorgelegt. Die erste Beratung des Entwurfs ist derzeit für den 14. Juli 2026 im SANT-Ausschuss vorgesehen. Im Anschluss haben die Abgeordneten die Möglichkeit, Änderungsanträge einzureichen. Die Frist hierfür ist vorläufig auf den 20. Juli 2026 festgelegt. Eine erste Analyse zeigt, dass zahlreiche Forderungen von Pharma Deutschland im Berichtsentwurf berücksichtigt wurden. Amendment 3: Zuständigkeit für Einstufungsentscheidungen beim Mitgliedstaat des Herstellers Amendments 6 und 31: Möglichkeit englischsprachiger Informationen für professionelle Anwender Amendment 13: Anpassung der Kriterien für bewährte Technologien Amendments 18 und 21: Einbindung betroffener Stakeholder in Verfahren nach Artikel 4 und 4a Amendment 23: Frist von 30 Tagen für Stellungnahmen der Expertengremien Amendments 62, 69 und 70: Stärkere Beteiligung von Herstellern und Benannten Stellen bei Klassifizierungsverfahren Amendment 98: Einbindung von Industrieverbänden durch Expertengremien Amendment 110: Elektronische Gebrauchsanweisung für alle Produkte unabhängig vom Anwender Amendment 122: Präzisierungen bei der Klassifizierungsregel 14 für Medizinprodukte mit Arzneimittelbestandteil Gleichzeitig entspricht der Berichtsentwurf nicht in allen Punkten der Position von Pharma Deutschland. Insbesondere hinsichtlich der Verfahren zur Festlegung des regulatorischen Status von Produkten nach Artikel 4 und 4a (Amendments 17 ff.) besteht aus Sicht des Verbandes weiterhin Änderungsbedarf. Kritisch bewertet werden zudem die vorgeschlagene Befristung der Erstzertifizierung (Amendment 82), einzelne Änderungen im Zusammenhang mit dem regelmäßig aktualisierten Bericht über die Sicherheit (PSUR) (Amendment 96) sowie die vorgeschlagenen Änderungen an Regel 11 für Softwareprodukte (Amendments 117 ff.). Die Vorschläge von Pharma Deutschland zur Regel 21 für stoffliche Medizinprodukte und zur verstärkten Rolle der EMA (Artikel 106b) wurden hingegen nicht berücksichtigt und werden von Pharma Deutschland im weiteren parlamentarischen Verfahren erneut eingebracht. Sollten Sie Änderungswünsche oder Anmerkungen haben, bitten wir um eine Rückmeldung bis zum 7. Juli 2026 an Marie Anton ( anton@pharmadeutschland.de ) . Pharma Deutschland beabsichtigt, seine Position bis zum 9. Juli 2026 zu finalisieren und diese den zuständigen Europaabgeordneten rechtzeitig vor der weiteren Beratung zu übermitteln. Die Abstimmung über den Berichtsentwurf und die eingereichten Änderungsanträge im SANT-Ausschuss ist derzeit für den 3. Dezember 2026 vorgesehen. Ziel ist die Festlegung des Verhandlungsmandats des Europäischen Parlaments. Anschließend wird der Text dem Plenum zur Annahme vorgelegt. Die Plenarabstimmung ist nach aktueller Planung für die Sitzungswoche ab dem 14. Dezember 2026 angesetzt.
02.07.2026
Beitrag
PD
EU reference dates list
The convention used to present the active substances and combinations of active substances has changed. From the 29th October 2015 the following principles apply:
- A slash ('/') is used to separate the different active substances contained in a combination, this can be a fixed-dose combination or a combination pack.
- A comma (',') is used to indicate that a single PSUR assessment covering the different substances and/or combinations of active substances will be produced.
1 July 2026
EMA/630645/2012 Rev.161
Procedure Management Department
List of Union reference dates and frequency of submission of periodic safety update reports (PSURs)
Related Information:
Introductory cover note to the List of European Union reference dates and frequency of submission of PSURs including requirements for PSURs submission https://www.ema.europa.eu/documents/other/introductory-cover-note-list-european-union-reference-dates-frequency-submission-periodic-safety_en.pdf
Requests for amendments of the EU reference dates list https://www.ema.europa.eu/documents/template-form/template-request-amendments-addition-active-substances-combinations-active-substances-european-union_en-1.docx
The PSUR assessment procedure will start according to the Timetables published on EMA website following the Submission Dates indicated in column E and G below https://www.ema.europa.eu/documents/other/timetable-periodic-safety-update-report-psur-psur-single-assessment-psusa_en.pdf
Single Assessment Reports of PSURs are shared among all Marketing Authorisation Holders involved in the concerned procedure.
ID Active substances and combinations of active substances European Union reference date (EURD)
Not Available* = EURD not provided during the consultation phases PSUR Submission Frequency DLP Submission date
(According to the timelines defined in GVP Module VII, Section A) Next DLP
(For active substances or combination of active substances with a PSUR frequency of less than one year) Next Submission date
(According to the timelines defined in GVP Module VII, Section A - For active substances or combination of active substances with a PSUR frequency of less than one year) Are PSURs required for products referred to in Articles 10(1), 10a, 16a of Directive 2001/83/EC as amended?
Yes/No Publication Date (in accordance with Article 107c(7) of Directive 2001/83/EC as amended) Notes Procedure number of the PSUR single assessment
(DLP) Procedure number of the PSUR single assessment
procedure (Next DLP) PRAC representative of the PSUR single assessment
procedure (Lead) Member State of the PSUR single assessment procedure Centrally authorised product(s) (CAP) Nationally authorised product(s) (NAP)
2 calcium chloride / histidine / magnesium chloride / mannitol / potassium chloride / sodium chloride / tryptophan / oxogluric acid 24/11/1989 6 years 31/01/2030 01/05/2030 No 28/06/2023 Lead MS and PRAC Rapporteur name added on 18/10/2023
New entry added on 28/06/2023 PSUSA/00000002/203001 Jean-Michel Dogné Belgium NAP
4 131i-6-iodo-norcholesterol 21/06/1990 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000004/202901 NAP
5 (3s,10s,14s)-1-[4-[[(2s)-4-carboxy-2-[(2s)-4-carboxy-2-(6-[18f] fluoropyridin-3-amido) butanamido] butanamido]methyl]phenyl]-3-[(naphthalen-2-YL)methyl]-1,4,12-trioxo-2,5,11,13-tetraazahexadecane-10,14,16-tricarboxylic acid 09/12/2021 3 years 08/12/2027 07/03/2028 No 28/06/2023 New entry added on 28/06/2023 PSUSA/00000005/202712 not yet assigned none NAP
6 ¹³C-urea, ¹4C-urea 14/08/1997 5 years 15/01/2028 14/04/2028 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00000006/202801 Jan Neuhauser Austria CAP NAP
7 5 fluorouracil (IV use) 16/12/1977 3 years 16/12/2026 16/03/2027 Yes 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000007/202612 Dennis Lex Germany NAP
8 5 fluorouracil / salicylic acid 25/05/1994 5 years 25/05/2026 23/08/2026 No 17/02/2022 DLP and PSUR frequency were updated on 02/02/2022
PRAC representative was updated on 22/12/2021
PRAC representative was updated on 06/05/2020
DLP was updated on 06/02/2019
Next DLP was updated on 04/02/2016
Lead MS was added on 06/03/2015 PSUSA/00000008/202605 Jana Pecherova Slovakia NAP
9 5-aminolevulinic acid (glioma) 07/09/2007 3 years 07/03/2027 05/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00000009/202703 Carla Torre Portugal CAP
10 abacavir 29/06/1998 3 years 31/12/2025 31/03/2026 No 27/05/2026 Reference to NAP removed on 27/05/2026
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/06/2025 PSUSA/00000010/202512 Zoubida Amimour France CAP
11 abacavir / lamivudine 14/11/2003 3 years 31/12/2025 31/03/2026 No 04/02/2026 Reference to NAP removed on 04/02/2026
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/06/2025 PSUSA/00000011/202512 Zoubida Amimour France CAP
13 abatacept 22/12/2005 3 years 22/12/2025 22/03/2026 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00000013/202512 Kimmo Jaakkola Finland CAP
15 abiraterone 28/04/2011 5 years 28/04/2029 27/07/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00000015/202904 Maria del Pilar Rayon Spain CAP NAP
16 acamprosate 24/07/1987 8 years 01/07/2030 29/09/2030 No 01/03/2023 DLP was updated on 01/03/2023
Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00000016/203007 Rhea Fitzgerald Ireland NAP
17 acarbose 31/03/1990 5 years 31/03/2028 29/06/2028 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00000017/202803 Maria del Pilar Rayon Spain NAP
18 acebutolol 16/12/1974 8 years 16/12/2030 16/03/2031 No 15/01/2025 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00000018/203012 Eva Jirsova Czech Republic NAP
22 aceclofenac 19/03/1990 5 years 31/03/2028 29/06/2028 No 20/12/2023 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00000022/202803 Melinda Palfi Hungary NAP
25 sirolimus (indicated for treatment of angiofibroma associated with tuberous sclerosis complex) 15/05/2023 1 year 14/11/2026 23/01/2027 14/11/2027 23/01/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000025/202611 PSUSA/00000025/202711 Jenny-Maria Jönsson Sweden CAP NAP
26 acemetacin Not available* 6 years 01/05/2030 30/07/2030 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00000026/203005 Melinda Palfi Hungary NAP
27 acenocoumarol 06/07/1955 3 years 01/07/2027 29/09/2027 No 05/03/2025 DLP was amended on 05/03/2025 PSUSA/00000027/202707 Maria Popova-Kiradjieva Bulgaria NAP
29 acetazolamide 27/07/1953 16 years 26/10/2028 24/01/2029 Yes 28/03/2017 DLP was updated on 28/03/2017 PSUSA/00000029/202810 NAP
31 respiratory Syncytial Virus (RSV) vaccine (recombinant, adjuvanted) 03/05/2023 1 year 02/05/2026 11/07/2026 02/05/2027 11/07/2027 No 01/07/2026 Active substance name was amended on 01/07/2026
DLP was amended on 30/07/2025
PSUR frequency amended and DLP updated on 25/06/2025
DLP was amended on 18/12/2024 PSUSA/00000031/202605 PSUSA/00000031/202705 Maria del Pilar Rayon Spain CAP
33 acetylcholine 09/06/1965 16 years 01/06/2028 30/08/2028 No 01/10/2012 PSUSA/00000033/202806 NAP
34 acetylcysteine 14/09/1963 5 years 13/09/2028 12/12/2028 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00000034/202809 Adam Przybylkowski Poland NAP
39 acetylsalicylic acid 17/10/1942 8 years 01/02/2030 02/05/2030 No 28/06/2023 PSUR frequency amended and DLP updated on 28/06/2023
DLP was updated on 19/10/2022
PRAC representative was updated on 06/05/2020
DLP was updated on 23/10/2019
Next DLP was amended on 19/10/2016
Lead MS was added on 31/07/2015 PSUSA/00000039/203002 Melinda Palfi Hungary NAP
40 acetylsalicylic acid / glycine Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 Active substance name was amended on 06/03/2015 PSUSA/00000040/203001 NAP
41 acetylsalicylic acid / caffeine Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000041/203001 NAP
42 acetylsalicylic acid / caffeine / codeine phosphate Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000042/203001 NAP
43 acetylsalicylic acid / caffeine / etenzamide Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000043/203001 NAP
45 ublituximab 28/12/2022 1 year 27/12/2025 07/03/2026 27/12/2026 07/03/2027 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025
DLP was amended on 05/02/2025 PSUSA/00000045/202512 PSUSA/00000045/202612 Liana Martirosyan Netherlands CAP
46 acetylsalicylic acid / codeine phosphate Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000046/203001 NAP
48 aciclovir 10/06/1981 3 years 09/06/2027 07/09/2027 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00000048/202706 Marie Louise Schougaard Christiansen Denmark NAP
49 mirikizumab 27/03/2023 1 year 27/03/2026 05/06/2026 27/03/2027 05/06/2027 No 27/05/2026 PSUR frequency amended and DLP updated on 27/05/2026
DLP was amended on 19/11/2025 PSUSA/00000049/202603 PSUSA/00000049/202703 Sonja Radowan Austria CAP
50 acipimox 05/05/1984 5 years 05/05/2026 03/08/2026 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00000050/202605 Karin Erneholm Denmark NAP
51 acitretin 01/12/1987 2 years 30/10/2026 28/01/2027 Yes 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00000051/202610 Marie Louise Schougaard Christiansen Denmark NAP
54 acrivastine, acrivastine / pseudoephedrine 31/12/1990 7 years 02/12/2031 01/03/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00000054/203112 Terhi Lehtinen Finland NAP
58 adapalene 03/07/1992 8 years 31/07/2026 29/10/2026 No 03/04/2019 DLP was updated on 03/04/2019
PRAC Rapporteur name updated on 23/10/2018
PRAC Representative and Lead MS were added on 19/12/2017 PSUSA/00000058/202607 Eamon O'Murchu Ireland NAP
59 adapalene / benzoyl peroxide 30/09/2007 3 years 30/09/2026 29/12/2026 No 02/02/2026 DLP was amended on 05/06/2024 PSUSA/00000059/202609 Polona Golmajer Slovenia NAP
61 ademetionine 28/04/1993 8 years 03/08/2033 01/11/2033 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00000061/203308 Amelia Cupelli Italy NAP
62 adenosine 14/08/1991 5 years 14/08/2027 12/11/2027 No 03/05/2023 DLP was amended on 03/05/2023
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 07/05/2018
PRAC representative and Lead Member State were added on 30/01/2017 PSUSA/00000062/202708 Adam Przybylkowski Poland NAP
66 sodium thiosulfate 20/09/2022 1 year 19/03/2026 28/05/2026 19/03/2027 28/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00000066/202603 PSUSA/00000066/202703 Karin Erneholm Denmark CAP
67 glofitamab 24/03/2023 1 year 23/03/2026 01/06/2026 23/03/2027 01/06/2027 No 17/12/2025 DLP was amended on 17/12/2025
DLP was amended on 19/11/2025 PSUSA/00000067/202603 PSUSA/00000067/202703 Veronika Macurova Czech Republic CAP
68 futibatinib 30/09/2022 6 months 29/03/2026 07/06/2026 29/09/2026 08/12/2026 No 02/06/2026 PSUSA/00000068/202603 PSUSA/00000068/202609 Jenny-Maria Jönsson Sweden CAP
69 agalsidase alfa 03/08/2001 3 years 03/08/2027 01/11/2027 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00000069/202708 Liana Martirosyan Netherlands CAP
70 agalsidase beta 03/08/2001 3 years 31/07/2028 29/10/2028 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00000070/202807 Liana Martirosyan Netherlands CAP
71 agomelatine 19/02/2009 5 years 19/02/2029 20/05/2029 No 20/10/2021 DLP was updated on 20/10/2021
PSUR Frequency and DLP updated on 26/09/2018
PRAC Rapporteur name amended on 04/07/2018
Next DLP was amended on 25/09/2017
PRAC Rapporteur name was amended on 20/12/2016
Next DLP was updated on 22/09/2016
DLP updated on 06/10/2015 PSUSA/00000071/202902 Pernille Harg Norway CAP
72 ajmaline 09/11/1962 10 years 22/08/2026 20/11/2026 No 26/04/2017 PSUR Frequency amended and DLP updated on 26/04/2017
Entry restored to the list on 20/12/2016 PSUSA/00000072/202608 Dennis Lex Germany NAP
73 albendazole 10/07/1981 5 years 10/07/2030 08/10/2030 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00000073/203007 Adam Przybylkowski Poland NAP
74 mavacamten 28/04/2022 1 year 27/04/2026 06/07/2026 27/04/2027 06/07/2027 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025
DLP was amended on 18/12/2024 PSUSA/00000074/202604 PSUSA/00000074/202704 Kimmo Jaakkola Finland CAP
75 alclometasone 03/06/1987 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000075/203001 NAP
76 aldesleukin 03/07/1989 7 years 31/12/2029 31/03/2030 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00000076/202912 Bianca Mulder Netherlands NAP
77 miglustat (for treatment of Pompe disease) 20/03/2023 1 year 19/03/2026 28/05/2026 19/03/2027 28/05/2027 No 02/06/2026 PSUSA/00000077/202603 PSUSA/00000077/202703 Jenny-Maria Jönsson Sweden CAP
78 alendronate 10/11/2000 5 years 15/01/2026 15/04/2026 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00000078/202601 Karin Erneholm Denmark NAP
79 alendronic acid / colecalciferol, alendronic acid / calcium / colecalciferol 24/08/2005 5 years 15/01/2026 15/04/2026 No 22/09/2021 DLP was updated on 22/09/2021
LMS and PRAC representative were updated on 05/06/2019
Next DLP was updated on 22/09/2016
Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended? Yes/No" was amended on 16/07/2015
Active substance name was amended on 12/05/2015 PSUSA/00000079/202601 Jan Neuhauser Austria CAP NAP
80 alfacalcidol 31/01/1978 7 years 15/06/2032 13/09/2032 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026
DLP was amended on 04/03/2026 PSUSA/00000080/203206 Terhi Lehtinen Finland NAP
81 neomycin / triamcinolone 30/12/1991 9 years 01/08/2033 30/10/2033 No 02/04/2025 PSUR frequency amended and DLP updated on 02/04/2025 PSUSA/00000081/203308 Eva Jirsová Czech Republic NAP
82 alfentanil Not available* 3 years 14/09/2027 13/12/2027 No 25/05/2022 DLP was updated on 25/05/2022
DLP was amended on 05/06/2019
PRAC Rapporteur name was amended on 23/10/2018
Next DLP was amended on 03/06/2016
Lead MS added on 12/05/2015 PSUSA/00000082/202709 Eamon O'Murchu Ireland NAP
84 alfuzosin 12/11/1987 5 years 12/11/2027 10/02/2028 No 02/06/2026 PSUSA/00000084/202711 Jenny Jönsson Sweden NAP
85 potassium chloride / sodium chloride / magnesium chloride / sodium acetate / sodium gluconate and/or glucose 22/03/1971 20 years 02/09/2044 01/12/2044 Yes 26/07/2023 Active substance name was amended on 26/07/2023
New entry added on 26/07/2023 PSUSA/00000085/204409 not yet assigned none NAP
86 alglucosidase alfa 29/03/2006 3 years 28/09/2027 27/12/2027 No 19/09/2024 PSUSA/00000086/202709 Zoubida Amimour France CAP
88 alimemazine 05/06/1956 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000088/203001 NAP
89 aliskiren, aliskiren / hydrochlorothiazide 22/08/2007 3 years 30/09/2027 29/12/2027 No 29/06/2022 DLP was updated on 29/06/2022
PRAC representative was updated on 17/11/2021
PRAC representative was updated on 25/09/2019
DLP updated on 30/04/2019
PRAC Rapporteur name amended on 04/07/2018
Entry name and DLP were updated on 07/05/2018
DLP was updated on 23/05/2017
Next DLP was amended on 03/05/2016
"Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended? Yes/No" was amended on 16/07/2015 PSUSA/00000089/202709 Amelia Cupelli Italy CAP
91 alizapride 09/01/1979 5 years 09/01/2026 09/04/2026 No 28/04/2022 PRAC representative was updated on 19/10/2022
PRAC Representative amended on 28/04/2022
DLP was updated on 22/09/2021
PRAC Representative amended on 18/11/2016
Next DLP was updated on 22/09/2016
Lead MS was added on 06/10/2015
DLP was amended on 16/06/2015 PSUSA/00000091/202601 Jo Robays Belgium NAP
92 allantoin Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000092/203001 NAP
93 ganaxolone 18/03/2022 6 months 17/03/2026 26/05/2026 17/09/2026 26/11/2026 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00000093/202603 PSUSA/00000093/202609 Adam Przybylkowski Poland CAP
95 allopurinol 01/01/1966 3 years 31/12/2026 31/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000095/202612 Dennis Lex Germany NAP
97 piflufolastat (18F) 26/05/2021 1 year 25/05/2026 03/08/2026 25/05/2027 03/08/2027 No 04/03/2026 Correction of DLP on 04/03/2026
PSUR frequency amended and DLP updated on 04/02/2026
DLP was amended on 30/07/2025 PSUSA/00000097/202605 PSUSA/00000097/202705 Kimmo Jaakkola Finland CAP
98 alminoprofen Not available* 10 years 03/05/2035 01/08/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000098/203505 NAP
99 talquetamab 09/08/2023 6 months 08/02/2026 19/04/2026 08/08/2026 17/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00000099/202602 PSUSA/00000099/202608 Barbara Kovacic Bytyqi Croatia CAP
100 atogepant 28/09/2021 6 months 27/03/2026 05/06/2026 27/09/2026 06/12/2026 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00000100/202603 PSUSA/00000100/202609 Rugile Pilviniene Lithuania CAP
101 almotriptan 23/12/1999 5 years 30/06/2028 28/09/2028 No 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 PSUSA/00000101/202806 Maria del Pilar Rayon Spain NAP
102 respiratory syncytial virus vaccine (bivalent, recombinant) 31/05/2023 1 year 30/05/2026 08/08/2026 30/05/2027 08/08/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000102/202605 PSUSA/00000102/202705 Liana Martirosyan Netherlands CAP
104 alfa amylase 06/06/1967 10 years 01/01/2032 31/03/2032 No 19/09/2024 PSUSA/00000104/203201 Zoubida Amimour France NAP
107 epcoritamab 22/09/2023 6 months 21/03/2026 30/05/2026 21/09/2026 30/11/2026 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00000107/202603 PSUSA/00000107/202609 Maria Martinez Gonzalez Spain CAP
108 human alfa1-proteinase inhibitor (apart from the centrally authorised product) 21/03/2006 5 years 31/12/2029 31/03/2030 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00000108/202912 Marie Louise Schougaard Christiansen Denmark NAP
109 alprazolam 12/03/1980 5 years 11/03/2030 09/06/2030 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00000109/203003 Tiphaine Vaillant France NAP
110 alprostadil (erectile dysfunction) 23/07/1981 5 years 31/01/2026 01/05/2026 Yes 20/10/2021 DLP was updated on 20/10/2021
Next DLP was amended on 19/10/2016
Lead MS added on 31/07/2015. PSUSA/00000110/202601 Eva Jirsová Czech Republic NAP
111 alprostadil (indicated in peripheral arterial occlusive diseases) 28/11/1984 8 years 31/07/2030 29/10/2030 No 05/04/2023 PSUR frequency amended and DLP updated on 05/04/2023
DLP and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" were updated on 07/05/2018
PRAC representative and Lead Member State were added on 30/01/2017 PSUSA/00000111/203007 Eva Jirsová Czech Republic NAP
112 alteplase 06/06/1987 5 years 31/05/2027 29/08/2027 No 01/02/2023 DLP was updated on 01/02/2023
DLP was amended on 31/01/2018
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00000112/202705 Dennis Lex Germany NAP
115 aluminium Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000115/202903 NAP
116 cabotegravir (for pre-exposure prophylaxis of HIV-1 infection) 18/03/2020 1 year 17/03/2026 26/05/2026 17/03/2027 26/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00000116/202603 PSUSA/00000116/202703 Dennis Lex Germany CAP
118 decitabine / cedazuridine 06/07/2020 1 year 06/07/2026 14/09/2026 06/07/2027 14/09/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00000118/202607 PSUSA/00000118/202707 Marie Louise Schougaard Christiansen Denmark CAP
119 aluminium chlorhydroxide-complex Not available* 10 years 03/05/2035 01/08/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000119/203505 none NAP
120 elacestrant 28/12/2022 6 months 27/12/2025 07/03/2026 27/06/2026 05/09/2026 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000120/202512 PSUSA/00000120/202606 Sonja Radowan Austria CAP
122 aluminium oxide hydrated / magnesium hydroxide / monmectite Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000122/202903 NAP
123 Any combinations of alginate sodium, alginic acid (antacids) Not available* 7 years 03/06/2031 01/09/2031 No 27/05/2026 DLP was amended on 05/02/2025 PSUSA/00000123/203106 Terhi Lehtinen Finland NAP
124 alverine, alverine / simeticone 10/02/1950 10 years 01/02/2032 01/05/2032 No 28/05/2025 Active substance name was amended on 28/05/2025
PRAC Rapporteur updated on 15/11/2023 PSUSA/00000124/203202 Petar Mas Croatia NAP
126 amantadine 14/12/1965 6 years 01/01/2030 01/04/2030 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000126/203001 Dennis Lex Germany NAP
127 ambazone Not available* 7 years 03/06/2031 01/09/2031 Yes 18/12/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 18/12/2024
PSUR frequency and DLP amended on 28/02/2024 PSUSA/00000127/203106 Roxana Dondera Romania NAP
128 ambenonium 14/12/1956 11 years 03/10/2037 01/01/2038 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000128/203710 NAP
129 ambrisentan 21/04/2008 3 years 14/06/2026 12/09/2026 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00000129/202606 Maria del Pilar Rayon Spain CAP
130 ambroxol 23/08/1978 5 years 30/09/2027 29/12/2027 No 31/05/2023 PSUR frequency amended and DLP updated on 31/05/2023
DLP was updated on 03/06/2020
Next DLP was amended on 27/06/2017
Correction of PRAC Rapporteur name on 28/02/2017
PRAC Rapporteur name updated on 30/01/2017
PRAC Rapporteur name was amended on 20/12/2016
PRAC representative and Lead Member State were added on 03/05/2016 PSUSA/00000130/202709 Ana Sofia Diniz Martins Portugal NAP
131 ambroxol / clenbuterol 27/06/1984 5 years 30/09/2027 29/12/2027 No 31/05/2023 PSUR frequency amended and DLP updated on 31/05/2023
DLP was updated on 03/06/2020
Next DLP was amended on 27/06/2017
Correction of PRAC Rapporteur name on 28/02/2017
PRAC representative and Lead Member State were added on 03/05/2016 PSUSA/00000131/202709 Ana Sofia Diniz Martins Portugal NAP
132 gefapixant 20/01/2022 6 months 19/01/2026 30/03/2026 19/07/2026 27/09/2026 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00000132/202601 PSUSA/00000132/202607 Jan Neuhauser Austria CAP
133 ritlecitinib 23/06/2023 1 year 22/12/2025 02/03/2026 22/12/2026 02/03/2027 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00000133/202512 PSUSA/00000133/202612 Adam Przybylkowski Poland CAP
135 amcinonide Not available* 10 years 03/05/2035 01/08/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000135/203505 NAP
136 tislelizumab 26/12/2019 1 year 25/12/2025 05/03/2026 25/12/2026 05/03/2027 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025
DLP was amended on 30/07/2025 PSUSA/00000136/202512 PSUSA/00000136/202612 Bianca Mulder Netherlands CAP
138 amfepramone 01/06/1961 13 years 01/06/2033 30/08/2033 Yes 03/02/2021 DLP was updated on 03/02/2021
PRAC representative was added on 06/05/2020
LMS was added on 25/09/2019
DLP and Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/04/2019 PSUSA/00000138/203306 Marie Louise Schougaard Christiansen Denmark NAP
141 amifampridine 23/12/2009 3 years 23/12/2027 22/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00000141/202712 Karin Bolin Sweden CAP
143 amikacin (except for centrally authorised products) 06/06/1975 5 years 05/06/2027 03/09/2027 No 01/02/2023 DLP was updated on 01/02/2023
Active substance name was amended on 18/11/2020
DLP was updated on 28/02/2018
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/01/2017
PRAC representative and Lead Member State were added on 18/11/2016 PSUSA/00000143/202706 Maia Uusküla Estonia NAP
148 amiloride, amiloride / furosemide, amiloride / hydrochlorothiazide, amiloride / hydrochlorothiazide / timolol, amiloride / bumetanide, amiloride / chlortalidone 25/04/1969 8 years 03/06/2033 01/09/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000148/203306 Guðrún Stefánsdóttir Iceland NAP
152 aminaphtone 07/07/2005 13 years 06/07/2032 04/10/2032 Yes 28/02/2024 Entry re-activated on 28/02/2024 PSUSA/00000152/203207 none NAP
155 pirtobrutinib 27/01/2023 6 months 27/01/2026 07/04/2026 27/07/2026 05/10/2026 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00000155/202601 PSUSA/00000155/202607 Bianca Mulder Netherlands CAP
156 sodium hypochlorite (concentrated solution) 09/12/1991 8 years 09/12/2031 08/03/2032 No 20/12/2023 New entry added on 20/12/2023 PSUSA/00000156/203112 none NAP
157 aminoacridine / lidocaine Not available* 12 years 06/09/2036 05/12/2036 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00000157/203609 John Joseph Borg Malta NAP
159 aminocaproic acid Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000159/202903 NAP
163 aminomethylbenzoic acid 17/09/1970 10 years 02/09/2034 01/12/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000163/203409 NAP
164 aminophylline 24/02/1963 14 years 01/01/2026 01/04/2026 No 26/05/2025 PSUSA/00000164/202601 Ana Sofia Diniz Martins Portugal NAP
166 amiodarone 20/12/1966 3 years 20/12/2026 20/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000166/202612 Bianca Mulder Netherlands NAP
167 amisulpride 20/01/1986 3 years 20/01/2026 20/04/2026 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00000167/202601 Eamon O'Murchu Ireland NAP
168 magnesium gluconate 21/02/2005 9 years 21/02/2032 21/05/2032 No 20/12/2023 New entry added on 20/12/2023 PSUSA/00000168/203202 none NAP
169 zilucoplan 25/09/2023 1 year 24/09/2026 03/12/2026 24/09/2027 03/12/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00000169/202609 PSUSA/00000169/202709 Karin Erneholm Denmark CAP
170 amitriptyline / perphenazine 31/07/1961 3 years 01/01/2027 01/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000170/202701 Georgia Gkegka Greece NAP
173 palopegteriparatide 17/11/2023 1 year 16/05/2026 25/07/2026 16/05/2027 25/07/2027 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
DLP was amended on 04/02/2026 PSUSA/00000173/202605 PSUSA/00000173/202705 Lina Seibokiene Lithuania CAP
174 amlodipine 08/03/1989 5 years 07/03/2027 05/06/2027 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00000174/202703 Karin Erneholm Denmark NAP
175 lebrikizumab 16/11/2023 1 year 13/09/2026 22/11/2026 13/09/2027 22/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00000175/202609 PSUSA/00000175/202709 Liana Martirosyan Netherlands CAP
176 quizartinib 18/06/2019 1 year 17/06/2026 26/08/2026 17/06/2027 26/08/2027 No 04/03/2026 Correction of DLP on 04/03/2026
PSUR frequency amended and DLP updated on 04/02/2026
DLP was amended on 30/07/2025 PSUSA/00000176/202606 PSUSA/00000176/202706 John Joseph Borg Malta CAP
177 amlodipine / atorvastatin 30/01/2004 5 years 31/01/2030 01/05/2030 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00000177/203001 Zoubida Amimour France NAP
179 amlodipine / perindopril 23/04/2008 5 years 22/10/2026 20/01/2027 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00000179/202610 Karin Erneholm Denmark NAP
180 amlodipine / telmisartan, amlodipine / telmisartan / hydrochlorothiazide 07/10/2010 5 years 31/03/2030 29/06/2030 No 23/10/2024 Active substance name was amended on 23/10/2024
PSUR frequency and DLP were updated on 16/12/2020
PRAC Rapporteur name was amended on 31/07/2018
DLP was updated on 19/12/2017
Reference to NAP products was added on 23/05/2017
Next DLP was amended on 01/12/2014
Next DLP was amended on 02/07/2014
Correction of the DLP was done on the 01/04/2014
Next DLP was amended on 29/11/2013 PSUSA/00000180/203003 Dennis Lex Germany CAP NAP
182 ammonia solutions 19/09/1984 16 years 01/01/2028 31/03/2028 No 01/10/2012 PSUSA/00000182/202801 NAP
183 ichthammol Not available* 16 years 01/01/2028 31/03/2028 No 01/10/2012 PSUSA/00000183/202801 NAP
184 ammonium chloride, ammonium chloride combinations Not available* 16 years 01/01/2028 31/03/2028 No 01/10/2012 PSUSA/00000184/202801 NAP
185 amorolfine 10/06/1991 5 years 30/06/2027 28/09/2027 No 01/03/2023 DLP was updated on 01/03/2023
PRAC representative was updated on 06/05/2020
DLP was updated on 27/03/2018
Lead MS and PRAC Rapporteur name was added on 20/12/2016 PSUSA/00000185/202706 Melinda Palfi Hungary NAP
186 amoxapine 01/06/1973 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000186/202806 NAP
187 amoxicillin 07/03/1972 5 years 07/03/2027 05/06/2027 No 16/11/2022 DLP was updated on 16/11/2022
DLP was amended on 15/11/2017
Lead MS was added on 22/09/2016
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/06/2016 PSUSA/00000187/202703 Jan Neuhauser Austria NAP
188 amoxicillin / clavulanate 07/03/1972 5 years 07/03/2027 05/06/2027 No 16/11/2022 DLP was updated on 16/11/2022
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was amended on 15/11/2017
Lead MS was added on 22/09/2016
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/06/2016 PSUSA/00000188/202703 Dennis Lex Germany NAP
193 amphotericin b 19/03/1958 15 years 18/03/2027 16/06/2027 Yes 01/10/2012 PSUSA/00000193/202703 NAP
194 amphotericin b / tetracycline 19/03/1958 11 years 02/04/2038 01/07/2038 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000194/203804 NAP
195 ampicillin 01/03/1962 9 years 01/02/2028 01/05/2028 Yes 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000195/202802 NAP
196 ampicillin / cloxacillin 01/03/1962 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00000196/203405 NAP
197 ampicillin / sulbactam 24/02/1987 3 years 28/02/2027 29/05/2027 No 19/10/2022 PRAC representative was updated on 19/10/2022
PRAC representative was updated on 27/07/2022
DLP corrected on 02/02/2022
DLP was updated on 17/11/2021
PRAC representative was updated on 30/06/2021
DLP was updated on 21/11/2018
PRAC Rapporteur name amended on 04/07/2018
PRAC Rapporteur name amended.
PRAC Rapporteur name amended.
Next DLP was amended on 29/10/2015
Lead MS added on 04/02/2015 PSUSA/00000197/202702 Amelia Cupelli Italy NAP
199 amsacrine 23/04/1982 5 years 01/06/2029 30/08/2029 Yes 23/10/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 23/10/2024
PRAC representative updated on 31/01/2024 PSUSA/00000199/202906 Bianca Mulder Netherlands NAP
201 enalapril maleate (centrally authorised product for use in children below the age of 18) 15/11/2023 1 year 31/03/2026 09/06/2026 31/03/2027 09/06/2027 No 02/06/2026 PSUSA/00000201/202603 PSUSA/00000201/202703 Karin Bolin Sweden CAP
202 latanoprost (eye drop emulsions containing CKC) 15/11/2023 1 year 14/11/2026 23/01/2027 14/11/2027 23/01/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000202/202611 PSUSA/00000202/202711 Jean-Michel Dogné Belgium CAP
204 amylmetacresol / dichlorobenzyl alcohol, amylmetacresol / ascorbic acid / dichlorobenzyl alcohol 01/09/1958 9 years 03/03/2029 01/06/2029 No 28/05/2025 Entry updated following merge on 28/05/2025
PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000204/202903 none NAP
205 amylmetacresol / dichlorobenzyl alcohol / levomenthol 01/09/1958 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000205/203001 NAP
206 amylmetacresol / dichlorobenzyl alcohol / lidocaine 01/09/1958 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000206/203001 NAP
208 anagrelide 16/11/2004 5 years 13/09/2027 12/12/2027 No 31/05/2023 PSUR frequency amended and DLP updated on 31/05/2023
Correction: Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 21/10/2022
PSUR frequency and DLP were updated on 28/04/2021
PRAC representative was updated on 29/07/2020
PRAC representative was updated on 03/06/2020
DLP was updated on 06/05/2020
DLP was updated on 30/04/2019
DLP was updated and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was updated on 07/05/2018
PRAC Rapporteur name updated on 21/07/2017
Next DLP was amended on 26/04/2017
PRAC Rapporteur name was amended on 28/07/2016
PRAC Rapporteur name updated on 03/06/2016
Next DLP was amended on 03/05/2016
"Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended? Yes/No" was amended on 16/07/2015
Rapporteur name amended on 04/11/2014 PSUSA/00000208/202709 Tiphaine Vaillant France CAP NAP
209 anakinra 08/03/2002 5 years 01/05/2030 30/07/2030 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00000209/203005 Karin Erneholm Denmark CAP
210 anastrozole 11/08/1995 3 years 11/08/2028 09/11/2028 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00000210/202808 Zane Neikena Latvia NAP
213 anethole trithione Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000213/204001 NAP
214 adagrasib 12/12/2022 6 months 11/12/2025 19/02/2026 11/06/2026 20/08/2026 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000214/202512 PSUSA/00000214/202606 Kimmo Jaakkola Finland CAP
215 anidulafungin 20/09/2007 5 years 31/01/2027 01/05/2027 No 19/10/2022 DLP and Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" were updated on 19/10/2022
PRAC Rapporteur name was amended on 23/10/2018
PSUR Frequency amended and DLP updated on 17/10/2017
PRAC Rapporteur name was amended on 25/09/2017 PSUSA/00000215/202701 Liana Martirosyan Netherlands CAP NAP
216 rozanolixizumab 26/06/2023 1 year 25/06/2026 03/09/2026 25/06/2027 03/09/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000216/202606 PSUSA/00000216/202706 Maria del Pilar Rayon Spain CAP
217 antazoline Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000217/203501 NAP
218 antazoline / naphazoline 01/06/1961 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000218/203906 NAP
219 antazoline / tetryzoline 03/10/1972 10 years 01/12/2034 01/03/2035 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00000219/203412 John Joseph Borg Malta NAP
220 antazoline / xylometazoline 01/01/1966 11 years 02/12/2039 01/03/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000220/203912 NAP
221 rezafungin 22/03/2023 1 year 21/03/2026 30/05/2026 21/03/2027 30/05/2027 No 29/04/2026 PSUR frequency amended and DLP updated on 29/04/2026
Reference to NAP removed on 04/02/2026
DLP was amended on 19/11/2025 PSUSA/00000221/202603 PSUSA/00000221/202703 Adam Przybylkowski Poland CAP
222 pegzilarginase 14/12/2023 1 year 13/12/2025 21/02/2026 13/12/2026 21/02/2027 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00000222/202512 PSUSA/00000222/202612 Dennis Lex Germany CAP
223 vamorolone 26/10/2023 6 months 25/04/2026 04/07/2026 25/10/2026 03/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000223/202604 PSUSA/00000223/202610 Rhea Fitzgerald Ireland CAP
225 elranatamab 14/08/2023 6 months 13/02/2026 24/04/2026 13/08/2026 22/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00000225/202602 PSUSA/00000225/202608 Barbara Kovacic Bytyqi Croatia CAP
226 apixaban 18/05/2011 3 years 17/05/2027 15/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00000226/202705 Bianca Mulder Netherlands CAP
227 apomorphine 28/05/2001 3 years 19/11/2025 17/02/2026 Yes 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00000227/202511 Karin Erneholm Denmark NAP
228 apraclonidine 16/08/1967 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000228/203408 NAP
229 aprepitant 25/03/2003 5 years 25/03/2029 23/06/2029 No 02/06/2026 PSUSA/00000229/202903 Jenny-Maria Jönsson Sweden CAP NAP
230 aprotinin Not available* 2 years 28/02/2026 29/05/2026 No 16/11/2022 DLP was updated on 16/11/2022
PRAC Rapporteur name was amended on 28/04/2022
DLP was updated on 21/10/2020
PRAC Rapporteur name was amended on 03/04/2019
DLP was updated on 21/11/2018
PSUR Frequency amended and DLP updated on 18/11/2016
Lead MS and PRAC Rapporteur name was added on 07/04/2016
The DLP was amended on 27/11/2015.
The DLP was amended on 02/07/2014 PSUSA/00000230/202602 Marie Louise Schougaard Christiansen Denmark NAP
231 fezolinetant 12/05/2023 1 year 11/11/2026 20/01/2027 11/11/2027 20/01/2028 No 17/12/2025 DLP was amended on 17/12/2025
PSUR frequency amended and DLP updated on 25/06/2025
DLP was amended on 18/12/2024 PSUSA/00000231/202611 PSUSA/00000231/202711 Dennis Lex Germany CAP
232 gadopiclenol 21/09/2022 2 years 30/04/2027 29/07/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000232/202704 Dennis Lex Germany CAP NAP
233 arginine hydrochloride / cyanocobalamin / cyproheptadine hydrochloride / levocarnitine Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000233/202903 NAP
234 aripiprazole 04/06/2004 3 years 16/07/2026 14/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00000234/202607 Ana Sofia Diniz Martins Portugal CAP NAP
235 arsenic trioxide 05/03/2002 5 years 30/09/2028 29/12/2028 No 05/06/2024 PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00000235/202809 Tiphaine Vaillant France CAP
236 artemether / lumefantrin (apart from the dispersible tablet) 14/10/1998 3 years 01/10/2028 30/12/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000236/202810 Jenny Jönsson Sweden NAP
238 articaine 29/04/1975 20 years 01/01/2032 31/03/2032 No 01/10/2012 PSUSA/00000238/203201 NAP
239 articaine / epinephrine 29/04/1975 20 years 01/01/2032 31/03/2032 No 01/10/2012 PSUSA/00000239/203201 NAP
240 triamcinolone / lidocaine (rectal use) 01/03/1974 9 years 28/02/2031 29/05/2031 No 28/02/2024 New entry added on 28/02/2024 PSUSA/00000240/203102 n/a none NAP
241 acetylsalicylic acid / ascorbic acid, acetylsalicylic acid / citric acid / sodium hydrogen carbonate 28/07/1972 23 years 04/02/2035 05/05/2035 No 23/10/2024 PSUSA/00000241/203502 none NAP
242 acetylsalicylic acid / ascorbic acid / bioflavonoids Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000242/203501 NAP
243 acetylsalicylic acid / ascorbic acid / codeine phosphate hemihydrate Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000243/203501 NAP
244 exagamglogene autotemcel 15/11/2023 6 months 14/05/2026 23/07/2026 14/11/2026 23/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000244/202605 PSUSA/00000244/202611 Bianca Mulder Netherlands CAP
245 omaveloxolone 28/02/2023 1 year 27/02/2026 08/05/2026 27/02/2027 08/05/2027 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
DLP was amended on 01/04/2026 PSUSA/00000245/202602 PSUSA/00000245/202702 Amelia Cupelli Italy CAP
246 alfatocopherol / ascorbic acid / biotin / calcium pantothenate / colecalciferol / cyanocobalamin / magnesium / manganese / pyridoxine / riboflavin / thiamine / vitamin a / zinc Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000246/203501 NAP
248 ascorbic acid / dichlorobenzyl alcohol Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000248/203501 NAP
249 alfatocopherol acetate / ascorbic acid / ergocalciferol / retinol Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000249/203501 NAP
250 ascorbic acid / caffeine / glucuronamide Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000250/203501 NAP
251 ascorbic acid / paracetamol Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000251/203501 NAP
252 acetylsalicylic acid / ascorbic acid / paracetamol 13/12/1985 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000252/203501 NAP
253 ascorbic acid / caffeine / paracetamol Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000253/203501 NAP
255 ascorbic acid / paracetamol / phenylephrine hydrochloride Not available* 5 years 15/06/2030 13/09/2030 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00000255/203006 Rugile Pilviniene Lithuania NAP
256 asenapine 01/09/2010 5 years 12/08/2030 10/11/2030 No 27/05/2026 DLP was corrected on 27/05/2026
PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00000256/203008 Ana Sofia Diniz Martins Portugal CAP
257 ascorbic acid / potassium aspartate / potassium bicarbonate Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000257/204001 NAP
258 atazanavir 02/03/2004 5 years 19/06/2029 17/09/2029 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00000258/202906 Tiphaine Vaillant France CAP
259 atenolol 19/02/1976 12 years 19/02/2037 20/05/2037 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00000259/203702 Terhi Lehtinen Finland NAP
260 atenolol / chlortalidone 09/09/1997 7 years 09/09/2031 08/12/2031 No 03/06/2020 PRAC representative was updated on 22/12/2021
DLP was updated on 03/06/2020
PRAC representative was updated on 06/05/2020
PRAC representative was added on 21/11/2018
Lead MS was added on 06/03/2015 PSUSA/00000260/203109 Miroslava Gocova Slovakia NAP
262 atomoxetine 26/11/2002 5 years 26/11/2028 24/02/2029 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00000262/202811 Maria del Pilar Rayon Spain NAP
263 momelotinib 15/09/2023 1 year 14/09/2026 23/11/2026 14/09/2027 23/11/2027 No 02/06/2026 PSUSA/00000263/202609 PSUSA/00000263/202709 Jenny-Maria Jönsson Sweden CAP
264 atosiban 20/01/2000 5 years 31/01/2029 01/05/2029 No 19/10/2022 PRAC representative was updated on 19/10/2022
PRAC representative was updated on 17/11/2021
DLP was updated on 20/10/2021
PRAC representative was updated on 25/09/2019
DLP was updated on 23/10/2018
Reference to NAP added on 25/09/2017
Next DLP was amended on 29/10/2015
PRAC Rapporteur name amended on PSUSA/00000264/202901 Amelia Cupelli Italy CAP NAP
265 atovaquone 25/11/1992 13 years 30/11/2027 28/02/2028 No 19/09/2024 PSUSA/00000265/202711 Zoubida Amimour France NAP
266 atovaquone / proguanil 21/10/1996 5 years 31/10/2027 29/01/2028 No 28/06/2023 Next DLP was updated on 28/06/2023
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 04/07/2018
PRAC representative and Lead Member State were added on 28/03/2017 PSUSA/00000266/202710 Ana Sofia Diniz Martins Portugal NAP
267 atracurium 16/12/1982 10 years 16/12/2032 16/03/2033 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00000267/203212 Dennis Lex Germany NAP
268 atropine (except myopia indication) 31/08/1945 14 years 31/08/2026 29/11/2026 No 25/06/2025 Active substance name was amended on 25/06/2025 PSUSA/00000268/202608 none NAP
269 atropine / diphenoxylate 29/09/1960 14 years 01/01/2026 01/04/2026 No 17/02/2026 PSUSA/00000269/202601 Jana Pecherova Slovakia NAP
273 etrasimod 12/10/2023 1 year 11/10/2026 20/12/2026 11/10/2027 20/12/2027 No 27/05/2026 PSUR frequency amended and DLP updated on 27/05/2026
PSUR frequency corrected on 04/03/2026
DLP was amended on 19/11/2025 PSUSA/00000273/202610 PSUSA/00000273/202710 Karin Bolin Sweden CAP
274 azacitidine 17/12/2008 5 years 18/05/2029 16/08/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00000274/202905 Bianca Mulder Netherlands CAP
275 azathioprine 13/12/1965 6 years 12/12/2030 12/03/2031 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00000275/203012 Karin Erneholm Denmark CAP NAP
276 azelaic acid 27/10/1988 8 years 03/06/2033 01/09/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000276/203306 Jan Neuhauser Austria NAP
277 azelastine 20/11/1990 3 years 31/12/2026 31/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000277/202612 Jan Neuhauser Austria NAP
280 azilsartan medoxomil, azilsartan medoxomil/chlortalidone 07/12/2011 3 years 24/08/2026 22/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00000280/202608 Bianca Mulder Netherlands CAP NAP
282 hydroxyethyl salicylate / mephenesin / methyl nicotinate 19/07/2003 10 years 19/07/2035 17/10/2035 Yes 30/04/2024 New entry added on 30/04/2024 PSUSA/00000282/203507 none none NAP
283 aztreonam (inhalation use) 21/09/2009 5 years 11/09/2028 10/12/2028 No 05/06/2024 PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00000283/202809 Liana Martirosyan Netherlands CAP
284 bacillus clausii multi-antibioresistant spores 03/11/1978 5 years 30/11/2027 28/02/2028 No 26/07/2023 PSUR frequency amended and DLP updated on 26/07/2023 PSUSA/00000284/202711 Amelia Cupelli Italy NAP
285 bacitracin, bacitracin / neomycin, bacitracin / polymyxin, bacitracin / neomycin / polymyxin, bacitracin / hydrocortisone / neomyicin, bacitracin zinc / cysteine / glycine / neomycin/ threonine 02/04/1962 9 years 03/05/2029 01/08/2029 No 20/12/2023 Active substance name, PSUR frequency and DLP were amended on 20/12/2023 PSUSA/00000285/202905 none NAP
286 efbemalenograstim alfa 06/05/2023 1 year 05/05/2026 14/07/2026 05/05/2027 14/07/2027 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025
DLP was amended on 18/12/2024 PSUSA/00000286/202605 PSUSA/00000286/202705 Bianca Mulder Netherlands CAP
293 baclofen (intrathecal use) 16/01/1963 5 years 31/01/2026 01/05/2026 Yes 20/10/2021 Active substance name and DLP were updated on 20/10/2021
Next DLP was amended on 19/10/2016
DLP was amended on 06/10/2015
Lead MS was added on 13/07/2015 PSUSA/00000293/202601 Adam Przybylkowski Poland NAP
294 baclofen (oral use, for muscle spasticity indication) 17/09/1970 3 years 30/09/2026 29/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00000294/202609 Eamon O'Murchu Ireland NAP
295 bambuterol 07/12/1990 5 years 07/12/2027 06/03/2028 No 12/09/2025 Next DLP was updated on 26/07/2023 PSUSA/00000295/202712 Veronika Macurová Czech Republic NAP
296 bamifylline Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000296/202905 NAP
297 bamipine Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000297/203506 NAP
299 barium sulphate, barium sulphate combinations 03/07/1973 28 years 01/01/2040 31/03/2040 No 01/10/2012 EURD was amended on 02/07/2014 PSUSA/00000299/204001 NAP
300 barnidipine 01/07/2000 7 years 03/03/2031 01/06/2031 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00000300/203103 Bianca Mulder Netherlands NAP
301 basiliximab 09/10/1998 3 years 30/04/2027 29/07/2027 No 06/10/2025 DLP was amended on 05/02/2025 PSUSA/00000301/202704 Dirk Mentzer Germany CAP
302 bazedoxifene 17/04/2009 10 years 16/10/2034 14/01/2035 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00000302/203410 Dennis Lex Germany CAP
303 BCG (bacillus calmette-guérin) for Immunotherapy 02/03/1988 5 years 02/03/2028 31/05/2028 No 06/10/2025 DLP was amended on 15/11/2023 PSUSA/00000303/202803 Dirk Mentzer Germany NAP
304 BCG vaccine (freeze-dried) Not available* 5 years 02/03/2028 31/05/2028 No 02/06/2026 PSUSA/00000304/202803 Jenny Jönsson Sweden NAP
305 cefepime / enmetazobactam 29/06/1993 3 years 28/06/2028 26/09/2028 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00000305/202806 Liana Martirosyan Netherlands CAP
306 beclometasone 13/12/1966 5 years 31/12/2026 31/03/2027 No 20/05/2026 DLP was updated on 21/09/2022
Lead MS and PRAC Rapporteur name amended on 19/12/2018
Next DLP was amended on 25/09/2017
European Union reference date was amended on 21/07/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00000306/202612 Katarzyna Ziolkowska Poland NAP
308 beclometasone dipropionate / neomycin sulfate Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000308/204003 NAP
309 beclometasone / salbutamol Not available* 5 years 01/01/2027 01/04/2027 No 21/09/2022 DLP was updated on 21/09/2022
PSUR Frequency amended and next DLP updated on 25/09/2017
Entry name corrected on 23/05/2017
PRAC Rapporteur name corrected on 28/02/2017
PRAC Rapporteur name was amended on 20/12/2016
Lead MS and PRAC Rapporteur name was added on 28/07/2016
Active substance name was amended on 03/06/2016
Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00000309/202701 Ana Sofia Diniz Martins Portugal NAP
311 belatacept 17/06/2011 5 years 14/06/2028 12/09/2028 No 02/06/2026 PSUSA/00000311/202806 Karin Bolin Sweden CAP
312 bemiparin 16/04/1998 5 years 30/04/2027 29/07/2027 No 19/09/2025 PSUR frequency and DLP were updated on 01/02/2023
PRAC Representative updated on 16/11/2022
DLP was updated on 05/02/2020
Next DLP amended and PRAC Rapporteur name updated on 30/01/2017
PRAC Rapporteur and Lead Member State added on 27/11/2015. PSUSA/00000312/202704 Maria Martinez Gonzalez Spain NAP
313 benazepril 28/11/1989 5 years 20/11/2025 18/02/2026 No 15/01/2025 DLP was updated on 28/07/2021
PRAC Rapporteur name updated on 23/10/2018
Next DLP was amended on 28/07/2016
DLP amended on 31/07/2015
Lead MS was added on 13/07/2015 PSUSA/00000313/202511 Amelia Cupelli Italy NAP
314 benazepril / hydrochlorothiazide 19/05/1992 5 years 31/05/2026 29/08/2026 No 19/09/2024 PSUSA/00000314/202605 Zoubida Amimour France NAP
315 bendazac 09/11/1968 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000315/203408 NAP
329 benperidol 01/08/1967 6 years 31/07/2030 29/10/2030 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00000329/203007 Dennis Lex Germany NAP
330 benserazide / levodopa 27/06/1973 5 years 26/06/2027 24/09/2027 No 01/03/2023 DLP was updated on 01/03/2023
PRAC representative was updated on 06/05/2020
DLP was updated on 28/02/2018
PRAC representative and Lead Member State were added on 18/11/2016 PSUSA/00000330/202706 Melinda Palfi Hungary NAP
331 bentazepam 01/07/1980 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000331/202811 NAP
332 benzalkonium (exluding vaginal use), benzalkonium chloride / hexylresorcinol Not available* 7 years 01/11/2028 30/01/2029 No 23/10/2024 Active substance name was amended on 23/10/2024
PSUR frequency amended and DLP updated on 23/10/2024
Active substance name changed on 28/04/2022 PSUSA/00000332/202811 Amelia Cupelli Italy NAP
339 benzalkonium chloride / dequalinium chloride Not available* 9 years 03/06/2029 01/09/2029 Yes 23/10/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 23/10/2024
PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000339/202906 none NAP
342 benzalkonium / ethyl alcohol Not available* 7 years 03/07/2031 01/10/2031 No 24/09/2025 Entry name updated on 24/09/2025
Entry name updated on 30/07/2025
DLP was amended on 05/03/2025 PSUSA/00000342/203107 Guðrún Stefánsdóttir Iceland NAP
349 acetylcysteine / tuaminoheptane, acetylcysteine / benzalkonium chloride / tuaminoheptane 01/03/1971 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000349/202806 Amelia Cupelli Italy NAP
354 benzbromarone 15/10/1970 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000354/202805 NAP
357 benzocaine Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000357/203001 NAP
358 benzocaine / cetylpyridinium chloride 01/01/1996 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000358/203001 NAP
361 benzocaine / chloroxylenol Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000361/203001 NAP
362 benzocaine / dequalinium hydrochloride 09/04/1991 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000362/203001 NAP
363 benzocaine / hamamelis water / racephedrine hydrochloride Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000363/203001 NAP
364 benzocaine / menthol / phenol, racemic / thymol Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000364/203001 NAP
365 benzocaine / phenazone Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000365/203001 NAP
366 benzocaine / triclosan Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000366/203001 NAP
368 benzododecinium / boric acid Not available* 11 years 03/03/2040 01/06/2040 No 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024
Active substance name was amended on 28/02/2024 PSUSA/00000368/204003 none NAP
372 benzoxonium chloride / lidocaine hydrochloride 17/04/1989 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000372/202901 NAP
373 benzoyl peroxide 01/03/1950 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000373/203212 NAP
375 benzydamine 10/07/1964 5 years 31/10/2029 29/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00000375/202910 Amelia Cupelli Italy NAP
378 benzydamine / cetylpyridine Not available* 7 years 01/01/2026 01/04/2026 No 27/07/2022 PRAC representative was updated on 27/07/2022
PRAC representative was updated on 30/06/2021
DLP was updated on 25/09/2019
PRAC Representative and Lead Member state assigned on 04/07/2018 PSUSA/00000378/202601 Amelia Cupelli Italy NAP
379 benzylbenzoate Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000379/203001 NAP
380 benzylnicotinate Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000380/203001 NAP
383 benzylpenicillin, benzathine benzylpenicillin, benzathine benzylpenicillin / lidocaine, procaine benzylpenicillin, benzathine benzylpenicillin / procaine benzylpenicillin 27/06/1952 5 years 15/06/2030 13/09/2030 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00000383/203006 Maia Uusküla Estonia NAP
385 besilesomab 11/01/2010 5 years 10/01/2029 10/04/2029 No 19/09/2025 DLP was amended on 25/09/2024 PSUSA/00000385/202901 Maria Martinez Gonzalez Spain CAP
387 beta-carotene Not available* 9 years 03/06/2029 01/09/2029 No 15/01/2025 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000387/202906 Adam Przybylkowski Poland NAP
389 betahistine 16/05/1968 3 years 31/12/2026 31/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000389/202612 Zane Neikena Latvia NAP
390 betaine anhydrous (centrally authorised product only) 15/02/2007 3 years 28/02/2026 29/05/2026 Yes 15/11/2023 DLP was amended on 15/11/2023
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 15/11/2023
New CAP authorised on 05/05/2022
DLP was updated on 21/10/2020
PRAC Rapporteur name was amended on 31/07/2018
PSUR Frequency amended and DLP updated on 17/10/2017
Next DLP was amended on 19/10/2016
DLP amended on 06/10/2015
Active substance name was amended on 13/03/2015 PSUSA/00000390/202602 Dennis Lex Germany CAP
391 betamethasone 25/09/1961 9 years 01/01/2030 01/04/2030 No 22/09/2021 DLP was updated on 22/09/2021
PRAC representative and LMS were added on 01/07/2020 PSUSA/00000391/203001 Eamon O'Murchu Ireland NAP
393 betamethasone dipropionate / calcipotriol Not available* 9 years 01/01/2030 01/04/2030 No 22/09/2021 DLP was updated on 22/09/2021
PRAC representative and LMS were added on 01/07/2020 PSUSA/00000393/203001 Eamon O'Murchu Ireland NAP
394 betamethasone dipropionate / clotrimazole Not available* 9 years 01/01/2030 01/04/2030 No 22/09/2021 LMS was updated on 27/07/2022
DLP was updated on 22/09/2021
PRAC representative and LMS were added on 01/07/2020 PSUSA/00000394/203001 Portugal NAP
395 betamethasone dipropionate / salicylic acid Not available* 9 years 01/01/2030 01/04/2030 No 22/09/2021 DLP was updated on 22/09/2021
PRAC representative and LMS were added on 01/07/2020 PSUSA/00000395/203001 Eamon O'Murchu Ireland NAP
397 betamethasone sodium phosphate / neomycin sulfate Not available* 9 years 01/01/2030 01/04/2030 No 22/09/2021 DLP was updated on 22/09/2021
PRAC representative and LMS were updated on 01/07/2020 PSUSA/00000397/203001 Eamon O'Murchu Ireland NAP
398 betamethasone valerate / clioquinol Not available* 9 years 01/01/2030 01/04/2030 No 22/09/2021 DLP was updated on 22/09/2021
PRAC representative and LMS were updated on 01/07/2020 PSUSA/00000398/203001 Eamon O'Murchu Ireland NAP
399 betamethasone valerate / fusidic acid Not available* 9 years 01/01/2030 01/04/2030 No 22/09/2021 DLP was updated on 22/09/2021
PRAC representative and LMS were updated on 01/07/2020 PSUSA/00000399/203001 Eamon O'Murchu Ireland NAP
401 betaxolol 10/05/1982 5 years 10/05/2027 08/08/2027 No 01/02/2023 DLP was updated on 01/02/2023
PRAC representative was updated on 06/05/2020
DLP was amended on 31/01/2018
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00000401/202705 Melinda Palfi Hungary NAP
402 bethanechol Not available* 5 years 15/06/2030 13/09/2030 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00000402/203006 Jan Neuhauser Austria NAP
403 bevacizumab 12/01/2005 3 years 25/02/2028 25/05/2028 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00000403/202802 Karin Erneholm Denmark CAP
404 bexarotene 29/03/2001 3 years 15/09/2026 14/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00000404/202609 Tiphaine Vaillant France CAP
405 bezafibrate 21/07/1978 7 years 01/01/2026 01/04/2026 No 26/05/2025 PRAC representative updated on 31/01/2024 PSUSA/00000405/202601 Carla Torre Portugal NAP
406 bibrocathol Not available* 7 years 03/08/2031 01/11/2031 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00000406/203108 Karin Bolin Sweden NAP
407 bicalutamide 28/02/1995 3 years 28/02/2026 29/05/2026 No 15/11/2023 DLP was amended on 15/11/2023 PSUSA/00000407/202602 Karin Erneholm Denmark NAP
408 biclotymol 11/06/2003 7 years 03/05/2031 01/08/2031 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00000408/203105 Zoubida Amimour France NAP
409 biclotymol / enoxolone / muramidase hydrochloride Not available* 8 years 01/12/2025 01/03/2026 No 11/06/2025 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00000409/202512 Guðrún Stefánsdóttir Iceland NAP
411 bifonazole 01/12/1982 8 years 03/05/2033 01/08/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000411/203305 Dennis Lex Germany NAP
412 bifonazole / urea 02/06/1985 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000412/202812 NAP
413 bimatoprost 08/03/2002 5 years 07/03/2026 05/06/2026 No 17/11/2021 DLP and frequency were updated on 17/11/2021
PRAC Rapporteur name was corrected on 03/04/2019
DLP was updated on 21/11/2018
PRAC Rapporteur name was amended on 06/06/2018
PRAC Representative amended on 17/10/2017
Next DLP updated on 27/11/2015. PSUSA/00000413/202603 Karin Erneholm Denmark CAP NAP
414 biotin Not available* 7 years 01/01/2026 01/04/2026 No 25/09/2019 DLP was updated on 25/09/2019
PRAC Representative and Lead Member state assigned on 04/07/2018 PSUSA/00000414/202601 Jan Neuhauser Austria NAP
415 biperiden 16/08/1955 3 years 31/08/2028 29/11/2028 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00000415/202808 Jan Neuhauser Austria NAP
416 bisacodyl, bisacodyl / senna dry extract / senna pods / sennae folium, sennosides calcium salts, cassia angustifolia / cassia fistula, senna glycosides 01/06/1954 10 years 01/01/2034 01/04/2034 No 17/12/2025 Active substance name was amended on 17/12/2025
Active substance name was amended on 28/05/2025
Active substance name, PSUR frequency and DLP were amended on 20/12/2023 PSUSA/00000416/203401 none NAP
419 bisoprolol 28/01/1986 6 years 30/09/2030 29/12/2030 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
DLP was updated on 30/06/2021
Next DLP was amended on 03/06/2016
PRAC Rapporteur name updated on 06/10/2015
Lead MS added on 12/05/2015 PSUSA/00000419/203009 Kimmo Jaakkola Finland NAP
420 bisoprolol / hydrochlorothiazide 30/01/1992 7 years 30/11/2031 28/02/2032 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00000420/203111 Zoubida Amimour France NAP
421 bivalirudin 20/09/2004 5 years 20/09/2030 19/12/2030 Yes 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00000421/203009 Veronika Macurová Czech Republic NAP
422 bleomycin 18/03/1970 10 years 31/03/2032 29/06/2032 No 21/12/2022 DLP was updated on 21/12/2022
PRAC Rapporteur name was amended on 28/04/2022
LMS and PRAC representative were added on 20/10/2021 PSUSA/00000422/203203 Marie Louise Schougaard Christiansen Denmark NAP
423 borax / boric acid Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000423/203501 NAP
424 bortezomib 26/04/2004 3 years 25/04/2026 24/07/2026 Yes 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00000424/202604 Amelia Cupelli Italy CAP NAP
425 bosentan 15/05/2002 3 years 19/11/2027 17/02/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00000425/202711 Zoubida Amimour France CAP NAP
426 botulinum toxin a (except for centrally authorised products) 29/12/1989 3 years 31/12/2027 30/03/2028 Yes 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00000426/202712 Eamon O'Murchu Ireland NAP
427 botulinum toxin a - haemagglutinin complex 06/12/1990 3 years 31/12/2027 30/03/2028 Yes 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00000427/202712 Karin Bolin Sweden NAP
430 brimonidine (except for the centrally authorised product) 06/09/1996 5 years 30/09/2026 29/12/2026 No 29/06/2022 DLP was updated on 29/06/2022
Lead MS and PRAC Rapporteur name amended on 19/12/2018
Next DLP was amended on 27/06/2017
PRAC representative and Lead Member State were added on 03/05/2016
Name of active substance was amended on 02/05/2014 PSUSA/00000430/202609 Eamon O'Murchu Ireland NAP
431 brimonidine / timolol 06/09/1996 5 years 30/09/2026 29/12/2026 No 29/06/2022 DLP was updated on 29/06/2022
Lead MS and PRAC Rapporteur name amended on 19/12/2018
Next DLP was amended on 27/06/2017
PRAC representative and Lead Member State were added on 03/05/2016 PSUSA/00000431/202609 Dennis Lex Germany NAP
432 brinzolamide 09/03/2000 5 years 31/08/2026 29/11/2026 No 28/04/2022 PRAC Representative updated on 16/11/2022
DLP was updated on 28/04/2022
PSUR Frequency amended and DLP updated on 23/05/2017
Reference to NAP products added on 18/11/2016
PRAC Representative amended on 28/06/2016 PSUSA/00000432/202608 Maria del Pilar Rayon Spain CAP NAP
433 brinzolamide / timolol 25/11/2008 5 years 30/04/2029 29/07/2029 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00000433/202904 Karin Erneholm Denmark CAP NAP
434 brivudine 06/07/2000 5 years 05/07/2029 03/10/2029 No 05/03/2025 DLP was amended on 05/03/2025 PSUSA/00000434/202907 Dennis Lex Germany NAP
435 bromazepam 01/09/1973 3 years 31/08/2026 29/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00000435/202608 Tiphaine Vaillant France NAP
436 bromfenac 18/05/2011 5 years 30/05/2030 28/08/2030 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00000436/203005 Karin Erneholm Denmark CAP NAP
437 bromhexine 01/07/1963 5 years 30/09/2030 29/12/2030 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
Next DLP was updated on 31/05/2023 PSUSA/00000437/203009 Amelia Cupelli Italy NAP
438 bromocriptine 15/10/1975 7 years 15/10/2030 13/01/2031 No 03/07/2024 PSUR frequency amended and DLP updated on 03/07/2024 PSUSA/00000438/203010 Maria del Pilar Rayon Spain NAP
439 bromperidol 30/09/1980 5 years 15/11/2027 13/02/2028 No 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00000439/202711 Liana Martirosyan Netherlands NAP
443 brompheniramine / caffeine / paracetamol, brompheniramine / caffeine / calcium / paracetamol Not available* 11 years 03/03/2040 01/06/2040 No 25/09/2024 Entry name updated on 25/09/2024 PSUSA/00000443/204003 none NAP
444 brotizolam 15/05/1983 3 years 01/12/2025 01/03/2026 No 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00000444/202512 Ana Sofia Diniz Martins Portugal NAP
448 buclizine / codeine / paracetamol, acetylsalicylic acid / codeine / paracetamol, caffeine / codeine / paracetamol Not available* 5 years 03/08/2030 01/11/2030 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00000448/203008 Rhea Fitzgerald Ireland NAP
449 budesonide (nationally authorised products only) 30/04/1992 5 years 30/04/2026 29/07/2026 No 22/12/2021 PRAC Rapporteur name was amended on 28/04/2022
DLP updated on 22/12/2021
PRAC Rapporteur name was amended on 21/11/2018
Entry name was corrected on 07/05/2018
Next DLP updated on 30/01/2017
Next DLP and Submission deadline were corrected on 04/03/2016
PSUR Frequency amended and DLP updated on 04/02/2016
PRAC Rapporteur and Lead Member State added on 27/11/2015.
Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015
PRAC Rapporteur name updated on 05/11/2018 PSUSA/00000449/202604 Marie Louise Schougaard Christiansen Denmark NAP
454 bumetanide 30/09/1972 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000454/202806 NAP
459 buprenorphine (all formulations except implants) 30/03/1982 4 years 30/09/2027 29/12/2027 No 05/06/2024 New CAP authorised on 19/12/2024
PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00000459/202709 Tiphaine Vaillant France CAP NAP
461 bupropion 30/12/1985 5 years 31/12/2029 31/03/2030 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00000461/202912 Liana Martirosyan Netherlands NAP
462 buserelin 16/08/1984 5 years 16/08/2026 14/11/2026 No 02/06/2026 PSUSA/00000462/202608 Jenny Jönsson Sweden NAP
463 buspirone 29/04/1983 3 years 30/04/2027 29/07/2027 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00000463/202704 Karin Erneholm Denmark NAP
464 busulfan 09/07/2003 3 years 08/07/2027 06/10/2027 Yes 19/09/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00000464/202707 Maria Martinez Gonzalez Spain NAP
468 butamirate 18/03/1967 10 years 03/07/2034 01/10/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000468/203407 NAP
469 butamirate / guaifenesin Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000469/202906 NAP
471 butoconazole 24/10/2003 5 years 28/02/2026 29/05/2026 No 17/11/2021 DLP was updated on 17/11/2021
PRAC representative was updated on 06/05/2020
Next DLP was updated on 18/11/2016
Lead MS was added on 06/10/2015 PSUSA/00000471/202602 Melinda Palfi Hungary NAP
474 hyoscine butylbromide 01/01/1952 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000474/202712 NAP
476 cabazitaxel 17/06/2010 5 years 17/06/2029 15/09/2029 Yes 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00000476/202906 Tiphaine Vaillant France CAP NAP
477 cabergoline 13/03/1992 5 years 12/03/2027 10/06/2027 No 16/11/2022 PSUR frequency and DLP were updated on 16/11/2022
PRAC representative was updated on 19/10/2022
PRAC representative was updated on 17/11/2021
PRAC representative was updated on 30/06/2021
PSUR frequency and DLP were updated on 23/10/2019
PSUR frequency amended and DLP updated on 21/11/2018
PRAC Rapporteur name amended on 04/07/2018
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 17/10/2017
PRAC Rapporteur name updated on 04/02/2016
Next DLP updated and PRAC Rapporteur amended on 27/11/2015.
Lead MS was added on 04/02/2015 PSUSA/00000477/202703 Amelia Cupelli Italy NAP
480 cafedrine hydrochloride / theodrenaline hydrochloride Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000480/202906 NAP
481 caffeine 14/04/1969 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000481/204001 NAP
482 caffeine (apnea) 02/07/2009 3 years 02/07/2026 30/09/2026 Yes 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00000482/202607 Sonja Hrabcik Austria CAP NAP
483 caffeine / dihydroergocryptine mesilate Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000483/204001 NAP
484 caffeine / diphenhydramine Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000484/204001 NAP
485 caffeine / ergotamine Not available* 3 years 30/11/2025 28/02/2026 Yes 26/07/2023 PSUR frequency amended and DLP updated on 26/07/2023 PSUSA/00000485/202511 Tiphaine Vaillant France NAP
486 caffeine / isometheptene / metamizole Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000486/204001 NAP
487 caffeine / metamizole Not available* 28 years 01/01/2040 31/03/2040 No 07/05/2018 Entry name updated on 07/05/2018 PSUSA/00000487/204001 NAP
488 caffeine / phenazone Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000488/204001 NAP
489 caffeine citrate / glyceryl trinitrate Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000489/204001 NAP
491 calcifediol Not available* 5 years 23/06/2030 21/09/2030 No 01/04/2026 DLP was corrected on 01/04/2026
PSUR frequency amended and DLP updated on 04/03/2026 PSUSA/00000491/203006 Dennis Lex Germany NAP
492 calcipotriol 30/11/1990 8 years 03/06/2033 01/09/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000492/203306 Rhea Fitzgerald Ireland NAP
494 calcitonin salmon, synthetic analogue of eel calcitonin 13/05/1975 5 years 19/06/2026 17/09/2026 No 19/09/2025 PRAC Representative updated on 16/11/2022
PSUR frequency and DLP were updated on 02/03/2022
Next DLP was updated on 06/03/2019
PRAC Representative updated on 26/09/2018
PRAC Rapporteur name updated on 03/06/2016
Next DLP was updated on 04/03/2016
Lead MS added on 01/04/2015 PSUSA/00000494/202606 Maria Martinez Gonzalez Spain NAP
495 calcitriol 01/01/1978 5 years 01/01/2026 01/04/2026 No 19/10/2022 PRAC representative was updated on 19/10/2022
PRAC representative was updated on 27/07/2022
PSUR frequency and DLP were updated on 22/09/2021
PRAC representative was updated on 25/09/2019
DLP was updated on 26/09/2018
PRAC Rapporteur name amended on 04/07/2018
DLP updated on 06/10/2015
Lead MS was added on 22/12/2014 PSUSA/00000495/202601 Amelia Cupelli Italy NAP
496 calcium 15/06/1935 15 years 01/01/2027 01/04/2027 No 01/10/2012 PSUSA/00000496/202701 NAP
500 Any combinations or monocomponents of aluminium, calcium, magnesium, potassium, sodium salts (antacids) Not available* 15 years 01/01/2027 01/04/2027 No 27/05/2026 Active substance name was amended on 28/04/2022
Active substance name was amended on 06/03/2015 PSUSA/00000500/202701 none NAP
501 calcium bromolactobionate Not available* 15 years 01/01/2027 01/04/2027 No 01/10/2012 PSUSA/00000501/202701 NAP
502 calcium carbonate Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000502/202906 NAP
507 calcium chloride Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000507/204003 NAP
508 calcium chloride / dipotassium phosphate / magnesium chloride hexahydrate / potassium chloride / potassium phosphate monobasic / sodium chloride, disodium phosphate dihydrate/ potassium dihydrogen phosphate/ potassium hydroxide Not available* 15 years 01/01/2027 01/04/2027 No 31/07/2018 New active substances added to the entry on 31/07/2018 PSUSA/00000508/202701 NAP
509 calcium chloride / glucose anhydrous / glutathione disulphide / magnesium chloride hexahydrate Not available* 15 years 01/01/2027 01/04/2027 No 01/10/2012 PSUSA/00000509/202701 NAP
511 calcium chloride / glycine / magnesium aspartate dihydrate / sodium succinate hexahydrate Not available* 15 years 01/01/2027 01/04/2027 No 01/10/2012 PSUSA/00000511/202701 NAP
513 calcium chloride / glucose monohydrate / magnesium chloride hexahydrate Not available* 15 years 01/01/2027 01/04/2027 No 01/10/2012 PSUSA/00000513/202701 NAP
517 calcium folinate / cyanocobalamin Not available* 15 years 01/01/2027 01/04/2027 No 01/10/2012 PSUSA/00000517/202701 NAP
519 calcium folinate 5-hydrate / glutamine Not available* 15 years 01/01/2027 01/04/2027 No 01/10/2012 PSUSA/00000519/202701 NAP
520 calcium gluconate Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000520/204003 NAP
521 calcium carbonate / calcium lactate Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000521/203506 NAP
525 camphor, camphor and other terpene derivates Not available* 9 years 03/07/2029 01/10/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000525/202907 NAP
526 canakinumab 23/10/2009 5 years 30/06/2029 28/09/2029 No 06/10/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00000526/202906 Dirk Mentzer Germany CAP
527 candesartan, candesartan / hydrochlorothiazide 29/04/1997 5 years 28/04/2027 27/07/2027 No 02/06/2026 PSUSA/00000527/202704 Karin Bolin Sweden NAP
531 capecitabine 30/04/1998 5 years 29/04/2029 28/07/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00000531/202904 Dennis Lex Germany CAP NAP
532 capreomycin 19/01/1968 9 years 02/04/2028 01/07/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000532/202804 NAP
533 capsaicin 15/05/2009 5 years 15/05/2026 13/08/2026 No 02/02/2022 DLP was updated on 02/02/2022
Correction of PRAC Rapporteur name on 28/02/2017
'PSUR submission frequency and DLP were updated on 30/01/2017
'PRAC Rapporteur name was amended on 20/12/2016
'PRAC Rapporteur name updated on 04/02/2016
'Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 22/12/2014
Rapporteur name amended on 04/11/2014
The DLP was amended on 08/01/2014 PSUSA/00000533/202605 Ana Sofia Diniz Martins Portugal CAP NAP
535 captopril 15/04/1980 5 years 14/04/2030 13/07/2030 No 16/12/2020 PRAC representative was updated on 22/12/2021
DLP was updated on 16/12/2020
PRAC representative was updated on 06/05/2020
Lead MS and PRAC Rapporteur name amended on 19/12/2018
Next DLP was updated on 21/12/2015. PSUSA/00000535/203004 Miroslava Gocova Slovakia NAP
536 captopril / hydrochlorothiazide 15/04/1980 5 years 14/04/2026 13/07/2026 No 05/08/2025 PSUSA/00000536/202604 Tiphaine Vaillant France NAP
537 carbachol 10/11/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000537/203406 NAP
538 carbaethopendecinium Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000538/203506 NAP
539 carbamazepine 12/12/1961 7 years 11/12/2027 10/03/2028 No 22/09/2021 DLP and PRAC representative were updated on 22/09/2021
PRAC representative was added on 06/05/2020
LMS was added on 01/04/2020
DLP was corrected on 20/11/2019
PSUR frequency, "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?Yes/No" and DLP were updated on 25/09/2019 PSUSA/00000539/202712 Liana Martirosyan Netherlands NAP
541 carbasalate 16/07/1981 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000541/202811 NAP
543 carbazochrome 19/03/1951 11 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000543/203611 NAP
545 boric acid / carbethopendecinium bromide / sodium tetraborate Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000545/204003 NAP
546 carbetocin 24/06/1997 5 years 30/06/2027 28/09/2027 No 12/09/2025 DLP was updated on 01/03/2023
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 27/03/2018
Lead MS and PRAC Rapporteur name was added on 20/12/2016 PSUSA/00000546/202706 Veronika Macurová Czech Republic NAP
547 carbidopa / entacapone / levodopa 17/10/2003 3 years 17/10/2027 15/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00000547/202710 Terhi Lehtinen Finland CAP NAP
548 carbidopa / levodopa 13/08/1973 3 years 01/10/2028 30/12/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000548/202810 Barbara Kovacic Bytyqi Croatia NAP
550 carbimazole 31/08/1988 7 years 02/12/2030 02/03/2031 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00000550/203012 Dennis Lex Germany NAP
554 carbocisteine 14/09/1963 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000554/202803 NAP
555 carbocisteine / prenoxidiazine Not available* 9 years 03/07/2029 01/10/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000555/202907 NAP
557 carbomers Not available* 5 years 31/01/2027 01/05/2027 No 19/10/2022 DLP was updated on 19/10/2022
PRAC representative was updated on 28/07/2021
PRAC representative was updated on 28/04/2021
DLP was updated on 17/10/2017
Lead MS was amended on 22/09/2016
Lead MS and PRAC Rapporteur name was added on 28/07/2016
Active substance name was amended on 03/06/2016 PSUSA/00000557/202701 Polona Golmajer Slovenia NAP
558 carbon dioxide Not available* 8 years 01/12/2033 01/03/2034 No 30/10/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00000558/203312 Melinda Pálfi Hungary NAP
559 carboplatin 23/01/1986 5 years 23/01/2027 23/04/2027 Yes 19/10/2022 PSUR frequency and DLP were updated on 19/10/2022
PRAC representative was updated on 17/11/2021
PRAC representative was updated on 30/06/2021
DLP was udpated on 25/09/2019
Next DLP was amended on 19/10/2016
PRAC Representative was amended on 27/11/2015.
EURD and DLP amended on 06/10/2015
Lead MS added on 31/07/2015. PSUSA/00000559/202701 Amelia Cupelli Italy NAP
560 carboprost 09/01/1979 5 years 08/01/2026 08/04/2026 No 22/09/2021 DLP was updated on 22/09/2021
PRAC Rapporteur name updated on 27/06/2017
Next DLP was updated on 22/09/2016
Lead MS was added on 13/07/2015 PSUSA/00000560/202601 Eva Jirsová Czech Republic NAP
562 carmellose (eye preparation) 01/10/1990 15 years 03/06/2040 01/09/2040 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00000562/204006 Karin Bolin Sweden NAP
564 carglumic acid 24/01/2003 5 years 31/01/2030 01/05/2030 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00000564/203001 Ana Sofia Diniz Martins Portugal CAP
572 carnitine 01/09/1969 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000572/203408 NAP
574 carteolol 07/03/1984 5 years 31/03/2029 29/06/2029 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00000574/202903 Miroslava Gocova Slovakia NAP
575 carvedilol 18/04/1990 5 years 17/04/2027 16/07/2027 No 21/12/2022 DLP was updated on 21/12/2022
DLP was updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00000575/202704 Kimmo Jaakkola Finland NAP
576 caspofungin 24/10/2001 3 years 13/12/2027 12/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00000576/202712 Jo Robays Belgium CAP
582 estrogen / medroxyprogesterone 01/08/1987 5 years 31/08/2029 29/11/2029 No 12/09/2025 DLP was amended on 30/04/2025 PSUSA/00000582/202908 Veronika Macurová Czech Republic NAP
583 cefaclor 19/08/1976 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00000583/203303 Melinda Palfi Hungary NAP
584 cefadroxil 12/07/1976 5 years 11/07/2027 09/10/2027 No 05/04/2023 DLP was updated on 05/04/2023
DLP was updated on 27/03/2018
Lead MS and PRAC Rapporteur name was added on 20/12/2016 PSUSA/00000584/202707 Jan Neuhauser Austria NAP
585 cefalexin 15/03/1967 8 years 02/12/2026 02/03/2027 No 27/05/2026 PSUR frequency amended and DLP updated on 27/05/2026
PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000585/202612 none NAP
586 cefalotin Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000586/203506 NAP
587 cefamandole 29/08/1977 9 years 03/11/2028 01/02/2029 No 15/01/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000587/202811 Zane Neikena Latvia NAP
588 cefatrizine 27/08/1979 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000588/202811 NAP
589 cefazolin 29/11/1972 5 years 30/11/2026 28/02/2027 No 27/07/2022 DLP was updated on 27/07/2022
Next DLP was amended on 25/09/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00000589/202611 Jan Neuhauser Austria NAP
592 cefditoren 01/04/1994 8 years 31/03/2033 29/06/2033 No 30/10/2024 DLP was amended on 23/10/2024
PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000592/203303 Maria del Pilar Rayon Spain NAP
593 cefepime 29/06/1993 5 years 28/06/2029 26/09/2029 Yes 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 18/12/2024
DLP was updated on 02/03/2022
Next DLP was updated on 06/03/2019
Correction of PRAC Rapporteur name on 28/02/2017
PRAC Rapporteur name was amended on 20/12/2016
Next DLP was amended on 04/03/2016
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 04/03/2016
Lead MS added on 01/04/2015 PSUSA/00000593/202906 Ana Sofia Diniz Martins Portugal NAP
594 cefixime 30/06/1987 5 years 03/06/2030 01/09/2030 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00000594/203006 Eva Jirsová Czech Republic NAP
596 cefonicid Not available* 9 years 03/07/2029 01/10/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000596/202907 NAP
597 cefoperazone 12/01/1981 5 years 11/01/2026 11/04/2026 No 26/05/2025 DLP was updated on 22/09/2021
PRAC Rapporteur name was amended on 06/03/2019
Next DLP was updated on 22/09/2016
Lead MS was added on 13/07/2015 PSUSA/00000597/202601 Lina Seibokiene Lithuania NAP
598 cefoperazone / sulbactam 12/01/1981 5 years 11/01/2026 11/04/2026 No 26/05/2025 DLP was updated on 22/09/2021
PRAC Rapporteur name was amended on 06/03/2019
Next DLP was updated on 22/09/2016
Lead MS was added on 13/07/2015 PSUSA/00000598/202601 Lina Seibokiene Lithuania NAP
599 cefotaxime 18/12/1979 3 years 18/12/2027 17/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00000599/202712 Sonja Hrabcik Austria NAP
601 cefoxitin 16/03/1977 9 years 03/10/2028 01/01/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000601/202810 NAP
604 cefpodoxim 02/08/1990 7 years 02/12/2030 02/03/2031 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00000604/203012 Amelia Cupelli Italy NAP
605 cefprozil 23/12/1991 5 years 22/12/2027 21/03/2028 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00000605/202712 Polona Golmajer Slovenia NAP
606 cefradine 23/11/1971 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000606/202806 NAP
608 ceftazidime 17/10/1983 5 years 17/10/2028 15/01/2029 No 12/02/2025 DLP was amended on 03/07/2024 PSUSA/00000608/202810 Karin Bolin Sweden NAP
612 ceftizoxime 07/12/1981 9 years 03/11/2028 01/02/2029 No 15/01/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000612/202811 Ana Sofia Diniz Martins Portugal NAP
613 ceftriaxone 27/05/1982 5 years 26/05/2028 24/08/2028 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00000613/202805 Zane Neikena Latvia NAP
614 ceftriaxone sodium / lidocaine hydrochloride 27/05/1982 8 years 03/05/2033 01/08/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000614/203305 Amelia Cupelli Italy NAP
615 cefuroxime sodium (except for intracameral use) 18/08/1987 5 years 07/04/2027 06/07/2027 No 21/12/2022 DLP was updated on 21/12/2022
DLP was updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016
Name of entry was amended on 03/03/2014
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00000615/202704 Maia Uusküla Estonia NAP
616 celecoxib 31/12/1998 5 years 31/12/2028 31/03/2029 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026
DLP was amended on 25/09/2024 PSUSA/00000616/202812 Karin Bolin Sweden NAP
617 celiprolol 17/01/1983 8 years 16/01/2028 15/04/2028 No 23/09/2020 DLP was updated on 23/09/2020
PRAC representative was added on 06/05/2020
LMS was added on 31/07/2019 PSUSA/00000617/202801 Maia Uusküla Estonia NAP
624 certolizumab 01/10/2009 3 years 06/03/2026 04/06/2026 No 15/11/2023 DLP was amended on 15/11/2023 PSUSA/00000624/202603 Karin Bolin Sweden CAP
625 certoparin Not available* 5 years 01/04/2027 30/06/2027 No 21/12/2022 DLP was updated on 21/12/2022
PRAC representative added on 21/09/2022
LMS was added on 02/02/2022
PSUR frequency and DLP updated on 17/11/2021 PSUSA/00000625/202704 Dennis Lex Germany NAP
626 cetalkonium / choline salicylate 24/04/1995 8 years 03/08/2033 01/11/2033 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00000626/203308 Zoubida Amimour France NAP
628 cetirizine 06/11/1986 5 years 05/11/2027 03/02/2028 No 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00000628/202711 Terhi Lehtinen Finland NAP
629 cetirizine / pseudoephedrine 04/09/1995 5 years 31/08/2026 29/11/2026 No 28/04/2022 PRAC representative was updated on 19/10/2022
DLP and PRAC Representative were updated on 28/04/2022
DLP was updated on 23/05/2017
PRAC Representative amended on 18/11/2016
Lead MS and PRAC Rapporteur name was added on 07/04/2016 PSUSA/00000629/202608 Jo Robays Belgium NAP
630 cetrimide / chlorhexidine Not available* 9 years 03/07/2029 01/10/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000630/202907 NAP
631 cetrimide / lidocaine, cetrimide / lidocaine hydrochloride / zinc sulphate Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000631/203506 Jo Robays Belgium NAP
632 cetrimide / quinisocain chlorhydrate Not available* 8 years 01/12/2033 01/03/2034 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00000632/203312 none NAP
633 cetrorelix 13/04/1999 5 years 12/04/2030 11/07/2030 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00000633/203004 Dennis Lex Germany CAP NAP
635 cetuximab 29/06/2004 5 years 30/09/2028 29/12/2028 No 02/06/2026 PSUSA/00000635/202809 Jenny-Maria Jönsson Sweden CAP
636 cetylpyridinium 23/03/1939 11 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000636/203611 NAP
639 cetylpyridinium / lidocaine, lidocaine / chlorocresol / cetylpyridinium Not available* 10 years 03/06/2035 01/09/2035 No 18/12/2024 Active substance name was amended on 18/12/2024
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000639/203506 none NAP
640 cetylpyridinium / lysozyme, lysozyme / pyridoxine 12/01/1994 10 years 03/08/2035 01/11/2035 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00000640/203508 Zoubida Amimour France NAP
645 charcoal activated 06/04/1949 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000645/204001 NAP
646 bismuth subgallate / charcoal activated / citric acid Not available* 7 years 03/08/2031 01/11/2031 No 12/09/2025 PSUR frequency and DLP amended on 27/03/2024 PSUSA/00000646/203108 Veronika Macurová Czech Republic NAP
650 chlorambucil 14/09/1956 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000650/203401 NAP
651 chloramphenicol 25/06/1949 18 years 30/06/2030 28/09/2030 No 01/10/2012 PSUSA/00000651/203006 NAP
652 aminoacids / chloramphenicol / vitamin a Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000652/203001 NAP
654 chloramphenicol / dexamethasone 19/05/1964 18 years 31/05/2030 29/08/2030 No 01/10/2012 PSUSA/00000654/203005 NAP
655 chloramphenicol / hydrocortisone (ocular) 06/11/1958 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000655/203001 NAP
660 chlordiazepoxide 31/01/1960 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000660/203404 NAP
661 chlordiazepoxide / clidinium, amitriptyline / chlordiazepoxide Not available* 3 years 10/01/2027 10/04/2027 No 23/10/2024 PSUR frequency amended and DLP updated on 23/10/2024
Active substance name was amended on 23/10/2024
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000661/202701 none NAP
662 chlorhexidine 11/08/1976 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00000662/203303 Rugile Pilviniene Lithuania NAP
663 cetrimonium / chlorhexidine Not available* 9 years 03/07/2029 01/10/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000663/202907 NAP
664 chlorhexidine / dexpanthenol Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000664/202911 NAP
665 chlorhexidine / lidocaine 11/09/1963 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00000665/203405 NAP
669 chlorhexidine gluconate / isopropyl alcohol (covers other synonymous terms such as 2-propanol) Not available* 8 years 01/12/2025 01/03/2026 No 04/02/2026 Active substance name was amended on 04/02/2026
PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00000669/202512 Jo Robays Belgium NAP
677 chlormadinone 18/11/1974 3 years 31/01/2027 01/05/2027 Yes 21/10/2022 PSUR frequency and DLP updated on 21/10/2022
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" and DLP was amended on 29/06/2022
Next DLP was amended on 25/09/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016
The DLP was amended on 01/04/2014 PSUSA/00000677/202701 Dennis Lex Germany NAP
679 chlormadinone acetate / ethinylestradiol Not available* 3 years 31/01/2027 01/05/2027 No 21/10/2022 PSUR frequency and DLP updated on 21/10/2022
Next DLP was amended on 29/06/2022
Next DLP was amended on 25/09/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00000679/202701 Dennis Lex Germany NAP
682 chlorocresol Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000682/202911 NAP
684 chloropyramine Not available* 8 years 01/12/2028 01/03/2029 Yes 27/05/2026 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 27/05/2026
DLP was amended on 27/05/2026
PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00000684/202812 Zane Neikena Latvia NAP
685 chloroquine 20/08/1947 5 years 18/04/2026 17/07/2026 No 16/10/2025 DLP updated on 22/12/2021
DLP was updated on 03/06/2020
PSUR frequency and DLP were amended on 30/04/2019
European Union reference date, DLP and Submission date were amended on 28/02/2018
PRAC Representative amended on 19/12/2017
Next DLP was amended on 07/04/2016
Lead MS added on 01/04/2015 PSUSA/00000685/202604 Liana Martirosyan Netherlands NAP
689 chloroxylenol 01/01/1933 11 years 03/05/2040 01/08/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000689/204005 NAP
692 chlorphenamine 07/06/1954 10 years 01/01/2034 01/04/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000692/203401 NAP
693 chlorphenamine / paracetamol / pseudoephedrine, chlorphenamine / paracetamol / phenylephrine Not available* 10 years 03/05/2035 01/08/2035 No 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024
Active substance name was amended on 30/04/2024 PSUSA/00000693/203505 none NAP
694 acetylsalicylic acid / chlorphenamine / phenylephrine Not available* 8 years 03/11/2033 01/02/2034 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000694/203311 Adam Przybylkowski Poland NAP
696 ascorbic acid / chlorphenamine / paracetamol Not available* 6 years 03/11/2029 01/02/2030 No 19/09/2024 PSUSA/00000696/202911 Zoubida Amimour France NAP
697 ascorbic acid / caffeine / chlorphenamine / paracetamol Not available* 10 years 03/05/2035 01/08/2035 No 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024
Active substance name was amended on 30/04/2024 PSUSA/00000697/203505 none NAP
699 chlorphenamine / dextromethorphan hydrobromide / paracetamol Not available* 10 years 03/11/2034 01/02/2035 Yes 19/09/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00000699/203411 Maria Martinez Gonzalez Spain NAP
703 chlorphenamine / paracetamol 22/08/2001 7 years 03/03/2031 01/06/2031 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00000703/203103 Zoubida Amimour France NAP
710 chlorphenamine / pseudoephedrine, chlorphenamine / phenylephrine Not available* 10 years 03/05/2035 01/08/2035 Yes 30/04/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/04/2024
PSUR frequency amended and DLP updated on 30/04/2024
Active substance name was amended on 30/04/2024
PSUR frequency and DLP amended on 27/03/2024 PSUSA/00000710/203505 none NAP
715 chlorpromazine 29/05/1952 5 years 29/05/2028 27/08/2028 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00000715/202805 Tiphaine Vaillant France NAP
717 chlorprothixene 31/03/1959 3 years 31/03/2027 29/06/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00000717/202703 Zane Neikena Latvia NAP
718 chlortalidone 24/06/1959 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000718/203401 NAP
720 chlortalidone / oxprenolol 27/09/1976 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000720/203503 NAP
721 chlortalidone / reserpine 06/02/1962 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00000721/203405 NAP
723 chlortetracycline 01/04/1949 11 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000723/203611 NAP
726 chlorzoxazone 28/06/1960 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000726/203404 NAP
730 cholera vaccine (inactivated, oral) 28/04/2004 3 years 28/04/2026 27/07/2026 No 02/06/2026 PSUSA/00000730/202604 Karin Bolin Sweden CAP
732 choline salicylate 10/12/1963 13 years 10/12/2025 10/03/2026 No 28/03/2025 PSUSA/00000732/202512 Adam Przybylkowski Poland NAP
733 chlorobutanol hemihydrate / choline salicylate / hexetidine Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000733/202911 NAP
736 choriogonadotropin alfa, chorionic gonadotrophin 02/02/2001 3 years 19/09/2028 18/12/2028 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00000736/202809 Bianca Mulder Netherlands CAP NAP
738 chrome alum Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000738/202911 NAP
739 chromium (51 cr) edta 30/11/1975 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000739/203503 NAP
742 ciclesonide 24/02/2004 5 years 23/08/2029 21/11/2029 No 02/06/2026 PSUSA/00000742/202908 Karin Bolin Sweden NAP
745 ciclosporin (systemic use) 15/12/1982 3 years 31/12/2027 30/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00000745/202712 Maia Uusküla Estonia NAP
748 cilastatin / imipenem 28/06/1984 5 years 27/06/2027 25/09/2027 No 01/03/2023 DLP was updated on 01/03/2023
PRAC Rapporteur name amended on 04/07/2018
PSUR Frequency amended and DLP updated on 28/02/2018
PRAC Representative name was amended on 17/10/2017
PRAC representative and Lead Member State were added on 18/11/2016
Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00000748/202706 Karen Pernille Harg Norway NAP
749 cilazapril, cilazapril / hydrochlorothiazide 21/02/1990 5 years 20/02/2029 21/05/2029 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00000749/202902 Carla Torre Portugal NAP
753 cimetidine 09/11/1976 9 years 02/09/2028 01/12/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000753/202809 NAP
755 cimicifuga racemosa (L.) nutt., rhizoma Not available* 5 years 01/01/2028 31/03/2028 Yes 20/09/2023 DLP amended on 20/09/2023 PSUSA/00000755/202801 Jan Neuhauser Austria NAP
757 cinchocaine Not available* 8 years 01/12/2028 01/03/2029 Yes 27/05/2026 DLP was amended on 27/05/2026
PSUR frequency amended and DLP updated on 27/05/2026
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 27/05/2026
PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00000757/202812 Dennis Lex Germany NAP
759 1,3-butanediol / cinchocaine hydrochloride / dexamethasone 23/09/1983 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000759/202812 NAP
761 cinchocaine hydrochloride / hydrocortisone Not available* 7 years 03/08/2031 01/11/2031 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00000761/203108 John Joseph Borg Malta NAP
762 cinchocaine hydrochloride / policresulen Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000762/202911 NAP
766 cinnarizine 01/11/1961 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00000766/203405 NAP
767 cinnarizine / dimenhydrinate 19/03/1996 8 years 03/11/2033 01/02/2034 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000767/203311 Jan Neuhauser Austria NAP
768 cinnarizine / piracetam Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000768/202911 NAP
769 cinolazepam 02/12/1994 8 years 01/12/2032 01/03/2033 Yes 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00000769/203212 Miroslava Gocova Slovakia NAP
771 ciprofibrate 09/12/1983 5 years 09/12/2026 09/03/2027 No 08/04/2026 DLP was updated on 27/07/2022
Lead MS and PRAC Rapporteur name amended on 19/12/2018
Next DLP was amended on 25/09/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00000771/202612 Jo Robays Belgium NAP
772 ciprofloxacin / fluocinolone acetonide 25/03/2002 7 years 02/04/2031 01/07/2031 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00000772/203104 Maria del Pilar Rayon Spain NAP
774 ciprofloxacin hydrochloride / hydrocortisone Not available* 3 years 30/11/2026 28/02/2027 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00000774/202611 Amelia Cupelli Italy NAP
775 ciprofloxacin (systemic use) 31/01/1987 5 years 02/04/2028 01/07/2028 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00000775/202804 Karen Pernille Harg Norway NAP
776 ciprofloxacin (topical use) 31/01/1987 5 years 31/01/2028 30/04/2028 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00000776/202801 Karen Pernille Harg Norway NAP
777 cisatracurium 07/08/1995 8 years 31/07/2033 29/10/2033 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00000777/203307 Veronika Macurová Czech Republic NAP
778 cisplatin 19/12/1978 5 years 18/12/2027 17/03/2028 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00000778/202712 Marie Louise Schougaard Christiansen Denmark NAP
779 citalopram 31/12/1989 5 years 31/12/2026 31/03/2027 No 21/09/2022 DLP was updated on 21/09/2022
PRAC Rapporteur name was amended on 31/07/2018
Next DLP was amended on 25/09/2017
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/09/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00000779/202612 Karin Bolin Sweden NAP
780 citicoline 31/12/1966 10 years 03/07/2034 01/10/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000780/203407 NAP
781 citric acid Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000781/204001 NAP
782 citric acid / magnesium / sodium, citric acid anhydrous / light magnesium oxide / sodium picosulfate Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000782/202911 none NAP
783 citric acid / potassium salts, potassium citrate, potassium sodium hydrogen citrate, citric acid / potassium citrate / sodium citrate Not available* 6 years 03/11/2029 01/02/2030 No 02/04/2025 Active substance name was amended on 02/04/2025
DLP was amended on 03/07/2024 PSUSA/00000783/202911 Polona Golmajer Slovenia NAP
785 citric acid / sodium Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000785/204001 NAP
786 citric acid / urea Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000786/204001 NAP
787 cladribine (apart from products with multiple sclerosis indication) 26/02/1993 3 years 25/02/2027 26/05/2027 No 20/10/2021 DLP was updated on 20/10/2021
PRAC representative was updated on 31/03/2021
PRAC representative was updated on 25/09/2019
LMS and PRAC representative were updated on 05/06/2019
DLP was updated on 21/11/2018
Entry name amended on 19/12/2017
PRAC Representative was amended on 28/03/2017
next DLP was amended on 29/10/2015 PSUSA/00000787/202702 Marie Louise Schougaard Christiansen Denmark CAP NAP
788 clarithromycin 17/07/1989 3 years 01/04/2026 30/06/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00000788/202604 Eamon O'Murchu Ireland NAP
789 clebopride 22/02/1979 8 years 30/06/2032 28/09/2032 No 19/09/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00000789/203206 Maria Martinez Gonzalez Spain NAP
790 clebopride hydrogen maleate / simeticone Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 PSUR frequency and DLP amended on 28/08/2024. PSUSA/00000790/202912 NAP
791 clemastine 11/10/1966 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000791/202803 NAP
792 clemastine / dexamethasone Not available* 7 years 03/08/2031 01/11/2031 No 27/03/2024 PSUR frequency and DLP amended on 27/03/2024 PSUSA/00000792/203108 none NAP
794 clenbuterol 12/12/1980 5 years 30/09/2031 29/12/2031 Yes 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
Next DLP was updated on 31/05/2023 PSUSA/00000794/203109 Amelia Cupelli Italy NAP
795 clindamycin 16/10/1969 3 years 15/10/2027 13/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00000795/202710 Sonja Hrabcik Austria NAP
796 benzoyl peroxide / clindamycin phosphate 26/01/1983 8 years 03/05/2033 01/08/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000796/203305 Rugile Pilviniene Lithuania NAP
797 clioquinol Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 PSUR frequency and DLP amended on 28/08/2024. PSUSA/00000797/202912 NAP
798 clobazam 06/02/1970 8 years 06/02/2028 06/05/2028 No 21/10/2020 DLP was updated on 21/10/2020
PRAC representative was updated on 23/09/2020
PRAC representative was added on 06/05/2020
LMS was added on 01/04/2020
PSUR frequency and DLP were updated on 25/09/2019 PSUSA/00000798/202802 Kimmo Jaakkola Finland NAP
799 clobetasol 21/02/1973 5 years 28/02/2030 29/05/2030 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00000799/203002 Jo Robays Belgium NAP
800 clobetasone 17/09/1975 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000800/202808 NAP
805 clofarabine 29/05/2006 3 years 28/12/2026 28/03/2027 Yes 25/09/2024 DLP was amended on 25/09/2024
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/09/2024
PSUR frequency, DLP and PSURs required for products referred to in Articles 10(1), 10a, 16a of Directive 2001/83/EC as amended were updated on 28/07/2021
DLP and PRAC representative were updated on 29/07/2020
Reference to NAP added on 01/07/2020
New CAP authorised on 14/11/2019
DLP and Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" were updated on 31/07/2019
PRAC representative was updated on 03/06/2020
PRAC representative was updated on 03/06/2020
DLP was updated on 31/07/2018
DLP updated and PRAC Rapporteur name amended on 21/07/2017
PRAC Rapporteur name was amended on 28/07/2016
Next DLP and PRAC Rapporteur name updated was amended on 28/07/2016
PRAC Rapporteur name updated on 03/06/2016 PSUSA/00000805/202612 Tiphaine Vaillant France CAP NAP
806 clofazimine 24/04/1969 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000806/202805 none NAP
809 clomethiazole 01/11/1959 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000809/203401 NAP
810 clomifene Not available* 8 years 01/12/2025 01/03/2026 No 30/10/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00000810/202512 Eva Jirsová Czech Republic NAP
811 clomipramine 18/10/1965 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00000811/203303 Dennis Lex Germany NAP
812 clonazepam 27/06/1973 5 years 26/06/2030 24/09/2030 Yes 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00000812/203006 Maia Uusküla Estonia NAP
813 clonidine 16/08/1967 5 years 16/08/2030 14/11/2030 No 27/05/2026 DLP was corrected on 27/05/2026
PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00000813/203008 Carla Torre Portugal NAP
815 clonixin 28/02/1975 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000815/203503 NAP
816 clopamide / dihydroegocrystine / reserpine 30/04/1966 10 years 03/07/2034 01/10/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000816/203407 NAP
819 cloperastine 12/08/1981 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000819/202811 NAP
820 acetylsalicylic acid / clopidogrel, clopidogrel 15/07/1998 3 years 17/11/2025 15/02/2026 No 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00000820/202511 Carla Torre Portugal CAP NAP
821 cloprednol Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 PSUR frequency and DLP amended on 28/08/2024. PSUSA/00000821/202912 NAP
822 clorazepate 03/08/1966 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000822/202803 NAP
824 clorazepate dipotassium Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 PSUR frequency and DLP amended on 28/08/2024. PSUSA/00000824/202912 NAP
826 clotiapine Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 PSUR frequency and DLP amended on 28/08/2024. PSUSA/00000826/202912 NAP
827 clotiazepam 18/05/1978 5 years 31/05/2030 29/08/2030 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000827/203005 Jo Robays Belgium NAP
828 clotrimazole / hexamidine diisetionate / prednisolone acetate 13/11/1991 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000828/202901 NAP
829 clotrimazole 08/10/1975 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00000829/203303 Melinda Palfi Hungary NAP
830 clotrimazole / dexamethasone Not available* 10 years 03/11/2034 01/02/2035 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00000830/203411 Carla Torre Portugal NAP
831 clotrimazole / hydrocortisone Not available* 10 years 03/11/2034 01/02/2035 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00000831/203411 Rhea Fitzgerald Ireland NAP
832 clotrimazole / metronidazole Not available* 7 years 03/11/2031 01/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00000832/203111 Roxana Dondera Romania NAP
834 clotrimazole / hexamidine diisetionate 13/11/1991 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000834/202901 NAP
835 cloxacillin 05/01/1962 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00000835/203405 NAP
836 clozapine 24/10/1969 5 years 03/03/2030 01/06/2030 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00000836/203003 Amelia Cupelli Italy NAP
838 cobamamide, hydroxocobalamin (except for products for chemical poisoning), hydroxocobalamin / cobamamide 27/11/1969 10 years 02/09/2034 01/12/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000838/203409 NAP
843 codeine 06/09/1954 5 years 31/01/2030 01/05/2030 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00000843/203001 Petar Mas Croatia NAP
850 codeine / ibuprofen 05/03/1993 5 years 02/12/2028 02/03/2029 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00000850/202812 Tiphaine Vaillant France NAP
851 codeine / paracetamol 01/09/1972 5 years 03/03/2030 01/06/2030 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00000851/203003 Veronika Macurová Czech Republic NAP
858 colchicine 30/07/1947 5 years 30/07/2028 28/10/2028 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00000858/202807 Maria del Pilar Rayon Spain NAP
863 sodium fluoride, colecalciferol / sodium fluoride, dectaflur / olaflur / sodium fluoride 22/01/1980 9 years 03/11/2028 01/02/2029 No 02/04/2025 Active substance name was amended on 02/04/2025
PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000863/202811 none NAP
864 colesevelam 10/03/2004 3 years 10/03/2027 08/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00000864/202703 Bianca Mulder Netherlands CAP NAP
865 colestipol 25/06/1976 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000865/202808 NAP
866 colestyramine 02/04/1965 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000866/202803 NAP
868 colistin sulphate 17/01/1962 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00000868/203405 NAP
873 conestat alfa 28/10/2010 6 months 28/04/2026 07/07/2026 28/10/2026 06/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000873/202604 PSUSA/00000873/202610 Jan Neuhauser Austria CAP
875 corifollitropin alfa 25/01/2010 3 years 24/07/2026 22/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00000875/202607 Bianca Mulder Netherlands CAP
876 corticorelin 01/10/1988 5 years 31/10/2029 29/01/2030 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00000876/202910 Jan Neuhauser Austria NAP
878 cortisone 18/06/1952 10 years 01/01/2034 01/04/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000878/203401 NAP
879 chloramphenicol / cortisone acetate / ethacridine lactate / zinc oxide 25/06/1949 11 years 03/05/2040 01/08/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000879/204005 NAP
883 cromoglicic acid 01/02/1969 5 years 01/02/2027 02/05/2027 No 19/10/2022 DLP was updated on 19/10/2022
PRAC Rapporteur name updated on 23/10/2018
Correction of DLP on 31/01/2018
DLP was amended on 15/11/2017
Lead MS was added on 22/09/2016 PSUSA/00000883/202702 Eamon O'Murchu Ireland NAP
884 crotamiton 14/11/1946 11 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000884/203611 NAP
885 crotamiton / hydrocortisone 17/12/1963 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000885/203406 NAP
886 cyamemazine 14/06/1971 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00000886/203303 Tiphaine Vaillant France NAP
888 cyanocobalamin 22/02/1952 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000888/203212 NAP
892 cyanocobalamin / folic acid, cyanocobalamin / folic acid / potassium iodide Not available* 7 years 03/11/2032 01/02/2033 Yes 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000892/203211 Ana Sofia Diniz Martins Portugal NAP
893 cyanocobalamin / folic acid / pyridoxine Not available* 7 years 03/11/2031 01/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00000893/203111 Dennis Lex Germany NAP
894 cyanocobalamin / l-arginine l-2 pyrrolidone-5-carboxylate Not available* 8 years 03/03/2026 01/06/2026 No 05/08/2025 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00000894/202603 Amelia Cupelli Italy NAP
896 cyclizine 02/02/1956 6 years 01/02/2032 01/05/2032 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00000896/203202 none NAP
898 cyclobenzaprine Not available* 12 years 03/06/2040 01/09/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000898/204006 NAP
899 cyclopenthiazide 11/01/1961 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000899/203906 NAP
900 cyclopentolate 19/02/1957 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000900/203401 NAP
901 cyclophosphamide 13/10/1958 12 years 31/01/2037 01/05/2037 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00000901/203701 Dennis Lex Germany NAP
902 cyproheptadine 21/12/1961 5 years 31/12/2028 31/03/2029 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00000902/202812 Melinda Palfi Hungary NAP
905 cyproterone 22/11/2009 5 years 03/07/2028 01/10/2028 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00000905/202807 Barbara Kovacic Bytyqi Croatia NAP
906 cyproterone / ethinylestradiol Not available* 3 years 31/05/2026 29/08/2026 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00000906/202605 Bianca Mulder Netherlands NAP
907 cyproterone acetate / estradiol valerate Not available* 8 years 03/03/2026 01/06/2026 No 05/08/2025 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00000907/202603 Tiphaine Vaillant France NAP
908 cystine Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000908/204003 NAP
910 cystine / pyridoxine hydrochloride Not available* 8 years 03/03/2026 01/06/2026 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00000910/202603 NAP
911 cytarabine 11/07/2001 5 years 31/03/2030 29/06/2030 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00000911/203003 Melinda Palfi Hungary NAP
913 cytisine, cytisinicline 25/02/2009 13 years 24/02/2031 25/05/2031 Yes 28/02/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/02/2024
DLP was amended on 28/02/2024
Active substance name was amended on 28/02/2024 PSUSA/00000913/203102 none NAP
914 cytomegalovirus immunoglobulin 29/12/1995 5 years 31/01/2026 01/05/2026 Yes 20/10/2021 PRAC representative was updated on 01/03/2023
DLP was updated on 20/10/2021
Next DLP was amended on 19/10/2016
The DLP was amended on 30/09/20145.
Lead MS was added on 13/07/2015 PSUSA/00000914/202601 Dirk Mentzer Germany NAP
918 dabigatran 18/03/2008 3 years 18/03/2026 16/06/2026 No 01/04/2026 Reference to NAP added on 01/04/2026
PSUR frequency amended and DLP updated on 15/11/2023 PSUSA/00000918/202603 Marie Louise Schougaard Christiansen Denmark CAP NAP
919 dacarbazine 01/02/1978 5 years 01/02/2028 01/05/2028 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00000919/202802 Jan Neuhauser Austria NAP
920 dactinomycin 01/07/1963 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000920/202803 NAP
922 dalteparin sodium 26/08/1985 2 years 31/08/2026 29/11/2026 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00000922/202608 Rugile Pilviniene Lithuania NAP
923 danaparoid 01/12/1992 5 years 01/12/2028 01/03/2029 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00000923/202812 Eamon O'Murchu Ireland NAP
924 danazol 10/06/1974 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000924/202808 NAP
925 dantrolene 31/01/1974 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000925/202808 NAP
927 dapiprazole 06/08/1985 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000927/202812 NAP
928 dapoxetine 17/12/2008 5 years 17/12/2028 17/03/2029 No 02/06/2026 PSUSA/00000928/202812 Jenny Jönsson Sweden NAP
929 dapsone Not available* 8 years 03/03/2026 01/06/2026 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00000929/202603 NAP
930 dapsone / ferrous oxalate 01/01/1974 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000930/202806 NAP
931 daptomycin 19/01/2006 5 years 11/09/2029 10/12/2029 No 25/05/2022 DLP was updated on 25/05/2022
Submission date corrected on 06/05/2020
DLP and PSUR frequency updated on 30/04/2019
PRAC Rapporteur name updated on 03/04/2018
Lead MS and PRAC Rapporteur name updated on 23/10/2018
DLP was updated on 07/05/2018
Next DLP was amended on 26/04/2017
Next DLP was amended on 03/05/2016
"Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended? Yes/No" was amended on 16/07/2015 PSUSA/00000931/202909 Pernille Harg Norway CAP
932 darbepoetin alfa 08/06/2001 3 years 31/10/2026 29/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00000932/202610 Dennis Lex Germany CAP
933 darifenacin 22/10/2004 5 years 31/10/2029 29/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00000933/202910 Maria del Pilar Rayon Spain CAP
934 darunavir 12/02/2007 5 years 23/12/2028 23/03/2029 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00000934/202812 Liana Martirosyan Netherlands CAP
935 dasatinib 20/11/2006 3 years 27/06/2028 25/09/2028 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00000935/202806 Marie Louise Schougaard Christiansen Denmark CAP NAP
936 daunorubicin 08/06/1966 3 years 07/06/2027 05/09/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00000936/202706 Sonja Hrabcik Austria NAP
939 deferasirox 28/08/2006 5 years 31/10/2030 29/01/2031 Yes 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
DLP was amended on 28/06/2023 PSUSA/00000939/203010 Tiphaine Vaillant France CAP NAP
940 deferiprone 25/08/1999 5 years 31/08/2029 29/11/2029 No 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00000940/202908 Tiphaine Vaillant France CAP
941 deferoxamine 01/12/1962 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000941/202803 NAP
943 deflazacort 26/03/1982 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000943/202811 NAP
944 degarelix 17/02/2009 5 years 17/02/2027 18/05/2027 No 19/10/2022 PSUR frequency and DLP were updated on 19/10/2022
PRAC representative was updated on 29/07/2020
PRAC representative was updated on 03/06/2020
DLP was updated on 23/10/2019
PRAC Rapporteur name updated on 21/07/2017
PSUR Frequency amended and DLP updated on 22/09/2016
PRAC Rapporteur name was amended on 28/07/2016
PRAC Rapporteur name updated on 03/06/2016
Next DLP was amended on 30/09/2015.
DLP was amended on 01/04/2015. PSUSA/00000944/202702 Tiphaine Vaillant France CAP
945 dehydrocholic acid Not available* 9 years 03/11/2026 01/02/2027 Yes 27/01/2026 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 05/03/2025
PSUR frequency amended and DLP updated on 05/03/2025
PSUR frequency and DLP amended on 27/03/2024 PSUSA/00000945/202611 Roxana Stefania Udrescu Romania NAP
949 delorazepam 24/02/1978 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000949/202811 NAP
951 demeclocycline 23/08/1967 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000951/203408 NAP
954 denosumab (indicated for osteoporosis and for bone loss associated with hormone ablation in prostate cancer) 26/05/2010 3 years 26/09/2027 25/12/2027 No 02/06/2026 PSUSA/00000954/202709 Karin Bolin Sweden CAP
957 dermatan sulfate Not available* 7 years 03/11/2031 01/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00000957/203111 Amelia Cupelli Italy NAP
958 desflurane 18/09/1992 3 years 30/09/2026 29/12/2026 Yes 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00000958/202609 Melinda Palfi Hungary NAP
962 desloratadine 15/01/2001 5 years 15/07/2026 13/10/2026 No 25/06/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/06/2025
PRAC representative was updated on 19/10/2022
PRAC Representative amended on 28/04/2022
DLP was updated on 30/03/2022
DLP was updated on 28/03/2017
PRAC Representative amended on 18/11/2016 PSUSA/00000962/202607 Jo Robays Belgium CAP NAP
963 desloratadine / pseudoephedrine 30/07/2007 5 years 15/07/2026 13/10/2026 No 28/04/2022 PRAC representative was updated on 19/10/2022
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 27/07/2022
PRAC Representative amended on 28/04/2022
DLP was updated on 30/03/2022
DLP was updated on 28/03/2017
PRAC Representative amended on 18/11/2016 PSUSA/00000963/202607 Jo Robays Belgium CAP
964 desmopressin 01/12/1972 3 years 31/12/2026 31/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000964/202612 Jan Neuhauser Austria NAP
966 desogestrel 01/07/1998 5 years 01/07/2026 29/09/2026 No 02/06/2026 PSUSA/00000966/202607 Jenny Jönsson Sweden NAP
967 desogestrel / ethinylestradiol 01/10/1994 5 years 30/09/2030 29/12/2030 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000967/203009 Kimmo Jaakkola Finland NAP
968 desonide 31/08/1985 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000968/202812 NAP
969 desoximetasone 23/01/1968 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000969/203408 NAP
973 dexamethasone (apart from centrally authorised products) 01/01/1952 5 years 31/01/2026 01/05/2026 No 19/10/2022 PRAC representative was updated on 19/10/2022
PRAC representative was updated on 27/07/2022
DLP was updated on 20/10/2021
PRAC representative was updated on 30/06/2021
Next DLP was amended on 19/10/2016
Entry name amended on 03/05/2016
Rapporteur's name was amended on 27/11/2015.
Lead MS added on 31/07/2015. PSUSA/00000973/202601 Amelia Cupelli Italy NAP
974 dexamethasone / framycetin / gramicidin 10/08/1954 11 years 01/12/2036 01/03/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000974/203612 NAP
977 dexamethasone / neomycin / polymyxin b, dexamethasone / neomycin 01/01/1952 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000977/203212 none NAP
978 dexamethasone / polymyxin b / trimethoprim 01/01/1952 12 years 03/06/2040 01/09/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000978/204006 NAP
979 dexamethasone / tobramycin (topical and ophtalmic use, except systemic formulations) Not available* 5 years 31/03/2026 29/06/2026 No 27/07/2022 PRAC representative was updated on 27/07/2022
DLP and active substance name updated on 22/12/2021
PRAC representative was updated on 30/06/2021
LMS and PRAC representative were added on 23/06/2020
PSUR Frequency amended and next DLP updated on 25/09/2017 PSUSA/00000979/202603 Amelia Cupelli Italy NAP
980 dexamethasone / lidocaine Not available* 8 years 11/05/2032 09/08/2032 Yes 05/06/2024 PSUR frequency amended and DLP updated on 05/06/2024
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 05/06/2024
Active substance name was amended on 05/06/2024 PSUSA/00000980/203205 none NAP
982 dexamethasone isonicotinate / tramazoline hydrochloride monohydrate 01/01/1963 11 years 03/07/2039 01/10/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000982/203907 NAP
983 dexamethasone / framycetin sulfate / polymyxin b sulfate Not available* 10 years 01/12/2032 01/03/2033 Yes 05/06/2024 PSUR frequency amended and DLP updated on 05/06/2024
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 05/06/2024
Entry re-activated on 05/06/2024
Name of active substance was amended on 28/02/2013 PSUSA/00000983/203212 none NAP
984 dexamethasone sodium phosphate / gentamicin sulfate Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000984/203008 NAP
985 dexamethasone (centrally authorised product indicated in uveitis and macular oedema) 27/07/2010 5 years 27/01/2030 27/04/2030 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00000985/203001 Maria del Pilar Rayon Spain CAP
986 dexamfetamine Not available* 3 years 11/09/2027 10/12/2027 Yes 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00000986/202709 Ana Sofia Diniz Martins Portugal NAP
989 dexchlorpheniramine 18/02/1962 3 years 30/06/2027 28/09/2027 No 05/03/2025 DLP was amended on 05/03/2025 PSUSA/00000989/202706 Ana Sofia Diniz Martins Portugal NAP
996 dexibuprofen 25/07/2000 3 years 31/08/2026 29/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00000996/202608 Jan Neuhauser Austria NAP
997 dexketoprofen, dexketoprofen / tramadol 07/07/2002 5 years 31/10/2029 29/01/2030 No 19/09/2025 Entry name updated on 24/09/2025
PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00000997/202910 Maria Martinez Gonzalez Spain NAP
998 dexmedetomidine 16/09/2011 3 years 15/03/2027 13/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00000998/202703 Karin Bolin Sweden CAP NAP
999 dexpanthenol 03/03/1999 10 years 02/01/2034 02/04/2034 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00000999/203401 Terhi Lehtinen Finland NAP
1000 dexpanthenol / dimethyl sulfoxide / heparin Not available* 8 years 03/03/2026 01/06/2026 No 05/08/2025 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00001000/202603 Jan Neuhauser Austria NAP
1001 dexrazoxane 17/02/1992 3 years 28/02/2028 28/05/2028 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00001001/202802 Tiphaine Vaillant France CAP NAP
1002 dextran Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001002/203506 NAP
1006 dextran 70 / sodium chloride Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001006/204003 NAP
1009 dextromethorphan, dextromethorphan / guaifenesin 01/01/1966 5 years 01/11/2026 30/01/2027 No 20/05/2026 Lead MS and PRAC Rapporteur name updated on 27/05/2026
Entry amended following merge on 28/05/2025
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 26/07/2023
PSUR frequency and DLP were updated on 28/06/2022
PRAC Representative was amended on 28/04/2022
DLP was updated on 03/07/2019
PRAC Representative was amended on 18/11/2016
Next DLP was amended on 28/07/2016
Lead MS added on 16/06/2015 PSUSA/00001009/202611 Maria del Pilar Rayon Spain NAP
1013 dextromethorphan hydrobromide / diphenhydramine hydrochloride / levomenthol Not available* 7 years 03/11/2031 01/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00001013/203111 John Joseph Borg Malta NAP
1015 dextromethorphan hydrobromide / paracetamol / phenylpropanolamine hydrochloride Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001015/203008 NAP
1021 dextromethorphan hydrobromide / pseudoephedrine hydrochloride / triprolidine hydrochloride Not available* 10 years 03/11/2034 01/02/2035 No 19/09/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00001021/203411 Maria Martinez Gonzalez Spain NAP
1026 diacerein 12/08/2007 5 years 15/12/2025 15/03/2026 Yes 22/09/2021 PSUR frequency and DLP were updated on 22/09/2021
PRAC representative was updated on 26/05/2021
PRAC Representative updated on 26/09/2018
DLP was updated on 31/07/2018
PSUR Frequency amended and next DLP updated on 25/09/2017
'PRAC Rapporteur name updated on 21/07/2017
Next DLP and PRAC Rapporteur name were amended on 28/07/2016
DLP amended on 31/07/2015
'Lead MS was added on 22/12/2014
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2014 PSUSA/00001026/202512 Tiphaine Vaillant France NAP
1028 diamorphine Not available* 7 years 03/11/2031 01/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00001028/203111 Liana Martirosyan Netherlands NAP
1029 diazepam 29/11/1963 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00001029/203303 Karin Erneholm Denmark NAP
1030 diazepam / pyridoxine 04/04/1966 11 years 02/12/2039 01/03/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001030/203912 NAP
1032 diazoxide 29/12/1972 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001032/202806 NAP
1034 dibotermin alfa 09/09/2002 5 years 08/09/2030 07/12/2030 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00001034/203009 Bianca Mulder Netherlands CAP
1040 diclofenac / misoprostol Not available* 3 years 17/07/2028 15/10/2028 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00001040/202807 Karin Erneholm Denmark NAP
1041 cyanocobalamin / diclofenac / pyridoxine / thiamine Not available* 5 years 01/01/2030 01/04/2030 Yes 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00001041/203001 Adam Przybylkowski Poland NAP
1044 diclofenac / lidocaine 11/11/2009 5 years 11/11/2029 09/02/2030 Yes 17/12/2025 Entry re-activated on 17/12/2025 PSUSA/00001044/202911 to be assigned none NAP
1045 diclofenac sodium / orphenadrine citrate Not available* 8 years 03/03/2026 01/06/2026 No 27/01/2026 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00001045/202603 Roxana Stefania Udrescu Romania NAP
1048 diclofenac (systemic formulations) 11/05/1977 5 years 30/09/2029 29/12/2029 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001048/202909 Karin Erneholm Denmark NAP
1050 dicloxacillin 24/02/1961 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001050/203404 NAP
1051 dicycloverine, dicyloverine/ paracetamol, dicycloverine/ doxylamine 11/05/1950 11 years 03/05/2040 01/08/2040 Yes 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001051/204005 NAP
1057 dienogest / ethinylestradiol 14/02/1995 5 years 15/03/2028 13/06/2028 No 15/11/2023 DLP was amended on 15/11/2023 PSUSA/00001057/202803 Dennis Lex Germany NAP
1058 diethylamine salicylate Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001058/204003 NAP
1059 diethylcarbamazine 09/01/1974 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001059/202806 NAP
1061 diflucortolone Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001061/203008 NAP
1062 diflucortolone valerate / isoconazole nitrate Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001062/203008 NAP
1063 diflunisal (for nationally authorised products) Not available* 9 years 03/11/2030 01/02/2031 No 24/09/2025 Entry name updated on 28/08/2024
PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001063/203011 none NAP
1064 digitoxin 11/09/1952 10 years 01/01/2034 01/04/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001064/203401 NAP
1065 digoxin, metildigoxin 01/11/1930 10 years 03/11/2032 01/02/2033 No 18/10/2023 PSUR frequency amended and DLP updated on 18/10/2023 PSUSA/00001065/203211 none NAP
1066 digoxin specific antibody fragments 05/10/1983 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001066/202812 NAP
1069 artenimol / piperaquine tetraphosphate 27/10/2011 5 years 27/10/2030 25/01/2031 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
DLP was amended on 28/06/2023 PSUSA/00001069/203010 Dennis Lex Germany CAP
1070 dihydrocodeine 11/11/1921 11 years 03/11/2036 01/02/2037 No 18/10/2023 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" , PSUR frequency and DLP wereamended on 18/10/2023 PSUSA/00001070/203611 none NAP
1075 dihydroergotamine 01/07/1946 3 years 01/04/2027 30/06/2027 Yes 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00001075/202704 Adam Przybylkowski Poland NAP
1080 dihydrotachysterol 01/04/1959 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001080/203401 NAP
1082 diiodohydroxyquinoline Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001082/203011 NAP
1083 diisopropylamine Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001083/203011 NAP
1084 diltiazem 02/05/1979 5 years 02/05/2027 31/07/2027 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001084/202705 Karin Erneholm Denmark NAP
1088 caffeine / dimenhydrinate, dimenhydrinate 10/02/1950 8 years 01/12/2025 01/03/2026 No 15/01/2025 Active substance name, PSUR frequency and DLP were amended on 18/10/2023 PSUSA/00001088/202512 Maria Martinez Gonzalez Spain NAP
1089 dimercaptosuccinic acid (dmsa) 31/05/1982 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001089/202812 NAP
1094 dimeticone 17/11/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001094/203406 NAP
1095 aluminium hydroxide gel / dimeticone / magnesium hydroxide Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001095/202903 NAP
1097 clebopride / dimeticone Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 PSUR frequency and DLP amended on 28/08/2024. PSUSA/00001097/202912 NAP
1098 dihydroxyaluminum sodium carbonate, dihydroxyaluminum sodium carbonate / dimeticone Not available* 10 years 03/11/2034 01/02/2035 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00001098/203411 Ana Sofia Diniz Martins Portugal NAP
1099 dimeticone / guaiazulene Not available* 8 years 03/03/2026 01/06/2026 No 05/08/2025 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00001099/202603 Tiphaine Vaillant France NAP
1100 dimeticone / metoclopramide / oxazepam hemisuccinate / polyenzymes Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001100/203506 NAP
1101 dimetindene 01/08/1961 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00001101/203405 NAP
1102 dimetindene / phenylephrine 29/09/1965 5 years 15/07/2030 13/10/2030 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00001102/203007 Jana Pecherova Slovakia NAP
1103 dinoprost trometamol 08/05/1973 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001103/202806 NAP
1104 dinoprostone 26/09/1972 3 years 30/09/2028 29/12/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00001104/202809 Jenny Jönsson Sweden NAP
1105 diosmectite 12/11/1975 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001105/202808 NAP
1106 diosmin Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001106/203011 NAP
1107 diosmin / hesperidin, ascorbic acid/ dry Ruscus extract titrated in sterolic heterosides/ Hesperidin methyl chalcone Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001107/203011 Polona Golmajer Slovenia NAP
1110 diphenhydramine / paracetamol Not available* 7 years 03/11/2031 01/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00001110/203111 Rhea Fitzgerald Ireland NAP
1112 dexamethasone / diphenhydramine hydrochloride Not available* 9 years 03/03/2030 01/06/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001112/203003 NAP
1113 allantoin / dexpanthenol / diphenhydramine hydrochloride Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001113/202903 NAP
1115 codeine phosphate / diphenhydramine hydrochloride / levomenthol Not available* 9 years 03/03/2030 01/06/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001115/203003 NAP
1116 diphenhydramine hydrochloride / lorazepam Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001116/203011 NAP
1117 anhydrous caffeine / codeine phosphate / diphenhydramine hydrochloride / paracetamol, caffeine / codeine phosphate / diphenhydramine hydrochloride / paracetamol / phenylephrine hydrochloride / ascorbic acid, caffeine / codeine phosphate / diphenhydramine hydrochloride / paracetamol / phenylephrine hydrochloride Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001117/202903 NAP
1118 diphenhydramine hydrochloride / paracetamol / pseudoephedrine hydrochloride Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001118/203011 NAP
1119 ammonium chloride / diphenhydramine hydrochloride / sodium citrate Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001119/202903 NAP
1122 diphtheria / tetanus / pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin) (acellular, component) / hepatitis b (rdna) / poliomyelitis (inactivated) / haemophilus type b conjugate vaccines (adsorbed) 23/10/2000 3 years 22/10/2026 20/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00001122/202610 Jean-Michel Dogné Belgium CAP
1124 diphtheria / tetanus / pertussis (acellular, component) / poliomyelitis (inactivated) / haemophilus type b conjugate vaccine (adsorbed) 27/06/1997 3 years 13/11/2026 11/02/2027 No 06/10/2025 DLP was amended on 31/07/2024 PSUSA/00001124/202611 Dirk Mentzer Germany NAP
1125 diphtheria / tetanus / pertussis (acellular, component) vaccine (adsorbed), diphtheria / tetanus / pertussis (acellular, component) vaccine (adsorbed) reduced antigens contents 17/03/1995 5 years 16/03/2027 14/06/2027 No 06/10/2025 PRAC representative was updated on 01/03/2023
DLP was updated on 16/11/2022
DLP was updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016
The DLP was amended on 30/09/2015
Name of active substance was amended on 28/03/2013 PSUSA/00001125/202703 Dirk Mentzer Germany NAP
1126 diphtheria / tetanus / pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed), diphtheria / tetanus / pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content) 08/07/1991 5 years 08/07/2030 06/10/2030 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00001126/203007 Marie Louise Schougaard Christiansen Denmark NAP
1127 diphtheria / tetanus / poliomyelitis (inactivated) vaccine (adsorbed, reduced antigens(s) content) 05/02/1999 5 years 04/08/2027 02/11/2027 No 06/10/2025 DLP was updated on 05/04/2023
PRAC representative was updated on 01/03/2023
DLP was updated on 07/05/2018
PRAC representative and Lead Member State were added on 30/01/2017 PSUSA/00001127/202708 Dirk Mentzer Germany NAP
1128 diphtheria / tetanus vaccines (adsorbed), diphtheria vaccines (adsorbed) 10/05/1990 5 years 09/05/2030 07/08/2030 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001128/203005 Dirk Mentzer Germany NAP
1135 diprophylline, diprophylline / turpentine oil Not available* 11 years 02/04/2040 01/07/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001135/204004 Amelia Cupelli Italy NAP
1138 dipyridamole 11/11/1959 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001138/202712 NAP
1143 disopyramide 18/04/1967 9 years 02/04/2028 01/07/2028 No 15/01/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001143/202804 Jean-Michel Dogné Belgium NAP
1144 distigmine 01/04/1979 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001144/202811 NAP
1145 disulfiram 04/03/1971 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001145/202806 NAP
1150 dobesilate calcium 13/10/1970 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001150/202805 NAP
1151 dobutamine 21/03/1977 3 years 01/03/2027 30/05/2027 No 19/09/2024 PSUSA/00001151/202703 Zoubida Amimour France NAP
1152 docetaxel 25/11/1995 5 years 30/11/2027 28/02/2028 No 26/07/2023 PSUR frequency amended and DLP updated on 26/07/2023 PSUSA/00001152/202711 Tiphaine Vaillant France CAP NAP
1158 domperidone 01/03/1978 5 years 19/11/2029 17/02/2030 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00001158/202911 Jo Robays Belgium NAP
1160 donepezil 25/11/1996 5 years 25/11/2026 23/02/2027 No 27/07/2022 DLP was updated on 27/07/2022
Lead MS and PRAC Rapporteur name amended on 19/12/2018
Next DLP was amended on 25/09/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00001160/202611 Dennis Lex Germany NAP
1161 dopamine 09/10/1975 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001161/202808 NAP
1162 dopexamine 13/11/1989 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001162/202901 NAP
1164 dornase alfa 03/09/1993 5 years 02/09/2027 01/12/2027 No 12/09/2025 DLP was amended on 03/05/2023
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 06/06/2018
Lead MS and PRAC Rapporteur name was added on 28/02/2017 PSUSA/00001164/202709 Veronika Macurová Czech Republic NAP
1166 dorzolamide / timolol 06/03/1998 5 years 18/02/2029 19/05/2029 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001166/202902 Karin Erneholm Denmark NAP
1167 dosulepin 17/04/1973 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001167/202806 NAP
1168 doxapram hydrochloride 18/12/1967 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001168/203408 NAP
1169 doxazosin 18/12/1986 7 years 17/12/2030 17/03/2031 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00001169/203012 Karin Erneholm Denmark NAP
1170 doxepin 01/08/1969 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001170/202805 NAP
1172 doxorubicin 21/06/1996 5 years 12/11/2027 10/02/2028 No 28/06/2022 PSUR frequency amended and DLP updated on 28/06/2023 PSUSA/00001172/202711 Eva Jirsová Czech Republic CAP NAP
1173 doxycycline 05/05/1967 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00001173/203303 Liana Martirosyan Netherlands NAP
1174 doxylamine 07/04/1948 5 years 06/04/2028 05/07/2028 No 20/12/2023 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00001174/202804 Ana Sofia Diniz Martins Portugal NAP
1176 doxylamine succinate / pyridoxine hydrochloride 07/04/1948 10 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001176/203211 NAP
1178 bemotrizinol / butyl methoxydibenzoylmethane / drometrizole Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001178/202905 NAP
1180 dronedarone 26/11/2009 5 years 31/07/2030 29/10/2030 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00001180/203007 Bianca Mulder Netherlands CAP
1181 droperidol 20/04/1963 9 years 03/03/2028 01/06/2028 No 26/07/2023 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 26/07/2023
Update of PSUR frequency & DLP resulting from PRAC re-allocation exercise for entries with DLPs in 2025 on 26/07/2023 PSUSA/00001181/202803 none NAP
1182 droperidol / fentanyl 14/08/1974 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001182/203503 NAP
1184 drospirenone / estradiol 07/03/2000 5 years 10/12/2029 10/03/2030 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00001184/202912 Bianca Mulder Netherlands NAP
1186 drotaverine Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001186/203011 none NAP
1187 duloxetine 11/08/2004 5 years 03/08/2028 01/11/2028 No 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00001187/202808 Maria del Pilar Rayon Spain CAP NAP
1188 ossein hydroxyapatite compound Not available* 8 years 03/11/2026 01/02/2027 No 11/06/2025 Correction of DLP on 20/11/2024
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001188/202611 Guðrún Stefánsdóttir Iceland NAP
1190 dydrogesterone 22/04/1960 9 years 01/02/2028 01/05/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001190/202802 NAP
1191 ebastine 01/01/1996 5 years 31/05/2028 29/08/2028 No 31/01/2024 Next DLP was updated on 31/01/2024 PSUSA/00001191/202805 Marie Louise Schougaard Christiansen Denmark NAP
1195 econazole, econazole nitrate / triamcinolone acetonide 04/01/1974 5 years 16/11/2027 14/02/2028 No 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00001195/202711 Melinda Palfi Hungary NAP
1198 eculizumab 20/06/2007 2 years 01/10/2027 30/12/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00001198/202710 Maria Martinez Gonzalez Spain CAP
1200 efavirenz 28/05/1999 5 years 16/04/2027 15/07/2027 Yes 22/10/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 22/10/2025
Entry re-activated on 22/10/2025
PSUR frequency and DLP were updated on 21/12/2022
PSUR frequency and DLP were updated on 18/12/2019
DLP was updated on 19/12/2018
DLP was updated on 19/12/2017
Reference to NAP added on 23/05/2017
Correction of PRAC Rapporteur name on 28/02/2017
Next DLP was updated on 18/11/2016
PSUR Frequency and Next DLP was amended on 21/12/2015.
"Are PSURs required for products referred to in Articles 10(1), 10a, 14 and 16a of Directive 2001/83/EC as amended?Yes/No" was amended on 06/03/2015 PSUSA/00001200/202704 Ana Sofia Diniz Martins Portugal NAP
1201 efavirenz / emtricitabine / tenofovir 13/12/2007 5 years 12/07/2026 10/10/2026 Yes 23/02/2026 Entry re-introduced and reference to NAP added on 27/03/2024
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" and PSUR frequency amended on 28/04/2022
Next DLP was updated on 06/03/2019
Next DLP updated on 04/03/2016 PSUSA/00001201/202607 Martin Huber Germany CAP NAP
1202 eflornithine (topical use) 20/03/2001 5 years 26/07/2028 24/10/2028 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00001202/202807 Rhea Fitzgerald Ireland CAP
1204 eletriptan 20/01/2000 5 years 19/02/2026 20/05/2026 No 20/10/2021 DLP was updated on 20/10/2021
PRAC Rapporteur name updated on 27/06/2017
Next DLP was updated on 18/11/2016
The DLP amended on 30/09/2015
Lead MS was added on 13/07/2015 PSUSA/00001204/202602 Eva Jirsová Czech Republic NAP
1205 eltrombopag 11/03/2010 3 years 30/09/2027 29/12/2027 No 19/09/2025 DLP was updated on 25/05/2022
PSUR frequency and DLP were updated on 30/04/2019
DLP was updated on 07/05/2018
DLP was updated on 23/05/2017
PRAC Representative amended on 28/06/2016
Next DLP was amended on 03/05/2016 PSUSA/00001205/202709 Maria Martinez Gonzalez Spain CAP
1207 emedastine 27/01/1999 3 years 31/05/2026 29/08/2026 No 19/09/2024 PSUSA/00001207/202605 Zoubida Amimour France CAP
1209 emtricitabine 24/10/2003 3 years 02/04/2026 01/07/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00001209/202604 Ana Sofia Diniz Martins Portugal CAP
1210 emtricitabine / tenofovir disoproxil 21/02/2005 3 years 02/04/2026 01/07/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00001210/202604 Ana Sofia Diniz Martins Portugal CAP
1211 enalapril 01/11/2004 5 years 31/03/2028 29/06/2028 No 02/06/2026 PSUSA/00001211/202803 Karin Bolin Sweden NAP
1212 enalapril / hydrochlorothiazide 24/03/2002 5 years 26/07/2027 24/10/2027 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001212/202707 Karin Erneholm Denmark NAP
1213 enalapril / nitrendipine 08/01/2002 7 years 08/01/2030 08/04/2030 No 20/09/2023 DLP and PSUR frequency amended on 20/09/2023 PSUSA/00001213/203001 Maria del Pilar Rayon Spain NAP
1214 enalapril maleate / felodipine Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001214/203011 NAP
1215 enalapril maleate / lercanidipine 26/07/2006 7 years 03/06/2031 01/09/2031 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00001215/203106 Carla Torre Portugal NAP
1217 enfuvirtide 27/05/2003 5 years 12/03/2026 10/06/2026 No 02/06/2026 PSUSA/00001217/202603 Karin Bolin Sweden CAP
1220 enoximone 27/10/1987 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001220/202901 NAP
1221 enoxolone 28/09/1988 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001221/202901 NAP
1223 entacapone 16/09/1998 3 years 16/01/2028 15/04/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00001223/202801 Terhi Lehtinen Finland CAP
1224 entecavir 26/06/2006 5 years 28/03/2027 26/06/2027 No 02/06/2026 PSUSA/00001224/202703 Karin Bolin Sweden CAP
1225 eosine Not available* 8 years 03/03/2026 01/06/2026 No 05/08/2025 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00001225/202603 Amelia Cupelli Italy NAP
1228 ephedrine 15/05/1952 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001228/203212 NAP
1229 ephedrine hydrochloride / glaucine hydrobromide Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001229/203011 NAP
1231 epinastine 18/10/2002 5 years 31/10/2027 29/01/2028 No 28/06/2023 Next DLP was updated on 28/06/2023
DLP was updated on 04/07/2018
PRAC representative and Lead Member State were added on 28/03/2017 PSUSA/00001231/202710 Karin Bolin Sweden NAP
1232 epinephrine (except for nasal use) 15/05/1952 5 years 15/07/2030 13/10/2030 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00001232/203007 Zoubida Amimour France NAP
1233 epinephrine / lidocaine 01/10/1948 8 years 30/09/2028 29/12/2028 No 30/06/2021 DLP was updated on 30/06/2021
PRAC representative was added on 06/05/2020
LMS was added on 01/04/2020
The DLP was amended on 03/03/2014 PSUSA/00001233/202809 Eamon O'Murchu Ireland NAP
1234 epirubicin 28/06/1982 5 years 30/06/2028 28/09/2028 No 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 PSUSA/00001234/202806 Marie Louise Schougaard Christiansen Denmark NAP
1235 epitizide / triamterene Not available* 8 years 03/03/2026 01/06/2026 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00001235/202603 NAP
1236 eplerenone 16/03/2004 7 years 15/03/2029 13/06/2029 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00001236/202903 Bianca Mulder Netherlands NAP
1237 epoetin alfa 04/08/1988 3 years 31/08/2027 29/11/2027 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00001237/202708 Tiphaine Vaillant France CAP NAP
1239 epoetin beta 16/07/1997 3 years 13/02/2026 14/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00001239/202602 Dennis Lex Germany CAP
1240 epoetin theta 23/10/2009 5 years 20/04/2029 19/07/2029 No 18/12/2024 PSUR frequency amended and DLP updated on 18/12/2024 PSUSA/00001240/202904 Tiphaine Vaillant France CAP
1241 epoetin zeta 18/12/2007 3 years 18/12/2026 18/03/2027 No 25/09/2024 Reference to NAP removed on 25/09/2024
Next DLP was updated on 25/09/2024
DLP was updated and reference to NAP added on 22/09/2021
PRAC Rapporteur name was amended on 31/07/2018
DLP was updated on 31/07/2018
Next DLP updated on 30/09/2015 PSUSA/00001241/202612 Dennis Lex Germany CAP
1242 epoprostenol 18/03/1981 5 years 31/03/2027 29/06/2027 No 21/12/2022 DLP was updated on 21/12/2022
PRAC Rapporteur name updated on 23/10/2018
DLP was updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00001242/202703 Eamon O'Murchu Ireland NAP
1243 eprosartan 30/04/1997 5 years 30/04/2027 29/07/2027 No 01/02/2023 DLP was updated on 01/02/2023
PRAC Rapporteur name was amended on 31/07/2018
DLP was amended on 31/01/2018
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00001243/202704 Dennis Lex Germany NAP
1244 eprosartan / hydrochlorothiazide 30/04/1997 5 years 30/04/2027 29/07/2027 No 01/02/2023 DLP was updated on 01/02/2023
PRAC Rapporteur name was amended on 31/07/2018
DLP was amended on 31/01/2018
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00001244/202704 Dennis Lex Germany NAP
1245 eptacog alfa 23/02/1996 5 years 31/12/2025 31/03/2026 No 22/09/2021 PSUR frequency, DLP and active substance name were updated on 22/09/2021
PRAC Representative updated on 26/09/2018
DLP was updated on 31/07/2018
Reference to NAP products removed on 19/12/2017
Reference to NAP products added on 17/10/2017
PSUR Frequency amended on 31/07/2015 PSUSA/00001245/202512 Bianca Mulder Netherlands CAP
1248 erdosteine Not available* 10 years 01/02/2026 02/05/2026 No 19/10/2016 PRAC Rapporteur name was amended on 28/04/2022
PRAC Rapporteur name was amended on 03/04/2019
PSUR Frequency amended and DLP updated on 19/10/2016
Lead MS added on 31/07/2015. PSUSA/00001248/202602 Marie Louise Schougaard Christiansen Denmark NAP
1251 ergometrine / oxytocin 15/06/1960 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001251/203404 NAP
1252 belladonna alkaloids / caffeine / ergotamine tartrate / paracetamol Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001252/202905 NAP
1253 belladonna alkaloids / ergotamine tartrate / phenobarbital Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001253/202905 NAP
1254 eribulin 15/11/2010 5 years 14/11/2028 12/02/2029 No 02/06/2026 PSUSA/00001254/202811 Jenny-Maria Jönsson Sweden CAP
1255 erlotinib 19/09/2005 3 years 17/11/2026 15/02/2027 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00001255/202611 Marie Louise Schougaard Christiansen Denmark CAP NAP
1256 ertapenem 18/04/2002 5 years 29/03/2030 27/06/2030 No 16/12/2020 New CAP authorised on 15/07/2022
PSUR frequency, DLP and Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" were updated on 16/12/2020
Reference to NAP added on 25/09/2019
LMS and PRAC representative updated 05/06/2019
DLP was amended on 15/11/2017
PRAC Representative was amended on 28/03/2017
PRAC Rapporteur name updated on 30/09/2015
The next DLP was amended on 01/12/2014 PSUSA/00001256/203003 Ana Sofia Diniz Martins Portugal CAP NAP
1258 benzoyl peroxide / erythromycin Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001258/202906 NAP
1259 erythromycin / tretinoin, isotretinoin, erythromycin / isotretinoin 24/10/2001 5 years 24/10/2026 22/01/2027 No 17/02/2026 Active substance name was amended on 30/07/2025
DLP was updated on 29/06/2022
PRAC representative was updated on 22/12/2021
PRAC representative was udpated on 06/05/2020
Next DLP was amended on 27/06/2017
PRAC representative and Lead Member State were added on 03/05/2016 PSUSA/00001259/202610 Jana Pecherova Slovakia NAP
1260 erythromycin / zinc acetate Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001260/203011 NAP
1263 escherichia coli lysate 11/12/1987 5 years 31/07/2030 29/10/2030 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00001263/203007 Dirk Mentzer Germany NAP
1264 escherichia coli (living cells) Not available* 15 years 31/12/2026 31/03/2027 No 19/12/2018 Entry name amended on 19/12/2018 PSUSA/00001264/202612 NAP
1265 escitalopram 31/12/2001 5 years 31/12/2026 31/03/2027 No 21/09/2022 DLP was updated on 21/09/2022
PRAC Rapporteur name was amended on 31/07/2018
Next DLP was amended on 25/09/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00001265/202612 Karin Bolin Sweden NAP
1266 esketamine (except for centrally authorised products) 01/08/1997 5 years 31/08/2026 29/11/2026 No 28/04/2022 DLP was updated on 28/04/2022
Entry name updated on 05/02/2020
DLP was updated and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 23/05/2017
Lead MS and PRAC Rapporteur name was added on 07/04/2016 PSUSA/00001266/202608 Terhi Lehtinen Finland NAP
1267 eslicarbazepine acetate 21/04/2009 3 years 21/04/2027 20/07/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00001267/202704 Dennis Lex Germany CAP NAP
1268 esmolol 13/12/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001268/202812 NAP
1269 esomeprazole 10/03/2000 5 years 10/03/2029 08/06/2029 No 20/11/2024 PSUR frequency amended and DLP updated on 20/11/2024 PSUSA/00001269/202903 Rugile Pilviniene Lithuania CAP NAP
1270 esomeprazole / naproxen Not available* 5 years 30/04/2027 29/07/2027 No 01/02/2023 DLP was updated on 01/02/2023
PRAC Rapporteur name updated on 23/10/2018
PRAC Representative updated on 26/09/2018
DLP was amended on 31/01/2018
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00001270/202704 Liana Martirosyan Netherlands NAP
1271 estazolam 30/04/1975 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001271/202808 NAP
1276 dydrogesterone / estradiol 22/02/1995 7 years 02/12/2030 02/03/2031 No 19/09/2024 PSUSA/00001276/203012 Zoubida Amimour France NAP
1277 estradiol / levonorgestrel Not available* 8 years 03/05/2026 01/08/2026 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001277/202605 NAP
1278 estradiol / norethisterone 22/06/1996 5 years 31/03/2027 29/06/2027 No 02/06/2026 PSUSA/00001278/202703 Jenny Jönsson Sweden NAP
1279 estradiol / testosterone 01/03/1976 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001279/203503 NAP
1280 estradiol valerate / norgestrel Not available* 8 years 03/05/2026 01/08/2026 No 23/09/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001280/202605 Adam Przybylkowski Poland NAP
1281 estramustine 02/09/1971 10 years 01/12/2034 01/03/2035 No 05/01/2025 Correction of DLP on 20/11/2024
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001281/203412 Tiphaine Vaillant France NAP
1282 estriol 01/01/1957 15 years 31/12/2025 31/03/2026 No 26/05/2025 PSUSA/00001282/202512 Terhi Lehtinen Finland NAP
1283 estradiol / estriol Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001283/203011 NAP
1284 estradiol / estriol / levonorgestrel Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001284/203011 NAP
1293 etacrynic acid 14/05/1965 11 years 02/12/2039 01/03/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001293/203912 NAP
1294 etamsylate 22/04/1987 15 years 03/06/2040 01/09/2040 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00001294/204006 Veronika Macurová Czech Republic NAP
1296 ethacridine Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001296/203011 NAP
1297 albumin tannate / ethacridine lactate monohydrate Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001297/202903 NAP
1298 ethambutol 17/10/1958 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001298/202712 NAP
1304 ethanol / povidone iodinated, povidone iodinated / isopropyl alcohol (covers other synonymous terms such as 2-propanol) 22/02/1974 9 years 03/08/2028 01/11/2028 No 04/02/2026 Active substance name was amended on 04/02/2026
PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001304/202808 Zoubida Amimour France NAP
1305 ethanolamine Not available* 8 years 03/06/2026 01/09/2026 No 23/09/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001305/202606 Tiphaine Vaillant France NAP
1306 ethinylestradiol 01/06/1976 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00001306/203303 Amelia Cupelli Italy NAP
1307 ethinylestradiol / etonogestrel 12/06/2001 5 years 01/07/2030 29/09/2030 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00001307/203007 Bianca Mulder Netherlands NAP
1308 ethinylestradiol / gestodene 09/07/1986 5 years 16/03/2026 14/06/2026 No 17/11/2021 PRAC Rapporteur name was amended on 28/04/2022
DLP was updated on 17/11/2021
Active substance name was amended on 05/06/2019
PRAC Rapporteur name was amended on 03/04/2019
Next DLP was updated on 18/11/2016
Lead MS was added on 30/09/2015
Name of entry was amended on 28/05/2014
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00001308/202603 Marie Louise Schougaard Christiansen Denmark NAP
1309 ethinylestradiol / levonorgestrel 22/04/1965 5 years 13/04/2030 12/07/2030 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00001309/203004 Marie Louise Schougaard Christiansen Denmark NAP
1311 ethinylestradiol / norelgestromin 20/11/2001 5 years 19/11/2029 17/02/2030 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00001311/202911 Bianca Mulder Netherlands CAP
1312 ethinylestradiol / norethisterone 07/08/1974 5 years 06/08/2027 04/11/2027 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00001312/202708 Bianca Mulder Netherlands NAP
1313 ethinylestradiol / norgestimate 29/10/1986 5 years 30/10/2026 28/01/2027 No 29/06/2022 DLP was updated on 29/06/2022
PRAC Rapporteur name was amended on 28/04/2022
PRAC representative and LMS were added on 31/03/2021
Lead MS and PRAC Rapporteur name removed on 05/02/2020
DLP was updated on 21/07/2017
Lead MS and PRAC Rapporteur name was added on 03/06/2016 PSUSA/00001313/202610 Marie Louise Schougaard Christiansen Denmark NAP
1316 ethosuximide 09/03/1961 3 years 09/03/2026 07/06/2026 No 15/11/2023 DLP was amended on 15/11/2023 PSUSA/00001316/202603 Karin Erneholm Denmark NAP
1317 ethyl loflazepate 03/11/1980 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00001317/203303 Jo Robays Belgium NAP
1318 ethyl nicotinate / hydroxyethyl salicylate / nonylic acid vanillylamide Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001318/203011 NAP
1319 ethylmorphine 19/07/1944 11 years 03/05/2040 01/08/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001319/204005 NAP
1320 etidronate 30/09/1977 5 years 30/09/2027 29/12/2027 Yes 19/12/2018 Next DLP was updated on 31/05/2023 PSUSA/00001320/202709 Rugile Pilviniene Lithuania NAP
1321 etifoxine Not available* 3 years 19/10/2026 17/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00001321/202610 Maria Popova-Kiradjieva Bulgaria NAP
1322 etilefrine (except for treatment of priapism) 17/04/1952 12 years 03/06/2040 01/09/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001322/204006 Terhi Lehtinen Finland NAP
1324 etodolac 02/08/1984 8 years 03/05/2033 01/08/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001324/203305 Karin Erneholm Denmark NAP
1325 etofenamate Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001325/203011 NAP
1326 benzyl nicotinate / etofenamate Not available* 8 years 01/12/2033 01/03/2034 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00001326/203312 none NAP
1329 etofylline, etofylline / theophylline Not available* 8 years 03/06/2027 01/09/2027 Yes 22/10/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 22/10/2025
DLP was amended on 22/10/2025
Active substance name was amended on 22/10/2025
PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001329/202706 none NAP
1330 etomidate Not available* 5 years 30/09/2027 29/12/2027 No 06/06/2018 Next DLP was updated on 31/05/2023 PSUSA/00001330/202709 Dennis Lex Germany NAP
1331 etonogestrel 25/08/1998 3 years 01/09/2027 30/11/2027 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00001331/202709 Bianca Mulder Netherlands NAP
1333 etoposide 09/07/1980 3 years 16/02/2026 17/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00001333/202602 Dennis Lex Germany NAP
1334 etoricoxib 13/02/2002 5 years 31/03/2027 29/06/2027 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00001334/202703 Carla Torre Portugal NAP
1335 etravirine 28/08/2008 3 years 27/09/2026 26/12/2026 No 19/09/2024 PSUSA/00001335/202609 Zoubida Amimour France CAP
1342 eugenol Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001342/203011 NAP
1343 everolimus (indicated for astrocytoma (SEGA), renal angiomyolipoma, refractory seizures) 02/09/2011 5 years 31/03/2029 29/06/2029 No 25/06/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/06/2025
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 18/12/2024
PSUR frequency amended and DLP updated on 18/12/2024
DLP updated on 22/12/2021
Active substance name was updated on 03/02/2021
DLP was updated on 21/11/2018
PSUR submission frequency and next DLP were amended on 29/10/2015
Correction of DLP was done on 28/05/2014
Conditional approval PSUSA/00001343/202903 Dennis Lex Germany CAP
1344 technetium (99mTc) exametazime 01/02/1986 15 years 31/01/2031 01/05/2031 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001344/203101 Karin Erneholm Denmark NAP
1345 exemestane 16/12/1998 5 years 15/12/2025 15/03/2026 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00001345/202512 Barbara Kovacic Bytyqi Croatia NAP
1346 ezetimibe 17/10/2002 5 years 31/10/2027 29/01/2028 No 28/06/2023 Next DLP was updated on 28/06/2023
PRAC Rapporteur name was amended on 31/07/2018
DLP was updated on 04/07/2018
Lead MS added on 16/06/2015 PSUSA/00001346/202710 Dennis Lex Germany NAP
1347 ezetimibe / simvastatin 02/04/2004 5 years 10/03/2029 08/06/2029 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00001347/202903 Dennis Lex Germany NAP
1349 famciclovir 10/12/1993 5 years 31/12/2025 31/03/2026 No 12/09/2025 PSUR frequency and DLP were updated on 22/09/2021
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 26/09/2018
PRAC representative and Lead Member State were added on 23/05/2017 PSUSA/00001349/202512 Veronika Macurová Czech Republic NAP
1350 famotidine 21/09/1984 5 years 30/09/2027 29/12/2027 No 27/07/2022 Next DLP was updated on 31/05/2023 PSUSA/00001350/202709 Amelia Cupelli Italy NAP
1351 calcium carbonate / famotidine / magnesium hydroxide Not available* 5 years 30/09/2028 29/12/2028 No 19/09/2024 PSUSA/00001351/202809 Zoubida Amimour France NAP
1352 fampridine 20/07/2011 5 years 21/01/2028 20/04/2028 No 23/09/2020 New CAP authorised on 24/09/2020
DLP was updated on 23/09/2020
PRAC Rapporteur name updated on 23/10/2018
PRAC Representative updated on 26/09/2018
PSUR Frequency amended and next DLP updated on 25/09/2017
Next DLP was updated on 22/09/2016
Next DLP was updated on 30/09/2105.
Next DLP was amended on 06/10/2014
Next DLP was amended on 03/03/2014
Conditional approval PSUSA/00001352/202801 Liana Martirosyan Netherlands CAP
1353 febuxostat 21/04/2008 1 year 20/04/2026 29/06/2026 20/04/2027 29/06/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00001353/202604 PSUSA/00001353/202704 Jan Neuhauser Austria CAP
1355 felbinac 25/09/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001355/202812 NAP
1356 felodipine 31/12/1987 5 years 31/12/2027 30/03/2028 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00001356/202712 Miroslava Gocova Slovakia NAP
1357 felodipine / metoprolol 31/12/1992 10 years 31/12/2027 30/03/2028 No 18/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001357/202712 Karin Erneholm Denmark NAP
1358 felodipine / ramipril 19/09/1997 5 years 19/09/2028 18/12/2028 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00001358/202809 Dennis Lex Germany NAP
1361 fenipentol Not available* 7 years 01/12/2031 29/02/2032 No 27/03/2024 PSUR frequency and DLP amended on 27/03/2024 PSUSA/00001361/203112 Miroslava Gocova Slovakia NAP
1362 fenofibrate 04/11/1974 3 years 31/07/2026 29/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00001362/202607 Jo Robays Belgium NAP
1363 fenofibrate / pravastatin 14/04/2011 3 years 14/04/2026 13/07/2026 No 19/09/2024 PSUSA/00001363/202604 Zoubida Amimour France CAP
1365 fenoprofen Not available* 8 years 03/06/2026 01/09/2026 No 23/09/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001365/202606 Tiphaine Vaillant France NAP
1366 fenoterol (respiratory indications) 27/09/1965 5 years 27/09/2027 26/12/2027 No 06/06/2018 Next DLP was updated on 31/05/2023 PSUSA/00001366/202709 Barbara Kovacic Bytyqi Croatia NAP
1367 fenoterol / ipratropium 28/05/1980 5 years 02/02/2028 02/05/2028 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00001367/202802 Bianca Mulder Netherlands NAP
1369 fentanyl (transmucosal route of administration) 04/04/2008 3 years 30/04/2026 29/07/2026 No 31/01/2024 Next DLP was updated on 31/01/2024 PSUSA/00001369/202604 Tiphaine Vaillant France CAP NAP
1370 fentanyl (transdermal patches, solution for injection - nationally authorised product only) 07/03/1995 3 years 30/04/2027 29/07/2027 No 18/12/2024 PSUR frequency amended and DLP updated on 18/12/2024 PSUSA/00001370/202704 Liana Martirosyan Netherlands NAP
1371 fenticonazole 16/04/1986 8 years 03/06/2033 01/09/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001371/203306 Marie Louise Schougaard Christiansen Denmark NAP
1382 ferucarbotran 01/07/2022 2 years 30/06/2027 28/09/2027 No 02/06/2026 PSUSA/00001382/202706 Jenny Jönsson Sweden NAP
1387 fesoterodine, desfesoterodine 20/04/2007 5 years 19/04/2030 18/07/2030 No 16/12/2020 PSUR frequency, DLP and reference to NAP were updated on 16/12/2020
PRAC Representative name was corrected on 29/07/2020
PRAC Representative updated on 26/09/2018
Entry name was amended on 06/06/2018
DLP was updated on 19/12/2017
PRAC Rapporteur name updated on 03/06/2016 PSUSA/00001387/203004 Maria del Pilar Rayon Spain CAP NAP
1388 fexofenadine 11/03/1996 5 years 11/03/2027 09/06/2027 No 16/11/2022 DLP was updated on 16/11/2022
PRAC Rapporteur name was amended on 28/04/2022
PRAC Rapporteur name was amended on 21/11/2018
DLP was amended on 15/11/2017
Lead MS was added on 22/09/2016
PRAC Rapporteur name updated on 05/11/2018 PSUSA/00001388/202703 Marie Louise Schougaard Christiansen Denmark NAP
1390 fidaxomicin 27/05/2011 3 years 26/05/2026 24/08/2026 No 02/06/2026 PSUSA/00001390/202605 Karin Bolin Sweden CAP
1391 filgrastim 15/03/1991 3 years 15/09/2027 14/12/2027 No 25/05/2022 New CAP authorised on 12/02/2025
DLP was updated on 25/05/2022
DLP was updated on 05/06/2019
Next DLP was amended on 03/06/2016
EURD was amended on 01/10/2013 PSUSA/00001391/202709 Terhi Lehtinen Finland CAP NAP
1392 finasteride, finasteride / doxazosin 17/04/1998 3 years 31/08/2028 29/11/2028 No 02/06/2026 PSUSA/00001392/202808 Jenny Jönsson Sweden NAP
1393 fingolimod 17/03/2011 3 years 28/02/2028 28/05/2028 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00001393/202802 Tiphaine Vaillant France CAP
1395 flavoxate 04/08/1967 11 years 02/12/2039 01/03/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001395/203912 NAP
1396 flecainide 25/06/1982 5 years 30/06/2027 28/09/2027 No 01/03/2023 DLP was updated on 01/03/2023
PRAC Rapporteur name amended on 04/07/2018
DLP was updated on 27/03/2018
PRAC Representative name was amended on 17/10/2017
Lead MS and PRAC Rapporteur name was added on 20/12/2016 PSUSA/00001396/202706 Karen Pernille Harg Norway NAP
1398 flopropione Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001398/203012 NAP
1399 fluanisone 01/10/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001399/202812 NAP
1400 flubendazole 10/03/1980 5 years 04/02/2029 05/05/2029 Yes 03/05/2023 Lead MS and PRAC Rapporteur name added on 26/07/2023
Entry re-activated on 03/05/2023
Entry re-activated on 21/10/2022
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 21/10/2022
DLP was updated on 17/10/2017
Correction of PRAC Rapporteur name on 28/02/2017
PRAC Rapporteur name was amended on 20/12/2016
Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00001400/202902 Ana Sofia Diniz Martins Portugal NAP
1402 flucloxacillin 14/01/1971 8 years 03/03/2028 01/06/2028 No 16/12/2020 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended" was amended on 16/12/2020
DLP was updated on 18/11/2020
PRAC representative was added on 06/05/2020
EURD updated on 25/09/2019
LMS was added on 31/07/2019 PSUSA/00001402/202803 Ana Sofia Diniz Martins Portugal NAP
1404 fluconazole 08/03/1988 3 years 02/03/2026 31/05/2026 No 15/11/2023 DLP was amended on 15/11/2023 PSUSA/00001404/202603 Marie Louise Schougaard Christiansen Denmark NAP
1405 flucytosine 01/10/1975 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00001405/203303 Zoubida Amimour France NAP
1406 fludarabine 11/08/1994 5 years 11/08/2027 09/11/2027 No 05/04/2023 DLP was updated on 05/04/2023
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 07/05/2018
PRAC Rapporteur name was amended on 27/03/2018
DLP was corrected on 28/03/2017
PRAC representative and Lead Member State were added on 30/01/2017 PSUSA/00001406/202708 Terhi Lehtinen Finland NAP
1408 fludrocortisone 28/10/1954 12 years 03/06/2040 01/09/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001408/204006 NAP
1411 fludroxycortide Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001411/203012 NAP
1412 fluindione 02/09/1969 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001412/202805 NAP
1413 flumazenil 30/12/1986 5 years 29/12/2029 29/03/2030 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00001413/202912 Liana Martirosyan Netherlands NAP
1414 flumetasone 01/01/1964 11 years 03/07/2039 01/10/2039 No 15/01/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001414/203907 Liana Martirosyan Netherlands NAP
1415 clioquinol / flumetasone 15/02/1966 10 years 03/07/2034 01/10/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001415/203407 NAP
1416 flunarizine 01/06/1977 5 years 31/05/2029 29/08/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00001416/202905 Ana Sofia Diniz Martins Portugal NAP
1417 flunisolide 25/08/1982 10 years 03/05/2035 01/08/2035 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00001417/203505 Dennis Lex Germany NAP
1418 flunitrazepam 01/01/2000 3 years 01/01/2028 31/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00001418/202801 Jan Neuhauser Austria NAP
1419 fluocinolone acetonide (all routes of administration apart from intravitreal implant in applicator) 26/02/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001419/203406 NAP
1420 fluocinolone / metronidazole / nystatin Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001420/203012 NAP
1421 clioquinol / fluocinolone acetonide Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 PSUR frequency and DLP amended on 28/08/2024. PSUSA/00001421/202912 NAP
1423 fluocinolone acetonide / lidocaine Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001423/203012 NAP
1424 bismuth subgallate / fluocinolone acetonide / lidocaine / menthol Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001424/202906 NAP
1425 fluocinonide Not available* 8 years 03/06/2026 01/09/2026 No 23/09/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001425/202606 Zane Neikena Latvia NAP
1426 fluocinonide / hexetidine / ruscogenin Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001426/203012 NAP
1427 fluocinonide / lidocaine Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001427/203012 NAP
1430 fluocortolone pivalate / lidocaine hydrochloride Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001430/203012 NAP
1431 fluorescein (topical ophthalmic use) 12/04/1961 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001431/203906 NAP
1432 fluorescein / oxybuprocaine 12/04/1961 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001432/203906 NAP
1433 fluoride (except sodium fluoride) Not available* 9 years 01/12/2030 01/03/2031 No 25/06/2025 Active substance name was amended on 25/06/2025
PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001433/203012 none NAP
1434 fluoride / malic acid Not available* 9 years 31/01/2031 01/05/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001434/203101 NAP
1435 fluoride / monofluorophosphate Not available* 9 years 31/01/2031 01/05/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001435/203101 NAP
1437 fludeoxyglucose (18F) 14/11/1994 10 years 30/11/2027 28/02/2028 No 19/12/2018 PRAC representative was updated on 29/07/2020
PRAC representative was updated on 03/06/2020
PSUR Frequency and DLP updated on 19/12/2018
DLP was updated on 31/07/2018
Active substance name was amended on 06/06/2018
Entry name was corrected and PRAC Rapporteur amended on 21/07/2017
PRAC Rapporteur name was amended on 28/07/2016
PRAC Rapporteur name updated on 07/04/2016
PRAC Rapporteur name updated on 04/02/2016
Lead MS was added on 22/12/2014 PSUSA/00001437/202711 Tiphaine Vaillant France NAP
1438 fluorometholone 14/04/1972 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001438/202806 NAP
1442 fluoxetine 07/09/1986 5 years 07/09/2027 06/12/2027 No 03/05/2023 DLP was amended on 03/05/2023
PRAC representative was updated on 29/07/2020
PRAC representative was updated on 03/06/2020
DLP was updated on 06/06/2018
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 06/06/2018
PRAC Rapporteur name updated on 21/07/2017
Lead MS and PRAC Rapporteur name was added on 28/02/2017 PSUSA/00001442/202709 Tiphaine Vaillant France NAP
1443 fluoxetine / olanzapine Not available* 9 years 31/01/2031 01/05/2031 No 24/09/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001443/203101 NAP
1444 flupentixol 30/11/1965 5 years 30/11/2028 28/02/2029 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025
DLP was amended on 31/07/2024 PSUSA/00001444/202811 Veronika Macurová Czech Republic NAP
1445 flupentixol / melitracene 31/01/1971 13 years 30/11/2036 28/02/2037 No 12/09/2025 DLP was amended on 31/07/2024 PSUSA/00001445/203611 Veronika Macurová Czech Republic NAP
1446 fluphenazine 18/12/1959 11 years 03/05/2039 01/08/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001446/203905 NAP
1448 fluprednidene / miconazole Not available* 8 years 03/06/2026 01/09/2026 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001448/202606 NAP
1449 flurazepam 02/03/1973 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001449/202806 NAP
1450 flurbiprofen 10/11/1976 5 years 30/11/2027 28/02/2028 No 26/07/2023 PSUR frequency amended and DLP updated on 26/07/2023 PSUSA/00001450/202711 Amelia Cupelli Italy NAP
1452 fluspirilene 01/09/1977 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001452/202811 NAP
1453 flutamide 24/03/1982 5 years 23/10/2028 21/01/2029 Yes 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00001453/202810 Dennis Lex Germany NAP
1454 fluticasone propionate 08/03/1990 5 years 28/02/2027 29/05/2027 No 16/11/2022 DLP was updated on 16/11/2022
PRAC representative was updated on 28/07/2021
PRAC representative was updated on 28/04/2021
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was amended on 15/11/2017
Lead MS was added on 22/09/2016 PSUSA/00001454/202702 Polona Golmajer Slovenia NAP
1455 fluticasone / salmeterol (for nationally authorised products) 25/10/1990 8 years 31/10/2032 29/01/2033 No 02/06/2026 PSUSA/00001455/203210 Karin Bolin Sweden NAP
1456 flutrimazole 01/12/1994 8 years 03/08/2033 01/11/2033 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00001456/203308 Maria Martinez Gonzalez Spain NAP
1457 fluvastatin 23/08/1993 5 years 31/08/2027 29/11/2027 No 03/05/2023 DLP was amended on 03/05/2023
DLP was updated on 06/06/2018
Lead MS and PRAC Rapporteur name was added on 28/02/2017 PSUSA/00001457/202708 Eva Jirsová Czech Republic NAP
1458 fluvoxamine 13/07/1983 5 years 31/07/2027 29/10/2027 No 05/04/2023 DLP was updated on 05/04/2023
PRAC Rapporteur name was amended on 06/03/2019
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 07/05/2018
PRAC representative and Lead Member State were added on 30/01/2017 PSUSA/00001458/202707 Rugile Pilviniene Lithuania NAP
1459 folic acid 13/12/1947 10 years 13/12/2027 12/03/2028 No 31/01/2018 PRAC Rapporteur name was amended on 28/04/2022
PRAC Rapporteur name was amended on 03/04/2019
PSUR frequency amended and DLP updated on 31/01/2018
Lead MS and PRAC Rapporteur name was added on 19/10/2016
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00001459/202712 Marie Louise Schougaard Christiansen Denmark NAP
1461 folic acid / nicotinamide Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00001461/204001 NAP
1463 follitropin alfa 20/10/1995 5 years 19/10/2029 17/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00001463/202910 Bianca Mulder Netherlands CAP
1464 follitropin alfa / lutropin alfa 25/06/2007 5 years 19/10/2029 17/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00001464/202910 Marie Louise Schougaard Christiansen Denmark CAP
1465 follitropin beta 03/05/1996 3 years 01/05/2026 30/07/2026 No 31/01/2024 Next DLP was updated on 31/01/2024 PSUSA/00001465/202605 Rhea Fitzgerald Ireland CAP
1466 fomepizole 21/09/2000 7 years 03/03/2032 01/06/2032 Yes 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00001466/203203 Zoubida Amimour France NAP
1467 fondaparinux 21/03/2002 3 years 06/12/2027 05/03/2028 No 02/06/2026 PSUSA/00001467/202712 Karin Bolin Sweden CAP NAP
1469 formoterol 29/06/1990 5 years 31/05/2030 29/08/2030 No 02/06/2026 PSUSA/00001469/203005 Karin Bolin Sweden NAP
1470 fosamprenavir 12/07/2004 5 years 20/10/2028 18/01/2029 No 19/09/2024 PSUSA/00001470/202810 Zoubida Amimour France CAP
1471 fosaprepitant 11/01/2008 5 years 25/03/2029 23/06/2029 No 02/06/2026 PSUSA/00001471/202903 Jenny-Maria Jönsson Sweden CAP
1472 foscarnet 31/03/1989 8 years 31/03/2031 29/06/2031 No 20/12/2023 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00001472/203103 Liana Martirosyan Netherlands NAP
1476 fosphenytoin 05/08/1996 5 years 05/08/2030 03/11/2030 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00001476/203008 Eamon O'Murchu Ireland NAP
1477 fotemustine 14/04/1989 8 years 03/06/2033 01/09/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001477/203306 Amelia Cupelli Italy NAP
1478 framycetin Not available* 11 years 02/04/2040 01/07/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001478/204004 NAP
1479 framycetin sulfate / lidocaine hydrochloride Not available* 9 years 31/01/2031 01/05/2031 No 24/09/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001479/203101 NAP
1482 framycetin sulfate / triamcinolone acetonide Not available* 9 years 31/01/2031 01/05/2031 No 24/09/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001482/203101 NAP
1484 frovatriptan 31/10/2001 5 years 01/03/2027 30/05/2027 No 16/11/2022 DLP was updated on 16/11/2022
DLP was amended on 15/11/2017
PRAC Rapporteur name updated on 27/06/2017
Lead MS was added on 22/09/2016 PSUSA/00001484/202703 Eva Jirsová Czech Republic NAP
1486 fructose / glucose / xylitol Not available* 9 years 31/01/2031 01/05/2031 No 24/09/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001486/203101 NAP
1489 fulvestrant 10/03/2004 5 years 25/04/2028 24/07/2028 No 02/06/2026 PSUSA/00001489/202804 Jenny-Maria Jönsson Sweden CAP
1491 furosemide 01/01/1955 5 years 01/01/2028 31/03/2028 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00001491/202801 Carla Torre Portugal NAP
1493 furosemide / spironolactone 11/01/1961 5 years 17/03/2028 15/06/2028 No 15/11/2023 DLP was amended on 15/11/2023 PSUSA/00001493/202803 Karin Erneholm Denmark NAP
1494 furosemide / triamterene Not available* 9 years 31/01/2031 01/05/2031 No 24/09/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001494/203101 NAP
1498 fusidic acid / hydrocortisone acetate Not available* 9 years 31/01/2031 01/05/2031 No 24/09/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001498/203101 NAP
1499 gabapentin 05/02/1993 3 years 01/02/2028 01/05/2028 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00001499/202802 Dennis Lex Germany NAP
1500 gadobenic acid 22/07/1997 2 years 30/04/2027 29/07/2027 Yes 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001500/202704 Dennis Lex Germany NAP
1502 gadobutrol 20/08/1998 2 years 30/04/2027 29/07/2027 Yes 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001502/202704 Dennis Lex Germany NAP
1503 gadodiamide 01/02/1993 2 years 30/04/2027 29/07/2027 No 02/06/2026 PSUSA/00001503/202704 Karin Bolin Sweden NAP
1504 gadopentetic acid Not available* 2 years 30/04/2027 29/07/2027 Yes 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001504/202704 Dennis Lex Germany NAP
1505 gadoteric acid (intra articular formulation) 31/01/2002 2 years 30/04/2027 29/07/2027 Yes 30/04/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00001505/202704 Bianca Mulder Netherlands NAP
1506 gadoteric acid (IV and intravascular formulations) 08/03/1989 2 years 30/04/2027 29/07/2027 Yes 30/04/2026 DLP was amended on 04/02/2026 PSUSA/00001506/202704 Bianca Mulder Netherlands NAP
1507 gadoteridol 29/10/1992 2 years 30/04/2027 29/07/2027 Yes 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001507/202704 Karin Erneholm Denmark NAP
1509 gadoxetic acid disodium 20/08/1998 2 years 30/04/2027 29/07/2027 No 03/06/2026 Correction of Lead Member State and PRAC rapporteur name on 29/04/2026
DLP was amended on 04/02/2026 PSUSA/00001509/202704 Karin Bolin Sweden NAP
1511 galactose / palmitic acid 21/06/1995 8 years 03/08/2033 01/11/2033 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00001511/203308 NAP
1512 galantamine 01/03/2000 5 years 01/03/2029 30/05/2029 No 18/11/2020 DLP was updated on 18/11/2020
PRAC Rapporteur name was amended on 31/07/2018
Next DLP was updated and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 18/11/2016
PRAC Rapporteur name amended on 29/10/2015
Lead MS was added on 30/09/2015 PSUSA/00001512/202903 Karin Bolin Sweden NAP
1513 gallium (67ga) citrate 31/03/1972 10 years 01/12/2034 01/03/2035 Yes 02/04/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 02/04/2025
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001513/203412 Eva Jirsova Czech Republic NAP
1514 gallopamil 30/12/1986 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001514/202901 NAP
1515 galsulfase 31/05/2005 3 years 31/05/2027 29/08/2027 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00001515/202705 Ana Sofia Diniz Martins Portugal CAP
1516 ganciclovir 15/06/1988 6 years 14/06/2031 12/09/2031 No 04/03/2026 PSUR frequency amended and DLP updated on 04/03/2026 PSUSA/00001516/203106 Liana Martirosyan Netherlands NAP
1517 ganirelix 17/05/2000 5 years 28/02/2027 29/05/2027 No 16/11/2022 DLP was updated on 16/11/2022
New CAP authorised on 15/07/2022
DLP was updated on 17/10/2017
PRAC Rapporteur name amended on 29/10/2015. PSUSA/00001517/202702 Kimmo Jaakkola Finland CAP
1518 gefitinib 24/06/2009 5 years 05/07/2026 03/10/2026 No 02/06/2026 PSUSA/00001518/202607 Jenny-Maria Jönsson Sweden CAP
1519 gemcitabine 12/01/1995 5 years 12/01/2028 11/04/2028 No 02/06/2026 PSUSA/00001519/202801 Jenny Jönsson Sweden NAP
1521 gemfibrozil 01/06/1981 8 years 03/05/2033 01/08/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001521/203305 Karin Erneholm Denmark NAP
1522 gentamicin (topical use) 28/02/1973 11 years 03/03/2036 01/06/2036 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00001522/203603 Amelia Cupelli Italy NAP
1523 betamethasone / gentamicin Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001523/202906 NAP
1524 dexamethasone / gentamicin / tetryzoline Not available* 9 years 03/03/2030 01/06/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001524/203003 NAP
1525 gestrinone 21/01/1983 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001525/202812 NAP
1529 glatiramer 23/12/1996 3 years 30/11/2026 28/02/2027 Yes 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00001529/202611 Karin Erneholm Denmark NAP
1530 glibenclamide (for nationally authorised products only) 01/01/1969 9 years 03/05/2028 01/08/2028 No 18/10/2023 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?", PSUR frequency and DLP were amended on 18/10/2023
Active substance name updated on 04/07/2018 PSUSA/00001530/202805 none NAP
1532 gliclazide 26/04/1971 5 years 28/02/2026 29/05/2026 No 05/08/2025 DLP updated on 17/11/2021
Correction to the PRAC representative name on 05/02/2020
Lead MS and PRAC Rapporteur name amended on 19/12/2018
Next DLP was updated and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 18/11/2016
European Union reference date (EURD) was amended on 28/06/2016
Lead MS was added on 30/09/2015 PSUSA/00001532/202602 Guðrún Stefánsdóttir Iceland NAP
1533 glicofosfopeptical 07/12/1987 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001533/202901 NAP
1534 glimepiride 20/06/1995 5 years 20/06/2027 18/09/2027 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00001534/202706 Bianca Mulder Netherlands NAP
1535 glipizide 20/11/1971 5 years 31/01/2030 01/05/2030 Yes 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00001535/203001 Petar Mas Croatia NAP
1536 glipizide / metformin Not available* 9 years 03/03/2031 01/06/2031 Yes 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001536/203103 NAP
1537 gliquidone 16/09/1969 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001537/204003 none NAP
1538 glucagon (except for centrally authorised products) Not available* 8 years 30/06/2026 28/09/2026 No 31/07/2024 DLP amended on 20/11/2024
PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001538/202606 Terhi Lehtinen Finland NAP
1539 glucosamine 31/07/1996 5 years 31/03/2027 29/06/2027 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001539/202703 Karin Erneholm Denmark NAP
1541 calcium / glucose / glutathione disulphide / magnesium / potassium / sodium / sodium bicarbonate Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001541/202906 NAP
1544 benfotiamine / glutamate sodium / inositol Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001544/202905 NAP
1545 glutathione Not available* 8 years 03/06/2026 01/09/2026 No 23/09/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001545/202606 Amelia Cupelli Italy NAP
1546 glutethimide 15/04/1974 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001546/203503 NAP
1548 glycerol Not available* 8 years 03/06/2026 01/09/2026 No 23/09/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001548/202606 Jan Neuhauser Austria NAP
1549 glycerol / paraffin liquid / vaselin Not available* 8 years 03/06/2026 01/09/2026 No 23/09/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001549/202606 Tiphaine Vaillant France NAP
1550 glycerol / sucrose Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001550/203103 NAP
1551 glycerol / lecithin / soybean oil / triglycerides medium-chain Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001551/203103 NAP
1552 glyceryl trinitrate 19/10/1981 5 years 15/07/2030 13/10/2030 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00001552/203007 Polona Golmajer Slovenia NAP
1553 glycine Not available* 8 years 03/08/2026 01/11/2026 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001553/202608 NAP
1556 glycopyrronium (all indications except for the treatment of severe sialorhoea or for the treatment of chronic obstructive pulmonary disease) Not available* 15 years 30/09/2030 29/12/2030 No 22/09/2021 Active substance name amended on 22/09/2021
PRAC Rapporteur name was amended on 23/10/2018
The name of the active substance was amended on 22/09/2016
PSUR Frequency amended and DLP updated on 03/06/2016
Lead MS added on 12/05/2015
Name of active substance was amended on 30/11/2012 PSUSA/00001556/203009 Eamon O'Murchu Ireland NAP
1557 neostigmine, glycopyrronium / neostigmine 06/03/1992 15 years 30/09/2030 29/12/2030 No 20/12/2023 Active substance name was amended on 20/12/2023
PRAC Rapporteur name was amended on 23/10/2018
PSUR Frequency amended and DLP updated on 03/06/2016
Lead MS added on 12/05/2015 PSUSA/00001557/203009 Eamon O'Murchu Ireland NAP
1558 glycosaminoglycan polysulphate / salicylic acid / suprarenal gland extract Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001558/203103 NAP
1560 golimumab 01/10/2009 3 years 06/04/2026 05/07/2026 No 04/03/2026 New CAP authorised on 10/02/2026
New CAP authorised on 17/11/2025
DLP was amended on 20/12/2023 PSUSA/00001560/202604 Karin Bolin Sweden CAP
1561 gonadorelin 29/08/1973 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001561/203503 NAP
1562 goserelin 12/05/1987 5 years 12/05/2026 10/08/2026 No 02/02/2022 DLP was updated on 02/02/2022
Next DLP was amended on 30/01/2017
PRAC Rapporteur and Lead Member State added on 27/11/2015. PSUSA/00001562/202605 Dennis Lex Germany NAP
1563 gramicidin Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001563/203103 NAP
1564 benzocaine / cetylpyridinium chloride / dichlorobenzyl alcohol / gramicidin Not available* 8 years 01/12/2033 01/03/2034 No 30/10/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00001564/203312 Terhi Lehtinen Finland NAP
1567 gramicidin / neomycin sulfate / polymyxin b sulphate Not available* 8 years 03/08/2026 01/11/2026 No 18/11/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001567/202608 Petar Mas Croatia NAP
1568 granisetron (all formulations except transdermal patch) 19/02/1991 5 years 18/02/2026 19/05/2026 No 17/02/2026 Name of active substance was amended on 25/05/2022
PRAC representative was updated on 22/12/2021
DLP was updated on 20/10/2021
PRAC representative was updated on 06/05/2020
Next DLP was updated on 18/11/2016
PRAC Rapporteur name and country updated on 29/10/2015.
Name of active substance was amended on 31/05/2013 PSUSA/00001568/202602 Jana Pecherova Slovakia NAP
1572 griseofulvin 16/07/1959 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001572/203401 NAP
1573 guaiazulene Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001573/203103 NAP
1574 guaifenesin 31/05/1949 10 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001574/203211 NAP
1576 codeine / guaifenesin, ammonium chloride / codeine phosphate hemihydrate / guaifenesin / thyme oil Not available* 7 years 03/11/2026 01/02/2027 Yes 01/04/2026 Active substance name was amended on 01/04/2026
DLP was amended on 28/05/2025
Active substance name was amended on 28/05/2025
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025
PSUR frequency and DLP amended on 27/03/2024 PSUSA/00001576/202611 Jan Neuhauser Austria NAP
1580 guaifenesin / pseudoephedrine / triprolidine, guaifenesin / pseudoephedrine Not available* 8 years 03/08/2026 01/11/2026 No 18/11/2025 Active substance name was amended on 23/10/2024
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001580/202608 Miroslava Gocova Slovakia NAP
1582 haemophilus influenzae / klebsiella ozaenae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus / streptococcus pneumoniae / streptococcus pyogenes / streptococcus viridans vaccine 26/09/1983 5 years 31/12/2027 30/03/2028 No 06/10/2025 DLP amended on 20/09/2023 PSUSA/00001582/202712 Dirk Mentzer Germany NAP
1583 haemophilus type b and meningococcal group C conjugate vaccine 19/12/2005 3 years 01/02/2026 02/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00001583/202602 Jean-Michel Dogné Belgium NAP
1584 haemophilus type b conjugate vaccines 06/02/1992 3 years 06/02/2026 07/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00001584/202602 Jean-Michel Dogné Belgium NAP
1587 haloperidol 25/04/1960 5 years 24/01/2030 24/04/2030 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00001587/203001 Maia Uusküla Estonia NAP
1588 halothane Not available* 8 years 03/08/2026 01/11/2026 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001588/202608 NAP
1589 heparin 31/03/1939 9 years 08/11/2027 06/02/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001589/202711 none NAP
1591 heparinoid 01/05/1964 10 years 03/06/2034 01/09/2034 No 15/01/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001591/203406 Miroslava Gocova Slovakia NAP
1592 heparinoid / ibuprofen Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001592/202611 Miroslava Gocova Slovakia NAP
1593 hepatitis a (inactivated) / hepatitis b (rdna) vaccines (adsorbed) 20/09/1996 3 years 20/09/2027 19/12/2027 No 25/05/2022 DLP was updated on 25/05/2022
DLP was updated on 05/06/2019
Lead MS and PRAC Rapporteur name added on 21/11/2018
PRAC Representative amended on 28/03/2017
PSUR Frequency amended and DLP updated on 03/05/2016 PSUSA/00001593/202709 Jean-Michel Dogné Belgium CAP
1594 hepatitis a (inactivated) / typhoid polysaccharide vaccine (adsorbed) 22/06/1999 3 years 22/06/2026 20/09/2026 No 06/10/2025 DLP was amended on 28/02/2024 PSUSA/00001594/202606 Dirk Mentzer Germany NAP
1596 hepatitis A vaccines (inactivated, adsorbed) 01/01/1992 5 years 01/01/2029 01/04/2029 No 06/10/2025 DLP was amended on 25/09/2024 PSUSA/00001596/202901 Dirk Mentzer Germany NAP
1597 hepatitis B vaccine (rDNA) 14/11/1986 5 years 28/02/2030 29/05/2030 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00001597/203002 Dirk Mentzer Germany CAP NAP
1598 hepatitis B (rDNA) vaccine (adjuvanted, adsorbed) 02/02/2005 3 years 01/02/2027 02/05/2027 No 19/10/2022 DLP was updated on 19/10/2022
DLP was updated on 21/10/2020
PRAC representative was updated on 23/09/2020
Reference to NAP removed on 01/07/2020
Reference to NAP added on 25/09/2019
DLP was updated on 26/09/2018
PRAC Representative amended on 18/11/2016
Next DLP was updated on 22/09/2016
DLP was corrected on 13/03/2015
PSUR submission frequency was corrected on 06/03/2015
Name of active substance was amended on 31/05/2013 PSUSA/00001598/202702 Jean-Michel Dogné Belgium CAP
1601 deanol and all combinations with deanol except for diclofenac deanol Not available* 9 years 03/03/2030 01/06/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001601/203003 Ana Sofia Diniz Martins Portugal NAP
1602 hexamidine 29/03/1951 11 years 01/12/2036 01/03/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001602/203612 NAP
1603 chlorocresol / chlorhexidine / hexamidine Not available* 7 years 03/08/2031 01/11/2031 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00001603/203108 Zoubida Amimour France NAP
1604 hexamidine / lidocaine 29/03/1951 11 years 01/12/2036 01/03/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001604/203612 Zoubida Amimour France NAP
1606 hexaminolevulinate hydrochloride 17/09/2004 5 years 16/09/2029 15/12/2029 No 02/06/2026 PSUSA/00001606/202909 Karin Bolin Sweden NAP
1607 hexetidine Not available* 10 years 12/02/2035 13/05/2035 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001607/203502 NAP
1608 hexylresorcinol Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001608/203106 NAP
1609 hidrosmin Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001609/203106 NAP
1610 histamine (indicated for acute myeloid leukemia) 07/10/2008 1 year 06/10/2026 15/12/2026 06/10/2027 15/12/2027 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00001610/202610 PSUSA/00001610/202710 Eamon O Murchu Ireland CAP
1614 human anti-d immunoglobulin 28/03/1969 3 years 28/03/2027 26/06/2027 No 06/10/2025 DLP was amended on 20/11/2024 PSUSA/00001614/202703 Dirk Mentzer Germany NAP
1617 human coagulation factor IX 12/07/1985 5 years 12/07/2027 10/10/2027 No 06/10/2025 PRAC representative was updated on 01/03/2023
Lead MS and PRAC Representative name added on 19/10/2022
DLP was updated on 01/04/2020
Reference to centrally authorised products removed on 23/10/2019
PRAC Representative updated on 26/09/2018
DLP was updated on 28/03/2017
The DLP was amended on 01/04/2014 PSUSA/00001617/202707 Dirk Mentzer Germany NAP
1619 human coagulation factor VII 01/11/1975 3 years 31/10/2028 29/01/2029 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00001619/202810 Sonja Hrabcik Austria NAP
1620 human coagulation factor VIII (antihemophilic factor A) 30/11/1989 5 years 30/11/2029 28/02/2030 No 06/10/2025 DLP was amended on 30/07/2025 PSUSA/00001620/202911 Dirk Mentzer Germany NAP
1621 human coagulation factor viii / human von willebrand factor 07/06/1982 5 years 07/10/2026 05/01/2027 No 06/10/2025 PRAC representative was updated on 01/03/2023
PSUR frequency and DLP were updated on 28/06/2022
DLP was updated on 03/07/2019
Next DLP was updated on 28/06/2016
Lead MS added on 16/06/2015 PSUSA/00001621/202610 Dirk Mentzer Germany NAP
1622 human coagulation factor XIII Not available* 5 years 30/06/2027 28/09/2027 No 06/10/2025 DLP was amended on 03/05/2023
PRAC representative was updated on 01/03/2023
DLP was updated on 27/03/2018
Lead MS and PRAC Rapporteur name was added on 20/12/2016 PSUSA/00001622/202706 Dirk Mentzer Germany NAP
1624 human fibrinogen 04/01/1966 5 years 30/06/2029 28/09/2029 No 06/10/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00001624/202906 Dirk Mentzer Germany NAP
1629 human hemin 05/05/1995 3 years 31/05/2027 29/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00001629/202705 Tiphaine Vaillant France NAP
1631 human hepatitis B immunoglobulin 02/06/1979 5 years 30/11/2028 28/02/2029 Yes 06/10/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 23/10/2024
PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00001631/202811 Dirk Mentzer Germany CAP NAP
1633 human normal immunoglobulin (IgG) 25/01/1985 5 years 31/05/2030 29/08/2030 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001633/203005 Dirk Mentzer Germany CAP NAP
1634 human papillomavirus vaccine (rDNA) - 4-valent 20/09/2006 5 years 31/05/2030 29/08/2030 No 02/06/2026 PSUSA/00001634/203005 Jenny Jönsson Sweden CAP
1635 human plasma (pooled and treated for virus inactivation) 31/05/2006 3 years 28/02/2026 29/05/2026 No 06/10/2025 DLP was amended on 15/11/2023 PSUSA/00001635/202602 Dirk Mentzer Germany NAP
1638 human prothrombin complex Not available* 5 years 30/04/2026 29/07/2026 Yes 06/10/2025 PRAC representative was updated on 01/03/2023
DLP and Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" were amended on 22/12/2021
Next DLP was amended on 30/01/2017
Lead MS was amended on 22/09/2016
PRAC Rapporteur and Lead Member State added on 27/11/2015. PSUSA/00001638/202604 Dirk Mentzer Germany NAP
1639 human rabies immunoglobulin 27/04/1984 5 years 26/04/2027 25/07/2027 No 06/10/2025 PRAC representative was updated on 01/03/2023
DLP was updated on 21/12/2022
PSUR frequency amended and DLP updated on 31/01/2018
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00001639/202704 Dirk Mentzer Germany NAP
1642 human von willebrand factor 30/09/2003 5 years 30/09/2028 29/12/2028 No 06/10/2025 PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00001642/202809 Dirk Mentzer Germany NAP
1644 hyaluronic acid Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001644/203106 NAP
1645 hyaluronidase 31/05/1960 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001645/203404 NAP
1646 hydralazine, dihydralazine 13/03/1952 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001646/202712 none NAP
1650 hydrochlorothiazide 22/12/1958 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001650/202712 NAP
1655 hydrochlorothiazide / losartan 15/02/1995 5 years 15/02/2028 15/05/2028 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00001655/202802 Bianca Mulder Netherlands NAP
1657 hydrochlorothiazide / metoprolol 11/05/1978 8 years 11/05/2026 09/08/2026 Yes 22/10/2025 DLP was amended on 22/10/2025
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 22/10/2025 PSUSA/00001657/202605 Dennis Lex Germany NAP
1658 hydrochlorothiazide / nebivolol 20/09/2009 6 years 03/11/2029 01/02/2030 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00001658/202911 Amelia Cupelli Italy NAP
1662 hydrochlorothiazide / spironolactone Not available* 5 years 01/01/2029 01/04/2029 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00001662/202901 Barbara Kovacic Bytyqi Croatia NAP
1664 hydrochlorothiazide / triamterene, hydrochlorothiazide / propranolol / triamterene Not available* 9 years 03/06/2031 01/09/2031 No 19/10/2023 Active substance name, PSUR frequency and DLP were amended on 19/10/2023 PSUSA/00001664/203106 none NAP
1672 hydrocortisone / natamycin / neomycine sulphate 20/06/1995 8 years 03/08/2033 01/11/2033 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00001672/203308 Terhi Lehtinen Finland NAP
1675 hydrocortisone / urea 31/12/1986 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001675/202901 NAP
1676 benzocaine / hydrocortisone acetate Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001676/202906 NAP
1678 gentamicin sulphate / hydrocortisone acetate Not available* 10 years 12/02/2035 13/05/2035 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001678/203502 NAP
1679 lidocaine / hydrocortisone Not available* 10 years 12/02/2035 13/05/2035 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001679/203502 NAP
1680 hydrocortisone acetate / lidocaine hydrochloride / mefenidramium metilsulfate Not available* 10 years 12/02/2035 13/05/2035 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001680/203502 NAP
1684 hydrocortisone acetate / zinc sulfate Not available* 8 years 03/11/2026 01/02/2027 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001684/202611 NAP
1686 hydromorphone 25/11/1998 3 years 30/11/2027 28/02/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00001686/202711 Polona Golmajer Slovenia NAP
1688 quinidine, hydroquinidine 02/07/1973 5 years 02/07/2027 30/09/2027 No 23/10/2024 Active substance name was amended on 23/10/2024
DLP was updated on 01/03/2023
PRAC Representative updated on 16/11/2022
PRAC representative was updated on 20/10/2021
European Union reference date, DLP and submission dates updated on 07/05/2018
PSUR frequency amended and DLP updated on 15/11/2017
Lead MS was added on 22/09/2016
Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00001688/202707 Maria del Pilar Rayon Spain NAP
1689 hydroquinone Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001689/202611 María Martínez González Spain NAP
1692 hydroxycarbamide (for centrally authorised product only) 29/06/2007 1 year 28/06/2026 06/09/2026 28/06/2027 06/09/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001692/202606 PSUSA/00001692/202706 Jo Robays Belgium CAP
1693 hydroxychloroquine 18/04/1955 5 years 18/04/2026 17/07/2026 No 22/12/2021 PSUR frequency and DLP were updated on 22/12/2021
LMS and PRAC representative were added on 23/09/2020
DLP was updated on 03/06/2020 PSUSA/00001693/202604 Marie Louise Schougaard Christiansen Denmark NAP
1694 hydroxyethyl starch, hydroxyethyl starch combinations Not available* 1 year 01/03/2026 10/05/2026 01/03/2027 10/05/2027 No 04/03/2026 Active substance name was amended on 04/03/2026
DLP was amended on 22/10/2025 PSUSA/00001694/202603 PSUSA/00001694/202703 Dennis Lex Germany NAP
1696 hydroxyzine, hydroxyzine combination 14/12/1955 5 years 01/11/2028 30/01/2029 No 03/07/2024 PSUR frequency amended and DLP updated on 03/07/2024 PSUSA/00001696/202811 Tiphaine Vaillant France NAP
1697 hymecromone 27/07/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001697/203406 NAP
1698 hyoscine 01/01/1952 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001698/203212 NAP
1699 hyoscyamine 01/02/1966 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001699/203406 NAP
1701 hypericum perforatum L., herba 07/04/1998 5 years 01/01/2028 31/03/2028 Yes 20/09/2023 DLP amended on 20/09/2023 PSUSA/00001701/202801 Melinda Palfi Hungary NAP
1702 ibandronic acid 25/06/1996 5 years 24/06/2029 22/09/2029 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00001702/202906 Karin Erneholm Denmark CAP NAP
1708 ibuprofen / levomenthol Not available* 8 years 15/07/2028 13/10/2028 No 13/08/2025 DLP was updated on 31/03/2021
LMS and PRAC representative were added on 18/12/2019
DLP was updated on 05/06/2019 PSUSA/00001708/202807 Veronika Macurová Czech Republic NAP
1711 ibuprofen / pseudoephedrine Not available* 3 years 18/07/2026 16/10/2026 Yes 18/11/2025 PSUSA/00001711/202607 Tiphaine Vaillant France NAP
1712 ibuprofen (indicated in ductus arteriosus) 29/07/2004 3 years 29/07/2026 27/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00001712/202607 Rhea Fitzgerald Ireland CAP
1713 ibutilide 28/12/1995 5 years 31/12/2027 30/03/2028 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00001713/202712 Georgia Gkegka Greece NAP
1714 icatibant 11/07/2008 3 years 11/07/2027 09/10/2027 No 02/06/2026 PSUSA/00001714/202707 Karin Bolin Sweden CAP
1718 calcium oxide / ichthammol / potassium aluminium sulfate / sodium perborate Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001718/202906 NAP
1720 idarubicin 29/11/1989 3 years 30/11/2025 28/02/2026 No 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00001720/202511 Jan Neuhauser Austria NAP
1722 idursulfase 08/01/2007 3 years 23/07/2027 21/10/2027 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00001722/202707 Liana Martirosyan Netherlands CAP
1723 ifosfamide 13/07/1976 8 years 31/07/2028 29/10/2028 No 02/06/2026 PSUSA/00001723/202807 Jenny Jönsson Sweden NAP
1724 iloprost (nebuliser solution only) 27/04/1994 5 years 15/09/2028 14/12/2028 No 19/09/2024 PSUSA/00001724/202809 Zoubida Amimour France CAP NAP
1725 imatinib 07/11/2001 3 years 10/05/2027 08/08/2027 No 19/09/2025 DLP was amended on 05/02/2025 PSUSA/00001725/202705 Maria Martinez Gonzalez Spain CAP NAP
1726 imidapril 10/10/1993 7 years 02/12/2030 02/03/2031 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00001726/203012 John Joseph Borg Malta NAP
1727 imiglucerase 23/05/1994 3 years 23/05/2026 21/08/2026 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00001727/202605 Liana Martirosyan Netherlands CAP
1728 imipramine 13/03/1958 8 years 15/07/2028 13/10/2028 No 31/03/2021 PSUR frequency and DLP were updated on 31/03/2021
LMS and PRAC representative were added on 04/03/2020
PSUR frequency and DLP were updated on 05/06/2019 PSUSA/00001728/202807 Dennis Lex Germany NAP
1729 imiquimod 18/09/1998 3 years 26/01/2026 26/04/2026 No 25/06/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/06/2025
Next DLP was updated on 18/10/2023 PSUSA/00001729/202601 Adam Przybylkowski Poland CAP NAP
1730 indacaterol 30/11/2009 5 years 30/11/2027 28/02/2028 No 26/07/2023 PSUR frequency amended and DLP updated on 26/07/2023 PSUSA/00001730/202711 Marie Louise Schougaard Christiansen Denmark CAP
1731 indapamide 25/02/2002 5 years 25/11/2025 23/02/2026 No 28/07/2021 DLP was updated on 28/07/2021
PRAC Rapporteur name was amended on 31/07/2018
Next DLP was amended on 28/07/2016
Lead MS was added on 16/06/2015 PSUSA/00001731/202511 Dennis Lex Germany NAP
1734 indium (111In) chloride, indium (111In) oxine Not available* 8 years 15/07/2029 13/10/2029 Yes 28/04/2022 PRAC representative was updated on 19/10/2022
PRAC Representative was amended on 28/04/2022
DLP was updated on 30/03/2022
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" and DLP were updated on 03/02/2021
LMS and PRAC representative were added on 18/12/2019
DLP was updated on 05/06/2019 PSUSA/00001734/202907 Jo Robays Belgium NAP
1736 indobufen 05/05/1984 8 years 04/05/2033 02/08/2033 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00001736/203305 Amelia Cupelli Italy NAP
1737 indocyanine green 16/04/2003 7 years 03/05/2031 01/08/2031 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00001737/203105 Jean-Michel Dogné Belgium NAP
1738 indometacin Not available* 3 years 15/07/2026 13/10/2026 No 19/09/2025 DLP was amended on 27/03/2024 PSUSA/00001738/202607 Maria Martinez Gonzalez Spain NAP
1742 influenza vaccine (live, nasal) 27/01/2011 1 year 31/08/2026 09/11/2026 31/08/2027 09/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00001742/202608 PSUSA/00001742/202708 Jean-Michel Dogné Belgium CAP
1744 influenza vaccine (surface antigen, inactivated) 16/02/1998 1 year 15/03/2026 24/05/2026 15/03/2027 24/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00001744/202603 PSUSA/00001744/202703 Amelia Cupelli Italy NAP
1749 insulin aspart 07/09/1999 3 years 30/09/2026 29/12/2026 No 02/06/2026 PSUSA/00001749/202609 Karin Bolin Sweden CAP
1750 insulin detemir 01/06/2004 5 years 31/10/2029 29/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00001750/202910 Marie Louise Schougaard Christiansen Denmark CAP
1751 insulin glargine 21/04/2000 3 years 21/04/2028 20/07/2028 No 31/01/2024 New CAP authorised on 09/01/2026
PRAC representative updated on 31/01/2024 PSUSA/00001751/202804 Bianca Mulder Netherlands CAP
1752 insulin glulisine 16/04/2004 3 years 16/04/2026 15/07/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00001752/202604 Marie Louise Schougaard Christiansen Denmark CAP
1753 insulin human, insulin human / insulin isophane (subcutaneous and intravenous routes of administration) 26/10/1980 5 years 26/10/2028 24/01/2029 No 03/07/2024 PSUR frequency amended and DLP updated on 03/07/2024 PSUSA/00001753/202810 Marie Louise Schougaard Christiansen Denmark CAP NAP
1755 insulin lispro 30/04/1995 3 years 30/04/2027 29/07/2027 No 02/06/2026 PSUSA/00001755/202704 Karin Bolin Sweden CAP
1759 interferon beta-1b 30/11/1995 5 years 23/07/2029 21/10/2029 No 02/04/2025 PSUR frequency amended and DLP updated on 02/04/2025 PSUSA/00001759/202907 Dennis Lex Germany CAP
1760 interferon gamma 28/09/1992 8 years 31/01/2033 01/05/2033 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00001760/203301 Liana Martirosyan Netherlands NAP
1761 iobitridol 24/08/1994 5 years 30/04/2029 29/07/2029 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00001761/202904 Eamon O'Murchu Ireland NAP
1763 iodine (123i) iobenguane 31/01/1995 8 years 03/08/2033 01/11/2033 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00001763/203308 Adam Przybylkowski Poland NAP
1764 iodine (131i) iobenguane 01/06/1991 5 years 01/05/2029 30/07/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00001764/202905 Karin Erneholm Denmark NAP
1766 iodixanol 01/05/1993 8 years 30/04/2028 29/07/2028 No 03/02/2021 DLP was updated on 03/02/2021
PRAC representative was added on 06/05/2020
LMS was added on 25/09/2019 PSUSA/00001766/202804 Karen Pernille Harg Norway NAP
1767 ioflupane (123i) 27/07/2000 5 years 27/07/2027 25/10/2027 No 05/04/2023 DLP was updated on 05/04/2023
New CAP authorised on 17/06/2021
PRAC representative was updated on 29/07/2020
PRAC representative was updated on 03/06/2020
New CAP authorised on 25/06/2019
LMS and PRAC representative updated 05/06/2019
DLP was updated on 27/03/2018 PSUSA/00001767/202707 Tiphaine Vaillant France CAP
1768 iohexol 04/06/1982 8 years 30/06/2028 28/09/2028 No 03/03/2021 DLP was updated on 03/03/2021
PRAC representative was added on 06/05/2020
LMS was added on 01/04/2020 PSUSA/00001768/202806 Karen Pernille Harg Norway NAP
1769 iomeprol 11/12/1992 8 years 30/04/2028 29/07/2028 No 03/02/2021 DLP was updated on 03/02/2021
PRAC representative was added on 06/05/2020
LMS was added on 25/09/2019 PSUSA/00001769/202804 Karen Pernille Harg Norway NAP
1771 iopamidol 18/05/1981 8 years 31/12/2027 30/03/2028 No 23/09/2020 DLP was updated on 23/09/2020
LMS and PRAC representatives were added on 31/07/2019 PSUSA/00001771/202712 Eamon O'Murchu Ireland NAP
1773 iopromide 28/02/1985 8 years 30/06/2028 28/09/2028 No 03/03/2021 DLP was updated on 03/03/2021
PRAC representative was added on 06/05/2020
LMS was added on 01/04/2020 PSUSA/00001773/202806 Karen Pernille Harg Norway NAP
1775 ioversol 01/06/1989 8 years 03/06/2033 01/09/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001775/203306 Rhea Fitzgerald Ireland NAP
1779 ioxitalamate 11/03/2003 8 years 10/03/2036 08/06/2036 No 30/04/2024 EURD, PSUR frequency and DLP updated on 30/04/2024
Active substance name was amended on 30/04/2024 PSUSA/00001779/203603 none NAP
1780 ipratropium 14/08/1974 3 years 31/01/2026 01/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00001780/202601 Melinda Palfi Hungary NAP
1781 ipratropium / salbutamol 22/03/1994 3 years 31/01/2026 01/05/2026 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00001781/202601 Petar Mas Croatia NAP
1783 irinotecan (except for liposomal formulations) 05/05/1995 5 years 04/05/2028 02/08/2028 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00001783/202805 Tiphaine Vaillant France NAP
1784 isocarboxazid Not available* 11 years 03/05/2040 01/08/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001784/204005 NAP
1785 isoconazole Not available* 9 years 03/07/2031 01/10/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001785/203107 NAP
1786 isoflurane 07/10/1981 3 years 31/10/2028 29/01/2029 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00001786/202810 Melinda Palfi Hungary NAP
1788 dichloralphenazone / isometheptene mucate / paracetamol Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001788/203008 NAP
1789 isoniazid, isoniazid / pyridoxine hydrochloride, isoniazid / rifampicin, isoniazid / pyrazinamide / rifampicin, ethambutol / isoniazid / pyrazinamide / rifampicin 28/02/1973 5 years 01/11/2029 30/01/2030 No 02/06/2026 PSUSA/00001789/202911 Jenny Jönsson Sweden NAP
1793 isoprenaline 04/04/1977 13 years 03/04/2034 02/07/2034 No 05/01/2025 DLP was amended on 18/12/2024 PSUSA/00001793/203404 Pernille Harg Norway NAP
1794 isosorbide 01/05/1980 13 years 30/04/2034 29/07/2034 No 05/01/2025 DLP was amended on 18/12/2024 PSUSA/00001794/203404 Dennis Lex Germany NAP
1797 isradipine 03/01/1989 15 years 03/06/2040 01/09/2040 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026
DLP was amended on 04/02/2026 PSUSA/00001797/204006 Veronika Macurová Czech Republic NAP
1798 itraconazole 31/08/1974 5 years 31/03/2027 29/06/2027 No 21/12/2022 DLP was updated on 21/12/2022
PRAC Rapporteur name was amended on 28/04/2022
PRAC Rapporteur name was amended on 03/04/2019
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00001798/202703 Marie Louise Schougaard Christiansen Denmark NAP
1799 ivabradine 25/04/2005 3 years 25/04/2026 24/07/2026 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00001799/202604 Bianca Mulder Netherlands CAP NAP
1801 japanese encephalitis virus (inactivated) 31/03/2009 3 years 31/03/2027 29/06/2027 No 06/10/2025 DLP was amended on 18/12/2024 PSUSA/00001801/202703 Dirk Mentzer Germany CAP
1803 kanamycin Not available* 10 years 12/02/2035 13/05/2035 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001803/203502 NAP
1804 ketamine 10/12/1968 3 years 09/12/2027 08/03/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00001804/202712 Jean-Michel Dogné Belgium NAP
1806 ketazolam Not available* 9 years 03/07/2031 01/10/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001806/203107 NAP
1807 ketobemidone, ketobemidone/dimethylaminodiphenylbutene hydrochloride 07/05/1993 9 years 31/05/2029 29/08/2029 No 03/02/2021 DLP and Name of active substance were updated on 03/02/2021
PSUR Frequency was amended on 03/06/2020
PRAC representative was added on 06/05/2020
LMS was added on 25/09/2019 PSUSA/00001807/202905 Karen Pernille Harg Norway NAP
1808 ketoconazole 01/06/1980 7 years 31/05/2031 29/08/2031 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00001808/203105 Guðrún Stefánsdóttir Iceland NAP
1809 ketoprofen (all formulations except topical) 27/07/1972 5 years 23/01/2027 23/04/2027 No 19/10/2022 DLP was updated on 19/10/2022
DLP was updated on 07/05/2018
PRAC representative and Lead Member State were added on 30/01/2017 PSUSA/00001809/202701 Karin Bolin Sweden NAP
1810 ketorolac (ophtalmic formulations) 20/07/1989 5 years 31/07/2027 29/10/2027 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001810/202707 Karin Erneholm Denmark NAP
1811 ketorolac (systemic formulations) 20/07/1989 5 years 19/07/2027 17/10/2027 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001811/202707 Karin Erneholm Denmark NAP
1812 ketotifen (ophtalmic formulations) 15/10/1977 10 years 30/06/2032 28/09/2032 No 01/03/2023 PSUR frequency and DLP were updated on 01/03/2023
DLP was updated on 27/03/2018
Lead MS and PRAC Rapporteur name was added on 20/12/2016 PSUSA/00001812/203206 Karin Bolin Sweden NAP
1813 ketotifen (oral formulations) 15/10/1977 5 years 31/10/2028 29/01/2029 No 03/07/2024 PSUR frequency amended and DLP updated on 03/07/2024 PSUSA/00001813/202810 Amelia Cupelli Italy NAP
1814 labetalol 04/03/1977 8 years 28/02/2028 28/05/2028 No 21/10/2020 DLP was updated on 21/10/2020
PRAC representative was added on 06/05/2020
LMS was added on 31/07/2019 PSUSA/00001814/202802 Karen Pernille Harg Norway NAP
1815 lacidipine 07/11/1990 5 years 31/10/2026 29/01/2027 No 29/06/2022 DLP was updated on 29/06/2022
DLP was updated on 21/07/2017
Lead MS and PRAC Rapporteur name was added on 03/06/2016 PSUSA/00001815/202610 Maia Uusküla Estonia NAP
1816 lacosamide 29/08/2008 3 years 31/08/2027 29/11/2027 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00001816/202708 Karin Bolin Sweden CAP
1817 lactic acid Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00001817/203001 NAP
1818 lactic acid / salicylic acid 25/04/1977 9 years 03/11/2028 01/02/2029 No 24/09/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001818/202811 Adam Przybylkowski Poland NAP
1819 lactitol 03/09/1985 5 years 23/09/2030 22/12/2030 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00001819/203009 Jan Neuhauser Austria NAP
1821 lactulose 21/05/1964 5 years 31/05/2026 29/08/2026 No 27/07/2022 PRAC representative was updated on 27/07/2022
DLP was updated on 02/02/2022
PRAC representative was updated on 30/06/2021
Next DLP was updated on 30/01/2017
PRAC Rapporteur name updated on 04/02/2016
PRAC Rapporteur and Lead Member State added on 27/11/2015 PSUSA/00001821/202605 Amelia Cupelli Italy NAP
1822 lactose monohydrate / lactulose Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00001822/203001 NAP
1823 lactulose / paraffin liquid / vaseline Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00001823/203001 NAP
1824 lamivudine (chronic hepatitis B) 29/07/1999 5 years 31/07/2030 29/10/2030 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00001824/203007 Zoubida Amimour France CAP NAP
1825 lamotrigine 05/11/1990 5 years 30/11/2027 28/02/2028 No 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00001825/202711 Liana Martirosyan Netherlands NAP
1826 lanreotide 16/05/1994 3 years 31/05/2026 29/08/2026 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00001826/202605 Zane Neikena Latvia NAP
1827 dexlansoprazole, lansoprazole 31/12/1990 5 years 31/12/2026 31/03/2027 No 21/09/2022 DLP was updated on 21/09/2022
Next DLP was amended on 25/09/2017
Correction of PRAC Rapporteur name on 28/02/2017
PRAC Rapporteur name was amended on 20/12/2016
Lead MS and PRAC Rapporteur name was added on 28/07/2016
Name of active substance was amended on 08/01/2014
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00001827/202612 Ana Sofia Diniz Martins Portugal NAP
1829 lapatinib 10/06/2008 5 years 12/03/2030 10/06/2030 No 02/06/2026 PSUSA/00001829/203003 Jenny-Maria Jönsson Sweden CAP
1830 laronidase 10/06/2003 3 years 30/04/2027 29/07/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00001830/202704 Zoubida Amimour France CAP
1832 latanoprost 05/06/1996 5 years 30/04/2028 29/07/2028 No 19/11/2025 Correction of DLP on 19/11/2025
Active substance name was amended on 05/03/2025
PRAC Representative amended on 28/04/2022
DLP was updated on 22/12/2021
Next DLP and typo in the name amended on 30/01/2017
PRAC Representative amended on 18/11/2016
Lead Member State was added on 21/12/2015.
Name of entry amended on 03/03/2014 PSUSA/00001832/202804 Jean-Michel Dogné Belgium NAP
1833 latanoprost / timolol 05/06/1996 5 years 04/06/2027 02/09/2027 No 01/02/2023 DLP was updated on 01/02/2023
PSUR Frequency amended and DLP updated on 28/02/2018
PRAC representative and Lead Member State were added on 18/11/2016
Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00001833/202706 Karin Bolin Sweden NAP
1835 lauromacrogol 400 25/05/1966 18 years 25/05/2030 23/08/2030 No 01/10/2012 PSUSA/00001835/203005 NAP
1836 lauromacrogols combinations Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00001836/203001 NAP
1837 leflunomide 10/09/1998 3 years 10/09/2026 09/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00001837/202609 Liana Martirosyan Netherlands CAP NAP
1838 lenalidomide 14/06/2007 3 years 26/12/2025 26/03/2026 Yes 20/09/2023 DLP and PSUR frequency amended on 20/09/2023 PSUSA/00001838/202512 Tiphaine Vaillant France CAP NAP
1839 lenograstim 11/10/1991 5 years 31/10/2027 29/01/2028 No 28/06/2023 PSUR frequency amended and DLP updated on 28/06/2023
PRAC representative was updated on 29/07/2020
DLP was updated on 01/07/2020
PRAC representative was updated on 03/06/2020
DLP updated and PRAC Rapporteur name amended on 21/07/2017
PRAC Rapporteur name was amended on 28/07/2016
Lead MS and PRAC Rapporteur name was added on 03/06/2016
Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00001839/202710 Tiphaine Vaillant France NAP
1841 lercanidipine 22/03/1996 5 years 31/08/2029 29/11/2029 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00001841/202908 Kimmo Jaakkola Finland NAP
1842 letrozole 24/07/1996 3 years 31/10/2027 29/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00001842/202710 Tiphaine Vaillant France NAP
1846 levetiracetam 29/09/2000 3 years 30/11/2027 28/02/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00001846/202711 Jo Robays Belgium CAP NAP
1848 levobupivacaine 01/01/1999 5 years 31/12/2027 30/03/2028 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00001848/202712 Karin Bolin Sweden NAP
1849 levocabastine 22/02/1993 5 years 14/11/2027 12/02/2028 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001849/202711 Karin Erneholm Denmark NAP
1850 levocetirizine 03/01/2001 6 years 02/07/2029 30/09/2029 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00001850/202907 Dennis Lex Germany NAP
1853 levodropropizine 08/05/1997 7 years 02/01/2031 02/04/2031 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00001853/203101 Melinda Palfi Hungary NAP
1855 levomethadone 22/03/1969 5 years 01/05/2030 30/07/2030 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00001855/203005 Jan Neuhauser Austria NAP
1858 levosimendan 22/09/2000 5 years 22/09/2029 21/12/2029 No 03/06/2020 PRAC Rapporteur name was amended on 01/02/2023
PRAC Rapporteur name was amended on 22/09/2022
PSUR frequency and DLP were updated on 03/06/2020
PRAC Rapporteur name updated on 23/10/2018
PRAC Rapporteur name was amended on 31/07/2018
Next DLP was amended on 27/06/2017
PRAC representative and Lead Member State were added on 03/05/2016
PSUSA number was amended on 06/10/2014 PSUSA/00001858/202909 Karin Bolin Sweden NAP
1859 levosulpiride, sulpiride 01/04/1986 8 years 03/06/2033 01/09/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001859/203306 Amelia Cupelli Italy NAP
1860 levothyroxine 01/01/1952 5 years 31/01/2027 01/05/2027 No 19/09/2024 PSUSA/00001860/202701 Zoubida Amimour France NAP
1867 lidocaine / prilocaine (not centrally authorised product) 01/04/1985 5 years 31/03/2027 29/06/2027 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001867/202703 Karin Erneholm Denmark NAP
1868 lidocaine / tetracaine 29/06/2006 8 years 30/06/2028 28/09/2028 No 03/03/2021 DLP was updated on 03/03/2021
PRAC representative was added on 06/05/2020
LMS was added on 01/04/2020 PSUSA/00001868/202806 Jean-Michel Dogné Belgium NAP
1869 carrageenin / titanium dioxide / zinc oxide, carrageenin / lidocaine / titanium dioxide / zinc oxide, titanium dioxide / zinc oxide / tetracaine hydrochloride, carrageenin / lidocaine / titanium dioxide Not available* 8 years 15/06/2028 13/09/2028 No 02/04/2025 Active substance name was amended on 02/04/2025
DLP was updated on 03/03/2021
PRAC representative was added on 06/05/2020
LMS was added on 01/04/2020
DLP was updated on 05/06/2019
The active substance name was amended on 01/04/2015
The active substance name was amended on 01/12/2014 PSUSA/00001869/202806 none NAP
1879 lidocaine hydrochloride / methylprednisolone acetate Not available* 8 years 01/08/2028 30/10/2028 No 31/03/2021 DLP was updated on 31/03/2021
PRAC representative and LMS were added on 04/03/2020
DLP was updated on 05/06/2019 PSUSA/00001879/202808 Zane Neikena Latvia NAP
1887 lincomycin 01/01/1960 10 years 03/03/2034 01/06/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001887/203403 NAP
1888 linezolid 18/04/2000 3 years 17/04/2028 16/07/2028 No 17/02/2026 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 17/12/2025
DLP was amended on 17/12/2025
PSUR frequency and DLP were updated on 21/12/2022
PRAC representative was updated on 27/07/2022
PRAC representative was updated on 06/05/2020
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00001888/202804 Jana Pecherova Slovakia NAP
1890 liothyronine 16/12/1997 7 years 02/01/2031 02/04/2031 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00001890/203101 Dennis Lex Germany NAP
1891 levothyroxine sodium / liothyronine sodium Not available* 9 years 02/09/2031 01/12/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001891/203109 NAP
1892 liraglutide, insulin degludec / liraglutide 30/06/2009 3 years 31/12/2026 31/03/2027 No 01/07/2026 Active substance name was amended on 01/07/2026
DLP was amended on 25/09/2024 PSUSA/00001892/202612 Bianca Mulder Netherlands CAP
1897 lithium 20/02/1967 6 years 03/08/2029 01/11/2029 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00001897/202908 Dennis Lex Germany NAP
1898 lodoxamide 02/07/1990 8 years 03/06/2033 01/09/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001898/203306 Terhi Lehtinen Finland NAP
1899 lofepramine 27/02/1976 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001899/202808 NAP
1902 lomustine 26/01/1976 5 years 26/01/2028 25/04/2028 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00001902/202801 Miroslava Gocova Slovakia NAP
1905 lopinavir / ritonavir 20/03/2001 5 years 30/09/2029 29/12/2029 No 19/09/2024 PSUSA/00001905/202909 Zoubida Amimour France CAP
1906 loprazolam 10/07/1981 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001906/202811 NAP
1907 loratadine 01/10/1991 5 years 02/02/2027 03/05/2027 No 19/10/2022 DLP was updated on 19/10/2022
PRAC Representative amended on 28/04/2022
DLP was updated on 17/10/2017
PRAC Representative amended on 18/11/2016
Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00001907/202702 Jean-Michel Dogné Belgium NAP
1908 loratadine / pseudoephedrine 01/10/1991 5 years 02/02/2027 03/05/2027 No 19/10/2022 DLP was updated on 19/10/2022
PRAC Representative amended on 28/04/2022
DLP was updated on 17/10/2017
PRAC Representative amended on 18/11/2016
Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00001908/202702 Jean-Michel Dogné Belgium NAP
1909 lorazepam 31/12/1963 3 years 31/01/2028 30/04/2028 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00001909/202801 Karin Erneholm Denmark NAP
1910 lormetazepam 07/12/1980 3 years 31/12/2026 31/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00001910/202612 Sonja Hrabcik Austria NAP
1911 lornoxicam Not available* 7 years 01/12/2031 29/02/2032 No 19/09/2025 DLP was amended on 30/07/2025 PSUSA/00001911/203112 Maria Martinez Gonzalez Spain NAP
1912 losartan 02/09/1994 8 years 01/09/2033 30/11/2033 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00001912/203309 Bianca Mulder Netherlands NAP
1913 loteprednol 31/03/2003 7 years 03/05/2031 01/08/2031 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00001913/203105 Amelia Cupelli Italy NAP
1916 loxapine 20/12/1961 9 years 01/02/2028 01/05/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001916/202802 NAP
1918 lutropin alfa 29/11/2000 5 years 28/11/2027 26/02/2028 No 26/07/2023 PSUR frequency amended and DLP updated on 26/07/2023 PSUSA/00001918/202711 Marie Louise Schougaard Christiansen Denmark CAP
1919 lymecycline 31/01/1961 9 years 01/02/2028 01/05/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001919/202802 NAP
1920 lynestrenol 20/03/1973 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001920/202806 NAP
1924 macrogol 3350, macrogol 3350 combinations (oral use) 15/04/1991 5 years 31/05/2027 29/08/2027 No 25/06/2025 Active substance name was amended on 25/06/2025
PSUR frequency and DLP were updated on 01/02/2023
PRAC representative was updated on 27/07/2022
DLP was updated on 05/02/2020
PRAC representative was updated on 25/09/2019
Lead MS and PRAC Rapporteur name amended on 19/12/2018
Next DLP amended on 30/01/2017
PRAC Rappoerteur and Lead Member State added on 27/11/2015.
PSUSA number was amended on 06/10/2014 PSUSA/00001924/202705 Amelia Cupelli Italy NAP
1926 magnesium hydroxide 09/11/1970 5 years 31/10/2026 29/01/2027 No 27/02/2026 DLP was updated on 29/06/2022
DLP was updated on 21/07/2017
Lead MS and PRAC Rapporteur name was added on 03/06/2016 PSUSA/00001926/202610 Polona Golmajer Slovenia NAP
1928 magnesium orotate, magnesium lactate Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001928/202611 Melinda Palfi Hungary NAP
1929 ascorbic acid / magnesium oxide, magnesium oxide Not available* 7 years 03/06/2031 01/09/2031 Yes 18/12/2024 Active substance name was amended on 18/12/2024
PSUR frequency and DLP amended on 28/02/2024 PSUSA/00001929/203106 Adam Przybylkowski Poland NAP
1930 malathion 04/03/1992 18 years 04/03/2030 02/06/2030 No 01/10/2012 PSUSA/00001930/203003 NAP
1932 manidipine 29/06/1990 5 years 29/06/2029 27/09/2029 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00001932/202906 Amelia Cupelli Italy NAP
1933 maprotiline 23/09/1970 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001933/202805 NAP
1934 maraviroc 18/09/2007 5 years 05/08/2026 03/11/2026 No 02/06/2026 PSUSA/00001934/202608 Karin Bolin Sweden CAP
1936 measles / mumps / rubella / varicella vaccines (live) 26/07/2006 3 years 05/09/2027 04/12/2027 No 06/10/2025 DLP was amended on 30/04/2025 PSUSA/00001936/202709 Dirk Mentzer Germany CAP NAP
1937 measles / mumps / rubella vaccines (live, attenuated) 28/11/1997 3 years 04/05/2027 02/08/2027 No 06/10/2025 DLP was amended on 05/02/2025 PSUSA/00001937/202705 Dirk Mentzer Germany CAP NAP
1939 mebendazole 03/05/1971 15 years 03/05/2040 01/08/2040 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001939/204005 Amelia Cupelli Italy NAP
1940 mebeverine 10/11/1964 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001940/202803 NAP
1942 mecasermin 03/08/2007 1 year 31/08/2026 09/11/2026 31/08/2027 09/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00001942/202608 PSUSA/00001942/202708 Terhi Lehtinen Finland CAP
1943 mecillinam 31/05/1977 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001943/202811 NAP
1945 meclozine 08/05/1953 15 years 31/08/2040 29/11/2040 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00001945/204008 Jo Robays Belgium NAP
1946 meclozine hydrochloride / pyridoxine hydrochloride Not available* 10 years 12/02/2035 13/05/2035 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001946/203502 NAP
1947 mecobalamin 22/02/1952 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001947/203212 NAP
1948 medazepam Not available* 9 years 02/09/2031 01/12/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001948/203109 NAP
1949 medrogestone Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001949/202611 Tiphaine Vaillant France NAP
1950 conjugated estrogens / medrogestone Not available* 9 years 03/03/2030 01/06/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001950/203003 NAP
1951 medroxyprogesterone 20/08/1959 5 years 19/08/2026 17/11/2026 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00001951/202608 none NAP
1954 mefenamic acid 28/03/1962 9 years 01/02/2028 01/05/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001954/202802 NAP
1955 mefloquine 20/02/1984 3 years 19/02/2026 20/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00001955/202602 Karen Pernille Harg Norway NAP
1956 mefruside / nifedipine 10/07/1984 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001956/202812 NAP
1957 megestrol 18/08/1971 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001957/202806 NAP
1959 meglumine antimonate 22/01/1947 11 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001959/203611 NAP
1963 melatonin 29/06/2007 3 years 28/09/2026 27/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00001963/202609 Ana Sofia Diniz Martins Portugal CAP NAP
1965 melperone 17/01/1968 9 years 02/04/2028 01/07/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001965/202804 NAP
1967 memantine 15/05/2002 5 years 15/09/2028 14/12/2028 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00001967/202809 Maria del Pilar Rayon Spain CAP NAP
1969 meningococcal group a, c, w135, y conjugate vaccine (conjugated to Corynebacterium diphtheriae CRM197 protein) 15/03/2010 5 years 14/03/2030 12/06/2030 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00001969/203003 Liana Martirosyan Netherlands CAP
1971 meningococcal group c polysaccharide conjugate vaccine 15/10/1999 3 years 15/10/2027 13/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00001971/202710 Jean-Michel Dogné Belgium NAP
1972 menotrophin Not available* 7 years 31/12/2031 30/03/2032 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00001972/203112 Veronika Macurová Czech Republic NAP
1974 mepartricin 28/02/1974 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001974/203503 NAP
1978 mephenoxalone Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001978/202611 Eva Jirsová Czech Republic NAP
1979 epinephrine / mepivacaine hydrochloride, mepivacaine / norepinephrine, mepivacaine 01/04/1956 7 years 31/03/2030 29/06/2030 No 20/12/2023 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00001979/203003 Karin Erneholm Denmark NAP
1982 mepivacaine hydrochloride / polyestradiol phosphate Not available* 11 years 03/05/2040 01/08/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001982/204005 NAP
1984 meptazinol Not available* 9 years 02/09/2031 01/12/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001984/203109 NAP
1985 mepyramine 31/12/1969 9 years 31/12/2031 30/03/2032 No 18/12/2024 PSUSA/00001985/203112 none NAP
1988 mercaptopurine 11/09/1953 3 years 01/09/2026 30/11/2026 No 02/06/2026 PSUSA/00001988/202609 Jenny-Maria Jönsson Sweden CAP NAP
1989 meropenem 31/08/1994 3 years 31/08/2027 29/11/2027 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00001989/202708 Jan Neuhauser Austria NAP
1990 mesalazine 20/02/1984 2 years 19/02/2026 20/05/2026 Yes 19/10/2022 DLP was updated on 19/10/2022
PRAC Rapporteur name was amended on 28/04/2022
LMS and PRAC representative and 'Are PSURs required for products referred to in Articles 10(1), 10a, 16a of Directive 2001/83/EC as amended' were updated on 28/07/2021
PSUR frequency and DLP were updated on 21/10/2020
Lead MS and PRAC Rapporteur name amended on 19/12/2018
The Next DLP was amended on 29/10/2015
Lead MS was added on 04/02/2015 PSUSA/00001990/202602 Marie Louise Schougaard Christiansen Denmark NAP
1991 mesna Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001991/202611 Adam Przybylkowski Poland NAP
1994 metacycline Not available* 10 years 03/08/2036 01/11/2036 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001994/203608 NAP
1995 metadoxine Not available* 9 years 02/12/2031 01/03/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001995/203112 NAP
1996 caffeine / drotaverine hydrochloride / metamizole sodium 24/11/1992 4 years 07/01/2028 06/04/2028 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00001996/202801 Miroslava Gocova Slovakia NAP
1997 metamizole 24/03/1923 3 years 24/03/2027 22/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00001997/202703 Melinda Palfi Hungary NAP
1998 hyoscine butylbromide / metamizole 03/11/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001998/203406 NAP
1999 metamizole sodium / triacetonamine tosilate Not available* 5 years 01/01/2030 01/04/2030 Yes 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00001999/203001 Maria Popova-Kiradjieva Bulgaria NAP
2001 metformin 19/03/1959 3 years 01/04/2027 30/06/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00002001/202704 Amimour Zoubida France NAP
2002 glibenclamide / metformin hydrochloride 18/06/1993 4 years 18/06/2028 16/09/2028 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00002002/202806 Zoubida Amimour France NAP
2004 methadone 01/01/1930 5 years 01/05/2030 30/07/2030 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00002004/203005 Eamon O'Murchu Ireland NAP
2005 methenamine 02/08/1956 11 years 03/10/2037 01/01/2038 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002005/203710 NAP
2006 boric acid / calcium thiocyanate / camphor / menthol / methenamine Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002006/202906 NAP
2007 calcium thiocyanate / methenamine Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002007/202906 NAP
2011 methocarbamol, methocarbamol / paracetamol Not available* 10 years 01/12/2034 01/03/2035 No 30/07/2025 Active substance name was amended on 30/07/2025
PSUR frequency amended and DLP updated on 30/07/2025
PSUR frequency and DLP amended on 27/03/2024 PSUSA/00002011/203412 Dennis Lex Germany NAP
2014 methotrexate 01/01/1962 5 years 31/10/2030 29/01/2031 Yes 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
DLP was amended on 03/07/2024 PSUSA/00002014/203010 Dennis Lex Germany CAP NAP
2016 methoxsalen 31/03/1958 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002016/203401 NAP
2017 methoxy polyethylene glycol-epoetin beta 20/07/2007 3 years 19/07/2026 17/10/2026 No 19/09/2025 DLP was amended on 27/03/2024 PSUSA/00002017/202607 Maria Martinez Gonzalez Spain CAP
2019 methylaminolevulinate 15/06/2001 5 years 30/06/2027 28/09/2027 No 02/06/2026 PSUSA/00002019/202706 Jenny Jönsson Sweden NAP
2021 methyldopa 01/01/1960 9 years 01/02/2028 01/05/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002021/202802 NAP
2022 methylergometrine Not available* 9 years 02/12/2031 01/03/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002022/203112 NAP
2023 methylnaltrexone bromide 02/07/2008 3 years 27/03/2028 25/06/2028 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00002023/202803 Dennis Lex Germany CAP
2024 methylphenidate 06/10/1954 5 years 31/10/2029 29/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00002024/202910 Dennis Lex Germany CAP NAP
2025 methylphenobarbital Not available* 5 years 31/03/2028 29/06/2028 Yes 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00002025/202803 Benjamin Micallef Malta NAP
2026 methylprednisolone (systemic use) 18/12/1957 3 years 30/11/2026 28/02/2027 No 30/04/2025 DLP was corrected on 30/04/2025
PSUR frequency amended and DLP updated on 25/09/2024
Entry name updated on 25/09/2024
DLP was amended on 31/07/2024 PSUSA/00002026/202611 Jan Neuhauser Austria NAP
2029 methylthioninium chloride 03/11/1987 3 years 05/05/2026 03/08/2026 No 02/06/2026 PSUSA/00002029/202605 Karin Bolin Sweden CAP
2036 metoclopramide 17/11/1964 5 years 17/11/2029 15/02/2030 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00002036/202911 Karen Pernille Harg Norway NAP
2037 metolazone 01/01/1991 8 years 03/06/2033 01/09/2033 No 02/06/2026 PSUSA/00002037/203306 Karin Bolin Sweden NAP
2039 metoprolol 28/02/1975 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00002039/203303 Dennis Lex Germany NAP
2041 metronidazole 29/07/1959 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002041/202712 NAP
2042 metronidazole / miconazole, chlorquinaldol / metronidazole 18/12/1992 8 years 03/07/2033 01/10/2033 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00002042/203307 Eva Jirsová Czech Republic NAP
2045 metronidazole / spiramycin 29/07/1959 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002045/203401 NAP
2046 metyrapone 14/06/1961 6 years 14/06/2030 12/09/2030 Yes 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00002046/203006 Kimmo Jaakkola Finland NAP
2047 mexazolam Not available* 7 years 01/12/2031 29/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00002047/203112 John Joseph Borg Malta NAP
2048 mexiletine (nationally authorised products only) 06/10/1975 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002048/202808 NAP
2050 mianserin 01/01/1974 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002050/202806 NAP
2051 micafungin 25/04/2008 5 years 08/10/2029 06/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00002051/202910 Dennis Lex Germany CAP
2052 miconazole, hydrocortisone / miconazole nitrate, miconazole nitrate / zinc oxide, benzoyl peroxide / miconazole 31/07/1971 10 years 09/10/2034 07/01/2035 No 02/06/2026 PSUSA/00002052/203410 Jenny Jönsson Sweden NAP
2057 midazolam (all pharmaceutical forms and indications apart from oromucosal and nasal routes of administration) 10/09/1982 5 years 09/09/2027 08/12/2027 No 01/04/2026 Active substance name was amended on 01/04/2026
DLP was amended on 03/05/2023
DLP correction on 19/12/2018
DLP was updated on 06/06/2018
Name of entry was amended, and Lead MS added on 12/05/2015.
Name of entry was amended on 06/10/2014
Name of active substance was amended on 30/04/2013 PSUSA/00002057/202709 Dennis Lex Germany NAP
2058 midecamycin 24/05/1984 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002058/202812 NAP
2059 mifamurtide 06/03/2009 5 years 05/03/2027 03/06/2027 No 16/11/2022 PSUR frequency and DLP were updated on 16/11/2022
DLP was updated on 23/10/2019
PRAC Representative updated on 26/09/2018
PSUR Frequency amended and DLP updated on 19/10/2016
Next DLP was updated on 30/09/2015 PSUSA/00002059/202703 Bianca Mulder Netherlands CAP
2060 mifepristone 31/05/1988 3 years 31/05/2026 29/08/2026 No 02/06/2026 PSUSA/00002060/202605 Jenny Jönsson Sweden NAP
2062 miglustat (all other indications) 20/11/2002 5 years 19/10/2029 17/01/2030 No 02/06/2026 PSUSA/00002062/202910 Karin Bolin Sweden CAP
2063 milnacipran 06/12/1966 3 years 30/04/2028 29/07/2028 Yes 25/09/2024 DLP was amended on 25/09/2024
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/09/2024
DLP was updated on 02/02/2022
PRAC representative was updated on 29/07/2020
PRAC representative was updated on 03/06/2020
DLP was updated on 06/02/2019
PRAC representative was updated on 03/06/2020
PRAC Rapporteur name updated on 21/07/2017
PRAC Rapporteur name was amended on 28/07/2016
Next DLP was amended on 04/02/2016
Lead MS was added on 06/03/2015 PSUSA/00002063/202804 Tiphaine Vaillant France NAP
2064 milrinone 16/10/1987 3 years 16/10/2027 14/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00002064/202710 Jan Neuhauser Austria NAP
2065 minocycline 07/08/1961 5 years 31/08/2027 29/11/2027 No 03/05/2023 DLP was amended on 03/05/2023
PRAC Representative name was corrected on 29/07/2020
PRAC Representative updated on 26/09/2018
DLP was updated on 06/06/2018
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/03/2017
Lead MS and PRAC Rapporteur name was added on 28/02/2017 PSUSA/00002065/202708 Maria del Pilar Rayon Spain NAP
2066 minoxidil (non topical formulations) 18/10/1979 3 years 31/10/2028 29/01/2029 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
DLP was updated on 30/06/2021
PRAC Rapporteur name updated on 23/10/2018
Next DLP was amended on 28/07/2016
"Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended? Yes/No" was amended on 16/07/2015
Lead MS added on 16/06/2015 PSUSA/00002066/202810 Eamon O'Murchu Ireland NAP
2067 minoxidil (topical formulation) 18/10/1979 3 years 31/10/2026 29/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00002067/202610 Eamon O'Murchu Ireland NAP
2068 mirtazapine 01/09/1994 5 years 31/08/2028 29/11/2028 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00002068/202808 Liana Martirosyan Netherlands NAP
2074 mitomycin 05/10/1962 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002074/202803 NAP
2075 mitotane 28/04/2004 5 years 28/04/2028 27/07/2028 No 25/06/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/06/2025
PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00002075/202804 Maria del Pilar Rayon Spain CAP
2076 mitoxantrone 15/06/1981 3 years 30/06/2028 28/09/2028 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00002076/202806 Karin Erneholm Denmark NAP
2077 mivacurium 22/01/1992 10 years 31/01/2028 30/04/2028 No 23/10/2018 PRAC Rapporteur name updated on 23/10/2018
PSUR frequency amended and DLP updated on 23/10/2018
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 21/07/2017
Lead MS and PRAC Rapporteur name was added on 27/06/2017 PSUSA/00002077/202801 Eamon O'Murchu Ireland NAP
2078 mizolastine 21/11/1995 5 years 21/11/2027 19/02/2028 No 12/09/2025 Next DLP was updated on 26/07/2023 PSUSA/00002078/202711 Veronika Macurová Czech Republic NAP
2079 moclobemide 26/10/1989 5 years 01/04/2027 30/06/2027 No 21/12/2022 DLP was updated on 21/12/2022
PRAC Rapporteur name updated on 23/10/2018
PRAC Representative updated on 26/09/2018
DLP was updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00002079/202704 Liana Martirosyan Netherlands NAP
2084 molsidomine Not available* 9 years 02/12/2031 01/03/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002084/203112 NAP
2085 mometasone 22/01/1997 5 years 22/05/2028 20/08/2028 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00002085/202805 Karin Bolin Sweden NAP
2087 montelukast 25/08/1997 3 years 30/07/2027 28/10/2027 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00002087/202707 Kimmo Jaakkola Finland NAP
2088 morniflumate Not available* 8 years 03/11/2026 01/02/2027 No 05/01/2025 Correction of DLP on 20/11/2024
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002088/202611 Amelia Cupelli Italy NAP
2089 moroctocog alfa 13/04/1999 5 years 26/08/2029 24/11/2029 No 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00002089/202908 Marie Louise Schougaard Christiansen Denmark CAP
2093 caffeine / moxastine teoclate Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002093/204003 NAP
2094 moxifloxacin (topical ophthalmic use) 31/05/1999 5 years 31/05/2026 29/08/2026 No 02/02/2022 DLP was updated on 02/02/2022
Next DLP was amended on 30/01/2017
'Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?
Yes/No' was amended on 27/11/2015.
PRAC Rapporteur and Lead Member state was added on 27/11/2015
Name of active substance was amended on 21/12/2012 PSUSA/00002094/202605 Dennis Lex Germany NAP
2095 moxonidine 23/01/1991 5 years 23/01/2027 23/04/2027 No 19/10/2022 DLP was updated on 19/10/2022
PRAC representative was updated on 06/05/2020
DLP was updated on 17/10/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00002095/202701 Melinda Palfi Hungary NAP
2096 mupirocin 26/03/1985 5 years 31/03/2027 29/06/2027 No 21/12/2022 DLP was updated on 21/12/2022
PRAC representative was updated on 28/07/2021
PRAC representative was updated on 28/04/2021
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00002096/202703 Polona Golmajer Slovenia NAP
2100 nabilone Not available* 6 years 02/12/2029 02/03/2030 Yes 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00002100/202912 Jan Neuhauser Austria NAP
2101 nabumetone 15/03/1984 10 years 01/03/2027 30/05/2027 No 15/11/2017 PRAC Rapporteur name updated on 23/10/2018
PRAC Representative updated on 26/09/2018
PSUR frequency amended and DLP updated on 15/11/2017
Lead MS was added on 22/09/2016 PSUSA/00002101/202703 Liana Martirosyan Netherlands NAP
2102 nadifloxacin 06/07/2000 5 years 31/05/2026 29/08/2026 No 02/02/2022 DLP was updated on 02/02/2022
Next DLP updated on 30/01/2017
PRAC Rapporteur and Lead Member State added on 27/11/2015. PSUSA/00002102/202605 Dennis Lex Germany NAP
2103 nadolol 22/07/1976 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002103/202808 NAP
2104 nadroparin 04/03/1985 5 years 31/03/2026 29/06/2026 No 19/09/2025 PRAC Representative updated on 16/11/2022
PSUR frequency and DLP were updated on 22/12/2021
DLP was updated on 19/12/2018
PRAC Rapporteur name was amended on 25/09/2017
Next DLP was updated on 21/12/2015.
Lead MS was added on 06/03/2015 PSUSA/00002104/202603 Maria Martinez Gonzalez Spain NAP
2105 nafarelin 15/02/1990 5 years 14/02/2029 15/05/2029 No 20/10/2021 DLP was updated on 20/10/2021
DLP was updated on 23/10/2018
PRAC Rapporteur name was updated on 04/07/2018
PRAC Rapporteur name was amended on 27/06/2017
The DLP was amended on
29/10/2015
Lead MS was added on 04/02/2015 PSUSA/00002105/202902 Karen Pernille Harg Norway NAP
2107 naftazone 18/12/1987 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002107/202901 NAP
2108 naftidrofuryl 30/10/1970 9 years 06/03/2028 04/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002108/202803 NAP
2109 naftifine Not available* 8 years 01/08/2028 30/10/2028 No 31/03/2021 DLP was updated on 31/03/2021
PRAC representative was added on 06/05/2020
LMS was added on 01/04/2020
DLP was updated on 05/06/2019 PSUSA/00002109/202808 Maia Uusküla Estonia NAP
2110 nalbuphine 15/05/1979 5 years 01/05/2028 30/07/2028 Yes 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00002110/202805 Eva Jirsová Czech Republic NAP
2112 naloxone (for use in medical settings only) 14/04/1975 9 years 03/08/2028 01/11/2028 No 24/09/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002112/202808 Adam Przybylkowski Poland NAP
2113 buprenorphine / naloxone 26/09/2006 4 years 26/09/2027 25/12/2027 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00002113/202709 Dennis Lex Germany CAP NAP
2114 naloxone / oxycodone 31/05/2006 3 years 03/08/2026 01/11/2026 No 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00002114/202608 Dennis Lex Germany NAP
2117 naltrexone 20/11/1984 3 years 19/11/2025 17/02/2026 Yes 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00002117/202511 Eamon O'Murchu Ireland NAP
2118 nandrolone 01/01/1960 10 years 03/03/2034 01/06/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002118/203403 NAP
2120 methylthioninium / naphazoline Not available* 10 years 03/08/2036 01/11/2036 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002120/203608 NAP
2125 naproxen 04/08/1961 3 years 03/08/2026 01/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00002125/202608 Amelia Cupelli Italy NAP
2126 naratriptan 10/03/1997 5 years 28/02/2027 29/05/2027 No 16/11/2022 DLP was updated on 16/11/2022
PRAC Rapporteur name was amended on 31/07/2018
DLP was amended on 15/11/2017
Lead MS was added on 22/09/2016 PSUSA/00002126/202702 Karin Bolin Sweden NAP
2127 natalizumab 27/06/2006 3 years 07/08/2027 05/11/2027 No 06/10/2025 DLP was amended on 02/04/2025 PSUSA/00002127/202708 Dirk Mentzer Germany CAP
2129 nebivolol 18/10/1995 6 years 31/03/2030 29/06/2030 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00002129/203003 Bianca Mulder Netherlands NAP
2130 nedocromil 24/04/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002130/202812 NAP
2131 nefopam Not available* 5 years 30/03/2030 28/06/2030 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00002131/203003 Barbara Kovacic Bytyqi Croatia NAP
2132 nelarabine 22/08/2007 3 years 27/10/2026 25/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00002132/202610 Marie Louise Schougaard Christiansen Denmark CAP
2134 neomycin 24/06/1954 10 years 31/01/2034 01/05/2034 No 15/01/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002134/203401 Ana Sofia Diniz Martins Portugal NAP
2135 hydrocortisone / neomycin Not available* 11 years 02/04/2040 01/07/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002135/204004 NAP
2139 neomycin sulfate / nystatin / polymyxin b sulfate Not available* 8 years 03/11/2032 01/02/2033 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00002139/203211 Zoubida Amimour France NAP
2140 neomycin sulfate / nystatin / triamcinolone acetonide Not available* 6 years 02/12/2029 02/03/2030 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00002140/202912 Adam Przybylkowski Poland NAP
2143 nepafenac 11/12/2007 5 years 30/05/2027 28/08/2027 No 01/02/2023 PSUR frequency and DLP were updatde on 01/02/2023
PRAC Representative updated on 16/11/2022
Reference to NAP added on 29/06/2022
DLP was updated on 05/02/2020
Next DLP updated on 30/01/2017
PRAC Representative amended on 28/06/2016
PSUR Frequency amended and DLP updated on 04/02/2016
DLP was amended on 04/02/2015
Next DLP was amended on 31/01/2014
Next DLP was amended on 31/01/2014 PSUSA/00002143/202705 Maria del Pilar Rayon Spain CAP NAP
2146 netilmicin 01/01/1982 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002146/202811 NAP
2147 nevirapine 05/02/1998 5 years 06/05/2026 04/08/2026 No 02/02/2022 DLP and PSUR frequency were updated on 02/02/2022
DLP was updated on 06/02/2019
Reference to NAP removed on 15/11/2017
Correction of PRAC Rapporteur name on 28/02/2017
PRAC Rapporteur name was amended on 20/12/2016
Next DLP was amended on 04/02/2016
"Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?Yes/No" was amended on 06/03/2015 PSUSA/00002147/202605 Ana Sofia Diniz Martins Portugal CAP
2149 nicardipine 31/05/1981 3 years 31/05/2028 29/08/2028 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00002149/202805 Amelia Cupelli Italy NAP
2150 nicergoline 26/05/1972 5 years 25/05/2030 23/08/2030 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00002150/203005 Zane Neikena Latvia NAP
2151 niclosamide 23/03/1964 5 years 01/08/2028 30/10/2028 No 27/03/2024 PSUR frequency amended and DLP updated on 27/03/2024 PSUSA/00002151/202808 Amelia Cupelli Italy NAP
2152 nicorandil 09/02/1990 3 years 28/02/2026 29/05/2026 Yes 30/07/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/07/2025
DLP was amended on 25/06/2025
DLP was updated on 16/11/2022
DLP was updated on 20/11/2019
Next DLP was updated on 18/11/2016
Lead Member State was added on 30/09/2015 PSUSA/00002152/202602 Jan Neuhauser Austria NAP
2153 nicotine Not available* 10 years 01/12/2034 01/03/2035 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00002153/203412 Karin Erneholm Denmark NAP
2156 nifedipine 31/08/1993 8 years 31/08/2033 29/11/2033 No 27/05/2026 DLP was corrected on 27/05/2026
PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00002156/203308 Bianca Mulder Netherlands NAP
2157 niflumic acid Not available* 5 years 31/12/2029 31/03/2030 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00002157/202912 Melinda Palfi Hungary NAP
2158 nifuratel 04/05/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002158/203406 NAP
2159 nifuratel / nystatin 12/10/1976 9 years 02/09/2028 01/12/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002159/202809 NAP
2160 nifuroxazide 18/08/1992 5 years 18/08/2026 16/11/2026 No 13/08/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/09/2024
PSUR frequency and DLP were updated on 28/04/2022
PSUR frequency, DLP and Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended" were updated on 06/05/2020
LMS and PRAC representatives were added on 31/07/2019
PSUR Frequency and Next DLP amended on 16/07/2015 PSUSA/00002160/202608 Veronika Macurová Czech Republic NAP
2162 nilotinib 19/11/2007 3 years 31/01/2027 01/05/2027 No 22/09/2021 PRAC Rapporteur name was amended on 28/04/2022
DLP and PSUR frequency were updated on 22/09/2021
PRAC representative was updated on 31/03/2021
DLP was updated on 23/09/2020
PRAC representative and DLP were updated on 25/09/2019
PRAC Rapporteur name was amended on 03/04/2019
DLP was updated on 26/09/2018
Next DLP was amended on 25/09/2017
Next DLP was updated on 22/09/2016
Next DLP was updated on 30/09/2015 PSUSA/00002162/202701 Marie Louise Schougaard Christiansen Denmark CAP
2163 nilutamide 02/07/1986 6 years 02/07/2030 30/09/2030 No 05/03/2025 DLP was amended on 05/03/2025 PSUSA/00002163/203007 Bianca Mulder Netherlands NAP
2165 nimesulide (topical formulations) 10/12/1999 5 years 30/06/2028 28/09/2028 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00002165/202806 Amelia Cupelli Italy NAP
2166 nimodipine 01/11/1987 5 years 01/11/2028 30/01/2029 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00002166/202811 Karen Pernille Harg Norway NAP
2169 nitisinone 21/02/2005 3 years 20/02/2028 20/05/2028 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00002169/202802 Amelia Cupelli Italy CAP
2170 nitrazepam 02/03/1965 3 years 02/03/2027 31/05/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00002170/202703 Karin Erneholm Denmark NAP
2171 nitrendipine 31/03/1985 3 years 31/03/2027 29/06/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00002171/202703 Jan Neuhauser Austria NAP
2172 nitric oxide 23/12/1999 3 years 23/12/2027 22/03/2028 Yes 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00002172/202712 Jo Robays Belgium CAP NAP
2173 nitrofural Not available* 11 years 03/05/2040 01/08/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002173/204005 none NAP
2174 nitrofurantoin, nitrofurantoin / pyridoxine hydrochloride 28/02/1953 5 years 28/02/2026 29/05/2026 No 05/08/2025 Active substance name was amended on 18/10/2023
PSUR frequency and DLP were updated on 17/11/2021
Active substance name was amended on 22/09/2021
PRAC Rapporteur name was amended on 06/03/2019
DLP was updated on 21/11/2018
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 17/10/2017
The next DLP was amended on 29/10/2015.
Lead MS was added on 04/02/2015
Name of active substance was amended on 03/07/2013 PSUSA/00002174/202602 Lina Seibokiene Lithuania NAP
2181 nomegestrol Not available* 3 years 31/01/2027 01/05/2027 No 20/10/2021 DLP was updated on 20/10/2021
DLP was updated on 23/10/2018
The next DLP was amended on 29/10/2015
Lead MS was added on 04/02/2015 PSUSA/00002181/202701 Adam Przybylkowski Poland NAP
2182 estradiol / nomegestrol acetate 27/07/2011 5 years 26/01/2029 26/04/2029 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00002182/202901 Zoubida Amimour France CAP NAP
2183 nonacog alfa 27/08/1997 5 years 10/08/2028 08/11/2028 No 06/10/2025 PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00002183/202808 Dirk Mentzer Germany CAP
2186 nordazepam Not available* 9 years 02/12/2031 01/03/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002186/203112 NAP
2187 norepinephrine 30/10/1962 9 years 03/03/2028 01/06/2028 No 26/07/2023 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 26/07/2023
Update of PSUR frequency & DLP resulting from PRAC re-allocation exercise for entries with DLPs in 2025 on 26/07/2023 PSUSA/00002187/202803 none NAP
2188 norethisterone 29/04/1971 5 years 06/08/2027 04/11/2027 No 05/04/2023 DLP was updated on 05/04/2023
DLP was updated on 07/05/2018
PRAC representative and Lead Member State were added on 30/01/2017 PSUSA/00002188/202708 Kimmo Jaakkola Finland NAP
2190 norfloxacin 04/11/1982 13 years 04/06/2036 02/09/2036 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00002190/203606 Maria del Pilar Rayon Spain NAP
2192 nortriptyline 31/03/1963 5 years 31/03/2028 29/06/2028 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00002192/202803 Maia Uusküla Estonia NAP
2193 diazepam / nortriptyline hydrochloride 17/03/1969 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002193/203408 NAP
2194 noscapine Not available* 10 years 03/08/2036 01/11/2036 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002194/203608 NAP
2195 nystatin 13/08/1954 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002195/203401 NAP
2197 obidoxime 29/01/1964 11 years 03/07/2039 01/10/2039 No 15/01/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002197/203907 Dennis Lex Germany NAP
2199 octenidine dihydrochloride / phenoxyethanol Not available* 10 years 01/01/2032 31/03/2032 Yes 21/09/2022 PSUR frequency and DLP were updated on 21/09/2022
PRAC Rapporteur name was amended on 06/03/2019
Next DLP was amended on 25/09/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016
PSUR Frequency and DLP was amended on 27/11/2015 PSUSA/00002199/203201 Rugile Pilviniene Lithuania NAP
2200 octocog alfa 04/08/2000 5 years 26/08/2030 24/11/2030 No 27/05/2026 DLP was corrected on 27/05/2026
PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00002200/203008 Dirk Mentzer Germany CAP NAP
2201 octreotide (for nationally authorised products) 23/06/1995 3 years 30/06/2026 28/09/2026 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00002201/202606 Eamon O'Murchu Ireland NAP
2203 ofloxacin (systemic use) 16/04/1985 5 years 16/04/2030 15/07/2030 No 17/12/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 17/12/2025
PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00002203/203004 Petar Mas Croatia NAP
2204 ofloxacin (topical use) 02/05/1989 5 years 16/04/2029 15/07/2029 No 18/12/2024 PSUR frequency amended and DLP updated on 18/12/2024 PSUSA/00002204/202904 Petar Mas Croatia NAP
2207 olmesartan 25/04/2002 5 years 24/10/2026 22/01/2027 No 29/06/2022 DLP was updated on 29/06/2022
PRAC Rapporteur name was amended on 31/07/2018
Next DLP was amended on 27/06/2017
PRAC representative and Lead Member State were added on 03/05/2016
The DLP was amended on 08/01/2014
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00002207/202610 Dennis Lex Germany NAP
2208 amlodipine / olmesartan 25/04/2012 5 years 24/04/2027 23/07/2027 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00002208/202704 Bianca Mulder Netherlands NAP
2209 hydrochlorothiazide / olmesartan 25/04/2002 5 years 24/10/2026 22/01/2027 No 29/06/2022 DLP was updated on 29/06/2022
PRAC Rapporteur name was amended on 31/07/2018
Next DLP was amended on 27/06/2017
PRAC representative and Lead Member State were added on 03/05/2016
EURD and DLP were amended on 08/01/2014 PSUSA/00002209/202610 Dennis Lex Germany NAP
2210 amlodipine besilate / hydrochlorothiazide / olmesartan medoxomil 02/12/2010 5 years 24/04/2027 23/07/2027 No 12/09/2025 DLP was updated on 21/12/2022
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was amended on 31/01/2018
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00002210/202704 Veronika Macurová Czech Republic NAP
2211 olopatadine 17/05/2002 5 years 30/04/2029 29/07/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00002211/202904 Eamon O Murchu Ireland CAP NAP
2213 olsalazine 01/06/1986 5 years 31/05/2027 29/08/2027 No 01/02/2023 DLP was updated on 01/02/2023
DLP was amended on 31/01/2018
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00002213/202705 Terhi Lehtinen Finland NAP
2214 omalizumab 25/10/2005 3 years 31/12/2025 31/03/2026 No 02/06/2026 PSUSA/00002214/202512 Karin Bolin Sweden CAP
2215 omeprazole 15/04/1987 5 years 15/04/2027 14/07/2027 No 21/12/2022 DLP was updated on 21/12/2022
PRAC representative was updated was updated on 04/03/2020
DLP was updated and PRAC Representative amended on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00002215/202704 Liana Martirosyan Netherlands NAP
2216 omoconazole 23/09/1987 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002216/202901 NAP
2217 ondansetron 23/02/1990 3 years 28/02/2027 29/05/2027 No 17/11/2021 DLP was updated on 17/11/2021
PRAC representative was updated on 28/07/2021
PRAC representative was updated on 28/04/2021
DLP was updated on 21/11/2018
Lead MS was amended on 22/09/2016
The next DLP was amended on 29/10/2015
Lead MS was added on 04/02/2015
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00002217/202702 Polona Golmajer Slovenia NAP
2218 opipramol 12/10/1961 9 years 01/02/2028 01/05/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002218/202802 NAP
2220 orlistat 08/08/1997 3 years 07/02/2028 07/05/2028 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00002220/202802 Zoubida Amimour France CAP NAP
2221 ornidazole 19/06/1979 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002221/202811 NAP
2224 orphenadrine / paracetamol, orphenadrine Not available* 10 years 03/08/2036 01/11/2036 No 23/10/2024 Active substance name was amended on 23/10/2024
PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00002224/203608 none NAP
2225 oseltamivir 20/06/2002 5 years 20/09/2029 19/12/2029 No 23/10/2024 Reference to NAP removed on 23/10/2024
DLP was updated on 25/05/2022
DLP was updated on 05/06/2019
Reference to NAP added on 31/01/2018
Next DLP was amended on 03/06/2016 PSUSA/00002225/202909 Terhi Lehtinen Finland CAP
2226 otilonium bromide 08/09/1976 9 years 02/09/2028 01/12/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002226/202809 NAP
2227 oxaceprol 15/10/1977 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002227/202811 NAP
2228 oxacillin 01/01/1962 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00002228/203405 NAP
2229 oxaliplatin 12/04/1996 5 years 12/04/2029 11/07/2029 Yes 18/12/2024 PSUR frequency amended and DLP updated on 18/12/2024 PSUSA/00002229/202904 Tiphaine Vaillant France NAP
2234 oxazepam 11/12/1963 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002234/202803 NAP
2235 oxcarbazepine 10/08/1999 3 years 31/08/2027 29/11/2027 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00002235/202708 Karin Erneholm Denmark NAP
2237 oxeladin 06/06/1967 10 years 03/07/2034 01/10/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002237/203407 NAP
2240 oxetorone 20/08/1973 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002240/202806 NAP
2241 oxiconazole Not available* 10 years 03/08/2036 01/11/2036 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002241/203608 NAP
2244 oxitriptan Not available* 9 years 03/03/2032 01/06/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002244/203203 NAP
2246 oxolamine 18/06/1960 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002246/203906 NAP
2247 oxolamine / propyphenazone 05/03/1963 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00002247/203405 NAP
2249 oxomemazine 11/03/1964 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002249/203406 NAP
2250 oxprenolol 26/02/1968 11 years 01/02/2040 01/05/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002250/204002 none NAP
2251 oxybuprocaine 20/03/1957 11 years 03/10/2037 01/01/2038 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002251/203710 NAP
2253 oxybutynin 17/07/1984 5 years 17/07/2027 15/10/2027 No 05/04/2023 DLP was updated on 05/04/2023
PRAC representative was updated on 19/10/2022
PRAC Representative amended on 28/04/2022
DLP was updated on 27/03/2018
PRAC Representative amended on 18/11/2016 PSUSA/00002253/202707 Jo Robays Belgium CAP NAP
2254 oxycodone 12/12/1995 3 years 12/04/2027 11/07/2027 No 20/11/2024 PSUR frequency amended and DLP updated on 20/11/2024 PSUSA/00002254/202704 Liana Martirosyan Netherlands NAP
2255 acetylsalicylic acid / oxycodone hydrochloride Not available* 9 years 03/03/2029 01/06/2029 Yes 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002255/202903 NAP
2256 oxycodone hydrochloride / paracetamol Not available* 3 years 03/07/2027 01/10/2027 Yes 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00002256/202707 Amelia Cupelli Italy NAP
2257 oxygen Not available* 7 years 01/12/2031 29/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00002257/203112 Amelia Cupelli Italy NAP
2258 oxymetazoline 31/05/1962 6 years 01/08/2026 30/10/2026 No 31/03/2021 DLP was updated on 31/03/2021
PSUR frequency, DLP and PRAC rapporteur were updated on 05/06/2019 PSUSA/00002258/202608 Maia Uusküla Estonia NAP
2261 oxymorphone Not available* 9 years 03/03/2032 01/06/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002261/203203 NAP
2262 oxytetracycline, hydrocortisone / oxytetracycline, hydrocortisone / oxytetracycline / polymyxin b, oxytetracycline / polymyxin b 31/05/1950 11 years 03/06/2040 01/09/2040 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024
Entry name updated on 25/09/2024 PSUSA/00002262/204006 none NAP
2264 paclitaxel 29/12/1992 5 years 28/12/2026 28/03/2027 No 20/05/2026 Reference to CAP removed on 28/02/2024
PSUR frequency and DLP were updated on 21/09/2022
DLP was updated on 31/07/2019
New CAP authorised on 20/11/2018
PRAC Representative updated on 26/09/2018
Next DLP was updated on 22/09/2016
Lead MS was added on 13/07/2015 PSUSA/00002264/202612 Ana Sofia Diniz Martins Portugal NAP
2266 paliperidone 25/06/2007 3 years 30/06/2027 28/09/2027 No 05/03/2025 DLP was amended on 05/03/2025 PSUSA/00002266/202706 Karin Bolin Sweden CAP
2267 palivizumab 13/08/1999 5 years 18/06/2029 16/09/2029 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00002267/202906 Marie Louise Schougaard Christiansen Denmark CAP
2268 palonosetron 22/03/2005 5 years 24/07/2030 22/10/2030 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00002268/203007 Rhea Fitzgerald Ireland CAP NAP
2269 pamidronate 02/05/1989 5 years 31/05/2026 29/08/2026 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00002269/202605 Bianca Mulder Netherlands NAP
2273 amylase / bromelain / chymotrypsin / lipase / pancreatin / papain / rutoside / trypsin, trypsin/ bromelain/ rutoside trihydrate Not available* 9 years 03/03/2029 01/06/2029 No 12/09/2025 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002273/202903 Veronika Macurová Czech Republic NAP
2275 pancuronium 01/01/1991 6 years 01/12/2025 01/03/2026 Yes 15/01/2025 DLP was updated on 29/07/2020
PRAC Rapporteur name updated on 23/10/2018
PRAC Representative and Lead Member state assigned on 04/07/2018
Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00002275/202512 Dennis Lex Germany NAP
2281 pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) 19/10/2009 3 years 19/05/2027 17/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00002281/202705 Liana Martirosyan Netherlands CAP
2283 panitumumab 03/12/2007 5 years 30/09/2030 29/12/2030 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
PSUR frequency amended and DLP updated on 03/05/2023
DLP was updated on 25/05/2022
DLP was updated on 26/05/2021
DLP was updated on 06/05/2020
DLP was updated on 30/04/2019
Lead MS and PRAC Rapporteur name updated on 23/10/2018
DLP was updated on 07/05/2018
DLP was updated on 23/05/2017
PRAC Representative amended on 28/03/2017
Next DLP was amended on 03/05/2016
Conditional approval
Next DLP was amended on 28/05/2014 PSUSA/00002283/203009 David Olsen Norway CAP
2285 pantoprazole 23/08/1994 5 years 23/08/2027 21/11/2027 No 03/05/2023 DLP was amended on 03/05/2023
LMS and PRAC representative updated 05/06/2019
DLP was updated on 07/05/2018
PRAC Representative amended on 28/03/2017 PSUSA/00002285/202708 Rugile Pilviniene Lithuania CAP NAP
2286 amoxicillin / clarithromycin / pantoprazole 23/08/1994 3 years 03/08/2028 01/11/2028 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00002286/202808 Dennis Lex Germany NAP
2287 papaverine 21/02/1950 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002287/203212 NAP
2289 paracetamol (non IV formulations) 21/12/1959 11 years 03/05/2039 01/08/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002289/203905 NAP
2290 acetylsalicylic acid / paracetamol Not available* 8 years 03/11/2033 01/02/2034 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00002290/203311 none NAP
2291 acetylsalicylic acid / caffeine / paracetamol 24/10/1972 15 years 01/12/2038 01/03/2039 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00002291/203812 Dennis Lex Germany NAP
2294 caffeine / paracetamol 24/06/1969 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002294/204003 NAP
2297 caffeine / paracetamol / phenylephrine hydrochloride Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002297/202906 NAP
2298 caffeine / paracetamol / propyphenazone, paracetamol / propyphenazone Not available* 8 years 01/12/2025 01/03/2026 No 27/01/2026 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00002298/202512 Roxana Stefania Udrescu Romania NAP
2300 dextromethorphan hydrobromide / paracetamol / promethazine hydrochloride Not available* 7 years 03/11/2031 01/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00002300/203111 John Joseph Borg Malta NAP
2302 caffeine / guaifenesin / paracetamol Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002302/202906 NAP
2303 hyoscine butylbromide / paracetamol 10/08/1983 8 years 03/05/2033 01/08/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00002303/203305 Dennis Lex Germany NAP
2305 ascorbic acid / caffeine / paracetamol / phenylephrine hydrochloride / terpine Not available* 8 years 03/11/2033 01/02/2034 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00002305/203311 Melinda Pálfi Hungary NAP
2306 guaifenesin / paracetamol / phenylephrine hydrochloride Not available* 8 years 03/08/2026 01/11/2026 No 18/11/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002306/202608 Maia Uusküla Estonia NAP
2307 paracetamol / pseudoephedrine, dextromethorphan / paracetamol / pseudoephedrine, ascorbic acid / dextromethorphan / paracetamol / pseudoephedrine Not available* 5 years 28/06/2028 26/09/2028 Yes 01/07/2026 Lead MS and PRAC Rapporteur name removed on 01/07/2026
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 23/10/2024
Active substance name was amended on 23/10/2024
DLP was amended on 28/02/2024 PSUSA/00002307/202806 none NAP
2308 ascorbic acid / paracetamol / pseudoephedrine Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002308/202905 NAP
2310 paracetamol / tramadol Not available* 5 years 01/08/2028 30/10/2028 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00002310/202808 Tiphaine Vaillant France NAP
2311 paracetamol (IV formulation) Not available* 5 years 07/05/2026 05/08/2026 Yes 02/02/2022 DLP and PSUR frequency were updated on 02/02/2022
PRAC representative was updated on 29/07/2020
PRAC representative was updated on 03/06/2020
PSUR frequency amended and DLP updated on 19/12/2018
DLP was updated on 19/12/2017
PRAC Rapporteur name updated on 21/07/2017
Next DLP was amended on 20/12/2016
PRAC Rapporteur name was amended on 28/07/2016
Next DLP was updated on 21/12/2015.
Lead MS was added on 06/03/2015 PSUSA/00002311/202605 Tiphaine Vaillant France NAP
2312 caffeine / codeine / paracetamol / propyphenazone, acetylsalicylic acid / caffeine / codeine / paracetamol 01/06/1957 5 years 01/06/2030 30/08/2030 Yes 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00002312/203006 Petar Mas Croatia NAP
2314 parecoxib 22/03/2002 3 years 31/03/2026 29/06/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00002314/202603 Rhea Fitzgerald Ireland CAP
2316 paricalcitol 17/04/1998 5 years 17/08/2027 15/11/2027 No 19/09/2025 PSUR frequency amended and DLP updated on 03/05/2023
PRAC Representative updated on 16/11/2022
DLP was updated on 06/05/2020
PRAC Representative updated on 26/09/2018
Next DLP was amended on 26/04/2017
PRAC representative and Lead Member State were added on 04/03/2016 PSUSA/00002316/202708 Maria Martinez Gonzalez Spain NAP
2318 paromomycin 29/11/1960 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002318/203404 NAP
2319 paroxetine 11/12/1990 5 years 10/12/2027 09/03/2028 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00002319/202712 Liana Martirosyan Netherlands NAP
2320 patent blue V sodium 31/03/1974 5 years 30/04/2028 29/07/2028 Yes 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00002320/202804 Melinda Palfi Hungary NAP
2321 pazopanib 14/06/2010 5 years 18/10/2029 16/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00002321/202910 Marie Louise Schougaard Christiansen Denmark CAP
2322 pefloxacin 07/08/1984 3 years 31/08/2026 29/11/2026 Yes 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00002322/202608 Polona Golmajer Slovenia NAP
2326 pegfilgrastim 31/01/2002 5 years 31/01/2030 01/05/2030 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00002326/203001 Bianca Mulder Netherlands CAP
2328 pegvisomant 13/11/2002 3 years 30/11/2025 28/02/2026 No 19/09/2024 PSUSA/00002328/202511 Zoubida Amimour France CAP
2329 pelargonium sidoides dc and/or pelargonium reniforme curt. / radix Not available* 5 years 01/06/2028 30/08/2028 Yes 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00002329/202806 Melinda Palfi Hungary NAP
2330 pemetrexed 20/09/2004 5 years 04/02/2029 05/05/2029 No 05/06/2024 New CAP authorised on 09/12/2022
DLP was updated on 20/10/2021
PRAC representative was updated on 29/07/2020
PRAC representative was updated on 03/06/2020
DLP was updated on 23/10/2018
Reference to NAP added on 25/09/2017
PRAC Rapporteur name updated on 21/07/2017
PRAC Rapporteur name was amended on 28/07/2016
PRAC Rapporteur name updated on 03/06/2016
Next DLP was updated on 30/09/2015 PSUSA/00002330/202902 Tiphaine Vaillant France CAP NAP
2333 penciclovir 28/02/1996 5 years 28/08/2026 26/11/2026 No 28/04/2022 DLP was updated on 28/04/2022
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 23/05/2017
Lead MS and PRAC Rapporteur name was added on 07/04/2016 PSUSA/00002333/202608 Jan Neuhauser Austria NAP
2335 penicillamine 04/04/1963 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002335/202803 NAP
2336 pentaerithrityl tetranitrate Not available* 9 years 03/03/2032 01/06/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002336/203203 NAP
2337 pentagastrin 09/11/1981 10 years 03/05/2035 01/08/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002337/203505 NAP
2338 pentamidine 15/06/1988 5 years 15/06/2027 13/09/2027 No 01/03/2023 DLP was updated on 01/03/2023
PRAC representative was updated on 19/10/2022
PRAC Representative amended on 28/04/2022
DLP was updated on 28/02/2018
PRAC representative and Lead Member State were added on 18/11/2016 PSUSA/00002338/202706 Jo Robays Belgium NAP
2339 pentazocine 15/09/1966 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002339/202803 NAP
2341 pentosan polysulfate sodium (apart from centrally authorised product) 13/06/1961 10 years 02/04/2034 01/07/2034 No 05/01/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002341/203404 Melinda Palfi Hungary NAP
2343 pentostatin Not available* 8 years 03/11/2026 01/02/2027 No 05/01/2025 Correction of DLP on 20/11/2024
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002343/202611 Marie Louise Schougaard Christiansen Denmark NAP
2344 pentoxifylline 14/05/1967 9 years 02/04/2028 01/07/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002344/202804 NAP
2345 pentoxyverine 15/12/1954 5 years 31/12/2028 31/03/2029 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00002345/202812 Dennis Lex Germany NAP
2347 peptidic preparation from porcine brain (cerebrolysin) Not available* 10 years 03/08/2036 01/11/2036 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002347/203608 NAP
2350 perflutren 18/05/1998 5 years 27/12/2029 27/03/2030 No 02/06/2026 PSUSA/00002350/202912 Karin Bolin Sweden CAP
2352 periciazine 09/05/1963 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00002352/203405 NAP
2354 perindopril 22/06/1988 5 years 22/10/2030 20/01/2031 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00002354/203010 Karin Erneholm Denmark NAP
2355 permethrin Not available* 3 years 31/08/2026 29/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00002355/202608 Dennis Lex Germany NAP
2356 perphenazine 15/10/1952 10 years 01/01/2034 01/04/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002356/203401 NAP
2357 pethidine 28/03/1941 5 years 01/08/2030 30/10/2030 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00002357/203008 Melinda Palfi Hungary NAP
2358 phenazone Not available* 9 years 03/03/2032 01/06/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002358/203203 NAP
2359 lidocaine / phenazone Not available* 5 years 01/01/2030 01/04/2030 Yes 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00002359/203001 Rugile Pilviniene Lithuania NAP
2363 phenelzine 01/03/1962 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00002363/203405 NAP
2368 paracetamol / pheniramine hydrogenomaleate / phenylephrine hydrochloride, ascorbic acid / paracetamol / pheniramine maleate, ascorbic acid / paracetamol / pheniramine hydrogenomaleate / phenylephrine hydrochloride 06/06/1980 8 years 07/03/2028 05/06/2028 No 22/10/2025 Active substance name was amended on 22/10/2025
DLP was updated on 18/11/2020
PRAC representative was added on 06/05/2020
LMS was added on 31/07/2019 PSUSA/00002368/202803 Maia Uusküla Estonia NAP
2370 phenobarbital 27/01/1943 8 years 27/01/2028 26/04/2028 No 21/10/2020 DLP was updated on 21/10/2020
PRAC representative was added on 06/05/2020
LMS was added on 01/04/2020
PSUR frequency, "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?Yes/No" and DLP were updated on 25/09/2019 PSUSA/00002370/202801 Maia Uusküla Estonia NAP
2373 phenoxymethylpenicillin 01/06/1956 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002373/202712 NAP
2374 phenprocoumon 16/02/1955 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002374/202712 NAP
2376 phentolamine 02/04/1951 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002376/203212 NAP
2377 phenylbutazone 19/02/1952 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002377/203212 NAP
2382 ascorbic acid / guaifenesin / paracetamol / phenylephrine hydrochloride Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002382/202905 NAP
2386 mepyramine / phenylephrine Not available* 9 years 02/09/2031 01/12/2031 No 18/12/2024 Active substance name was amended on 18/12/2024
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002386/203109 none NAP
2387 paracetamol / phenylephrine hydrochloride Not available* 9 years 03/03/2032 01/06/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002387/203203 NAP
2392 phenytoin 12/08/1960 3 years 12/08/2026 10/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00002392/202608 Eamon O'Murchu Ireland NAP
2393 metylphenobarbital / phenytoin sodium 20/04/1950 10 years 01/12/2032 01/03/2033 No 18/10/2023 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?", PSUR frequency and DLP were amended on 18/10/2023 PSUSA/00002393/203212 none NAP
2398 phosphocreatine Not available* 8 years 03/11/2032 01/02/2033 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00002398/203211 Amelia Cupelli Italy NAP
2400 phytomenadione, menadiol 01/01/1954 10 years 01/01/2034 01/04/2034 No 23/10/2024 Active substance name was amended on 23/10/2024
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002400/203401 none NAP
2402 phytosterol Not available* 10 years 03/08/2036 01/11/2036 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002402/203608 NAP
2403 picloxydine 13/04/1962 11 years 03/07/2039 01/10/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002403/203907 NAP
2408 pilocarpine / timolol 13/02/1989 5 years 15/07/2026 13/10/2026 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00002408/202607 Karin Erneholm Denmark NAP
2409 pilocarpine (non ophthalmic formulations) 01/04/1994 5 years 31/07/2027 29/10/2027 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00002409/202707 Petar Mas Croatia NAP
2410 pilocarpine (ophthalmic formulation) 01/04/1994 7 years 31/08/2028 29/11/2028 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00002410/202808 Petar Mas Croatia NAP
2411 pimecrolimus 14/12/2001 3 years 31/03/2026 29/06/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00002411/202603 Marie Louise Schougaard Christiansen Denmark NAP
2413 pimozide 15/02/1971 12 years 15/02/2037 16/05/2037 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00002413/203702 Jo Robays Belgium NAP
2414 pinaverium 01/12/1975 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002414/202808 NAP
2415 pindolol 10/11/1969 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002415/202805 NAP
2417 glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone 13/10/2000 3 years 31/07/2027 29/10/2027 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00002417/202707 Rhea Fitzgerald Ireland CAP
2420 pipamperone 14/10/1965 15 years 14/10/2040 12/01/2041 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00002420/204010 Dennis Lex Germany NAP
2422 pipecuronium Not available* 9 years 03/05/2032 01/08/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002422/203205 NAP
2424 piperacillin 07/05/1980 8 years 03/03/2026 01/06/2026 Yes 30/07/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/07/2025
PSUR frequency amended and DLP updated on 03/07/2024 PSUSA/00002424/202603 Amelia Cupelli Italy NAP
2425 piperacillin / tazobactam 02/07/1992 5 years 01/09/2027 30/11/2027 No 17/02/2026 DLP was amended on 03/05/2023
PRAC representative was updated on 27/07/2022
PRAC representative was updated on 06/05/2020
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 06/06/2018
Lead MS and PRAC Rapporteur name was added on 28/02/2017 PSUSA/00002425/202709 Jana Pecherova Slovakia NAP
2426 piperazine Not available* 10 years 03/11/2036 01/02/2037 No 15/01/2025 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00002426/203611 Ana Sofia Diniz Martins Portugal NAP
2429 piracetam 19/04/1971 5 years 30/04/2027 29/07/2027 No 01/02/2023 DLP was updated on 01/02/2023
DLP was amended on 31/01/2018
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00002429/202704 Terhi Lehtinen Finland NAP
2430 dihydroergocristine / piracetam Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002430/203011 NAP
2431 pirenoxine Not available* 7 years 01/01/2032 31/03/2032 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00002431/203201 Amelia Cupelli Italy NAP
2434 piretanide / ramipril, piretanide 17/10/1980 8 years 03/08/2033 01/11/2033 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00002434/203308 Zoubida Amimour France NAP
2435 pirfenidone 28/02/2011 3 years 27/02/2027 28/05/2027 No 20/10/2021 New CAP authorised on 10/01/2023
New CAP authorised on 20/06/2022
DLP and PSUR frequency were updated on 20/10/2021
DLP was updated on 21/10/2020
DLP was updated on 25/09/2019
Lead MS and PRAC Rapporteur name updated on 30/04/2019
DLP was updated on 26/09/2018
DLP was updated on 17/10/2017
Next DLP was amended on 19/10/2016
Next DLP was updated on 30/09/2015
Next DLP was amended on 02/05/2014 PSUSA/00002435/202702 Rhea Fitzgerald Ireland CAP
2436 piribedil 10/10/1990 3 years 31/03/2026 29/06/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00002436/202603 Zane Neikena Latvia NAP
2437 piritramide 01/04/1969 5 years 31/03/2030 29/06/2030 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00002437/203003 Jo Robays Belgium NAP
2438 piroxicam 03/04/1979 3 years 01/04/2026 30/06/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00002438/202604 Melinda Palfi Hungary NAP
2441 fenpiverinium bromide / metamizole sodium / pitofenone hydrochloride Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002441/203011 NAP
2443 metamizole sodium / pitofenone hydrochloride Not available* 7 years 01/12/2031 29/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00002443/203112 Miroslava Gocova Slovakia NAP
2444 pivampicillin 31/10/1974 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002444/202808 NAP
2445 pivmecillinam 31/05/1977 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002445/202811 NAP
2446 pizotifen 14/07/1969 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002446/202805 NAP
2451 plerixafor 31/07/2009 3 years 15/12/2025 15/03/2026 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00002451/202512 Bianca Mulder Netherlands CAP
2453 pneumococcal polysaccharide vaccine 06/02/1981 3 years 03/05/2028 01/08/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00002453/202805 Pernille Harg Norway NAP
2454 podophyllotoxin Not available* 6 years 15/09/2026 14/12/2026 No 02/02/2026 DLP was updated on 26/05/2021
PRAC representative and LMS were added on 04/03/2020
PSUR frequency and DLP were updated on 05/06/2019 PSUSA/00002454/202609 Rhea Fitzgerald Ireland NAP
2455 policresulen Not available* 8 years 01/12/2026 01/03/2027 No 23/10/2024 DLP amended on 23/10/2024 PSUSA/00002455/202612 NAP
2456 lauromacrogol 400 / urea Not available* 8 years 01/12/2026 01/03/2027 No 01/07/2026 Active substance name was amended on 01/07/2026
DLP amended on 23/10/2024 PSUSA/00002456/202612 Dennis Lex Germany NAP
2459 poliovirus type 1 / poliovirus type 2 / poliovirus type 3 vaccine (inactivated) 02/07/1982 5 years 01/07/2030 29/09/2030 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024
Entry re-introduced and entry name changed on 04/03/2020 PSUSA/00002459/203007 none NAP
2468 polygeline Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002468/203611 NAP
2469 polymyxin b 01/01/1956 11 years 01/12/2036 01/03/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002469/203612 NAP
2470 polymyxin b / trimethoprim Not available* 9 years 03/05/2032 01/08/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002470/203205 NAP
2472 polystyrene sulfonate 26/10/1955 8 years 26/10/2030 24/01/2031 No 12/09/2025 PSUR frequency amended and DLP updated on 31/05/2023
DLP and Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was updated on 29/06/2022
PSUR frequency, DLP and
PRAC representative and PSURs required for products referred to in Articles 10(1), 10a, 16a of Directive 2001/83/EC as amended? were updated on 30/06/2021
LMS were added on 01/04/2020
The DLP was amended on 30/09/2015 PSUSA/00002472/203010 Veronika Macurová Czech Republic NAP
2475 povidone, polyvinyl alcohol / povidone 01/01/1981 8 years 02/09/2033 01/12/2033 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00002475/203309 Adam Przybylkowski Poland NAP
2476 polyvinyl alcohol 27/08/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002476/203406 NAP
2478 poractant alfa 06/08/1992 5 years 31/08/2030 29/11/2030 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00002478/203008 Terhi Lehtinen Finland NAP
2480 posaconazole 25/10/2005 3 years 25/10/2026 23/01/2027 No 19/09/2024 PSUSA/00002480/202610 Zoubida Amimour France CAP NAP
2481 potassium / sodium Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00002481/202612 Amelia Cupelli Italy NAP
2483 potassium chloride Not available* 9 years 03/05/2032 01/08/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002483/203205 NAP
2485 potassium iodate 06/03/1978 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002485/203503 NAP
2486 perchlorates Not available* 7 years 20/03/2026 18/06/2026 Yes 05/08/2025 DLP was amended on 28/05/2025
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025
PSUR frequency and DLP amended on 27/03/2024 PSUSA/00002486/202603 Jan Neuhauser Austria NAP
2487 povidone iodinated 24/04/1996 5 years 02/01/2029 02/04/2029 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00002487/202901 Zoubida Amimour France NAP
2488 allantoine / povidone iodinated Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002488/202903 NAP
2489 prajmalium 22/12/1972 10 years 31/01/2035 01/05/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002489/203501 NAP
2490 pralidoxime 02/07/1968 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002490/203408 NAP
2491 pramipexole 14/10/1997 3 years 06/04/2026 05/07/2026 No 15/11/2023 PSUR frequency amended and DLP updated on 15/11/2023 PSUSA/00002491/202604 Karin Erneholm Denmark CAP NAP
2492 pramiracetam Not available* 5 years 30/09/2029 29/12/2029 No 03/06/2020 DLP was updated on 03/06/2020
Next DLP amended on 13/07/2015
'PRAC Rapporteur name amended on 16/06/2015
PRAC Rapporteur name and country updated on 01/12/2014 PSUSA/00002492/202909 Zane Neikena Latvia NAP
2498 estradiol / prasterone enantate Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002498/203506 NAP
2499 prasugrel 23/02/2009 5 years 25/02/2029 26/05/2029 No 20/10/2021 DLP was updated on 20/10/2021
PRAC Rapporteur name was corrected on 03/04/2019
PSUR Frequency and DLP updated on 26/09/2018
PRAC Rapporteur name was amended on 06/06/2018
DLP was updated and PRAC representative amended on 17/10/2017
Next DLP was updated on 22/09/2016
Next DLP was updated on 30/09/2015
The next DLP was amended on 01/04/2014 PSUSA/00002499/202902 Marie Louise Schougaard Christiansen Denmark CAP
2500 pravastatin 31/03/1989 5 years 30/03/2028 28/06/2028 No 19/09/2024 PSUSA/00002500/202803 Zoubida Amimour France NAP
2502 prazepam 18/12/1974 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00002502/203303 Jo Robays Belgium NAP
2503 praziquantel 30/04/1980 3 years 30/04/2027 29/07/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00002503/202704 Zoubida Amimour France NAP
2504 prazosin 24/05/1974 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002504/202808 NAP
2505 prednicarbate 02/10/1985 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002505/202812 NAP
2506 prednisolone 13/07/1956 6 years 03/08/2029 01/11/2029 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00002506/202908 Polona Golmajer Slovenia NAP
2507 prednisolone / salicylic acid Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00002507/202612 Petar Mas Croatia NAP
2508 estradiol benzoate / prednisolone / salicylic acid Not available* 8 years 03/05/2026 01/08/2026 No 23/09/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002508/202605 Dennis Lex Germany NAP
2510 prednisone 18/05/1955 8 years 31/01/2033 01/05/2033 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00002510/203301 Karin Erneholm Denmark NAP
2511 pregabalin 06/07/2004 3 years 31/01/2026 01/05/2026 No 18/10/2023 PSUR frequency amended and DLP updated on 18/10/2023 PSUSA/00002511/202601 Liana Martirosyan Netherlands CAP NAP
2512 prenoxdiazin hydrochloride 26/05/1965 13 years 26/05/2026 24/08/2026 No 18/11/2025 Entry reintroduced and renamed 24/09/2025 PSUSA/00002512/202605 Melinda Palfi Hungary NAP
2522 prilocaine 01/01/1963 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002522/202803 NAP
2524 felypressin / prilocaine hydrochloride Not available* 10 years 12/02/2035 13/05/2035 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002524/203502 NAP
2525 primidone 30/06/1953 8 years 30/06/2028 28/09/2028 No 03/03/2021 DLP was updated on 03/03/2021
LMS and PRAC representative were added on 04/03/2020
PSUR frequency, "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?Yes/No" and DLP were updated on 25/09/2019 PSUSA/00002525/202806 Dennis Lex Germany NAP
2527 probenecid 01/05/1960 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002527/203404 NAP
2528 procainamide Not available* 11 years 03/05/2040 01/08/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002528/204005 NAP
2529 procaine Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002529/203611 NAP
2533 phenazone / procaine hydrochloride Not available* 11 years 03/05/2040 01/08/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002533/204005 none NAP
2534 procarbazine 07/10/1966 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002534/202803 NAP
2536 perazine 06/12/1957 9 years 02/12/2027 01/03/2028 No 31/01/2024 Active substance name, PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00002536/202712 none NAP
2537 procyanidolic oligomers 11/05/1977 10 years 11/05/2032 09/08/2032 No 01/02/2023 DLP was updated on 01/02/2023
LMS and PRAC representative were added on 20/10/2021 PSUSA/00002537/203205 Melinda Palfi Hungary NAP
2538 procyclidine 07/03/1953 10 years 01/01/2034 01/04/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002538/203401 NAP
2540 progesterone 09/09/1971 10 years 09/09/2035 08/12/2035 No 02/06/2026 PSUSA/00002540/203509 Jenny Jönsson Sweden NAP
2541 proglumetacin 01/02/1980 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002541/202811 Carla Torre Portugal NAP
2543 promazine 13/04/1956 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002543/203401 NAP
2544 promegestone 31/07/1981 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002544/202811 NAP
2545 promethazine 26/10/1948 9 years 26/04/2033 25/07/2033 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00002545/203304 Eva Jirsová Czech Republic NAP
2547 carbocisteine / promethazine hydrochloride Not available* 13 years 03/11/2026 01/02/2027 Yes 28/05/2025 DLP was amended on 28/05/2025
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025
DLP was amended on 19/10/2023 PSUSA/00002547/202611 Amelia Cupelli Italy NAP
2550 propafenone 10/12/1978 5 years 31/01/2026 01/05/2026 No 20/10/2021 DLP was updated on 20/10/2021
PRAC representative was updated on 28/07/2021
PRAC representative was updated on 28/04/2021
Lead MS and PRAC Rapporteur name amended on 19/12/2018
Next DLP was amended on 19/10/2016
The DLP was amended on 30/09/2015
Lead MS was added on 13/07/2015 PSUSA/00002550/202601 Polona Golmajer Slovenia NAP
2554 propiverine 22/10/1981 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002554/202811 NAP
2555 propofol 08/11/1995 5 years 07/11/2027 05/02/2028 No 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00002555/202711 Karen Pernille Harg Norway NAP
2558 propylthiouracil Not available* 7 years 31/01/2032 30/04/2032 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00002558/203201 Maia Uusküla Estonia NAP
2562 protamine 31/12/1951 11 years 31/12/2034 31/03/2035 No 18/12/2024 PSUR frequency amended and DLP updated on 18/12/2024 PSUSA/00002562/203412 none NAP
2563 human protein C 16/07/2001 5 years 31/07/2030 29/10/2030 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00002563/203007 Dirk Mentzer Germany CAP NAP
2564 prothipendyl 07/10/2005 3 years 07/10/2028 05/01/2029 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00002564/202810 Jan Neuhauser Austria NAP
2565 protionamide Not available* 7 years 31/01/2027 01/05/2027 Yes 30/07/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/07/2025
DLP was amended on 30/07/2025
PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00002565/202701 Dennis Lex Germany NAP
2567 proxymetacaine 01/03/1971 10 years 02/09/2034 01/12/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002567/203409 NAP
2568 prucalopride 15/10/2009 3 years 14/10/2028 12/01/2029 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026 PSUSA/00002568/202810 Karin Bolin Sweden CAP
2569 prulifloxacin 21/06/2004 3 years 30/09/2026 29/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00002569/202609 Amelia Cupelli Italy NAP
2578 pyrantel 30/12/1970 10 years 02/09/2034 01/12/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002578/203409 NAP
2579 pyrazinamide 25/01/1956 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002579/202712 NAP
2580 pyridostigmine 01/12/1953 10 years 01/01/2034 01/04/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002580/203401 NAP
2582 pyrimethamine 01/01/1952 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002582/203212 NAP
2583 pyrimethamine / sulfadoxine 14/07/1970 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002583/202805 NAP
2584 pyrithione zinc Not available* 9 years 03/06/2032 01/09/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002584/203206 NAP
2585 pyritinol 17/01/1960 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002585/203404 NAP
2587 pyrvinium Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002587/203611 NAP
2589 quetiapine 31/07/1997 3 years 31/07/2026 29/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00002589/202607 Liana Martirosyan Netherlands NAP
2590 quinagolide 29/06/1993 10 years 31/07/2027 29/10/2027 No 02/06/2026 PSUSA/00002590/202707 Jenny Jönsson Sweden NAP
2591 quinapril 14/04/1989 5 years 13/04/2026 12/07/2026 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00002591/202604 Karin Erneholm Denmark NAP
2592 hydrochlorothiazide / quinapril 14/04/1989 5 years 13/04/2026 12/07/2026 No 27/01/2026 DLP was updated on 22/12/2021
Next DLP was amended on 20/12/2016
Lead Member State and PRAC Rapporteur added on 27/11/2015. PSUSA/00002592/202604 Roxana Stefania Udrescu Romania NAP
2598 quinine 15/01/1951 5 years 30/11/2026 28/02/2027 No 27/07/2022 DLP was updated on 27/07/2022
PRAC Rapporteur name updated on 23/10/2018
Next DLP was amended on 25/09/2017
PRAC representative and Lead Member State were added on 30/01/2017
Next DLP was amended on 03/06/2016
The 8 digit unique identification
number was corrected. PSUSA/00002598/202611 Eamon O'Murchu Ireland NAP
2600 quinisocaine Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00002600/202612 Dennis Lex Germany NAP
2601 rabeprazole 14/10/1997 5 years 13/10/2026 11/01/2027 No 29/06/2022 DLP was updated on 29/06/2022
EURD corrected on 05/06/2019
Next DLP was amended on 27/06/2017
PSUR Frequency amended and DLP updated on 28/06/2016
Lead MS added on 16/06/2015
The DLP was amended on 01/04/2014 PSUSA/00002601/202610 Jan Neuhauser Austria NAP
2602 racecadotril Not available* 5 years 31/03/2028 29/06/2028 No 19/09/2025 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00002602/202803 Maria Martinez Gonzalez Spain NAP
2603 raloxifene 05/08/1998 5 years 09/12/2028 09/03/2029 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00002603/202812 Terhi Lehtinen Finland CAP
2605 raltitrexed 11/08/1995 8 years 02/09/2033 01/12/2033 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00002605/203309 Veronika Macurová Czech Republic NAP
2607 ramipril 10/01/1989 6 years 03/08/2029 01/11/2029 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00002607/202908 Dennis Lex Germany NAP
2609 ranibizumab 22/01/2007 3 years 05/10/2028 03/01/2029 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00002609/202810 Karin Bolin Sweden CAP
2610 ranitidine 15/06/1981 5 years 31/05/2029 29/08/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00002610/202905 Amelia Cupelli Italy NAP
2611 ranolazine 09/07/2008 3 years 26/01/2027 26/04/2027 No 02/06/2026 PSUSA/00002611/202701 Karin Bolin Sweden CAP
2612 rasagiline 21/02/2005 5 years 02/01/2029 02/04/2029 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00002612/202901 Ana Sofia Diniz Martins Portugal CAP NAP
2613 rasburicase 23/02/2001 5 years 23/02/2028 23/05/2028 No 18/10/2023 PSUR frequency amended and DLP updated on 18/10/2023 PSUSA/00002613/202802 Bianca Mulder Netherlands CAP
2615 reboxetine 10/04/1997 5 years 09/04/2030 08/07/2030 No 24/09/2024 DLP was updated on 16/12/2020
Lead MS and PRAC Rapporteur name amended on 19/12/2018
Next DLP amended on 21/12/2015
Lead MS was added on 06/03/2015 PSUSA/00002615/203004 Karin Bolin Sweden NAP
2616 regadenoson 10/04/2008 3 years 09/04/2027 08/07/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00002616/202704 Maria del Pilar Rayon Spain CAP
2617 remifentanil 17/05/1996 5 years 16/05/2026 14/08/2026 No 02/02/2022 DLP and PSUR frequency were updated on 02/02/2022
PRAC representative and LMS were added on 23/09/2020
"Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?Yes/No" was amended on 12/05/2015 PSUSA/00002617/202605 Dennis Lex Germany NAP
2618 repaglinide 17/08/1998 5 years 31/12/2025 31/03/2026 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00002618/202512 Bianca Mulder Netherlands CAP NAP
2620 resorcinol Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002620/203611 NAP
2625 retinol 13/10/1966 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002625/202803 NAP
2633 a-tocopherol / ergocalciferol / phytomenadion / retinol palmitate Not available* 10 years 03/11/2035 01/02/2036 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002633/203511 Miroslava Gocova Slovakia NAP
2638 haemophilus influenzae / membrane fraction of klebsiella pneumoniae / ribosomal fractions of klebsiella pneumoniae / streptococcus pneumoniae / streptococcus pyogenes vaccine 30/03/1989 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002638/202901 NAP
2639 rifabutin 19/10/1992 11 years 03/07/2036 01/10/2036 No 04/03/2026 PSUR frequency amended and DLP updated on 04/03/2026 PSUSA/00002639/203607 Marie Louise Schougaard Christiansen Denmark NAP
2640 rifampicin 01/05/1968 5 years 03/03/2030 01/06/2030 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00002640/203003 Maria Popova-Kiradjieva Bulgaria NAP
2641 rifamycin 01/04/1962 11 years 01/04/2034 30/06/2034 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00002641/203404 Marie Louise Schougaard Christiansen Denmark NAP
2642 rifaximin 14/09/1985 8 years 03/05/2033 01/08/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00002642/203305 Melinda Pálfi Hungary NAP
2643 rilmenidine 23/04/1987 5 years 23/08/2029 21/11/2029 No 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00002643/202908 Melinda Palfi Hungary NAP
2645 riluzole 10/12/1995 5 years 12/12/2028 12/03/2029 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00002645/202812 Karin Erneholm Denmark CAP NAP
2648 risedronate, risedronate / calcium / colecalciferol 31/03/1998 5 years 31/03/2026 29/06/2026 No 02/06/2026 PSUSA/00002648/202603 Karin Bolin Sweden NAP
2649 risperidone 01/06/1993 5 years 31/05/2027 29/08/2027 No 26/07/2023 Reference to CAP added and active substance name was amended on 26/07/2023
DLP was updated on 01/02/2023
Active substance name updated on 02/03/2022
DLP was amended on 31/01/2018
Lead MS and PRAC Rapporteur name was added on 19/10/2016
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 19/10/2016 PSUSA/00002649/202705 Dennis Lex Germany CAP NAP
2650 ritodrine hydrochloride Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00002650/202612 Pilar Rayón Iglesias Spain NAP
2651 ritonavir 26/08/1996 5 years 31/08/2028 29/11/2028 No 29/04/2026 PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00002651/202808 Liana Martirosyan Netherlands CAP
2652 rituximab 02/06/1998 3 years 17/11/2026 15/02/2027 No 28/08/2024 New CAP authorised on 19/09/2024
PSUR frequency amended and DLP updated on 28/08/2024
DLP was amended on 03/07/2024 PSUSA/00002652/202611 Karin Erneholm Denmark CAP
2653 rivaroxaban, acetylsalicylic acid / rivaroxaban 30/09/2008 3 years 15/09/2027 14/12/2027 No 02/06/2026 PSUSA/00002653/202709 Karin Bolin Sweden CAP NAP
2654 rivastigmine 12/05/1998 5 years 31/01/2029 01/05/2029 No 25/09/2019 Reference to NAP added on 23/10/2024
PRAC representative was updated on 29/07/2020
PRAC representative was updated on 03/06/2020
PSUR frequency and DLP were updated on 25/09/2019
Reference to NAP products removed on 04/07/2018
PRAC Rapporteur name updated on 21/07/2017
PSUR Frequency amended and DLP updated on 22/09/2016
PRAC Rapporteur name was amended on 28/07/2016
Next DLP was updated on 30/09/2015
Rapporteur amended on 04/11/2014 PSUSA/00002654/202901 Tiphaine Vaillant France CAP NAP
2655 rizatriptan 11/02/1998 5 years 11/06/2028 09/09/2028 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00002655/202806 Liana Martirosyan Netherlands NAP
2656 rocuronium 17/03/1994 5 years 28/02/2030 29/05/2030 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00002656/203002 Eva Jirsová Czech Republic NAP
2658 roflumilast 05/07/2010 5 years 05/01/2029 05/04/2029 No 19/09/2025 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00002658/202901 Maria Martinez Gonzalez Spain CAP
2660 romiplostim 04/02/2009 5 years 31/07/2027 29/10/2027 No 19/09/2025 PSUR frequency amended and DLP updated on 05/04/2023
DLP was updated on 01/04/2020
PSUR Frequency amended and DLP updated on 28/02/2017
PRAC Representative amended on 28/06/2016
Next DLP was updated on 04/03/2016
The DLP was amended on 06/03/2015
The DLP was amended on 01/04/2014 PSUSA/00002660/202707 Maria Martinez Gonzalez Spain CAP
2661 ropinirole 08/07/1996 3 years 08/07/2028 06/10/2028 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00002661/202807 Tiphaine Vaillant France NAP
2662 ropivacaine 15/09/1995 5 years 14/09/2027 13/12/2027 No 06/06/2018 Next DLP was updated on 31/05/2023 PSUSA/00002662/202709 Liana Martirosyan Netherlands NAP
2664 rosuvastatin 06/11/2002 5 years 06/11/2027 04/02/2028 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00002664/202711 Bianca Mulder Netherlands NAP
2665 rotavirus vaccine monovalent (live, oral) 21/02/2006 3 years 11/07/2028 09/10/2028 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00002665/202807 Jean-Michel Dogné Belgium CAP
2666 rotavirus vaccine pentavalent (live, oral) 27/06/2006 3 years 27/11/2026 25/02/2027 No 02/06/2026 PSUSA/00002666/202611 Karin Bolin Sweden CAP
2667 rotigotine 15/02/2006 3 years 15/02/2026 16/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00002667/202602 Ana Sofia Diniz Martins Portugal CAP
2669 roxithromycin 04/08/1986 3 years 31/12/2027 30/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00002669/202712 Amelia Cupelli Italy NAP
2671 rufinamide 16/01/2007 5 years 15/01/2028 14/04/2028 No 25/06/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/06/2025
DLP and PSUR frequency amended on 20/09/2023 PSUSA/00002671/202801 Tiphaine Vaillant France CAP
2673 rupatadine 12/12/2005 5 years 30/12/2028 30/03/2029 No 19/09/2025 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00002673/202812 Maria Martinez Gonzalez Spain NAP
2674 rutoside 31/10/1962 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00002674/203405 NAP
2679 salicylamide Not available* 8 years 01/12/2026 01/03/2027 No 23/10/2024 DLP amended on 23/10/2024 PSUSA/00002679/202612 NAP
2680 salicylic acid (topical use) Not available* 6 years 02/12/2029 02/03/2030 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00002680/202912 Dennis Lex Germany NAP
2681 salmeterol 25/10/1990 5 years 31/10/2030 29/01/2031 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00002681/203010 Karin Bolin Sweden NAP
2682 samarium (153sm) lexidronam 05/02/1998 5 years 04/02/2029 05/05/2029 No 25/09/2019 PSUR frequency, DLP and PRAC representative were updated on 25/09/2019
Lead MS and PRAC Rapporteur name updated on 30/04/2019
PRAC Representative amended on 28/03/2017
Next DLP was updated on 22/09/2016 PSUSA/00002682/202902 Karin Erneholm Denmark CAP
2683 sapropterin 02/12/2008 3 years 01/12/2027 29/02/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00002683/202712 Eamon O Murchu Ireland CAP
2685 saxagliptin, metformin / saxagliptin 01/10/2009 3 years 30/07/2026 28/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00002685/202607 Bianca Mulder Netherlands CAP
2687 secnidazole Not available* 9 years 03/06/2032 01/09/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002687/203206 NAP
2688 selegiline 14/03/1980 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00002688/203303 Veronika Macurová Czech Republic NAP
2690 selenium Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00002690/202612 Dennis Lex Germany NAP
2693 serrapeptase 30/09/1968 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002693/203408 NAP
2694 sertaconazole 10/03/1992 10 years 03/06/2035 01/09/2035 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00002694/203506 Ana Sofia Martins Portugal NAP
2695 sertindole 11/07/2002 3 years 11/01/2026 11/04/2026 Yes 20/09/2023 DLP amended on 20/09/2023 PSUSA/00002695/202601 Melinda Palfi Hungary NAP
2696 sertraline 01/03/1990 5 years 31/03/2027 29/06/2027 No 21/12/2022 DLP was updated on 21/12/2022
PRAC Rapporteur name updated on 23/10/2018
PRAC Representative updated on 26/09/2018
DLP was updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016
Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00002696/202703 Liana Martirosyan Netherlands NAP
2697 sevelamer 30/10/1998 3 years 30/10/2027 28/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00002697/202710 Jo Robays Belgium CAP NAP
2698 sevoflurane 23/01/1990 5 years 31/01/2030 01/05/2030 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00002698/203001 Eamon O'Murchu Ireland NAP
2699 sildenafil (indicated for erectile dysfunction) 14/09/1998 5 years 31/12/2026 31/03/2027 No 21/09/2022 DLP was updated on 21/09/2022
Reference to NAP added on 25/05/2022
PSUR Frequency amended and next DLP updated on 25/09/2017
PSUSA procedure published on 01/04/2014. Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00002699/202612 Liana Martirosyan Netherlands CAP NAP
2700 sildenafil (indicated for pulmonary hypertension) 28/10/2005 3 years 31/05/2027 29/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00002700/202705 Bianca Mulder Netherlands CAP NAP
2701 silodosin 29/01/2010 3 years 30/01/2026 30/04/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00002701/202601 Amelia Cupelli Italy CAP
2702 silver sulfadiazine 25/01/1973 8 years 15/09/2033 14/12/2033 No 27/05/2026 PSUR frequency amended and DLP updated on 27/05/2026
DLP was updated on 26/05/2021
PRAC representative was added on 06/05/2020
LMS was added on 01/04/2020
PSUR frequency and DLP were updated on 05/06/2019 PSUSA/00002702/203309 Maia Uusküla Estonia NAP
2703 cerium nitrate / silver sulfadiazine 25/01/1973 10 years 31/01/2035 01/05/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002703/203501 NAP
2705 simeticone, pancreatin / simeticone, dimethicone / pancreatin, pancreatic enzymes, pancreatic extracts, pancreatin 28/04/1967 9 years 02/04/2028 01/07/2028 No 18/10/2023 Active substance name, PSUR frequency and DLP were amended on 18/10/2023
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00002705/202804 none NAP
2706 aluminium oxide / magnesium hydroxide / simeticone Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002706/202903 NAP
2709 simvastatin 06/04/1988 5 years 05/04/2030 04/07/2030 No 16/12/2020 PSUR frequency and DLP were updated on 16/12/2020
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016
Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00002709/203004 Terhi Lehtinen Finland NAP
2710 sirolimus (for prophylaxis of organ rejection indication) 13/03/2001 3 years 14/09/2026 13/12/2026 No 02/06/2026 PSUSA/00002710/202609 Karin Bolin Sweden CAP
2713 sobrerol Not available* 9 years 03/06/2032 01/09/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002713/203206 NAP
2719 sodium benzoate / sodium phenylacetate Not available* 9 years 03/06/2032 01/09/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002719/203206 NAP
2723 sodium bicarbonate / sodium hydrogen phoshate / sodium sulphate 11/01/1966 11 years 02/12/2039 01/03/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002723/203912 NAP
2724 solutions for haemofiltration and haemodiafiltration, solutions for haemodialysis Not available* 9 years 03/08/2032 01/11/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002724/203208 none NAP
2731 succinylated gelatin, sodium chloride / sodium hydroxide / succinylated gelatin, calcium chloride / magnesium chloride / potassium chloride / sodium acetate /sodium chloride / succinylated gelatin, gelatin / sodium chloride / potassium chloride / magnesium chloride hexahydrate / sodium lactate 27/09/2006 15 years 26/09/2033 25/12/2033 No 23/10/2024 PSUR frequency amended and DLP updated on 23/10/2024
EURD added on 23/10/2024
Active substance name was amended on 01/04/2020
Active substance name was amended on 05/02/2020 PSUSA/00002731/203309 Liana Martirosyan Netherlands NAP
2732 sodium chloride / urea Not available* 8 years 01/12/2026 01/03/2027 No 23/10/2024 DLP amended on 23/10/2024 PSUSA/00002732/202612 NAP
2735 sodium citrate / sodium lauryl sulfoacetate, sodium citrate / sodium lauryl sulfoacetate / sorbitol Not available* 7 years 31/01/2032 30/04/2032 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00002735/203201 Zoubida Amimour France NAP
2737 disodium hydrogen phosphate / sodium dihydrogen phosphate, phosphate sodium 06/01/2005 13 years 06/01/2038 06/04/2038 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00002737/203801 Guðrún Stefánsdóttir Iceland NAP
2738 disodium edetate dihydrate / sodium dihydrogen phosphate dihydrate / sodium hydrogen phosphate dodecahydrate / water for injection Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002738/203011 none NAP
2739 glucose monohydrate / sodium dihydrogen phosphate dihydrate / zinc acetate dihydrate Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002739/203103 NAP
2745 sodium glycerophosphate pentahydrate Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00002745/202612 Jo Robays Belgium NAP
2748 sodium hydrogen carbonate Not available* 9 years 03/08/2032 01/11/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002748/203208 NAP
2752 sodium iodide (123i) 31/01/1995 7 years 31/03/2027 29/06/2027 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00002752/202703 Karin Erneholm Denmark NAP
2753 sodium iodide (131i) 01/10/1973 5 years 01/03/2027 30/05/2027 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00002753/202703 Carla Torre Portugal NAP
2756 sodium nitroprusside 30/11/1976 9 years 02/09/2028 01/12/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002756/202809 NAP
2758 sodium phenylbutyrate 08/12/1999 3 years 31/12/2027 30/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00002758/202712 Rhea Fitzgerald Ireland CAP
2759 sodium picosulfate 01/10/1967 9 years 02/04/2028 01/07/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002759/202804 NAP
2760 liquid paraffin / sodium picosulfate Not available* 13 years 03/06/2040 01/09/2040 No 23/10/2024 DLP amended on 23/10/2024 PSUSA/00002760/204006 NAP
2767 sodium tetradecyl sulphate Not available* 3 years 30/04/2026 29/07/2026 Yes 12/09/2025 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00002767/202604 Veronika Macurová Czech Republic NAP
2769 solifenacin 08/06/2004 5 years 08/06/2030 06/09/2030 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00002769/203006 Liana Martirosyan Netherlands NAP
2770 somatorelin 01/01/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002770/202812 NAP
2771 somatostatin 03/12/1989 8 years 03/06/2033 01/09/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00002771/203306 Maria Martinez Gonzalez Spain NAP
2772 somatropin 28/04/1988 3 years 31/03/2026 29/06/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00002772/202603 Karin Erneholm Denmark CAP NAP
2773 sorafenib 19/07/2006 5 years 31/12/2029 31/03/2030 No 02/06/2026 PSUSA/00002773/202912 Jenny-Maria Jönsson Sweden CAP NAP
2774 sotalol 22/08/1973 7 years 21/08/2031 19/11/2031 No 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00002774/203108 Karin Erneholm Denmark NAP
2775 spaglumic acid Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002775/203211 NAP
2777 spectinomycin 21/08/1970 10 years 02/09/2034 01/12/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002777/203409 NAP
2778 spiramycin 08/02/1955 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002778/202712 NAP
2780 spironolactone 01/03/1962 3 years 08/03/2027 06/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00002780/202703 Terhi Lehtinen Finland CAP NAP
2781 altizide / spironolactone 21/01/1964 3 years 21/01/2027 21/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00002781/202701 Barbara Kovacic Bytyqi Croatia NAP
2786 bacterial lysate of haemophilus influenzae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus / streptococcus mitis / streptococcus pneumoniae / streptococcus pyogenes, bacterial lysate of haemophilus influenzae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus / streptococcus pneumoniae / streptococcus pyogenes, streptococcus pneumoniae / streptococcus agalactiae / staphylococcus aureus / haemophilus influenzae 11/01/1974 5 years 31/03/2026 29/06/2026 No 06/10/2025 PRAC representative was updated on 01/03/2023
DLP was updated on 22/12/2021
Entry name and EURD were amended on 31/01/2018
Next DLP was amended on 20/12/2016
DLP was corrected on 04/02/2016.
Active Substance and DLP was amended on 21/12/2015.
PRAC representative name was amended on 31/07/2015
Active Substance name amended on 16/07/2015
Lead MS was added on 04/02/2015 PSUSA/00002786/202603 Dirk Mentzer Germany NAP
2788 stibogluconate 30/03/1966 10 years 03/07/2034 01/10/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002788/203407 NAP
2789 stiripentol 04/01/2007 1 year 04/11/2026 13/01/2027 04/11/2027 13/01/2028 Yes 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00002789/202611 PSUSA/00002789/202711 Maia Uusküla Estonia CAP NAP
2791 streptodornase / streptokinase 01/03/1933 11 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002791/203611 NAP
2792 streptokinase Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002792/203611 NAP
2793 streptomycin 15/04/1956 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002793/203401 NAP
2794 streptozocin 07/05/1982 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002794/202812 NAP
2796 sucralfate 23/02/1968 9 years 02/04/2028 01/07/2028 No 15/01/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002796/202804 Amelia Cupelli Italy NAP
2798 sufentanil 30/11/1978 3 years 30/11/2027 28/02/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00002798/202711 Adam Przybylkowski Poland CAP NAP
2799 sugammadex 25/07/2008 5 years 31/01/2029 01/05/2029 No 23/10/2019 Reference to NAP added on 03/07/2024
New CAP authorised on 23/06/2023
New CAP authorised on 26/05/2023
New CAP authorised on 10/01/2023
New CAP authorised on 15/07/2022
New CAP authorised on 15/11/2021
DLP and frequency were updated on 23/10/2019
DLP was updated on 25/09/2019
Next DLP was updated on 22/09/2016
The DLP was amended on 08/01/2014 PSUSA/00002799/202901 Terhi Lehtinen Finland CAP NAP
2801 sulbutiamine 28/05/1973 10 years 03/11/2035 01/02/2036 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
EURD updated on 01/07/2026
PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002801/203511 Tiphaine Vaillant France NAP
2802 sulconazole 30/09/1987 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002802/202901 NAP
2805 sulfacetamide Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002805/203611 NAP
2806 sulfadiazine Not available* 8 years 03/08/2027 01/11/2027 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002806/202708 NAP
2807 sodium hyaluronate / sulfadiazine silver Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00002807/202612 Amelia Cupelli Italy NAP
2809 sulfaguanidine 07/01/1974 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002809/203503 NAP
2816 sulfasalazine 25/04/1942 10 years 02/12/2033 02/03/2034 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00002816/203312 Marie Louise Schougaard Christiansen Denmark NAP
2818 sulfinpyrazone 25/09/1958 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002818/203401 NAP
2822 sulfur hexafluoride 26/03/2001 3 years 30/09/2026 29/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00002822/202609 Tiphaine Vaillant France CAP
2823 sulindac 30/06/1975 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002823/202808 NAP
2824 sulodexide 09/10/1972 10 years 01/12/2034 01/03/2035 No 05/01/2025 Correction of DLP on 20/11/2024
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002824/203412 Amelia Cupelli Italy NAP
2828 sulprostone 17/12/1980 3 years 21/04/2028 20/07/2028 No 19/09/2024 PSUSA/00002828/202804 Zoubida Amimour France NAP
2829 sultamicillin 01/11/1983 5 years 20/11/2025 18/02/2026 No 28/07/2021 DLP was updated on 28/07/2021
Next DLP was amended on 28/07/2016
DLP amended on 13/07/2015
Lead MS was added on 13/07/2015 PSUSA/00002829/202511 Maia Uusküla Estonia NAP
2830 sultiame Not available* 10 years 03/11/2036 01/02/2037 No 18/10/2023 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" , PSUR frequency and DLP were amended on 18/10/2023 PSUSA/00002830/203611 none NAP
2831 sultopride 01/10/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002831/202812 NAP
2832 sumatriptan, naproxen / sumatriptan 11/04/1991 5 years 30/09/2029 29/12/2029 No 21/12/2022 Active substance name changed on 21/12/2022
DLP was updated on 03/06/2020
PRAC Rapporteur name updated on 23/10/2018
PRAC Representative updated on 26/09/2018
Next DLP amended on 13/07/2015
PRAC Rapporteur name and country updated on 01/12/2014
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00002832/202909 Liana Martirosyan Netherlands NAP
2833 sunitinib 19/07/2006 3 years 30/04/2026 29/07/2026 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00002833/202604 Amelia Cupelli Italy CAP
2834 suxamethonium 14/08/1952 3 years 13/08/2026 11/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00002834/202608 Barbara Kovacic Bytyqi Croatia NAP
2835 suxibuzone Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002835/203611 NAP
2838 tacalcitol Not available* 8 years 03/08/2027 01/11/2027 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002838/202708 NAP
2839 tacrolimus (systemic formulations) 02/04/1993 3 years 31/03/2027 29/06/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00002839/202703 Eamon O'Murchu Ireland CAP NAP
2840 tacrolimus (topical formulations) 28/02/2002 3 years 31/03/2028 29/06/2028 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00002840/202803 Rhea Fitzgerald Ireland CAP NAP
2841 tadalafil 12/11/2002 3 years 15/10/2028 13/01/2029 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00002841/202810 Maria del Pilar Rayon Spain CAP NAP
2842 tafamidis 16/11/2011 2 years 15/05/2026 13/08/2026 No 18/12/2024 PSUR frequency amended and DLP updated on 18/12/2024 PSUSA/00002842/202605 Zoubida Amimour France CAP
2843 tafluprost 30/04/2008 3 years 29/04/2027 28/07/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00002843/202704 Dennis Lex Germany NAP
2846 tamoxifen 29/04/1974 5 years 29/04/2030 28/07/2030 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00002846/203004 Eamon O'Murchu Ireland NAP
2847 tamsulosin 02/07/1993 5 years 01/07/2026 29/09/2026 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00002847/202607 Liana Martirosyan Netherlands NAP
2849 tapentadol 20/11/2008 5 years 20/11/2029 18/02/2030 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00002849/202911 Dennis Lex Germany NAP
2850 tasonermin 13/04/1999 7 years 14/08/2030 12/11/2030 No 29/04/2026 PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00002850/203008 Karin Erneholm Denmark CAP
2855 technetium (99mtc) albumin nanocolloid 29/11/1993 15 years 29/11/2027 27/02/2028 No 25/09/2019 PSUR frequency and DLP were updated on 25/09/2019 PSUSA/00002855/202711 NAP
2856 technetium (99mTc) bicisate 08/10/1993 15 years 07/10/2034 05/01/2035 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00002856/203410 Karin Erneholm Denmark NAP
2857 technetium (99mtc) depreotide 29/11/2000 15 years 15/09/2027 14/12/2027 No 25/09/2019 PSUR frequency and DLP were updated on 25/09/2019
DLP was updated on 05/06/2019 PSUSA/00002857/202709 NAP
2859 technetium (99mtc) human albumin Not available* 15 years 01/01/2027 01/04/2027 No 25/09/2019 PSUR frequency and DLP were updated on 25/09/2019 PSUSA/00002859/202701 NAP
2860 technetium (99mtc) macrosalb 02/03/1990 15 years 28/02/2028 28/05/2028 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00002860/202802 Karin Erneholm Denmark NAP
2861 technetium (99mtc) mebrofenin 29/11/1993 15 years 01/11/2030 30/01/2031 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00002861/203011 Karin Erneholm Denmark NAP
2862 technetium (99mtc) medronic acid Not available* 15 years 01/01/2027 01/04/2027 No 20/05/2026 PSUR frequency and DLP were updated on 25/09/2019 PSUSA/00002862/202701 Katarzyna Ziolkowska Poland NAP
2863 technetium (99mTc) mertiatide, technetium (99mTc) betiatide Not available* 15 years 01/01/2027 01/04/2027 Yes 20/05/2026 Active substance name was amended and 'Are PSURs required for products referred to in Articles 10(1), 10a, 16a of Directive 2001/83/EC as amended?' was updated on 29/07/2020
PSUR frequency and DLP were updated on 25/09/2019 PSUSA/00002863/202701 Katarzyna Ziolkowska Poland NAP
2864 technetium (99mtc) oxidronate 21/03/1983 15 years 21/03/2027 19/06/2027 No 25/09/2019 PSUR frequency and DLP were updated on 25/09/2019 PSUSA/00002864/202703 NAP
2865 technetium (99mtc) pentetate 21/06/1990 15 years 21/06/2027 19/09/2027 No 25/09/2019 PSUR frequency and DLP were updated on 25/09/2019 PSUSA/00002865/202706 NAP
2866 technetium (99mTc) pertechnetate 01/06/1983 15 years 01/06/2032 30/08/2032 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00002866/203206 Karin Erneholm Denmark NAP
2867 sodium pyrophosphate, technetium (99mtc) pyrophosphate (for diagnosistic purpose) 04/02/1991 15 years 04/02/2027 05/05/2027 Yes 25/09/2019 PSUR frequency and DLP were updated on 25/09/2019
Entry name amended and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 21/07/2017 PSUSA/00002867/202702 NAP
2868 technetium (99mtc) sestamibi 09/12/1987 15 years 08/06/2032 06/09/2032 Yes 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00002868/203206 Karin Erneholm Denmark NAP
2869 technetium (99mTc) succimer Not available* 15 years 01/01/2027 01/04/2027 No 25/09/2019 PSUR frequency and DLP were updated on 25/09/2019 PSUSA/00002869/202701 NAP
2870 technetium (99mTc) tetrofosmin, tetrofosmin 31/05/1993 15 years 31/05/2032 29/08/2032 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00002870/203205 Karin Erneholm Denmark NAP
2872 technetium (99mTc) tin colloid Not available* 15 years 01/01/2027 01/04/2027 No 25/09/2019 PSUR frequency and DLP were updated on 25/09/2019 PSUSA/00002872/202701 NAP
2873 technetium (99mTc) trimethylphenylcarbamoylmethyliminodiacetic acid Not available* 15 years 01/01/2027 01/04/2027 No 25/09/2019 PSUR frequency and DLP were updated on 25/09/2019 PSUSA/00002873/202701 NAP
2874 tegafur Not available* 8 years 03/08/2027 01/11/2027 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002874/202708 NAP
2875 gimeracil / oteracil monopotassium / tegafur 14/03/2011 5 years 24/01/2026 24/04/2026 No 04/03/2026 Reference to NAP added on 04/03/2026
PSUR frequency and DLP were updated on 20/10/2021
PSUR Frequency, DLP and PRAC Representative were updated on 26/09/2018
Next DLP was amended on 25/09/2017
Next DLP was updated on 22/09/2016
Next DLP was updated on 30/09/2015
Next DLP was amended on 28/05/2014 PSUSA/00002875/202601 Bianca Mulder Netherlands CAP NAP
2878 teicoplanin 01/11/1986 5 years 01/11/2026 30/01/2027 No 29/06/2022 DLP was updated on 29/06/2022
Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?
Yes/No was corrected on 07/05/2018
DLP was updated and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 21/07/2017
Lead MS and PRAC Rapporteur name was added on 03/06/2016 PSUSA/00002878/202611 Eva Jirsová Czech Republic NAP
2882 hydrochlorothiazide / telmisartan, telmisartan 11/12/1998 5 years 31/03/2030 29/06/2030 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00002882/203003 Amelia Cupelli Italy CAP NAP
2883 temazepam 26/11/1969 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002883/202805 NAP
2884 temocillin 25/10/1984 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002884/202812 NAP
2885 temoporfin 24/10/2001 13 years 30/04/2037 29/07/2037 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00002885/203704 Bianca Mulder Netherlands CAP
2886 temozolomide 26/01/1999 3 years 12/07/2026 10/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00002886/202607 Dennis Lex Germany CAP
2887 temsirolimus 19/11/2007 5 years 31/03/2029 29/06/2029 No 25/06/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/06/2025
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 18/12/2024
PSUR frequency amended and DLP updated on 18/12/2024
DLP was updated on 22/12/2021
DLP was updated on 21/11/2018
Next DLP and PRAC Rapporteur amended on 27/11/2015.
PRAC Representative amended on 31/07/2015 PSUSA/00002887/202903 Dennis Lex Germany CAP
2888 tenecteplase 23/02/2001 3 years 31/08/2028 29/11/2028 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00002888/202808 Dennis Lex Germany CAP
2889 teniposide 05/04/1976 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002889/202808 NAP
2891 eucalyptus / paracetamol / tenoate sodium 15/05/1964 11 years 02/12/2039 01/03/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002891/203912 NAP
2892 tenofovir disoproxil 05/02/2002 3 years 31/03/2026 29/06/2026 No 19/09/2024 PSUSA/00002892/202603 Zoubida Amimour France CAP
2893 tenoxicam 20/02/1986 5 years 28/02/2026 29/05/2026 No 19/10/2022 PRAC representative was updated on 19/10/2022
PRAC representative was updated on 27/07/2022
DLP and PSUR frequency were updated on 17/11/2021
PRAC representative was updated on 30/06/2021
DLP was updated on 21/11/2018
PRAC Rapporteur name was updated on 04/07/2018
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 17/10/2017
PRAC Rapporteur name updated on 04/02/2016
PRAC Representative amended on 27/11/2015.
The Next DLP was amended on 29/10/2015
Lead MS was added on 04/02/2015 PSUSA/00002893/202602 Amelia Cupelli Italy NAP
2895 terazosin 30/11/1984 8 years 20/11/2031 18/02/2032 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00002895/203111 Liana Martirosyan Netherlands NAP
2896 terbinafine 03/10/1990 3 years 30/09/2028 29/12/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00002896/202809 Jana Pecherova Slovakia NAP
2897 terbutaline 31/12/1970 5 years 31/12/2026 31/03/2027 No 21/09/2022 PLP was updated on 21/09/2022
PRAC representative was updated on 23/09/2020
Next DLP was amended on 25/09/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00002897/202612 Melinda Palfi Hungary NAP
2898 guaifenesin / terbutaline sulfate Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002898/203103 NAP
2903 teriparatide 10/06/2003 3 years 12/09/2027 11/12/2027 No 28/05/2025 New CAP authorised on 27/04/2026
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025
DLP was amended on 28/05/2025
New CAP authorised on 12/01/2023
New CAPs authorised on 18/11/2022
DLP and Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" were amended on 25/05/2022
New CAP authorised on 24/03/2022
PRAC representative was updated on 26/05/2021
New CAPs authorised on 27/08/2020
DLP updated on 05/06/2019
Lead MS and PRAC Rapporteur name amended on 06/02/2019
Lead MS and PRAC Rapporteur name amended on 21/11/2018
Reference to NAP added on 31/01/2018
PSUR Frequency amended and DLP updated on 03/05/2016 PSUSA/00002903/202709 Tiphaine Vaillant France CAP NAP
2904 terizidone 25/01/1973 5 years 15/09/2030 14/12/2030 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00002904/203009 Rugile Pilviniene Lithuania NAP
2905 terlipressin 01/05/1980 3 years 30/04/2027 29/07/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00002905/202704 Karin Erneholm Denmark NAP
2906 tertatolol 25/04/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002906/202812 NAP
2908 testosterone (topical use) 28/07/2006 3 years 31/12/2027 30/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00002908/202712 Maia Uusküla Estonia NAP
2909 human tetanus immunoglobulin 30/08/1999 5 years 29/08/2027 27/11/2027 No 06/10/2025 DLP was amended on 03/05/2023
PRAC representative was updated on 01/03/2023
DLP was updated on 07/05/2018
PRAC representative and Lead Member State were added on 30/01/2017 PSUSA/00002909/202708 Dirk Mentzer Germany NAP
2910 tetanus vaccines 01/01/1978 5 years 01/01/2028 31/03/2028 No 06/10/2025 DLP amended on 20/09/2023 PSUSA/00002910/202801 Dirk Mentzer Germany NAP
2911 tetrabenazine 23/10/1995 5 years 31/10/2028 29/01/2029 No 03/07/2024 PSUR frequency amended and DLP updated on 03/07/2024 PSUSA/00002911/202810 Eamon O'Murchu Ireland NAP
2912 tetracaine 01/06/1973 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002912/202806 NAP
2914 tetracosactide 07/05/1965 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002914/202803 NAP
2915 tetracycline 19/11/1953 10 years 01/01/2034 01/04/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002915/203401 NAP
2918 tetryzoline Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002918/203611 NAP
2919 thalidomide 16/04/2008 3 years 09/10/2027 07/01/2028 Yes 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00002919/202710 Tiphaine Vaillant France CAP NAP
2920 thallium [201TL] 31/08/1980 10 years 31/08/2034 29/11/2034 Yes 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00002920/203408 Jean-Michel Dogné Belgium NAP
2921 theophylline 14/06/1947 5 years 14/06/2027 12/09/2027 No 01/03/2023 DLP was updated on 01/03/2023
European Union reference date and DLP amended on 0405/2018
DLP was updated on 27/03/2018
Lead MS and PRAC Rapporteur name was added on 20/12/2016 PSUSA/00002921/202706 Maria Popova-Kiradjieva Bulgaria NAP
2922 thiamazole 30/06/1978 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00002922/203303 Dennis Lex Germany NAP
2924 cyanocobalamin / pyridoxine / thiamine Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002924/203506 NAP
2925 thiamphenicol 14/07/1960 5 years 31/05/2028 29/08/2028 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00002925/202805 Amelia Cupelli Italy NAP
2928 thioctic acid Not available* 8 years 03/08/2027 01/11/2027 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002928/202708 NAP
2929 thiopental 15/10/1945 15 years 31/03/2031 29/06/2031 No 20/12/2016 PRAC Rapporteur name updated on 23/10/2018
PSUR Frequency amended and DLP updated on 20/12/2016
Lead Member State and PRAC Representative added on 27/11/2015. PSUSA/00002929/203103 Eamon O'Murchu Ireland NAP
2931 thioridazine 01/02/1959 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002931/202712 NAP
2932 thiotepa 09/03/1959 3 years 31/03/2027 29/06/2027 Yes 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00002932/202703 Tiphaine Vaillant France CAP NAP
2936 thiamphenicol glycinate acetylcysteinate Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002936/203611 Amelia Cupelli Italy NAP
2940 thyrotropin alfa 30/11/1998 5 years 30/11/2029 28/02/2030 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00002940/202911 Rhea Fitzgerald Ireland CAP
2942 tiagabine 14/06/1996 5 years 30/06/2029 28/09/2029 Yes 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00002942/202906 Tiphaine Vaillant France NAP
2943 tianeptine 06/02/1987 5 years 30/06/2029 28/09/2029 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00002943/202906 Tiphaine Vaillant France NAP
2944 tiapride 27/07/1988 3 years 27/07/2027 25/10/2027 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00002944/202707 Tiphaine Vaillant France NAP
2945 tiaprofenic acid 26/08/1974 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002945/202808 NAP
2946 tibezonium iodide 23/11/1976 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002946/203503 NAP
2947 tibolone 01/12/1987 5 years 01/12/2029 01/03/2030 No 02/06/2026 PSUSA/00002947/202912 Jenny Jönsson Sweden NAP
2948 ticagrelor, acetylsalicylic acid / ticagrelor 03/12/2010 3 years 31/12/2026 31/03/2027 No 01/04/2026 Reference to NAP added on 01/04/2026
Active substance name was amended on 01/04/2026
DLP was amended on 25/09/2024 PSUSA/00002948/202612 Bianca Mulder Netherlands CAP NAP
2950 clavulanate / ticarcillin 12/09/1973 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002950/203503 NAP
2951 tick-borne encephalitis vaccine (inactivated) 29/01/2001 3 years 31/01/2026 01/05/2026 No 06/10/2025 Next DLP was updated on 18/10/2023 PSUSA/00002951/202601 Dirk Mentzer Germany NAP
2952 ticlopidine 08/05/1978 8 years 08/05/2033 06/08/2033 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00002952/203305 Amelia Cupelli Italy NAP
2954 tigecycline 24/04/2006 5 years 14/06/2028 12/09/2028 No 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 PSUSA/00002954/202806 Maria del Pilar Rayon Spain CAP
2955 tilactase Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002955/203211 NAP
2957 tilidine 08/07/1970 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002957/202805 NAP
2958 tilbroquinol / tiliquinol 15/11/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002958/203406 NAP
2961 bimatoprost / timolol 19/06/2006 5 years 19/11/2026 17/02/2027 No 27/07/2022 PSUR frequency and DLP were updated on 27/07/2022
DLP was updated on 31/07/2019
PRAC Rapporteur name was corrected on 03/04/2019
Reference to NAP added on 19/12/2018
PRAC Rapporteur name was amended on 06/06/2018
PRAC Representative amended on 17/10/2017
Next DLP was amended on 28/07/2016 PSUSA/00002961/202611 Karin Erneholm Denmark CAP NAP
2962 timolol / travoprost 24/04/2006 5 years 28/02/2028 28/05/2028 No 15/11/2023 PSUR frequency amended and DLP updated on 15/11/2023 PSUSA/00002962/202802 Maria del Pilar Rayon Spain CAP NAP
2967 tinzaparin 28/02/1991 7 years 02/12/2030 02/03/2031 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00002967/203012 Jo Robays Belgium NAP
2969 tioguanine 18/01/1966 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002969/202803 NAP
2972 tiotropium 09/10/2001 5 years 09/10/2026 07/01/2027 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00002972/202610 Bianca Mulder Netherlands NAP
2973 tipranavir 25/10/2005 5 years 31/12/2027 30/03/2028 No 19/09/2024 PSUSA/00002973/202712 Zoubida Amimour France CAP
2974 tirofiban 14/05/2003 5 years 31/05/2027 29/08/2027 No 01/02/2023 PSUR frequency and DLP were updated on 01/02/2023
DLP was updated on 05/02/2020
Next DLP updated on 30/01/2017
PRAC Rapporteur and Lead Member State was added on 27/11/2015.
PSUSA number was amended on 06/10/2014 PSUSA/00002974/202705 Dennis Lex Germany NAP
2975 tiropramide 30/03/1982 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002975/202811 NAP
2977 tizanidine 15/12/1983 5 years 31/12/2029 31/03/2030 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00002977/202912 Terhi Lehtinen Finland NAP
2980 tocilizumab 11/04/2005 3 years 10/04/2028 09/07/2028 No 06/10/2025 New CAP authorised on 27/04/2026
New CAP authorised on 14/02/2025
New CAP authorised on 20/06/2024
New CAP authorised on 15/09/2023
PRAC representative was updated on 01/03/2023
DLP was updated on 21/12/2022
PSUR frequency and DLP were updated on 20/11/2019
DLP was updated on 21/11/2018
DLP was amended on 15/11/2017
PSUR Frequency amended and DLP updated on 23/05/2017
Next DLP was updated on 18/11/2016
Next DLP was amended on 03/06/2016
Next DLp was updated on 27/11/2015.
Next DLP was amended on 01/12/2014
Next DLP was amended on 28/05/2014
Next DLP was amended 30/11/2013 PSUSA/00002980/202804 Dirk Mentzer Germany CAP
2981 tocofersolan 24/07/2009 1 year 31/07/2026 09/10/2026 31/07/2027 09/10/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00002981/202607 PSUSA/00002981/202707 Melinda Palfi Hungary CAP
2982 tofisopam Not available* 7 years 31/01/2032 30/04/2032 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00002982/203201 Melinda Palfi Hungary NAP
2984 tolbutamide Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002984/203611 NAP
2985 tolcapone 27/08/1997 3 years 01/03/2027 30/05/2027 No 17/11/2021 DLP was updated on 17/11/2021
PRAC Rapporteur name updated on 19/12/2018
DLP and PRAC Rapporteur name updated on 23/10/2018
The Next DLP was amended on 29/10/2015 PSUSA/00002985/202703 Eamon O Murchu Ireland CAP
2986 tolfenamic acid Not available* 8 years 03/08/2027 01/11/2027 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002986/202708 NAP
2988 tolnaftate 16/10/1977 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002988/202811 NAP
2989 nystatine / tolnaftate Not available* 9 years 03/03/2032 01/06/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002989/203203 NAP
2990 tolnaftate / triclosan Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002990/203211 NAP
2991 tolperisone Not available* 3 years 01/06/2027 30/08/2027 Yes 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00002991/202706 Melinda Palfi Hungary NAP
2993 tolterodine 05/09/1997 5 years 05/09/2026 04/12/2026 No 02/06/2026 PSUSA/00002993/202609 Jenny Jönsson Sweden NAP
2994 tolvaptan (indicated for adults with hyponatraemia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH)) 03/08/2009 3 years 18/05/2027 16/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00002994/202705 Amelia Cupelli Italy CAP
2996 topiramate 18/07/1995 5 years 18/01/2027 18/04/2027 No 21/09/2022 DLP was updated on 21/09/2022
PRAC Rapporteur name was amended on 31/07/2018
Next DLP was amended on 25/09/2017
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/09/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00002996/202701 Karin Bolin Sweden NAP
2997 topotecan 12/11/1996 5 years 28/05/2030 26/08/2030 No 02/06/2026 PSUSA/00002997/203005 Jenny Jönsson Sweden CAP NAP
2998 torasemide 14/04/1987 8 years 03/06/2033 01/09/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00002998/203306 Dennis Lex Germany NAP
2999 toremifene 14/02/1996 5 years 30/09/2028 29/12/2028 No 05/06/2024 PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00002999/202809 Tiphaine Vaillant France CAP
3000 tosylchloramide Not available* 8 years 03/11/2026 01/02/2027 Yes 28/05/2025 DLP was amended on 28/05/2025
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025
PSUR frequency and DLP amended on 28/08/2024 PSUSA/00003000/202611 Amelia Cupelli Italy NAP
3001 trabectedin 17/09/2007 3 years 17/09/2028 16/12/2028 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00003001/202809 Marie Louise Schougaard Christiansen Denmark CAP NAP
3002 tramadol 18/04/1973 3 years 22/06/2026 20/09/2026 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00003002/202606 Tiphaine Vaillant France NAP
3003 tramazoline 01/02/1964 11 years 02/12/2039 01/03/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003003/203912 NAP
3004 trandolapril, verapamil / trandolapril 19/02/1992 8 years 18/02/2027 19/05/2027 No 19/11/2025 Active substance name was amended on 19/11/2025
DLP was amended on 19/11/2025
PRAC representative updated on 31/01/2024 PSUSA/00003004/202702 Bianca Mulder Netherlands NAP
3006 tranexamic acid 21/01/1966 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00003006/203303 Rhea Fitzgerald Ireland NAP
3007 transfer factor porcine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003007/203211 NAP
3008 tranylcypromine Not available* 8 years 03/11/2027 01/02/2028 No 05/01/2025 Correction of DLP on 20/11/2024
PSUR frequency and DLP amended on 28/08/2024 PSUSA/00003008/202711 Dennis Lex Germany NAP
3010 trastuzumab 25/09/1998 3 years 24/09/2027 23/12/2027 No 06/10/2025 New CAP authorised on 30/06/2025
New CAP authorised on 19/09/2024
New CAP authorised on 15/11/2023
PRAC representative was updated on 01/03/2023
DLP was updated on 29/06/2022
PSUR frequency and DLP were updated on 05/06/2019
New CAP authorised on 12/12/2018
PSUR Frequency amended and DLP updated on 26/04/2017
Next DLP was amended on 03/05/2016
The Next DLP was amended on 29/10/2015
Next DLP was amended on 16/07/2015, and the 1-yearly cycle PSUR should be submitted after the current Next DLP (24/09/2015).
Next DLP was amended on 04/11/2014
Next DLP was amended on 02/05/2014 PSUSA/00003010/202709 Dirk Mentzer Germany CAP
3011 travoprost 27/11/2001 5 years 28/02/2027 29/05/2027 No 16/11/2022 PSUR frequency and DLP were updated on 16/11/2022
DLP was updated on 20/11/2019
PSUR Frequency amended and DLP updated on 19/10/2016
PRAC Representative amended on 28/06/2016
The Next DLP was amended on 29/10/2015 PSUSA/00003011/202702 Maria del Pilar Rayon Spain CAP NAP
3012 trazodone 15/10/1971 6 years 03/08/2029 01/11/2029 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00003012/202908 Rugile Pilviniene Lithuania NAP
3013 treprostinil 21/05/2002 3 years 21/05/2028 19/08/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00003013/202805 Zane Neikena Latvia CAP NAP
3015 tretinoin (oral formulations) 31/03/1994 5 years 30/03/2027 28/06/2027 No 11/06/2025 DLP was updated on 21/12/2022
PRAC representative was updated on 19/10/2022
PRAC representative was updated on 17/11/2021
PRAC representative was updated on 28/07/2021
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00003015/202703 Zoubida Amimour France NAP
3016 tretinoin (topical formulations) 25/01/1973 5 years 31/08/2027 29/11/2027 Yes 03/05/2023 DLP was amended on 03/05/2023
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 06/06/2018
Lead MS and PRAC Rapporteur name was added on 28/02/2017 PSUSA/00003016/202708 Adam Przybylkowski Poland NAP
3017 triamcinolone (topical and nasal formulations) 14/12/1953 5 years 13/07/2027 11/10/2027 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00003017/202707 Carla Torre Portugal NAP
3019 carbethopendecinium bromide / salicylic acid / triamcinolone Not available* 9 years 03/07/2029 01/10/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00003019/202907 NAP
3020 chloroxine / triamcinolone Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00003020/202911 NAP
3021 salicylic acid / triamcinolone acetonide Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00003021/202612 Polona Golmajer Slovenia NAP
3022 triamterene 19/06/1963 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00003022/203405 NAP
3023 triazolam 08/03/1997 5 years 31/07/2027 29/10/2027 No 05/04/2023 DLP was updated on 05/04/2023
DLP was updated on 07/05/2018
PRAC representative and Lead Member State were added on 30/01/2017 PSUSA/00003023/202707 Kimmo Jaakkola Finland NAP
3024 tribenoside 06/04/1967 10 years 03/07/2034 01/10/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003024/203407 NAP
3025 lidocaine / tribenoside 01/06/1971 10 years 02/09/2034 01/12/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003025/203409 NAP
3027 triclocarban Not available* 9 years 03/11/2032 01/02/2033 No 11/06/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003027/203211 Zoubida Amimour France NAP
3028 triclosan 01/01/1985 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00003028/202812 NAP
3029 benzalkonium / chloride solution / light liquid paraffin / triclosan Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00003029/202906 NAP
3033 trifluperidol 31/01/1964 11 years 03/07/2039 01/10/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003033/203907 NAP
3035 triflusal 19/01/1981 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00003035/202811 NAP
3036 trihexyphenidyl 05/06/1956 11 years 03/10/2037 01/01/2038 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003036/203710 NAP
3038 trimebutine 15/03/1988 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00003038/202901 NAP
3039 ruscogenin / trimebutine 10/12/1973 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003039/203503 NAP
3040 trimecaine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003040/203211 NAP
3041 carbaethopendecinium bromide / trimecaine hydrochloride Not available* 8 years 01/12/2025 01/03/2026 No 30/10/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00003041/202512 Eva Jirsová Czech Republic NAP
3043 trimetazidine 06/08/2001 3 years 06/08/2026 04/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00003043/202608 Amelia Cupelli Italy NAP
3045 trimethoprim Not available* 7 years 31/01/2032 30/04/2032 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00003045/203201 Maia Uusküla Estonia NAP
3046 trimipramine 05/10/1960 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003046/203906 NAP
3047 pseudoephedrine / triprolidine Not available* 3 years 31/12/2026 31/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00003047/202612 Dennis Lex Germany NAP
3048 triptorelin 05/03/1986 5 years 31/03/2027 29/06/2027 No 21/12/2022 DLP was updated on 21/12/2022
DLP was updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00003048/202703 Dennis Lex Germany NAP
3049 trolamine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003049/203211 NAP
3050 tromantadine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003050/203211 NAP
3051 disodium phosphate anhydrous / sodium hydrogen carbonate / trometamol Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00003051/203011 NAP
3053 tropicamide 01/03/1951 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003053/203212 NAP
3055 trospium 17/10/1984 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00003055/202812 none NAP
3056 troxerutin, troxerutin / heptaminol / ginkgo leaf 09/10/1970 8 years 03/11/2027 01/02/2028 No 05/01/2025 DLP correction on 20/11/2024
Active substance name, PSUR frequency and DLP were amended on 20/12/2023 PSUSA/00003056/202711 Dennis Lex Germany NAP
3059 amylase / cortex granati / gentiana lutea / lipase / quercus cortex / radix ratanhiae / rhizoma tormentillae / salicylic acid / tannic acid / trypsin Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00003059/202903 NAP
3062 tryptophan Not available* 8 years 03/11/2027 01/02/2028 Yes 28/05/2025 DLP was amended on 28/05/2025
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025
PSUR frequency and DLP amended on 28/08/2024 PSUSA/00003062/202711 Dennis Lex Germany NAP
3063 tuberculin purified protein derivative 16/11/1979 7 years 01/09/2028 30/11/2028 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00003063/202809 Karin Erneholm Denmark NAP
3065 typhoid polysaccharide vaccine 05/08/1998 3 years 05/08/2026 03/11/2026 No 06/10/2025 DLP was amended on 30/04/2024 PSUSA/00003065/202608 Dirk Mentzer Germany NAP
3067 typhoid vaccine (live, attenuated) 12/12/1984 3 years 31/12/2027 30/03/2028 Yes 06/10/2025 DLP was amended on 24/09/2025 PSUSA/00003067/202712 Dirk Mentzer Germany NAP
3068 tyrothricin 20/10/1950 11 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003068/203611 NAP
3070 benzalkonium / benzocaine / tyrothricin Not available* 8 years 01/12/2025 01/03/2026 No 30/10/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00003070/202512 Dennis Lex Germany NAP
3071 benzocaine / dequalinium chloride / dexamethasone / tyrothricin Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00003071/202906 NAP
3072 chlorhexidine digluconate / lidocaine hydrochloride / tyrothricin Not available* 13 years 01/01/2028 31/03/2028 Yes 21/07/2017 PSUR Frequency, DLP and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended updated on 21/07/2017 PSUSA/00003072/202801 NAP
3073 ubidecarenone Not available* 8 years 03/11/2026 01/02/2027 Yes 28/05/2025 DLP was amended on 28/05/2025
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025
PSUR frequency and DLP amended on 28/08/2024 PSUSA/00003073/202611 Amelia Cupelli Italy NAP
3074 ulipristal (female emergency contraceptive) 15/05/2009 3 years 14/05/2027 12/08/2027 Yes 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00003074/202705 Bianca Mulder Netherlands CAP NAP
3075 ulobetasol Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003075/203211 NAP
3076 undecylenic acid Not available* 8 years 03/11/2032 01/02/2033 Yes 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00003076/203211 Polona Golmajer Slovenia NAP
3078 urapidil 31/07/1980 5 years 01/07/2026 29/09/2026 No 02/03/2022 DLP and PSUR frequency were updated on 02/03/2022
Next DLP was updated on 06/03/2019
Correction of Lead MS and PRAC Rapporteur on 28/02/2017
PRAC Representative amended on 18/11/2016
Lead MS and PRAC Rapporteur name were amended on 28/07/2016
Next DLP was updated on 04/03/2016
Lead MS added on 01/04/2015. PSUSA/00003078/202607 Eva Jirsová Czech Republic NAP
3080 uridine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003080/203211 NAP
3082 urofollitropin 24/03/2004 5 years 23/03/2027 21/06/2027 No 19/12/2018 Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00003082/202703 Eamon O'Murchu Ireland NAP
3083 urokinase 24/05/1972 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00003083/203303 Dennis Lex Germany NAP
3085 ustekinumab 16/01/2009 2 years 31/12/2025 31/03/2026 No 31/07/2024 New CAP authorised on 18/11/2025
New CAP authorised on 17/09/2025
New CAP authorised on 02/06/2025
New CAP authorised on 14/02/2025
New CAP authorised on 12/12/2024
New CAP authorised on 25/09/2024
New CAP authorised on 12/09/2024
New CAP authorised on 22/08/2024
PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00003085/202512 Rhea Fitzgerald Ireland CAP
3086 valaciclovir 20/12/1994 5 years 19/12/2029 19/03/2030 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00003086/202912 Veronika Macurová Czech Republic NAP
3089 valganciclovir 29/03/2001 5 years 28/03/2026 26/06/2026 No 22/12/2021 DLP was updated on 22/12/2021
PRAC representative was updated on 04/03/2020
PRAC Representative updated on 26/09/2018
Next DLP was amended on 20/12/2016
Lead Member State added on 27/11/2015. PSUSA/00003089/202603 Liana Martirosyan Netherlands NAP
3090 valproic acid, sodium valproate, valproate pivoxil, valproate semisodium, valpriomide, valproate bismuth, calcium valproate, valproate magnesium 23/01/1967 3 years 23/01/2027 23/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00003090/202701 Liana Martirosyan Netherlands NAP
3097 vancomycin 01/01/1955 5 years 31/01/2030 01/05/2030 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00003097/203001 Marie Louise Schougaard Christiansen Denmark NAP
3098 vardenafil 04/03/2003 5 years 04/03/2029 02/06/2029 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00003098/202903 Maria del Pilar Rayon Spain CAP
3099 varenicline 26/09/2006 3 years 09/05/2026 07/08/2026 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00003099/202605 Karin Erneholm Denmark CAP
3102 vecuronium bromide 01/11/1990 5 years 30/11/2025 28/02/2026 Yes 28/07/2021 PSUR frequency and DLP were updated on 28/07/2021
DLP was updated and Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 20/11/2019
Next DLP was amended on 25/09/2017
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/09/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016
Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00003102/202511 Eva Jirsová Czech Republic NAP
3103 velaglucerase alfa 26/02/2010 2 years 25/02/2026 26/05/2026 No 16/11/2022 DLP was updated on 16/11/2022
DLP was updated on 21/10/2020
DLP was updated on 23/10/2018
PRAC Rapporteur name was amended on 31/07/2018
PSUR Frequency amended and DLP updated on 22/09/2016
Next DLP was updated on 06/10/2015
EURD was amended on 21/12/2012 PSUSA/00003103/202602 Dennis Lex Germany CAP
3104 venlafaxine, desvenlafaxine 23/09/1993 5 years 05/05/2028 03/08/2028 No 28/02/2024 Active substance name was amended on 28/02/2024
PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00003104/202805 Karin Bolin Sweden NAP
3105 verapamil 25/01/1963 7 years 25/01/2027 25/04/2027 No 21/10/2020 DLP was updated on 21/10/2020
PRAC representative was added on 06/05/2020
LMS was added on 31/07/2019 PSUSA/00003105/202701 Terhi Lehtinen Finland NAP
3107 hydrochlorothiazide / verapamil hydrochloride, hydrochlorothiazide / triamterene / verapamil hydrochloride Not available* 9 years 03/06/2031 01/09/2031 No 19/10/2023 Active substance name, PSUR frequency and DLP were amended on 19/10/2023 PSUSA/00003107/203106 none NAP
3109 vernakalant hydrochloride 01/09/2010 5 years 31/08/2028 29/11/2028 No 29/04/2026 PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00003109/202808 Bianca Mulder Netherlands CAP
3110 verteporfin 27/07/2000 3 years 31/12/2027 30/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00003110/202712 Zoubida Amimour France CAP
3112 vigabatrin 22/09/1989 3 years 22/09/2026 21/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00003112/202609 Terhi Lehtinen Finland CAP NAP
3113 vildagliptin, metformin / vildagliptin 26/09/2007 3 years 28/02/2027 29/05/2027 No 02/06/2026 PSUSA/00003113/202702 Karin Bolin Sweden CAP NAP
3117 vinblastine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003117/203211 NAP
3118 vinburnine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003118/203211 NAP
3119 vincamine 26/06/1982 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00003119/202812 NAP
3120 piracetam / vincamine Not available* 9 years 03/05/2032 01/08/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003120/203205 NAP
3121 vincristine 12/04/1995 6 years 03/08/2029 01/11/2029 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00003121/202908 Dennis Lex Germany NAP
3122 vindesine 11/04/1979 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00003122/202811 NAP
3123 vinflunine 21/09/2009 5 years 21/09/2026 20/12/2026 No 25/05/2022 PSUR frequency and DLP were updated on 25/05/2022
PSUR frequency and DLP were updated on 05/06/2019
Lead MS and PRAC Rapporteur name amended on 21/11/2018
PSUR Frequency amended and DLP updated on 26/04/2017
PRAC Representative amended on 28/03/2017
Next DLP was amended on 03/05/2016 PSUSA/00003123/202609 Maria del Pilar Rayon Spain CAP
3124 vinorelbine 11/04/1989 5 years 01/04/2027 30/06/2027 No 21/12/2022 DLP was updated on 21/12/2022
DLP was updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00003124/202704 Eva Jirsová Czech Republic NAP
3125 vinpocetine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003125/203211 NAP
3127 voriconazole 19/03/2002 3 years 28/02/2027 29/05/2027 No 17/11/2021 DLP corrected on 02/02/2022
DLP was updated on 17/11/2021
PSUR frequency, DLP and PRAC Rapporteur amended on 23/10/2018
DLP was updated on 17/10/2017
PRAC Rapporteur name was amended on 25/09/2017
Next DLP was amended on 19/10/2016
NAP products added on 22/09/2016
NAP products removed on 03/06/2016
The Next DLP was amended on 29/10/2015
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 04/11/2014 PSUSA/00003127/202702 Liana Martirosyan Netherlands CAP NAP
3129 warfarin 31/05/1962 8 years 31/01/2033 01/05/2033 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00003129/203301 Marie Louise Schougaard Christiansen Denmark NAP
3133 xipamide, triamterene / xipamide 30/07/1969 7 years 31/01/2032 30/04/2032 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00003133/203201 Dennis Lex Germany NAP
3134 xylometazoline 29/08/1959 5 years 31/05/2028 29/08/2028 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00003134/202805 Zane Neikena Latvia NAP
3135 yellow fever vaccine (live) 27/01/1986 3 years 02/12/2025 02/03/2026 No 06/10/2025 Next DLP was updated on 26/07/2023 PSUSA/00003135/202512 Dirk Mentzer Germany NAP
3136 yohimbine 01/06/1944 5 years 31/05/2029 29/08/2029 Yes 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00003136/202905 Jan Neuhauser Austria NAP
3137 yttrium (90y) chloride 24/03/2003 7 years 23/03/2032 21/06/2032 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00003137/203203 Karin Erneholm Denmark CAP
3141 zanamivir (except for centrally authorised products) 09/02/1999 5 years 31/01/2027 01/05/2027 No 02/06/2026 PSUSA/00003141/202701 Jenny Jönsson Sweden NAP
3142 ziconotide 21/02/2005 5 years 28/12/2029 28/03/2030 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00003142/202912 Jo Robays Belgium CAP
3143 zidovudine 03/03/1987 5 years 30/09/2029 29/12/2029 No 13/08/2025 DLP was updated on 29/06/2022
PSUR frequency and DLP updated on 05/06/2019
Lead MS and PRAC Rapporteur name amended on 21/11/2018
PSUR Frequency amended and DLP updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00003143/202909 Veronika Macurová Czech Republic NAP
3144 abacavir / lamivudine / zidovudine 28/12/2000 3 years 31/12/2025 31/03/2026 Yes 19/09/2024 PSUSA/00003144/202512 Zoubida Amimour France CAP NAP
3145 zinc acetate dihydrate 13/10/2004 5 years 30/10/2026 28/01/2027 No 29/06/2022 DLP was updated on 29/06/2022
PRAC Rapporteur name updated on 19/12/2018
PRAC Rapporteur name was amended on 23/10/2018
Next DLP was amended on 27/06/2017 PSUSA/00003145/202610 Eamon O Murchu Ireland CAP
3146 ziprasidone 05/02/1998 5 years 31/07/2030 29/10/2030 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00003146/203007 Karin Bolin Sweden NAP
3147 zofenopril 30/07/1998 7 years 02/01/2031 02/04/2031 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00003147/203101 Amelia Cupelli Italy NAP
3148 hydrochlorothiazide / zofenopril 03/03/2004 7 years 03/05/2031 01/08/2031 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00003148/203105 Amelia Cupelli Italy NAP
3149 zoledronic acid (indicated for cancer and fractures) 20/03/2001 3 years 31/08/2026 29/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00003149/202608 Karin Erneholm Denmark CAP NAP
3150 zolmitriptan 07/03/1997 5 years 06/03/2027 04/06/2027 No 16/11/2022 DLP was updated on 16/11/2022
PRAC Rapporteur name was amended on 31/07/2018
DLP was amended on 15/11/2017
Lead MS was added on 22/09/2016 PSUSA/00003150/202703 Karin Bolin Sweden NAP
3151 zolpidem 09/06/1987 3 years 03/08/2026 01/11/2026 No 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00003151/202608 Amelia Cupelli Italy NAP
3152 zonisamide 10/03/2005 3 years 31/03/2028 29/06/2028 No 21/12/2022 PSUR frequency and DLP were updated on 21/12/2022
DLP was corrected on 03/03/2021
PSUR frequency and DLP were updated on 18/11/2020
DLP was updated on 20/11/2019
DLP was updated on 21/11/2018
PRAC Rapporteur name was amended on 23/10/2018
Reference to NAP added on 31/07/2018
DLP was amended on 15/11/2017
DLP was updated on 18/11/2016
DLP was amended on 29/10/2015
Requirement to submit generics changed on 31/01/2014 PSUSA/00003152/202803 Rhea Fitzgerald Ireland CAP NAP
3153 zopiclone, eszopiclone 10/12/1984 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00003153/202812 NAP
3154 zotepine 07/12/1981 8 years 03/05/2033 01/08/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00003154/203305 Veronika Macurová Czech Republic NAP
3155 zuclopenthixol 31/05/1976 5 years 31/05/2028 29/08/2028 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00003155/202805 Jean-Michel Dogné Belgium NAP
3157 ascorbic acid 25/02/1960 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003157/203906 Roxana Dondera Romania NAP
3158 N(2)-L-alanyl-L-glutamine 29/03/1995 5 years 29/03/2026 27/06/2026 No 27/01/2026 PRAC representative was updated on 31/05/2023
DLP was updated on 22/12/2021
PRAC representative was updated on 31/03/2021
Next DLP was amended on 20/12/2016
Lead Member State added on 27/11/2015. PSUSA/00003158/202603 Roxana Stefania Udrescu Romania NAP
3159 antithrombin III 01/01/1983 5 years 31/12/2025 31/03/2026 No 22/09/2021 PRAC representative was updated on 17/11/2021
PSUR frequency, DLP and active substance name were updated on 22/09/2021
PRAC representative was updated on 30/06/2021
PSUR frequency amended and DLP updated on 31/07/2018
Next DLP was amended on 25/09/2017
PSUR Frequency amended and DLP updated on 09/09/2016
PRAC Representative amended on 27/11/2015.
Lead MS was added on 13/07/2015 PSUSA/00003159/202512 Amelia Cupelli Italy NAP
3160 arginine aspartate 07/10/1964 10 years 03/06/2034 01/09/2034 No 11/06/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003160/203406 Zoubida Amimour France NAP
3161 asparaginase, crisantaspase (L-asparaginase from Erwinia chrysanthemi) 03/04/1988 3 years 31/08/2027 29/11/2027 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00003161/202708 Jan Neuhauser Austria CAP
3162 bendamustine hydrochloride 07/07/2010 5 years 06/01/2030 06/04/2030 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00003162/203001 Dennis Lex Germany NAP
3163 bilastine 08/09/2010 5 years 07/03/2029 05/06/2029 No 20/11/2024 PSUR frequency amended and DLP updated on 20/11/2024 PSUSA/00003163/202903 Roxana Dondera Romania NAP
3164 chlorquinaldol Not available* 8 years 01/12/2028 01/03/2029 Yes 27/05/2026 DLP was amended on 27/05/2026
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 27/05/2026
PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00003164/202812 Roxana Stefania Udrescu Romania NAP
3165 ciclopirox and ciclopirox olamine 02/04/1975 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003165/203503 Melinda Palfi Hungary NAP
3166 cycloserine Not available* 8 years 03/03/2026 01/06/2026 No 27/01/2026 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00003166/202603 Roxana Stefania Udrescu Romania NAP
3167 dienogest 02/12/2009 3 years 02/12/2025 02/03/2026 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00003167/202512 Bianca Mulder Netherlands NAP
3168 dorzolamide 11/11/1994 5 years 18/02/2030 19/05/2030 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00003168/203002 Zoubida Amimour France NAP
3170 hexoprenaline sulfate 13/08/1970 5 years 13/08/2030 11/11/2030 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00003170/203008 Roxana Dondera Romania NAP
3171 hypromellose 30/11/1955 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003171/203401 NAP
3175 lanthanum Not available* 3 years 18/03/2027 16/06/2027 No 02/06/2026 PSUSA/00003175/202703 Karin Bolin Sweden NAP
3177 methandienone Not available* 8 years 03/11/2026 01/02/2027 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003177/202611 NAP
3178 midodrine 06/02/1974 10 years 06/06/2026 04/09/2026 No 27/01/2026 PRAC representative was updated on 31/05/2023
PRAC representative was updated on 31/03/2021
PSUR Frequency amended and DLP updated on 28/02/2017
Lead MS and PRAC Rapporteur name updated on 04/02/2016
PSUSA number was amended on 06/10/2014 PSUSA/00003178/202606 Roxana Stefania Udrescu Romania NAP
3179 natamycin Not available* 8 years 03/11/2032 01/02/2033 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00003179/203211 Adam Przybylkowski Poland NAP
3180 sodium chloride 24/11/1972 10 years 31/01/2035 01/05/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003180/203501 NAP
3181 riboflavin Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003181/203611 NAP
3183 silibinin, dry extract from Milk Thistle fruit (silymarin)) Not available* 9 years 03/06/2032 01/09/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003183/203206 Roxana Dondera Romania NAP
3184 sorbitol Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00003184/202612 Roxana Dondera Romania NAP
3185 tenonitrozole 11/02/1997 13 years 11/02/2028 11/05/2028 No 27/01/2026 PRAC representative was updated on 31/05/2023
PRAC representative was updated on 31/03/2021
PRAC Rapporteur amended on 06/02/2019
PRAC Representative updated on 26/09/2018
PRAC Rapporteur amended on 28/02/2018
The PSUR Frequency and Next DLP was amended on 29/10/2015
Lead MS was added on 04/02/2015 PSUSA/00003185/202802 Roxana Stefania Udrescu Romania NAP
3186 a-tocopheril, a-tocopherol, vitamin E Not available* 8 years 03/11/2033 01/02/2034 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00003186/203311 Roxana Stefania Udrescu Romania NAP
9004 aciclovir / hydrocortisone 31/07/2009 5 years 30/07/2028 28/10/2028 No 27/03/2024 PSUR frequency amended and DLP updated on 27/03/2024 PSUSA/00009004/202807 Jan Neuhauser Austria NAP
9005 aclidinium bromide 20/07/2012 1 year 20/07/2026 28/09/2026 20/07/2027 28/09/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00009005/202607 PSUSA/00009005/202707 Adam Przybylkowski Poland CAP
9050 aluminium chloride hexahydrate Not available* 10 years 03/11/2035 01/02/2036 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009050/203511 Dennis Lex Germany NAP
9052 amlodipine / bisoprolol, amlodipine / nebivolol Not available* 9 years 03/03/2027 01/06/2027 No 22/10/2025 DLP was amended on 22/10/2025
Active substance name was amended on 22/10/2025
PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009052/202703 none NAP
9054 amoxicillin / lansoprazole / metronidazole Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009054/202903 NAP
9057 argatroban 31/01/1990 2 years 31/01/2026 01/05/2026 No 02/06/2026 PSUSA/00009057/202601 Karin Bolin Sweden NAP
9062 ascorbic acid / biotin / calcium pantotenate Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009062/202905 NAP
9068 atropine sulfate / phenylephrine acetate / prednisolone acetate 13/12/1960 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009068/203906 NAP
9071 bacampicillin Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009071/202905 NAP
9074 balsalazide 18/12/1997 7 years 02/01/2031 02/04/2031 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00009074/203101 Amelia Cupelli Italy NAP
9075 belimumab 13/07/2011 3 years 08/03/2027 06/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00009075/202703 Karin Bolin Sweden CAP
9080 bisulepin Not available* 7 years 03/08/2031 01/11/2031 Yes 23/10/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 23/10/2024
PSUR frequency and DLP amended on 27/03/2024 PSUSA/00009080/203108 Miroslava Gocova Slovakia NAP
9083 bornaprin 13/12/1974 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009083/203503 NAP
9084 botulinum neurotoxin type a (150 kd) free from complexing proteins 31/05/2005 3 years 31/12/2027 30/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00009084/202712 Rhea Fitzgerald Ireland NAP
9088 caffeine / dextropropoxyphene / paracetamol Not available* 8 years 01/12/2033 01/03/2034 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00009088/203312 none NAP
9091 calcium lactate Not available* 8 years 01/12/2033 01/03/2034 No 30/10/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00009091/203312 John Joseph Borg Malta NAP
9092 calcium pantothenate Not available* 8 years 01/12/2033 01/03/2034 No 30/10/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00009092/203312 Polona Golmajer Slovenia NAP
9099 cefuroxime axetil 18/08/1987 5 years 07/04/2027 06/07/2027 No 21/12/2022 DLP was updated on 21/12/2022
DLP was updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00009099/202704 Maia Uusküla Estonia NAP
9100 chloral hydrate 08/02/1967 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009100/202803 NAP
9107 cloricromen hydrochloride 18/06/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009107/202812 NAP
9112 colistimethate sodium (dry inhalation powder) 13/02/2012 3 years 12/02/2026 13/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00009112/202602 Adam Przybylkowski Poland CAP
9113 conjugated estrogens 09/03/1950 10 years 01/12/2032 01/03/2033 No 11/06/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009113/203212 Guðrún Stefánsdóttir Iceland NAP
9114 conjugated estrogens / norgestrel Not available* 9 years 03/03/2030 01/06/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009114/203003 NAP
9118 decitabine 02/05/2006 5 years 01/05/2028 30/07/2028 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00009118/202805 Tiphaine Vaillant France CAP
9119 denosumab (indicated for skeletal related events associated with bone metastases and for giant cell tumour of bone) 13/07/2011 3 years 26/09/2026 25/12/2026 No 02/06/2026 PSUSA/00009119/202609 Karin Bolin Sweden CAP
9120 dexamethasone / heparin sodium 16/08/1961 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009120/203906 NAP
9121 dexpanthenol / polyvinyl alcohol Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009121/203008 NAP
9128 diclofenac / pyridoxine / thiamine Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009128/203008 NAP
9129 didecyldimethylammonium chloride Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009129/203008 NAP
9131 diethylamine salicylate / myrtecaine 20/11/1967 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009131/203408 NAP
9136 diphenhydramine / racemic camphor / zinc oxide Not available* 8 years 03/03/2026 01/06/2026 No 05/08/2025 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00009136/202603 Carla Torre Portugal NAP
9139 dithranol Not available* 8 years 03/03/2026 01/06/2026 No 05/08/2025 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00009139/202603 Rhea Fitzgerald Ireland NAP
9142 emtricitabine / rilpivirine / tenofovir disoproxil 28/11/2011 3 years 10/08/2026 08/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00009142/202608 Liana Martirosyan Netherlands CAP
9143 escin 06/04/1983 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009143/202812 NAP
9144 diethylamine-salicylate / escin Not available* 8 years 03/03/2026 01/06/2026 No 05/08/2025 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00009144/202603 Eva Jirsová Czech Republic NAP
9145 estradiol (17-beta) / progesterone Not available* 7 years 01/12/2031 29/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00009145/203112 Amelia Cupelli Italy NAP
9146 estriol / lactobacillus acidophilus Not available* 8 years 03/06/2026 01/09/2026 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009146/202606 NAP
9147 exenatide 20/11/2006 3 years 31/03/2027 29/06/2027 No 02/06/2026 PSUSA/00009147/202703 Karin Bolin Sweden CAP
9150 clonazoline hydrochloride / fluocinolone acetonide Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 PSUR frequency and DLP amended on 28/08/2024. PSUSA/00009150/202912 NAP
9152 fluocinolone / neomycin, fluocinolone / neomycin / polymyxin b 01/05/1965 10 years 01/05/2033 30/07/2033 No 23/10/2024 PSUR frequency amended and DLP updated on 23/10/2024
Active substance name was amended on 23/10/2024
EURD added on 23/10/2024
Active substance name was amended on 22/12/2021 PSUSA/00009152/203305 Dennis Lex Germany NAP
9153 fluorescein (systemic use) 30/11/1971 3 years 30/04/2026 29/07/2026 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00009153/202604 Dennis Lex Germany NAP
9154 fluticasone furoate 11/01/2008 3 years 26/04/2027 25/07/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00009154/202704 Adam Przybylkowski Poland CAP NAP
9159 gentamicin (systemic use) 28/02/1973 3 years 31/03/2026 29/06/2026 Yes 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00009159/202603 Amelia Cupelli Italy NAP
9162 calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide 25/03/2004 5 years 25/03/2029 23/06/2029 No 20/11/2024 PSUR frequency amended and DLP updated on 20/11/2024 PSUSA/00009162/202903 Maria Popova-Kiradjieva Bulgaria NAP
9163 guaiazulene / matricaria oil Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009163/203103 NAP
9164 guaifenesin / herbal extracts Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009164/203103 NAP
9165 guaifenesin / levomenthol Not available* 8 years 03/08/2026 01/11/2026 No 18/11/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009165/202608 Rhea Fitzgerald Ireland NAP
9166 diphenhydramine / guaifenesin / levomenthol Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009166/203011 NAP
9167 glucose / guaiphenesin / treacle Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009167/203103 NAP
9168 halometasone Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009168/203103 NAP
9169 halometasone / triclosan Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009169/203106 NAP
9170 dexpanthenol / heparin Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009170/203008 NAP
9171 hydroxyethyl salicylate / heparin / menthol Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009171/203106 Jan Neuhauser Austria NAP
9172 benzyl nicotinate / heparin sodium Not available* 8 years 01/12/2033 01/03/2034 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00009172/203312 none NAP
9174 human coagulation factor VIII (inhibitor bypassing fraction) 04/02/1977 3 years 28/02/2027 29/05/2027 No 20/10/2021 PSUR frequency and DLP were updated on 20/10/2021
DLP was updated on 21/10/2020
DLP was updated on 23/10/2019
PRAC Rapporteur name was updated on 05/06/2019
DLP was updated on 23/10/2018
DLP was updated and PRAC Representative name amended on 17/10/2017
Next DLP was amended on 19/10/2016
DLP was amended on 30/09/2015.
Lead MS was added on 13/07/2015
Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00009174/202702 Sonja Hrabcik Austria NAP
9175 human papillomavirus vaccine (rDNA) - 2-valent 20/09/2007 3 years 17/11/2025 15/02/2026 No 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00009175/202511 Jean-Michel Dogné Belgium CAP
9176 hydrocortisone (for centrally authorised products for adrenal insufficiency, congenital adrenal hyperplasia, modified-release formulations) 03/11/2011 3 years 03/11/2028 01/02/2029 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00009176/202811 Karin Bolin Sweden CAP
9177 dexpanthenol / hydrocortisone Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009177/203008 NAP
9178 hydrogen peroxide Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009178/203106 NAP
9179 hydrotalcite Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009179/202611 Dennis Lex Germany NAP
9180 hydrotalcite / simeticone Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009180/203106 NAP
9182 hydroxycarbamide (except for centrally authorised product) 07/12/1967 3 years 06/12/2026 06/03/2027 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00009182/202612 Petar Mas Croatia NAP
9183 hyetellose / sodium chloride 11/01/1990 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009183/202901 NAP
9187 ibuprofen / phenylephrine Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009187/202611 Adam Przybylkowski Poland NAP
9188 ichthammol / titanium dioxide / zinc oxide and other substances, zinc oxide/dimethicone 18/01/1934 13 years 03/06/2040 01/09/2040 No 23/10/2024 DLP amended on 23/10/2024 PSUSA/00009188/204006 NAP
9190 iloprost (intravenous (IV)use only) 27/04/1994 5 years 31/01/2029 01/05/2029 No 19/09/2024 PSUSA/00009190/202901 Zoubida Amimour France NAP
9191 indium (111In) pentetate 06/03/1992 8 years 15/07/2028 13/10/2028 Yes 28/04/2022 PRAC representative was updated on 19/10/2022
PRAC Representative was amended on 28/04/2022
DLP was updated on 31/03/2021
LMS and PRAC representative were added on 18/12/2019
DLP was updated on 05/06/2019
Active substance name was amended on 19/10/2016 PSUSA/00009191/202807 Jo Robays Belgium NAP
9192 indium (111In) pentetreotide 16/02/1994 8 years 15/07/2028 13/10/2028 No 31/03/2021 PRAC representative was updated on 19/10/2022
DLP was updated on 31/03/2021
PRAC representative was added on 06/05/2020
LMS was added on 01/04/2020
DLP was updated on 05/06/2019 PSUSA/00009192/202807 Jo Robays Belgium NAP
9200 ipilimumab 13/07/2011 3 years 24/03/2027 22/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00009200/202703 Bianca Mulder Netherlands CAP
9201 ipratropium / xylometazoline 07/04/2006 6 years 03/08/2029 01/11/2029 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00009201/202908 Petar Mas Croatia NAP
9204 ivacaftor 23/07/2012 3 years 23/01/2026 23/04/2026 No 19/09/2025 Next DLP was updated on 18/10/2023 PSUSA/00009204/202601 Maria Martinez Gonzalez Spain CAP
9205 ketoprofen (topical use only) 23/01/1975 5 years 23/01/2027 23/04/2027 No 19/10/2022 PSUR frequency and DLP were updated on 19/10/2022
DLP was updated on 25/09/2019
DLP was corrected on 28/02/2018
PSUR Frequency amended and DLP updated and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" amended on 23/05/201
Next DLP was amended on 03/06/2016
EURD and DLP amended on 16/07/2015
Lead MS added on 12/05/2015
For advice on submission for DLPs falling before 10/09/2015 please consult the List of substance under Work sharing scheme and other substance contained in Nationally Authorised Products with DLPs synchronised. PSUSA/00009205/202701 Karin Bolin Sweden NAP
9206 lactic acid / propylene glycol, propylene glycol Not available* 9 years 03/07/2031 01/10/2031 Yes 01/04/2026 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 01/04/2026
Active substance name was amended on 01/04/2026
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009206/203107 none NAP
9207 lamivudine (HIV infections), lamivudine / zidovudine 18/03/1998 5 years 30/11/2029 28/02/2030 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00009207/202911 Zoubida Amimour France CAP
9208 white soft paraffin, white soft paraffin combinations (except ocular indications) 30/06/1982 13 years 30/06/2040 28/09/2040 No 01/04/2026 Active substance name was amended on 01/04/2026
DLP was amended on 18/12/2024
Name of active substance was amended on 21/12/2012 PSUSA/00009208/204006 Jo Robays Belgium NAP
9210 levomenthol Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009210/202611 Maria Popova-Kiradjieva Bulgaria NAP
9212 levothyroxine / potassium iodide Not available* 9 years 02/09/2031 01/12/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009212/203109 NAP
9213 fluorescein sodium / lidocain hydrochloride Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009213/203012 NAP
9215 isopropyl myristate / liquid paraffin Not available* 9 years 03/07/2031 01/10/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009215/203107 NAP
9216 acetylated wool alcohols / liquid paraffin Not available* 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009216/202901 NAP
9219 magaldrate Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009219/202611 Jo Robays Belgium NAP
9225 magnesium sulfate Not available* 5 years 30/06/2030 28/09/2030 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00009225/203006 Marie Louise Schougaard Christiansen Denmark NAP
9226 mannitol (indicated in cystic fibrosis) 13/04/2012 3 years 12/04/2028 11/07/2028 No 19/09/2024 PSUSA/00009226/202804 Zoubida Amimour France CAP
9231 moxifloxacin (systemic use) 31/05/1999 4 years 31/05/2027 29/08/2027 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00009231/202705 Dennis Lex Germany NAP
9234 nicotinamide Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 Correction of DLP on 20/11/2024
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009234/202611 Tiphaine Vaillant France NAP
9236 nimesulide (systemic formulations) 06/08/1985 5 years 30/06/2029 28/09/2029 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00009236/202906 Amelia Cupelli Italy NAP
9237 nitroxoline Not available* 8 years 03/11/2026 01/02/2027 Yes 28/05/2025 DLP was amended on 28/05/2025
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009237/202611 Dennis Lex Germany NAP
9239 amoxicillin / clarithromycin / omeprazole Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009239/202903 NAP
9241 aspergillus orizae / pancreatin Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009241/202905 NAP
9242 belladonna extract / hyosciamine / papaverine hydrochloride Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009242/202905 NAP
9243 dextromethorphan / doxylamine / paracetamol Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009243/203008 NAP
9244 dextromethorphan / doxylamine / ephedrine / paracetamol Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009244/203008 NAP
9245 dextromethorphan / doxylamine / paracetamol / pseudoephedrine Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009245/203008 NAP
9247 dextromethorphan / paracetamol / phenylephrine Not available* 10 years 03/11/2034 01/02/2035 Yes 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00009247/203411 Miroslava Gocova Slovakia NAP
9248 ascorbic acid / paracetamol / propyphenazone 21/12/1959 11 years 03/05/2039 01/08/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009248/203905 NAP
9251 paraffin liquid Not available* 12 years 03/06/2040 01/09/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009251/204006 Jo Robays Belgium NAP
9253 pasireotide 24/04/2012 3 years 24/10/2026 22/01/2027 No 02/06/2026 PSUSA/00009253/202610 Karin Bolin Sweden CAP
9254 peginterferon alfa-2a 05/07/2001 3 years 04/07/2026 02/10/2026 No 02/06/2026 PSUSA/00009254/202607 Karin Bolin Sweden CAP
9255 perampanel 23/07/2012 3 years 22/07/2028 20/10/2028 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00009255/202807 Tiphaine Vaillant France CAP NAP
9256 phenol Not available* 10 years 16/04/2030 15/07/2030 Yes 16/12/2020 Correction of PSUR frequency and DLP on 29/06/2022
DLP was updated on 16/12/2020
PRAC Representative amended on 07/05/2018
DLP was updated and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/03/2017
Lead MS was added on 06/03/2015 PSUSA/00009256/203004 John Joseph Borg Malta NAP
9257 esculoside / phenylephrine Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009257/203011 NAP
9258 piketoprofen 08/08/1983 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009258/202812 NAP
9260 pinazepam 24/03/1975 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009260/203503 NAP
9262 pneumococcal polysaccharide conjugate vaccine (adsorbed) - 10 valent 30/03/2009 5 years 10/12/2027 09/03/2028 No 02/06/2026 PSUSA/00009262/202712 Karin Bolin Sweden CAP
9263 pneumococcal polysaccharide conjugate vaccine (adsorbed) - 13 valent 09/12/2009 5 years 09/01/2028 08/04/2028 No 02/06/2026 PSUSA/00009263/202801 Karin Bolin Sweden CAP
9264 magnesium aspartate / potassium aspartate Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009264/202611 Melinda Palfi Hungary NAP
9266 potassium canrenoate Not available* 7 years 31/01/2026 01/05/2026 Yes 28/05/2025 DLP was amended on 28/05/2025
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025
PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00009266/202601 Amelia Cupelli Italy NAP
9268 potassium iodide, potassium iodide / iodine Not available* 9 years 03/05/2032 01/08/2032 Yes 27/05/2026 Active substance name was amended on 27/05/2026
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009268/203205 none NAP
9269 chloramphenicol hemisuccinate / prednisolone sodium succinate Not available* 9 years 03/08/2029 01/11/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009269/202908 none NAP
9271 promestriene (cream and vaginal capsules) 31/01/1974 5 years 31/03/2029 29/06/2029 No 27/01/2026 PSUR frequency amended and DLP updated on 18/12/2024 PSUSA/00009271/202903 Roxana Dondera Romania NAP
9272 chlorquinaldol (vaginal tablet) / promestriene 13/06/1977 13 years 30/09/2032 29/12/2032 No 03/06/2020 PRAC representative was updated on 31/03/2021
PSUR frequency and CLP were updated on 03/06/2020
PSUR Frequency amended and DLP updated on 23/05/2017
EURD date amended on 22/09/2016
PSUR Frequency amended and DLP updated on 03/06/2016
Lead MS added on 12/05/2015 PSUSA/00009272/203209 Roxana Dondera Romania NAP
9273 protirelin 01/01/1974 8 years 01/01/2032 31/03/2032 No 12/09/2025 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00009273/203201 Veronika Macurová Czech Republic NAP
9275 pyridoxine Not available* 9 years 03/05/2032 01/08/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009275/203205 NAP
9276 l(+)biaspartate / glutamic acid / glycin / magnesium / potassium / pyridoxine 01/12/1975 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009276/203503 NAP
9277 rabies vaccine 16/05/1975 5 years 11/03/2026 09/06/2026 No 17/11/2021 DLP was updated on 17/11/2021
PRAC representative was updated on 17/11/2021
PRAC representative was updated on 25/09/2019
Next DLP was updated on 18/11/2016
PRAC Representative was amended on 27/11/2015.
Lead Member State was added on 30/09/2015 PSUSA/00009277/202603 Amelia Cupelli Italy NAP
9279 ascorbic acid / colecalciferol / retinol Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009279/202905 NAP
9280 a-tocopherol nicotinate / retinol palmitate 31/12/1968 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009280/204003 NAP
9282 rilpivirine (for oral use) 28/11/2011 3 years 19/05/2027 17/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00009282/202705 Liana Martirosyan Netherlands CAP
9284 saccharomyces boulardii Not available* 5 years 07/02/2028 07/05/2028 No 18/10/2023 PSUR frequency amended and DLP updated on 18/10/2023 PSUSA/00009284/202802 Eva Jirsová Czech Republic NAP
9286 flumetasone / salicylic acid Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009286/203012 NAP
9288 scopolamine aminoxide hydrobromide Not available* 9 years 03/06/2032 01/09/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009288/203206 NAP
9292 silver nitrate Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00009292/202612 Benjamin Micallef Malta NAP
9295 sodium chloride (eye drops) Not available* 9 years 03/06/2032 01/09/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009295/203206 NAP
9296 sodium chloride (nasal drops) Not available* 9 years 03/08/2032 01/11/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009296/203208 NAP
9298 chamomile extract / glucose / potassium chloride / sodium chloride / sodium hydrogen carbonate Not available* 9 years 03/07/2029 01/10/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009298/202907 NAP
9300 strontium chloride hexahydrate Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009300/203211 NAP
9302 sucrose Not available* 8 years 03/08/2027 01/11/2027 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009302/202708 NAP
9303 hamamelis virginiana l. extract / phenazone / tannic acid Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009303/203106 NAP
9305 teduglutide 30/08/2012 2 years 30/08/2026 28/11/2026 No 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00009305/202608 Marie Louise Schougaard Christiansen Denmark CAP
9310 tetracycline (topical use) 23/08/1984 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009310/202812 NAP
9312 thiamine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009312/203211 NAP
9315 tobramycin (inhalation powder, capsules) 20/07/2011 6 years 30/06/2030 28/09/2030 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00009315/203006 Liana Martirosyan Netherlands CAP
9316 tobramycin (nebuliser solution) (apart from centrally authorised product) 10/12/1999 3 years 31/12/2026 31/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00009316/202612 Amelia Cupelli Italy NAP
9317 tobramycin (ophthalmic and otic use) 01/06/1977 5 years 31/03/2026 29/06/2026 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00009317/202603 Carla Torre Portugal NAP
9318 tobramycin (systemic use) 29/10/1973 8 years 15/09/2028 14/12/2028 No 19/10/2022 PRAC representative was updated on 19/10/2022
PRAC representative was updated on 27/07/2022
DLP was updated on 26/05/2021
PRAC representative and LMS were added on 04/03/2020
DLP was updated on 05/06/2019 PSUSA/00009318/202809 Amelia Cupelli Italy NAP
9319 treosulfan (except for centrally authorised product) Not available* 5 years 31/08/2027 29/11/2027 No 03/05/2023 DLP was amended on 03/05/2023
PRAC Rapporteur name was amended on 28/04/2022
Active substance name amended on 31/07/2019
PRAC Rapporteur name was amended on 03/04/2019
DLP was updated on 06/06/2018
Lead MS and PRAC Rapporteur name was added on 28/02/2017 PSUSA/00009319/202708 Marie Louise Schougaard Christiansen Denmark NAP
9321 triamterene / trichlormethiazide Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009321/203211 NAP
9323 cetrimonium bromide / lidocaine / tyrothricin 28/09/1966 10 years 03/07/2034 01/10/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009323/203407 NAP
9326 urea hydrogen peroxide Not available* 8 years 03/11/2032 01/02/2033 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00009326/203211 Melinda Palfi Hungary NAP
9327 vandetanib 06/04/2011 3 years 06/04/2028 05/07/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00009327/202804 Tiphaine Vaillant France CAP
9329 vemurafenib 17/02/2012 3 years 16/08/2028 14/11/2028 No 02/06/2026 PSUSA/00009329/202808 Jenny-Maria Jönsson Sweden CAP
9330 xylene 14/05/1957 11 years 02/04/2038 01/07/2038 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009330/203804 NAP
9331 zinc orotate Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009331/203211 NAP
9333 zinc sulfate, zinc histidine 30/03/1973 10 years 31/01/2035 01/05/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009333/203501 Dennis Lex Germany NAP
9334 zoledronic acid (indicated for Osteoporosis) 15/04/2005 5 years 31/08/2028 29/11/2028 No 02/06/2026 PSUSA/00009334/202808 Karin Bolin Sweden CAP
9999 levomepromazine Not available* 9 years 03/07/2031 01/10/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009999/203107 NAP
10000 5 fluorouracil (topical application) Not available* 3 years 16/01/2026 16/04/2026 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00010000/202601 Dennis Lex Germany NAP
10002 fluorodopa (18F) Not available* 3 years 10/03/2027 08/06/2027 Yes 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010002/202703 John Joseph Borg Malta NAP
10005 mannitol (all indications apart from cystic fibrosis) Not available* 5 years 28/02/2030 29/05/2030 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010005/203002 Petar Mas Croatia NAP
10006 5-aminolevulinic acid (keratosis) 07/09/2007 5 years 14/06/2029 12/09/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010006/202906 Dennis Lex Germany CAP NAP
10007 ribavirin (oral formulations) 07/05/1999 3 years 24/07/2026 22/10/2026 Yes 18/11/2025 PSUSA/00010007/202607 Tiphaine Vaillant France NAP
10008 pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted), prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted), prepandemic influenza vaccine (H5N8) (surface antigen, inactivated, adjuvanted) 19/10/2009 3 years 19/10/2027 17/01/2028 No 28/05/2025 Active substance name was amended on 28/05/2025
DLP was amended on 05/06/2024 PSUSA/00010008/202710 Amelia Cupelli Italy CAP
10012 ciprofloxacin / dexamethasone (ear drops, suspension) 31/05/2012 5 years 30/04/2030 29/07/2030 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010012/203004 Dennis Lex Germany NAP
10013 ceftaroline fosamil 29/10/2010 3 years 28/10/2027 26/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00010013/202710 Maia Uusküla Estonia CAP
10015 ruxolitinib 23/08/2012 1 year 22/02/2026 03/05/2026 22/02/2027 03/05/2027 No 02/06/2026 PSUSA/00010015/202602 PSUSA/00010015/202702 Jenny-Maria Jönsson Sweden CAP
10019 aflibercept (oncological indication(s)) 03/08/2012 5 years 03/08/2029 01/11/2029 No 02/06/2026 PSUSA/00010019/202908 Jenny-Maria Jönsson Sweden CAP
10020 aflibercept (ophthalmological indication(s)) 22/11/2012 3 years 30/11/2025 28/02/2026 No 19/09/2024 New CAP authorised on 15/09/2025
New CAP authorised on 14/08/2025
New CAP authorised on 04/04/2025
New CAP authorised on 12/02/2025
New CAP authorised on 13/01/2025
New CAP authorised on 13/11/2024 PSUSA/00010020/202511 Zoubida Amimour France CAP
10021 alprostadil (patency of the ductus arteriosus) 23/07/1981 3 years 22/07/2027 20/10/2027 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00010021/202707 Sonja Hrabcik Austria NAP
10022 axitinib 27/01/2012 3 years 26/01/2028 25/04/2028 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010022/202801 David Olsen Norway CAP
10025 linaclotide 30/08/2012 3 years 26/08/2028 24/11/2028 No 27/05/2026 DLP was corrected on 27/05/2026
PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00010025/202808 Dennis Lex Germany CAP
10026 dectaflur / olaflur Not available* 8 years 03/03/2026 01/06/2026 No 05/08/2025 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00010026/202603 Dennis Lex Germany NAP
10028 concentrate of proteolytic enzymes enriched in bromelain 18/12/2012 1 year 17/12/2025 25/02/2026 17/12/2026 25/02/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010028/202512 PSUSA/00010028/202612 Dennis Lex Germany CAP
10029 dapagliflozin, dapagliflozin / metformin, saxagliptin / dapagliflozin, dapagliflozin / sitagliptin 05/10/2012 3 years 04/10/2027 02/01/2028 No 02/06/2026 PSUSA/00010029/202710 Karin Bolin Sweden CAP
10030 dexpanthenol / xylometazoline Not available* 8 years 31/05/2028 29/08/2028 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00010030/202805 Barbara Kovacic Bytyqi Croatia NAP
10031 mirabegron 01/07/2011 3 years 30/06/2028 28/09/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010031/202806 Maria del Pilar Rayon Spain CAP
10032 florbetapir (18f) 06/04/2012 5 years 06/04/2030 05/07/2030 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00010032/203004 Dennis Lex Germany CAP
10034 catridecacog 19/07/2012 3 years 31/07/2026 29/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00010034/202607 Tiphaine Vaillant France CAP
10036 insulin degludec, insulin degludec / insulin aspart 28/09/2012 3 years 30/09/2026 29/12/2026 No 02/06/2026 PSUSA/00010036/202609 Karin Bolin Sweden CAP
10039 brentuximab vedotin 19/08/2011 3 years 18/08/2028 16/11/2028 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010039/202808 Bianca Mulder Netherlands CAP
10041 magnesium pidolate 01/04/1992 15 years 03/06/2040 01/09/2040 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010041/204006 Veronika Macurová Czech Republic NAP
10042 crizotinib 26/08/2011 3 years 25/08/2027 23/11/2027 No 29/04/2026 PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00010042/202708 Tiphaine Vaillant France CAP
10043 meningococcal group-B vaccine (rDNA, component, adsorbed) 14/01/2013 3 years 13/01/2027 13/04/2027 No 02/06/2026 PSUSA/00010043/202701 Karin Bolin Sweden CAP
10044 meningococcal group a, c, w135, y conjugate vaccine (conjugated to tetanus toxoid carrier protein) 20/04/2012 3 years 19/04/2026 18/07/2026 No 20/12/2023 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00010044/202604 David Olsen Norway CAP
10047 glycopyrronium bromide (for centrally authorised product indicated for chronic obstructive pulmonary disease) 28/09/2012 5 years 28/09/2027 27/12/2027 No 31/05/2023 PSUR frequency amended and DLP updated on 31/05/2023
PRAC Rapporteur name was amended on 28/04/2022
PRAC representative was updated on 31/03/2021
DLP was updated on 03/06/2020
PRAC representative was updated on 25/09/2019
PRAC Rapporteur name was corrected on 03/04/2019
PRAC Rapporteur name was amended on 06/06/2018
PRAC Representative amended on 17/10/2017
PSUR Frequency amended and DLP updated on 26/04/2017
The name of the active substance was amended on 22/09/2016
Next DLP was amended on 03/05/2016
Next DLP amended on 04/11/2014
Next DLP amended on 02/05/2014 PSUSA/00010047/202709 Marie Louise Schougaard Christiansen Denmark CAP
10049 zinc gluconate Not available* 8 years 03/11/2026 01/02/2027 Yes 11/06/2025 DLP was amended on 28/05/2025
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025
PSUR frequency and DLP amended on 28/08/2024 PSUSA/00010049/202611 Guðrún Stefánsdóttir Iceland NAP
10050 caffeine / dexpanthenol / nicotinamide / pyridoxine / riboflavine / thiamin 23/06/1966 11 years 02/12/2039 01/03/2040 No 02/06/2026 PSUSA/00010050/203912 Karin Bolin Sweden NAP
10051 lovastatin 21/07/1987 5 years 20/07/2026 18/10/2026 No 30/03/2022 PRAC Representative updated on 16/11/2022
DLP was updated on 30/03/2022
PRAC Representative updated on 26/09/2018
PSUR Frequency amended and DLP updated on 28/03/2017
Lead MS and PRAC Rapporteur name updated on 04/02/2016 PSUSA/00010051/202607 Maria del Pilar Rayon Spain NAP
10052 vortioxetine 18/12/2013 2 years 29/09/2026 28/12/2026 No 28/04/2022 Next DLP was updated on 31/05/2023 PSUSA/00010052/202609 Jo Robays Belgium CAP
10054 afatinib 25/09/2013 5 years 25/09/2028 24/12/2028 No 02/06/2026 PSUSA/00010054/202809 Jenny-Maria Jönsson Sweden CAP
10055 alemtuzumab 12/09/2013 3 years 12/09/2028 11/12/2028 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00010055/202809 Karin Erneholm Denmark CAP
10061 alogliptin, alogliptin / metformin, alogliptin / pioglitazone 16/04/2013 3 years 15/04/2028 14/07/2028 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00010061/202804 Bianca Mulder Netherlands CAP
10066 avanafil 21/06/2013 5 years 21/06/2028 19/09/2028 No 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 PSUSA/00010066/202806 Maria del Pilar Rayon Spain CAP
10067 azelastine / fluticasone 24/01/2013 5 years 26/10/2029 24/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010067/202910 Jan Neuhauser Austria NAP
10068 beclometasone / formoterol (inhalative application) 14/07/2006 5 years 14/07/2030 12/10/2030 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00010068/203007 Dennis Lex Germany NAP
10070 benzalkonium chloride / chlorhexidine digluconate 19/11/1998 7 years 01/11/2028 30/01/2029 No 29/06/2022 PSUR frequency and DLP were updated on 29/06/2022
PRAC Rapporteur name was amended on 06/03/2019
DLP was updated on 21/07/2017
Lead MS and PRAC Rapporteur name was added on 03/06/2016 PSUSA/00010070/202811 Rugile Pilviniene Lithuania NAP
10071 betamethasone / chloramphenicol 24/03/1964 18 years 31/08/2030 29/11/2030 No 29/11/2013 PSUSA/00010071/203008 NAP
10072 betamethasone / tetryzoline 17/05/1966 9 years 30/09/2033 29/12/2033 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00010072/203309 Petar Mas Croatia NAP
10073 bosutinib 04/09/2012 3 years 03/03/2027 01/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010073/202703 Dennis Lex Germany CAP
10074 bedaquiline 05/03/2014 3 years 05/09/2028 04/12/2028 No 02/06/2026 PSUSA/00010074/202809 Karin Bolin Sweden CAP
10075 dolutegravir, dolutegravir / abacavir / lamivudine, dolutegravir / lamivudine 16/01/2014 3 years 16/01/2028 15/04/2028 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00010075/202801 Dennis Lex Germany CAP
10077 canagliflozin, canagliflozin / metformin 29/03/2013 3 years 28/03/2026 26/06/2026 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00010077/202603 Dennis Lex Germany CAP
10078 chloroprocaine hydrochloride 19/03/2012 5 years 19/03/2027 17/06/2027 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00010078/202703 Petar Mas Croatia NAP
10080 clindamycin phosphate / tretinoin 22/03/2013 5 years 31/07/2027 29/10/2027 No 17/02/2026 DLP was updated on 05/04/2023
PRAC representative was updated on 22/12/2021
PRAC representative was updated on 06/05/2020
DLP was updated on 07/05/2018
PRAC representative and Lead Member State were added on 30/01/2017 PSUSA/00010080/202707 Jana Pecherova Slovakia NAP
10081 cobicistat 27/08/2013 3 years 26/08/2026 24/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010081/202608 Ana Sofia Diniz Martins Portugal CAP
10082 cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil 27/08/2012 3 years 26/08/2026 24/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010082/202608 Ana Sofia Diniz Martins Portugal CAP
10084 dabrafenib 26/08/2013 3 years 29/05/2028 27/08/2028 No 02/06/2026 PSUSA/00010084/202805 Jenny Jönsson Sweden CAP
10086 defibrotide 18/10/2013 3 years 18/10/2026 16/01/2027 No 02/06/2026 PSUSA/00010086/202610 Karin Bolin Sweden CAP
10087 dexpanthenol / retinol palmitate 16/07/1975 20 years 31/08/2032 29/11/2032 No 29/11/2013 PSUSA/00010087/203208 NAP
10088 dextran 40 / sodium chloride / potassium chloride / magnesium sulphate heptahydrate / disodium phosphate dodecahydrate / monopotassium phosphate / dextrose monohydrate 22/05/1970 10 years 02/09/2034 01/12/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010088/203409 NAP
10091 diphtheria / tetanus / pertussis antigens (pertussis toxoid, filamentous haemagglutinin) (acellular, component) / hepatitis b (rdna) / poliomyelitis (inactivated) / haemophilus type b conjugate vaccines (adsorbed) 17/04/2013 3 years 17/04/2028 16/07/2028 No 06/10/2025 PRAC representative was updated on 01/03/2023
DLP was updated on 21/12/2022
PSUR frequency and DLP were updated on 20/11/2019
DLP was updated on 21/11/2018
DLP was amended on 15/11/2017
DLP was updated on 18/11/2016
DLP was updated on 27/11/2015
DLP was amended on 01/12/2014
DLP was amended on 28/05/2014 PSUSA/00010091/202804 Dirk Mentzer Germany CAP
10092 docosanol 14/11/2003 5 years 30/04/2026 29/07/2026 No 22/12/2021 DLP was updated on 22/12/2021
Next DLP was updated on 30/01/2017
PRAC Representative amended on 18/11/2016
Lead Member State and PRAC Representative was added on 27/11/2015. PSUSA/00010092/202604 Petar Mas Croatia NAP
10093 brimonidine (centrally authorised product only) 21/02/2014 3 years 21/02/2027 22/05/2027 No 20/10/2021 DLP and PSUR frequency were updated on 20/10/2021
DLP was updated on 21/10/2020
DLP was updated on 25/09/2019
Lead MS and PRAC Rapporteur name updated on 30/04/2019
DLP was updated on 26/09/2018
PSUR frequency amended and DLP updated on 27/03/2018
Next DLP was amended on 25/09/2017
DLP was updated and PRAC Representative amended on 28/03/2017
Next DLP was updated on 22/09/2016
Next DLP was amended on 07/04/2016
DLP and Next DLP was updated on 06/10/2015
Next DLP was amended on 01/04/2015 PSUSA/00010093/202702 Rhea Fitzgerald Ireland CAP
10094 florbetaben (18f) 20/02/2014 3 years 20/02/2026 21/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00010094/202602 Dennis Lex Germany CAP
10095 enzalutamide 31/08/2012 3 years 30/08/2026 28/11/2026 No 30/04/2024 New CAP authorised on 09/01/2026
DLP was amended on 30/04/2024 PSUSA/00010095/202608 Maria del Pilar Rayon Spain CAP
10096 fenofibrate / simvastatin 26/08/2013 3 years 25/02/2028 25/05/2028 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010096/202802 Maia Uusküla Estonia CAP
10097 fluprednidene Not available* 10 years 11/03/2034 09/06/2034 No 12/09/2025 DLP was amended on 20/11/2024 PSUSA/00010097/203403 Veronika Macurová Czech Republic NAP
10098 fluprednidene / gentamicin Not available* 10 years 11/03/2034 09/06/2034 No 12/09/2025 DLP was amended on 20/11/2024 PSUSA/00010098/203403 Veronika Macurová Czech Republic NAP
10099 fluticasone furoate / vilanterol 10/05/2013 5 years 09/05/2029 07/08/2029 No 19/09/2025 PSUR frequency amended and DLP updated on 30/04/2025
DLP was amended on 05/02/2025 PSUSA/00010099/202905 Maria Martinez Gonzalez Spain CAP
10100 framycetin sulphate / hydrocortisone acetate Not available* 9 years 31/01/2031 01/05/2031 No 12/09/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010100/203101 Veronika Macurová Czech Republic NAP
10101 granisetron (transdermal patch) 20/04/2012 3 years 19/10/2026 17/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010101/202610 Rugile Pilviniene Lithuania CAP
10102 human coagulation factor viii / human von willebrand factor (centrally authorised product only) 12/08/2013 5 years 12/08/2026 10/11/2026 No 28/04/2022 PSUR frequency amended and DLP updated on 28/04/2022
PSUR frequency amended and DLP updated on 03/04/2019
PRAC Representative updated on 26/09/2018
DLP was updated on 27/03/2018
DLP was updated on 28/03/2017
Next DLP was updated on 22/09/2016
PSUR Frequency amended and DLP updated on 07/04/2016
Next DLP was updated on 30/09/2015
Next DLP was amended on 01/04/2015
Correction of PSUSA number (Next DLP) on 06/10/2014
Correction of submission date on 31/01/2014
Name of active substance was amended on 30/11/2013 PSUSA/00010102/202608 Bianca Mulder Netherlands CAP
10104 C1-inhibitor, human plasma derived (centrally authorised products) 16/07/2001 2 years 15/06/2027 13/09/2027 No 01/04/2026 Reference to CAP removed on 01/04/2026
Active substance name was amended on 01/04/2026
DLP was amended on 04/03/2026 PSUSA/00010104/202706 Dirk Mentzer Germany NAP
10105 indacaterol / glycopyrronium bromide 19/09/2013 5 years 28/09/2028 27/12/2028 No 05/06/2024 PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00010105/202809 Marie Louise Schougaard Christiansen Denmark CAP
10107 insulin human (Intraperitoneal use only) 19/09/2013 3 years 19/09/2026 18/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00010107/202609 Jean-Michel Dogné Belgium CAP
10108 isopropyl alcohol (covers other synonymous terms such as 2-propanol) / propyl alcohol / mecetronium ethyl sulfate 20/01/1984 5 years 30/09/2026 29/12/2026 No 04/02/2026 Active substance name was amended on 04/02/2026
PSUR frequency and DLP were updated on 29/06/2022
PRAC representative added on 25/05/2022
LMS was added on 03/03/2021 PSUSA/00010108/202609 Dennis Lex Germany NAP
10109 levobunolol (ophthalmic indication) 02/01/1985 5 years 02/01/2027 02/04/2027 No 21/09/2022 DLP was updated on 21/09/2022
Next DLP was amended on 25/09/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00010109/202701 Eva Jirsová Czech Republic NAP
10110 lidocaine / prilocaine (centrally authorised product only) 15/11/2013 5 years 15/05/2030 13/08/2030 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010110/203005 Maria del Pilar Rayon Spain CAP
10111 lipegfilgrastim 25/07/2013 3 years 25/07/2027 23/10/2027 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00010111/202707 Terhi Lehtinen Finland CAP
10112 lomitapide 31/07/2013 1 year 31/07/2026 09/10/2026 31/07/2027 09/10/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010112/202607 PSUSA/00010112/202707 Bianca Mulder Netherlands CAP
10113 loxapine (pre-dispensed inhalation powder) 20/02/2013 3 years 20/08/2027 18/11/2027 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00010113/202708 Liana Martirosyan Netherlands CAP
10114 lurasidone 28/10/2010 3 years 27/10/2026 25/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010114/202610 Karin Bolin Sweden CAP
10115 macitentan 20/12/2013 3 years 17/10/2026 15/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010115/202610 Maria del Pilar Rayon Spain CAP
10118 midazolam (oromucosal solution or nasal routes of administration) 05/09/2011 3 years 09/09/2028 08/12/2028 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00010118/202809 Liana Martirosyan Netherlands CAP NAP
10119 smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara) 31/07/2013 1 year 31/07/2026 09/10/2026 31/07/2027 09/10/2027 No 04/03/2026 PSUR frequency amended and DLP updated on 04/03/2026
DLP was amended on 24/09/2025 PSUSA/00010119/202607 PSUSA/00010119/202707 Dirk Mentzer Germany CAP
10120 nalmefene 25/02/2013 3 years 24/02/2027 25/05/2027 No 20/10/2021 DLP was updated on 20/10/2021
PSUR Frequency and DLP updated on 26/09/2018
DLP was updated on 17/10/2017
Next DLP was updated on 22/09/2016
Next DLP was updated on 30/09/2015
Next DLP was amended on 06/10/2014
Next DLP was amended on 01/04/2014 PSUSA/00010120/202702 Dennis Lex Germany CAP
10123 paclitaxel albumin 11/01/2008 5 years 06/01/2027 06/04/2027 No 21/09/2022 PSUR frequency and DLP were updated on 21/09/2022
DLP was updated on 25/09/2019
New CAP authorised on 06/05/2019
PRAC Representative updated on 26/09/2018
PSUR Frequency amended and DLP updated on 22/09/2016 PSUSA/00010123/202701 Bianca Mulder Netherlands CAP
10124 papaverine / phentolamine Not available* 8 years 03/11/2026 01/02/2027 No 20/11/2024 DLP corrected on 20/11/2024
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010124/202611 Liana Martirosyan Netherlands NAP
10125 pertuzumab 08/06/2012 3 years 07/06/2027 05/09/2027 No 05/02/2025 New CAP authorised on 23/04/2026
DLP was amended on 05/02/2025 PSUSA/00010125/202706 Marie Louise Schougaard Christiansen Denmark CAP
10126 phenol-methanal-urea polycondensate / sulphonated / sodium salt Not available* 20 years 22/12/2034 22/03/2035 No 31/01/2014 PSUSA/00010126/203412 NAP
10127 pomalidomide 08/02/2013 5 years 07/02/2029 08/05/2029 Yes 19/09/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 20/11/2024
PSUR frequency and DLP were updated on 20/10/2021
Correction to PSUR frequency, DLP and submission date on 05/02/2020
DLP was updated on 25/09/2019
Lead MS and PRAC Rapporteur name updated on 30/04/2019
DLP was updated on 26/09/2018
Next DLP was amended on 25/09/2017
Correction of the next DLP and PSUR frequency on 11/04/2017
DLP was updated and PRAC representative amended on 28/03/2017
Next DLP was updated on 22/09/2016
Next DLP was amended on 07/04/2016
Next DLP was updated on 30/09/2015
Next DLP was amended on 01/04/2015
Next DLP was amended on 06/10/2014 PSUSA/00010127/202902 Maria Martinez Gonzalez Spain CAP
10128 ponatinib 14/12/2012 3 years 13/12/2026 13/03/2027 No 02/06/2026 PSUSA/00010128/202612 Jenny-Maria Jönsson Sweden CAP
10130 potassium para-aminobenzoate Not available* 5 years 04/02/2030 05/05/2030 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010130/203002 Dennis Lex Germany NAP
10132 radium-223 dichloride 13/11/2013 3 years 14/05/2027 12/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010132/202705 Rugile Pilviniene Lithuania CAP
10133 regorafenib 26/09/2012 3 years 26/09/2026 25/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00010133/202609 Bianca Mulder Netherlands CAP
10134 sofosbuvir 06/12/2013 5 years 05/12/2029 05/03/2030 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00010134/202912 Ana Sofia Diniz Martins Portugal CAP
10135 teriflunomide 12/09/2013 3 years 12/09/2026 11/12/2026 Yes 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00010135/202609 Dennis Lex Germany CAP NAP
10136 trastuzumab emtansine 15/11/2013 2 years 21/02/2026 22/05/2026 No 19/10/2022 PSUR frequency and DLP were updated on 19/10/2022
DLP was updated on 20/10/2021
PRAC representative was updated on 31/03/2021
DLP was updated on 21/10/2020
PRAC representative and DLP were updated on 25/09/2019
PRAC Rapporteur name was amended on 03/04/2019
DLP was updated on 26/09/2018
DLP was updated on 17/10/2017
Next DLP was updated on 22/09/2016
Next DLP was updated on 30/09/2015
The DLP was amended on 01/04/2014 PSUSA/00010136/202602 Karin Erneholm Denmark CAP
10137 triamcinolone (tablets and injectables) 28/09/1966 8 years 28/09/2028 27/12/2028 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00010137/202809 Carla Torre Portugal NAP
10138 turoctocog alfa 15/10/2013 3 years 31/10/2026 29/01/2027 No 06/10/2025 DLP was amended on 03/07/2024 PSUSA/00010138/202610 Dirk Mentzer Germany CAP
10139 unsaturated fatty acids (C18:2)(topical use) 28/06/1968 28 years 28/06/2040 26/09/2040 No 29/11/2013 PSUSA/00010139/204006 NAP
10140 vismodegib 30/01/2012 3 years 29/01/2027 29/04/2027 No 02/06/2026 PSUSA/00010140/202701 Jenny-Maria Jönsson Sweden CAP
10143 dimethyl fumarate, diroximel fumarate (multiple sclerosis) 30/01/2014 3 years 26/03/2028 24/06/2028 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00010143/202803 Dennis Lex Germany CAP
10155 felbamate 15/05/1994 5 years 30/09/2030 29/12/2030 Yes 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
Next DLP was updated on 31/05/2023 PSUSA/00010155/203009 Tiphaine Vaillant France NAP
10156 lidocaine / norepinephrine 01/10/1948 8 years 30/09/2021 29/12/2021 No 06/10/2014 PRAC representative and LMS were added on 03/03/2021 PSUSA/00010156/202109 Adam Przybylkowski Poland NAP
10163 C1-inhibitor, human plasma derived (nationally authorised products) 23/07/1979 2 years 04/08/2027 02/11/2027 No 01/04/2026 DLP was amended on 01/04/2026
Active substance name was amended on 01/04/2026
DLP was amended on 30/04/2024 PSUSA/00010163/202708 Dirk Mentzer Germany NAP
10171 para-aminosalicylic acid (centrally authorised product) 07/04/2014 5 years 07/10/2029 05/01/2030 Yes 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010171/202910 Karin Bolin Sweden CAP
10174 riociguat 19/03/2013 3 years 19/09/2027 18/12/2027 No 25/05/2022 DLP was updated on 25/05/2022
PSUR frequency was amended on 01/10/2019
PRAC Rapporteur name was updated on 03/07/2019
DLP was updated on 30/04/2019
Lead MS and PRAC Rapporteur name updated on 23/10/2018
DLP was updated on 07/05/2018
Next DLP was amended on 26/04/2017
PSUR frequency and following DLP updated on 18/11/2016
Next DLP was amended on 19/10/2016
DLP and next DLP were amended on 03/05/2016
The Next DLP was amended on 29/10/2015.
Next DLP was amended on 12/05/2015
EURD was amended on 04/11/2014 PSUSA/00010174/202709 Kimmo Jaakkola Finland CAP
10178 aztreonam (parenteral use) 04/08/1984 7 years 03/08/2030 01/11/2030 No 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00010178/203008 Marie Louise Schougaard Christiansen Denmark NAP
10180 cabozantinib 29/11/2012 3 years 28/11/2027 26/02/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010180/202711 Bianca Mulder Netherlands CAP
10186 vedolizumab 20/05/2014 3 years 19/05/2027 17/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010186/202705 Adam Przybylkowski Poland CAP
10187 amino acid combinations (only combinations of pure amino acids or combination of amino acids with mineral compounds/electrolytes, i.v. application) Not available* 7 years 01/01/2026 01/04/2026 No 25/09/2019 DLP was updated on 25/09/2019
PRAC Representative and Lead Member state assigned on 04/07/2018 PSUSA/00010187/202601 Dennis Lex Germany NAP
10190 amino acid combinations / glucose / triglyceride combinations (e.g. olive oil, soya bean oil, fish oil)/ with or without electrolytes/ mineral compounds (i.v. application) - only for the drug Numeta 20/01/2011 3 years 31/12/2027 30/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010190/202712 Karin Bolin Sweden NAP
10191 amlodipine / candesartan, amlodipine / candesartan / hydrochlorothiazide, candesartan / amlodipine / atorvastatin 20/03/2014 5 years 28/04/2027 27/07/2027 No 23/10/2024 Active substance name was amended on 23/10/2024
Active substance name was amended on 20/12/2023
DLP was updated on 21/12/2022
DLP was updated on 21/11/2018
DLP was amended on 31/01/2018
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00010191/202704 Eva Jirsová Czech Republic NAP
10192 amlodipine / lisinopril 30/04/2004 5 years 31/12/2026 31/03/2027 No 21/09/2022 DLP was updated on 21/09/2022
Next DLP was amended on 25/09/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00010192/202612 Zane Neikena Latvia NAP
10196 benfotiamine 21/08/2013 5 years 03/07/2028 01/10/2028 Yes 15/11/2023 DLP was amended on 15/11/2023
Lead MS and PRAC Rapporteur name added on 26/07/2023
Update of PSUR frequency & DLP resulting from PRAC re-allocation exercise for entries with DLPs in 2025 on 05/04/2023 PSUSA/00010196/202807 Maia Uusküla Estonia NAP
10198 bismuth salts and combinations (except for fixed dose combination bismuth subcitrate potassium / metronidazole / tetracycline) Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 Name of entry was amended on 02/07/2014 PSUSA/00010198/203501 NAP
10199 bismuth subcitrate potassium / metronidazole / tetracycline 24/11/2011 3 years 24/05/2027 22/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010199/202705 Barbara Kovacic Bytyqi Croatia NAP
10203 calcium gluconate / colecalciferol / nicotinic acid Not available* 13 years 20/01/2027 20/04/2027 No 17/10/2017 Entry name amended on 17/10/2017
Correction of DLP was done on 08/08/2014 PSUSA/00010203/202701 NAP
10204 calcium levofolinate, calcium folinate 03/04/1982 15 years 03/04/2029 02/07/2029 No 01/12/2014 PSUSA/00010204/202904 NAP
10206 cefuroxime sodium (for intracameral use) 18/08/1987 3 years 15/05/2027 13/08/2027 Yes 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010206/202705 Maia Uusküla Estonia NAP
10208 cholic acid (oxosteroid-reductase or hydroxy-steroid dehydrogenase deficiency indication) 12/09/2013 3 years 12/09/2027 11/12/2027 Yes 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00010208/202709 Maria Poulianiti Greece CAP
10209 cilostazol 20/01/1988 3 years 19/01/2026 19/04/2026 Yes 20/09/2023 DLP amended on 20/09/2023 PSUSA/00010209/202601 Adam Przybylkowski Poland NAP
10210 colistimethate sodium (all applications except for dry inhalation powder) 08/10/1962 13 years 31/12/2026 31/03/2027 No 06/10/2014 PSUSA/00010210/202612 NAP
10213 delamanid 28/04/2014 6 months 27/04/2026 06/07/2026 27/10/2026 05/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010213/202604 PSUSA/00010213/202610 Jo Robays Belgium CAP
10217 drospirenone / ethinylestradiol 07/03/2000 5 years 06/09/2030 05/12/2030 No 27/05/2026 DLP was corrected on 27/05/2026
PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00010217/203009 Bianca Mulder Netherlands NAP
10218 elosulfase alfa 14/02/2014 3 years 13/02/2027 14/05/2027 No 20/10/2021 PSUR frequency updated on 17/11/2021
DLP was updated on 20/10/2021
DLP was updated on 23/09/2020
DLP was updated on 25/09/2019
Lead MS and PRAC Rapporteur name updated on 30/04/2019
DLP was updated on 26/09/2018
Next DLP was amended on 25/09/2017
PSUR Frequency and DLP updated and PRAC Representative amended on 28/03/2017
PSUR Frequency and following DLP updated and EURD date amended on 18/11/2016
PSUR Frequency amended and DLP updated on 22/09/2016
Next DLP was amended on 07/04/2016
Next DLP updated on 30/09/2015
The next DLP was amended on 01/04/2015
The DLP was corrected on 08/08/2014 PSUSA/00010218/202702 Rhea Fitzgerald Ireland CAP
10220 ethanol (cutaneous route of administration) Not available* 16 years 15/06/2030 13/09/2030 No 06/10/2015 PSUSA/00010220/203006 NAP
10221 ethyl esters of iodised fatty acids from poppyseed oil 31/03/1978 15 years 31/01/2028 30/04/2028 No 02/07/2014 PSUSA/00010221/202801 NAP
10224 fluocinolone acetonide (intravitreal implant in applicator) 04/05/2012 3 years 26/08/2028 24/11/2028 No 27/05/2026 DLP was corrected on 27/05/2026
PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00010224/202808 Carla Torre Portugal NAP
10226 fusidic acid (systemic use) 31/05/1962 3 years 30/05/2028 28/08/2028 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010226/202805 Zoubida Amimour France NAP
10227 fusidic acid (topical use) 31/05/1962 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00010227/202803 Zoubida Amimour France NAP
10228 hydroxocobalamin (only for products for chemical poisoning) 23/11/2007 3 years 23/11/2025 21/02/2026 No 19/09/2024 PSUSA/00010228/202511 Zoubida Amimour France CAP
10230 indapamide / perindopril, indapamide / ramipril 30/08/2001 5 years 25/11/2026 23/02/2027 No 22/10/2025 Active substance name was amended on 22/10/2025
PRAC representative updated on 31/01/2024 PSUSA/00010230/202611 Carla Torre Portugal NAP
10233 iron in any combination with multivitamins and/or minerals and/or aminoacids (except for combinations with folic acid) 09/05/1969 13 years 03/11/2032 01/02/2033 No 11/06/2025 DLP was amended on 23/10/2024
Active substance name was amended on 23/10/2024 PSUSA/00010233/203211 Guðrún Stefánsdóttir Iceland NAP
10234 iron in combination with folic acid and/or multivitamins and/or minerals and/or aminoacids 10/07/1962 13 years 03/11/2032 01/02/2033 No 16/01/2025 DLP was amended on 23/10/2024
Active substance name was amended on 23/10/2024 PSUSA/00010234/203211 Georgia Gkegka Greece NAP
10235 iron / oral preparations 01/01/1949 10 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010235/203211 Zane Neikena Latvia NAP
10239 magnesium sulfate / sodium sulfate / potassium sulfate 05/08/2010 3 years 05/08/2027 03/11/2027 No 12/09/2025 DLP was amended on 02/04/2025 PSUSA/00010239/202708 Veronika Macurová Czech Republic NAP
10242 modafinil 01/09/1994 3 years 31/08/2026 29/11/2026 No 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00010242/202608 Dennis Lex Germany NAP
10245 olodaterol 18/09/2013 5 years 03/03/2029 01/06/2029 No 20/11/2024 PSUR frequency amended and DLP updated on 20/11/2024 PSUSA/00010245/202903 Bianca Mulder Netherlands NAP
10250 propranolol (centrally authorised product) 23/04/2014 5 years 23/04/2029 22/07/2029 No 19/09/2025 PSUR frequency amended and DLP updated on 18/12/2024
DLP and PSUR frequency were updated on 02/02/2022
PSUR frequency and DLP were updated on 20/11/2019
DLP was updated on 21/11/2018
DLP was updated on 19/12/2017
Next DLP was amended on 20/12/2016
PRAC Representative amended on 28/06/2016
PSUR Frequency amended and DLP updated on 03/06/2016
Next DLP was updated on 27/11/2015.
Next DLP was amended on 16/06/2015 PSUSA/00010250/202904 Maria Martinez Gonzalez Spain CAP
10251 propranolol (except for centrally authorised product) 30/06/1965 8 years 30/06/2032 28/09/2032 Yes 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00010251/203206 Guðrún Stefánsdóttir Iceland NAP
10252 anti-t lymphocyte immunoglobulin for human use, rabbit 16/04/1984 3 years 30/06/2027 28/09/2027 No 04/03/2026 Active substance name was amended on 04/03/2026
DLP was amended on 05/03/2025 PSUSA/00010252/202706 Maia Uusküla Estonia NAP
10254 siltuximab 23/04/2014 3 years 22/04/2028 21/07/2028 No 06/10/2025 PRAC representative was updated on 01/03/2023
DLP was updated on 21/12/2022
PSUR frequency and DLP were updated on 18/12/2019
DLP was updated on 20/11/2019
DLP was updated on 21/11/2018
DLP was updated on 06/06/2018
PSUR Frequency amended and DLP updated on 19/12/2017
DLP was updated on 23/05/2017
Next DLP was amended on 20/12/2016
Next DLP was amended on 03/06/2016
Next DLP was updated on 27/11/2015.
Next DLP was amended on 16/06/2015
The DLP was corrected on 27/07/2014 PSUSA/00010254/202804 Dirk Mentzer Germany CAP
10256 sodium feredetate Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00010256/202612 Tiphaine Vaillant France NAP
10262 trametinib 29/05/2014 3 years 29/05/2028 27/08/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010262/202805 David Olsen Norway CAP
10263 umeclidinium 16/04/2014 3 years 17/12/2027 16/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010263/202712 Amelia Cupelli Italy CAP
10264 umeclidinium bromide / vilanterol 18/12/2013 3 years 17/12/2027 16/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010264/202712 Amelia Cupelli Italy CAP
10266 varicella-zoster immunoglobuline 29/12/1995 5 years 31/12/2029 31/03/2030 No 06/10/2025 DLP was amended on 24/09/2025 PSUSA/00010266/202912 Dirk Mentzer Germany NAP
10268 everolimus (indicated for advanced renal cell carcinoma, advanced breast cancer, advanced neuroendocrine tumors (gastrointestinal, lung, pancreatic cancers) (NET) 03/08/2009 5 years 31/03/2029 29/06/2029 No 25/06/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/06/2025
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 18/12/2024
PSUR frequency amended and DLP updated on 18/12/2024
Reference to NAP added on 30/03/2022
PSUR frequency and DLP were updated on 22/12/2021
Active substance name was updated on 03/02/2021
PSUR frequency and DLP were amended on 15/11/2017
DLP was updated on 18/11/2016
The Next DLP was amended on 29/10/2015. PSUSA/00010268/202903 Dennis Lex Germany CAP NAP
10269 everolimus (indicated for rejection of transplanted organs) 08/07/2003 3 years 31/07/2027 29/10/2027 No 02/06/2026 PSUSA/00010269/202707 Karin Bolin Sweden NAP
10270 paracetamol / pseudoephedrine hydrochloride / triprolidine hydrochloride Not available* 8 years 03/11/2036 01/02/2037 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010270/203611 Amelia Cupelli Italy NAP
10271 ezetimibe / rosuvastatin 24/07/2014 3 years 24/07/2026 22/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00010271/202607 Barbara Kovacic Bytyqi Croatia NAP
10273 brinzolamide / brimonidine tartrate 18/07/2014 5 years 30/06/2027 28/09/2027 No 01/03/2023 PSUR frequency and DLP were updated on 01/03/2023
DLP was updated on 03/03/2021
PSUR frequency amended and DLP updated on 06/02/2019
PRAC Rapporteur name updated on 19/12/2018
DLP was amended on 31/01/2018
Next DLP updated on 30/01/2017
PSUR Frequency amended and DLP updated on 04/02/2016
PSUR Frequency and Next DLP amended on 31/07/2015
The Next DLP was amended on 01/12/2014
New CAP authorised on 18/07/2014 PSUSA/00010273/202706 Eamon O Murchu Ireland CAP
10275 peginterferon beta-1A 18/07/2014 3 years 18/07/2027 16/10/2027 No 05/02/2025 PSUR frequency and DLP corrected on 02/04/2025
PSUR frequency amended and DLP updated on 05/02/2025
PSUR Frequency and next DLP were updated on 02/03/2022
DLP was updated on 03/03/2021
DLP was updated on 04/03/2020
Next DLP, Lead MS and PRAC Rapporteur name were amended on 06/03/2019
DLP was updated on 28/02/2018
PSUR Frequency amended and next DLP updated on 25/09/2017
Next DLP was amended on 28/02/2017
Next DLP was updated on 22/09/2016
DLP and Next DLP were updated on 04/03/2016
Next DLP was updated on 30/09/2015 PSUSA/00010275/202707 Karin Bolin Sweden CAP
10276 simoctocog alfa 22/07/2014 2 years 22/01/2027 22/04/2027 No 02/06/2026 DLP was amended on 24/09/2025 PSUSA/00010276/202701 Karin Bolin Sweden CAP
10279 obinutuzumab 01/11/2013 3 years 31/10/2026 29/01/2027 No 02/06/2026 PSUSA/00010279/202610 Jenny-Maria Jönsson Sweden CAP
10280 acetylsalicylic acid / atorvastatin / ramipril 20/02/2014 3 years 20/02/2026 21/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00010280/202602 Jan Neuhauser Austria NAP
10283 gaxilose 10/11/2011 9 years 09/11/2032 07/02/2033 No 05/06/2024 Entry re-activated and DLP updated on 05/06/2024
PRAC Representative name was corrected on 29/07/2020
PRAC Representative updated on 26/09/2018
PSUR Frequency amended and next DLP updated on 25/09/2017
Next DLP was updated on 22/09/2016
PRAC Rapporteur name updated on 03/06/2016
PSUR Frequency amended and DLP updated on 07/04/2016
Active Substance corrected on 21/12/2015.
Next DLP was updated on 30/09/2015
Lead MS was added on 22/12/2014 PSUSA/00010283/203211 Maria del Pilar Rayon Spain NAP
10285 solifenacin / tamsulosin 06/05/2013 5 years 01/07/2026 29/09/2026 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00010285/202607 Bianca Mulder Netherlands NAP
10287 acetylsalicylic acid / bisoprolol 05/11/2010 7 years 05/11/2031 03/02/2032 No 17/02/2026 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00010287/203111 Jana Pecherova Slovakia NAP
10288 clevidipine 23/11/2011 3 years 23/11/2026 21/02/2027 No 03/07/2024 PSUR frequency amended and DLP updated on 03/07/2024 PSUSA/00010288/202611 Jan Neuhauser Austria NAP
10289 lisdexamfetamine 23/02/2007 3 years 22/02/2028 22/05/2028 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00010289/202802 Karin Bolin Sweden NAP
10291 misoprostol (gastrointestinal indication) 28/06/1984 3 years 30/06/2028 28/09/2028 Yes 01/04/2026 Correction of DLP on 01/04/2026
PSUR frequency amended and DLP updated on 04/03/2026 PSUSA/00010291/202806 Marie Louise Schougaard Christiansen Denmark NAP
10292 triamcinolone (intraocular formulations) 31/03/2011 3 years 31/03/2028 29/06/2028 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00010292/202803 Carla Torre Portugal NAP
10293 flutemetamol (18f) 22/08/2014 3 years 31/10/2027 29/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00010293/202710 Dennis Lex Germany CAP
10296 sucroferric oxyhydroxide 27/11/2013 3 years 26/11/2027 24/02/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010296/202711 Kimmo Jaakkola Finland CAP
10297 human fibrinogen / human thrombin 08/06/2004 3 years 08/06/2026 06/09/2026 No 06/10/2025 DLP was amended on 31/01/2024 PSUSA/00010297/202606 Dirk Mentzer Germany CAP
10298 influenza vaccine (split virion, inactivated) (non centrally authorised products) 08/08/1996 1 year 15/03/2026 24/05/2026 15/03/2027 24/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010298/202603 PSUSA/00010298/202703 Dirk Mentzer Germany NAP
10300 influenza vaccine (surface antigen, inactivated, adjuvanted) 20/09/2010 1 year 15/03/2026 24/05/2026 15/03/2027 24/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010300/202603 PSUSA/00010300/202703 Jean-Michel Dogné Belgium CAP
10301 ibrutinib 13/11/2013 2 years 12/11/2025 10/02/2026 No 03/07/2024 PSUR frequency amended and DLP updated on 03/07/2024 PSUSA/00010301/202511 Barbara Kovacic Bytyqi Croatia CAP
10302 ibuprofen / paracetamol Not available* 8 years 03/11/2026 01/02/2027 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010302/202611 Lina Šeibokienė Lithuania NAP
10303 idelalisib 23/07/2014 5 years 22/07/2029 20/10/2029 No 02/04/2025 PSUR frequency amended and DLP updated on 02/04/2025 PSUSA/00010303/202907 Dennis Lex Germany CAP
10304 folinic acid, (di)sodium folinate, levomefolic acid 03/04/1982 15 years 03/04/2029 02/07/2029 No 28/02/2018 Entry name amended on 28/02/2018 PSUSA/00010304/202904 NAP
10305 Phenol / halogenated phenols / sodium salicylate / chloroxylenol / triclosan 07/07/1988 13 years 30/06/2027 28/09/2027 No 22/12/2014 PSUSA/00010305/202706 NAP
10306 sofosbuvir / ledipasvir 10/10/2014 5 years 09/10/2029 07/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010306/202910 Ana Sofia Diniz Martins Portugal CAP
10307 aclidinium bromide / formoterol fumarate dihydrate 19/11/2014 3 years 19/11/2025 17/02/2026 No 28/06/2023 PSUR frequency amended and DLP updated on 28/06/2023
DLP was updated on 29/06/2022
DLP was updated on 30/06/2021
DLP was updated on 01/07/2020
DLP was updated on 03/07/2019
PRAC Representative and LMS updated on 19/12/2018
DLP was updated on 04/07/2018
PSUR Frequency amended and DLP updated on 19/12/2017
Next DLP was amended on 27/06/2017
Next DLP was amended on 20/12/2016
Next DLP was amended on 28/06/2016
Next DLP was updated on 21/12/2015.
New CAP authorised on 19/11/2014 PSUSA/00010307/202511 Adam Przybylkowski Poland CAP
10311 dulaglutide 18/09/2014 3 years 18/09/2027 17/12/2027 No 27/07/2022 PRAC representative was updated on 27/07/2022
PSUR frequency and DLP were updated on 28/04/2022
PSUR frequency and DLP were corrected on 26/05/2021
PSUR frequency and DLP were updated on 28/04/2021
DLP was updated on 06/05/2020
PRAC representative was updated on 25/09/2019
DLP was updated on 30/04/2019
PRAC Rapporteur name amended on 04/07/2018
DLP was updated on 07/05/2018
PSUR Frequency amended and DLP updated on 17/10/2017
Next DLP was amended on 26/04/2017
Next DLP was amended on 19/10/2016
Next DLP was amended on 03/05/2016
The Next DLP was amended on 29/10/2015.
New CAP authorised on 21/11/2014 PSUSA/00010311/202709 Amelia Cupelli Italy CAP
10312 omega-3-acid ethyl esters 12/07/2000 3 years 22/01/2028 21/04/2028 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00010312/202801 Amelia Cupelli Italy NAP
10314 afamelanotide 22/12/2014 2 years 22/06/2027 20/09/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010314/202706 Dennis Lex Germany CAP
10315 darunavir / cobicistat 19/11/2014 3 years 18/05/2026 16/08/2026 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00010315/202605 Amelia Cupelli Italy CAP
10316 ketoconazole (centrally authorised product only) 19/11/2014 3 years 19/11/2027 17/02/2028 Yes 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010316/202711 Petar Mas Croatia CAP
10317 naloxegol 16/09/2014 3 years 15/09/2027 14/12/2027 No 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00010317/202709 Eamon O Murchu Ireland CAP
10318 nintedanib (oncology indications) 15/10/2014 3 years 15/10/2028 13/01/2029 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010318/202810 Georgia Gkegka Greece CAP
10319 nintedanib (respiratory indication) 15/10/2014 6 months 15/04/2026 24/06/2026 15/10/2026 24/12/2026 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010319/202604 PSUSA/00010319/202610 Barbara Kovacic Bytyqi Croatia CAP
10320 nonacog gamma 19/12/2014 3 years 30/06/2026 28/09/2026 No 06/10/2025 DLP was amended on 28/02/2024 PSUSA/00010320/202606 Dirk Mentzer Germany CAP
10321 oestrogens conjugated / bazedoxifene 16/12/2014 5 years 02/04/2030 01/07/2030 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00010321/203004 Dennis Lex Germany CAP
10322 olaparib 16/12/2014 3 years 15/12/2027 14/03/2028 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00010322/202712 Amelia Cupelli Italy CAP
10323 ramucirumab 21/04/2014 3 years 21/04/2028 20/07/2028 No 06/10/2025 PRAC representative was updated on 01/03/2023
DLP was updated on 21/12/2022
PSUR frequency and DLP were updated on 20/11/2019
DLP was updated on 21/11/2018
DLP was updated on 19/12/2017
PSUR Frequency amended and DLP updated on 23/05/2017
Next DLP was amended on 20/12/2016
Next DLP was amended on 03/06/2016
Next DLP was updated on 27/11/2015.
New CAP authorised on 19/12/2014. PSUSA/00010323/202804 Dirk Mentzer Germany CAP
10324 tafluprost / timolol 02/12/2014 3 years 02/12/2026 02/03/2027 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00010324/202612 Dennis Lex Germany NAP
10325 yttrium (90Y) citrate 28/10/1985 10 years 27/10/2035 25/01/2036 Yes 23/10/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 23/10/2024
DLP was amended on 23/10/2024
DLP was amended on 03/07/2024 PSUSA/00010325/203510 Amelia Cupelli Italy NAP
10326 fosfomycin (oral formulation) 27/08/1986 5 years 31/07/2027 29/10/2027 No 19/09/2024 PSUSA/00010326/202707 Zoubida Amimour France NAP
10330 salbutamol 31/01/1969 3 years 31/01/2026 01/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00010330/202601 Melinda Palfi Hungary NAP
10332 porfimer 19/04/1993 3 years 19/04/2026 18/07/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00010332/202604 Petar Mas Croatia NAP
10333 tixocortol, chlorhexidine gluconate / tixocortol pivalate 18/11/1976 5 years 01/11/2027 30/01/2028 No 19/09/2024 PSUSA/00010333/202711 Zoubida Amimour France NAP
10335 bupivacaine, bupivacaine / epinephrine 27/04/1966 5 years 26/04/2029 25/07/2029 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010335/202904 Zane Neikena Latvia NAP
10336 fosfomycin (IV formulation) 13/07/1983 5 years 31/07/2027 29/10/2027 No 19/09/2024 PSUSA/00010336/202707 Zoubida Amimour France NAP
10338 apremilast 21/03/2014 3 years 20/03/2028 18/06/2028 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010338/202803 Maria Martinez Gonzalez Spain CAP
10339 fluticasone propionate / formoterol fumarate dihydrate 23/08/2012 5 years 31/07/2026 29/10/2026 No 02/06/2026 PSUSA/00010339/202607 Karin Bolin Sweden NAP
10340 ospemifene 26/02/2013 3 years 26/02/2027 27/05/2027 No 20/10/2021 PSUR frequency and DLP were updated on 20/10/2021
DLP was updated on 21/10/2020
DLP was updated on 25/09/2019
Lead MS and PRAC Rapporteur name updated on 30/04/2019
DLP was updated on 26/09/2018
PSUR frequency amended and DLP updated on 27/03/2018
DLP was updated on 17/10/2017
DLP was updated on 28/03/2017
Next DLP was amended on 19/10/2016
Next DLP was amended on 07/04/2016
New CAP authorised on 15/01/2015. PSUSA/00010340/202702 Terhi Lehtinen Finland CAP
10341 secukinumab 26/12/2014 3 years 25/12/2026 25/03/2027 No 19/09/2025 DLP was amended on 25/09/2024 PSUSA/00010341/202612 Maria Martinez Gonzalez Spain CAP
10342 diclofenac (topical formulations), diclofenac / heparin 11/05/1977 6 years 30/09/2029 29/12/2029 No 03/07/2024 Active substance name was amended on 03/07/2024
PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00010342/202909 Karin Erneholm Denmark NAP
10344 amlodipine / valsartan, amlodipine / hydrochlorothiazide / valsartan 16/01/2007 5 years 30/06/2026 28/09/2026 No 02/03/2022 DLP was updated on 02/03/2022
Correction of Reference to NAP added on 20/10/2021
PRAC Rapporteur name was corrected on 03/04/2019
PRAC Rapporteur name was amended on 06/06/2018
PRAC Representative amended on 17/10/2017
DLP was updated on 28/03/2017 PSUSA/00010344/202606 Karin Erneholm Denmark CAP NAP
10346 aprotinin / calcium chloride / human factor xiii / human fibrinogen / human thrombin, aprotinin / fibrinogen / fibronectin / human coagulation factor XIII / plasma protein fraction / plasminogen / thrombin, aprotinin / human fibrinogen / thrombin / calcium chloride, aprotinin / calcium chloride / factor xiii / human thrombin / human clottable protein containing mainly fibrinogen and fibronectin, calcium chloride / human fibrinogen / factor xiii / fibronectin / plasminogen / human thrombin / bovine aprotinin, calcium chloride / human fibrinogen / factor xiii / fibronectin / human thrombin / bovine aprotinin, human fibrinogen / calcium chloride dihydrate / plasma fibronectin / thrombin / bovine aprotinin / human coagulation factor xiii, human fibrinogen / calcium chloride dihydrate / plasma protein fraction / fibronectin / thrombin / bovine aprotinin / human coagulation factor xiii, human fibrinogen / plasminogen / human thrombin / bovine aprotinin / human coagulation factor xiii / human fibronectin Not available* 5 years 30/11/2026 28/02/2027 No 06/10/2025 PRAC representative was updated on 01/03/2023
DLP was updated on 27/07/2022
Next DLP was amended on 25/09/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016
The name of the active substance was amended on 06/10/2015 PSUSA/00010346/202611 Dirk Mentzer Germany NAP
10347 atorvastatin 07/11/1996 6 years 31/10/2029 29/01/2030 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010347/202910 Dennis Lex Germany NAP
10348 carmustine (implant) 23/09/1996 5 years 23/09/2029 22/12/2029 No 25/05/2022 DLP was updated on 25/05/2022
PRAC representative was updated on 29/07/2020
PRAC representative was updated on 03/06/2020
DLP was updated 05/06/2019
PRAC Rapporteur name updated on 21/07/2017
PRAC Rapporteur name was amended on 28/07/2016
Next DLP was amended on 03/06/2016
PRAC Rapporteur name updated on 07/04/2016
PRAC Rapporteur name updated on 04/02/2016
DLP was amended on 16/06/2015 PSUSA/00010348/202909 Tiphaine Vaillant France NAP
10349 carmustine (powder and solvent for solution for infusion) 23/04/1974 5 years 22/04/2029 21/07/2029 No 18/12/2024 PSUR frequency amended and DLP updated on 18/12/2024 PSUSA/00010349/202904 Tiphaine Vaillant France NAP
10350 dalbavancin 23/05/2014 3 years 22/11/2026 20/02/2027 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00010350/202611 Rugile Pilviniene Lithuania CAP
10351 eliglustat 19/01/2015 3 years 19/08/2027 17/11/2027 No 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00010351/202708 Maria del Pilar Rayon Spain CAP
10352 ex vivo expanded autologous human corneal epithelial cells containing stem cells 17/02/2015 1 year 17/02/2026 28/04/2026 17/02/2027 28/04/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010352/202602 PSUSA/00010352/202702 Eamon O Murchu Ireland CAP
10353 misoprostol (gynaecological indication - labour induction) Not available* 3 years 31/05/2028 29/08/2028 Yes 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010353/202805 Marie Louise Schougaard Christiansen Denmark NAP
10354 misoprostol (gynaecological indication - termination of pregnancy) Not available* 3 years 31/05/2026 29/08/2026 Yes 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00010354/202605 Marie Louise Schougaard Christiansen Denmark NAP
10355 phloroglucinol, phloroglucinol / trimethylphloroglucinol, phloroglucinol / simeticone 18/02/1992 3 years 30/09/2027 29/12/2027 No 02/04/2025 Active substance name was amended on 02/04/2025 PSUSA/00010355/202709 Zoubida Amimour France NAP
10356 safinamide 24/02/2015 5 years 24/02/2028 24/05/2028 No 18/10/2023 PSUR frequency amended and DLP updated on 18/10/2023 PSUSA/00010356/202802 Eamon O Murchu Ireland CAP
10358 amlodipine / indapamide, amlodipine / indapamide / perindopril 23/09/2013 5 years 25/11/2027 23/02/2028 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00010358/202711 Bianca Mulder Netherlands NAP
10359 benzoyl peroxide hydrous / potassium hydroxyquinoline sulphate 03/02/1987 13 years 30/03/2033 28/06/2033 No 19/10/2022 Entry re-activated on 19/10/2022
LMS and PRAC representative were added on 06/05/2020 PSUSA/00010359/203303 Eamon O'Murchu Ireland NAP
10360 cangrelor 23/03/2015 3 years 23/03/2028 21/06/2028 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010360/202803 Amelia Cupelli Italy CAP
10361 chlorphenoxamine Not available* 9 years 17/05/2027 15/08/2027 Yes 26/07/2023 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 26/07/2023
Active substance name, PSUR frequency and DLP were amended on 26/07/2023
DLP was updated on 06/02/2019
PRAC representative added on 17/10/2017 PSUSA/00010361/202705 Eva Jirsová Czech Republic NAP
10362 ciclosporin (topical use) 19/03/2015 1 year 19/03/2026 28/05/2026 19/03/2027 28/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010362/202603 PSUSA/00010362/202703 Jan Neuhauser Austria CAP NAP
10364 germanium (68Ge) chloride / gallium (68Ga) chloride 15/09/2014 5 years 15/03/2030 13/06/2030 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00010364/203003 Eva Jirsová Czech Republic CAP NAP
10366 naltrexone / bupropion 26/03/2015 1 year 09/09/2026 18/11/2026 09/09/2027 18/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010366/202609 PSUSA/00010366/202709 Dennis Lex Germany CAP
10368 oritavancin 19/03/2015 1 year 11/03/2026 20/05/2026 11/03/2027 20/05/2027 No 04/02/2026 DLP was amended on 04/02/2026
DLP was amended on 22/10/2025 PSUSA/00010368/202603 PSUSA/00010368/202703 Adam Przybylkowski Poland CAP
10369 tedizolid phosphate 20/06/2014 3 years 20/06/2026 18/09/2026 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00010369/202606 Maria del Pilar Rayon Spain CAP
10370 tobramycin (nebuliser solution) (centrally authorised product only) 18/03/2015 3 years 18/09/2028 17/12/2028 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00010370/202809 Karin Bolin Sweden CAP
10372 ceritinib 29/04/2014 3 years 28/10/2028 26/01/2029 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010372/202810 Jenny-Maria Jönsson Sweden CAP
10373 raltegravir 26/03/2015 3 years 26/09/2028 25/12/2028 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026 PSUSA/00010373/202809 Zoubida Amimour France CAP
10374 amitriptyline, amitriptyline / amitriptylinoxide, amitriptylinoxide 31/07/1961 3 years 10/01/2027 10/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010374/202701 Georgia Gkegka Greece NAP
10376 ivermectin (topical use) 22/03/2015 3 years 22/04/2027 21/07/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010376/202704 Zoubida Amimour France NAP
10377 ivermectin (systemic use) 15/10/1987 3 years 14/04/2028 13/07/2028 No 19/09/2024 PSUSA/00010377/202804 Zoubida Amimour France NAP
10378 mifepristone / misoprostol Not available* 3 years 31/05/2026 29/08/2026 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00010378/202605 Bianca Mulder Netherlands NAP
10379 nivolumab 04/09/2014 3 years 03/07/2027 01/10/2027 No 05/03/2025 DLP was amended on 05/03/2025 PSUSA/00010379/202707 Dirk Mentzer Germany CAP
10380 lenvatinib 13/02/2015 3 years 12/02/2027 13/05/2027 No 02/06/2026 PSUSA/00010380/202702 Jenny Jönsson Sweden CAP
10382 tioconazole, tioconazole / hydrocortisone 13/04/1981 13 years 01/04/2030 30/06/2030 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00010382/203004 Carla Torre Portugal NAP
10385 atorvastatin / ezetimibe 13/11/2014 7 years 15/07/2030 13/10/2030 No 27/03/2024 PSUR frequency amended and DLP updated on 27/03/2024 PSUSA/00010385/203007 Dennis Lex Germany NAP
10386 colecalciferol, colecalciferol / calcium, ergocalciferol, ergocalciferol / calcium Not available* 5 years 31/10/2029 29/01/2030 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00010386/202910 Jan Neuhauser Austria NAP
10387 edoxaban 22/04/2011 3 years 21/10/2026 19/01/2027 No 19/09/2024 PSUSA/00010387/202610 Zoubida Amimour France CAP
10388 empagliflozin, empagliflozin / metformin 17/04/2014 2 years 17/04/2026 16/07/2026 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010388/202604 Maria del Pilar Rayon Spain CAP
10389 human papillomavirus 9-valent vaccine (recombinant, adsorbed) 10/12/2014 3 years 09/06/2028 07/09/2028 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010389/202806 Jean-Michel Dogné Belgium CAP
10390 lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide 02/07/2015 5 years 21/07/2029 19/10/2029 No 02/04/2025 PSUR frequency amended and DLP updated on 02/04/2025 PSUSA/00010390/202907 Karin Erneholm Denmark NAP
10391 lutetium (177Lu) chloride 19/06/2015 3 years 19/12/2026 19/03/2027 Yes 25/09/2024 New CAP authorised on 26/03/2026
New CAP authorised on 22/11/2024
DLP was amended on 25/09/2024 PSUSA/00010391/202612 Rhea Fitzgerald Ireland CAP NAP
10392 macrogol 4000, macrogol 4000 combinations (oral use) 05/05/1995 5 years 31/05/2027 29/08/2027 No 19/09/2024 PSUSA/00010392/202705 Zoubida Amimour France NAP
10393 netupitant / palonosetron 10/10/2014 5 years 10/10/2029 08/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010393/202910 Amelia Cupelli Italy CAP
10394 tasimelteon 03/07/2015 3 years 03/07/2027 01/10/2027 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010394/202707 Adam Przybylkowski Poland CAP
10395 tolvaptan (indicated for adults with autosomal dominant polycystic kidney disease (ADPKD)) 27/05/2015 3 years 18/05/2027 16/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010395/202705 Amelia Cupelli Italy CAP
10396 valsartan, hydrochlorothiazide / valsartan 13/05/1996 5 years 30/04/2030 29/07/2030 No 02/06/2026 PSUSA/00010396/203004 Karin Bolin Sweden NAP
10398 chlorhexidine / phenol Not available* 13 years 16/03/2028 14/06/2028 No 06/10/2015 New active substance added on 06/10/2015 PSUSA/00010398/202803 NAP
10399 betamethasone dipropionate / clotrimazole / gentamicin 02/12/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00010399/202812 Petar Mas Croatia NAP
10400 tinidazole, nystatin / tinidazole 15/06/1972 10 years 01/12/2034 01/03/2035 No 05/01/2025 Correction of DLP on 20/11/2024
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010400/203412 Adam Przybylkowski Poland NAP
10401 phenylephrine (IV, nasal or oral formulations ) 01/01/1940 13 years 01/01/2028 31/03/2028 No 29/10/2015 PSUSA/00010401/202801 NAP
10402 phenylephrine (ophthalmic formulations) 01/01/1940 5 years 01/01/2030 01/04/2030 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010402/203001 Eva Jirsová Czech Republic NAP
10403 pembrolizumab 04/09/2014 3 years 03/09/2027 02/12/2027 No 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00010403/202709 Bianca Mulder Netherlands CAP
10404 atazanavir / cobicistat 29/01/2015 5 years 28/01/2029 28/04/2029 No 19/09/2024 PSUSA/00010404/202901 Tiphaine Vaillant France CAP
10405 evolocumab 17/07/2015 3 years 17/07/2026 15/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00010405/202607 Kimmo Jaakkola Finland CAP
10406 1-propanol / isopropyl alcohol (covers other synonymous terms such as 2-propanol) / orthophenylphenol 23/10/1980 10 years 23/10/2029 21/01/2030 No 04/02/2026 Active substance name was amended on 04/02/2026
PSUR frequency and DLP were updated on 01/07/2020
Lead MS and PRAC Rapporteur name added on 03/04/2019
Entry name changed and Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?
Yes/No was updated on 07/05/2018
New substance added on 27/11/2015 PSUSA/00010406/202910 Adam Przybylkowski Poland NAP
10407 dibrompropamidine , propamidine 16/01/1959 11 years 02/04/2038 01/07/2038 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010407/203804 Rhea Fitzgerald Ireland NAP
10408 sonidegib 30/06/2015 2 years 29/06/2026 27/09/2026 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010408/202606 Petar Mas Croatia CAP
10409 panobinostat 23/02/2015 3 years 22/08/2026 20/11/2026 No 16/01/2025 PSUR frequency amended and DLP updated on 27/03/2024 PSUSA/00010409/202608 Georgia Gkegka Greece CAP
10410 human alfa1-proteinase inhibitor (centrally authorised product) 20/08/2015 5 years 31/12/2026 31/03/2027 No 22/10/2025 DLP was amended on 22/10/2025
PSUR frequency amended and DLP updated on 03/05/2023
PRAC Representative name was corrected on 29/07/2020
PSUR frequency and DLP were updated on 01/04/2020
DLP was updated on 03/04/2019
PRAC Representative updated on 26/09/2018
DLP was updated on 27/03/2018
PSUR Frequency amended and DLP updated on 17/10/2017
DLP was updated on 28/03/2017
Next DLP was updated on 22/09/2016
PRAC Representative amended on 28/06/2016
Entry name amended on 03/05/2016
New CAP was authorised on 20/08/2015 PSUSA/00010410/202612 Maria Martinez Gonzalez Spain CAP
10411 ceftolozane / tazobactam 19/12/2014 3 years 19/12/2026 19/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010411/202612 Adam Przybylkowski Poland CAP
10412 idebenone (centrally authorised products) 08/09/2015 3 years 08/09/2027 07/12/2027 No 28/05/2025 PSUR frequency amended and DLP updated on 28/05/2025
DLP was amended on 30/04/2025 PSUSA/00010412/202709 Amelia Cupelli Italy CAP
10413 guanfacine 17/09/2015 3 years 17/03/2027 15/06/2027 No 20/11/2024 New CAP authorised on 26/02/2025
DLP was amended on 20/11/2024 PSUSA/00010413/202703 Maria del Pilar Rayon Spain CAP
10414 1-propanol / isopropyl alcohol (covers other synonymous terms such as 2-propanol) / lactic acid 07/09/1981 10 years 07/09/2029 06/12/2029 No 04/02/2026 Active substance name was amended on 04/02/2026
PSUR frequency and DLP were updated on 03/06/2020
LMS and PRAC representatives were added on 31/07/2019
Procedure number was corrected on 18/11/2016
New substance added on 27/11/2015 PSUSA/00010414/202909 Adam Przybylkowski Poland NAP
10415 demeclocycline / triamcinolone Not available* 13 years 13/07/2030 11/10/2030 No 27/11/2015 DLP was updated on 27/03/2018
Lead MS and PRAC Rapporteur name was added on 20/12/2016
New active substance added on 27/11/2015 PSUSA/00010415/203007 Eva Jirsová Czech Republic NAP
10416 ethanol / orthophenylphenol 05/02/1997 10 years 05/02/2029 06/05/2029 No 13/08/2025 PSUR frequency and DLP were updated on 23/10/2019
Lead MS and PRAC Rapporteur name added on 31/07/2018
Active substance name was amended on 20/12/2016
New active substance added on 27/11/2015 PSUSA/00010416/202902 Veronika Macurová Czech Republic NAP
10417 octenidine dihydrochloride / 1-propanol / isopropyl alcohol (covers other synonymous terms such as 2-propanol) 30/01/1987 10 years 30/01/2034 30/04/2034 No 04/02/2026 Active substance name was amended on 04/02/2026
PRAC Rapporteur updated on 15/11/2023 PSUSA/00010417/203401 Barbara Kovacic Bytyqi Croatia NAP
10421 asfotase alfa 03/07/2015 3 years 03/07/2026 01/10/2026 No 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 PSUSA/00010421/202607 Eamon O Murchu Ireland CAP
10422 sebelipase alfa 28/08/2015 3 years 28/08/2027 26/11/2027 No 02/06/2026 PSUSA/00010422/202708 Karin Bolin Sweden CAP
10423 alirocumab 24/07/2015 3 years 24/07/2027 22/10/2027 No 06/10/2025 DLP was amended on 02/04/2025 PSUSA/00010423/202707 Dirk Mentzer Germany CAP
10424 glucose (apart from glucose1- phosphate), glucose in combination with calcium chloride and/or sodium chloride and/or magnesium chloride and/or sodium citrate and/or potassium chloride and/or sodium acetate (intravenous or parenteral use except haemodialysis, hemodiafiltration), potassium phosphate / sodium chloride / glucose / lactic acid / magnesium chloride / sodium lactate / potassium chloride 22/03/1971 10 years 02/09/2034 01/12/2034 Yes 17/12/2025 Active substance name was amended on 17/12/2025
Active substance name was amended on 05/06/2024
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?", PSUR frequency and DLP were amended on 26/07/2023
Active substance name, PSUR frequency and DLP were amended on 03/05/2023
Active substance name was amended on 23/10/2018
New active substance added on 21/12/2015 PSUSA/00010424/203409 none NAP
10425 inosine pranobex 01/08/1978 5 years 01/08/2028 30/10/2028 No 27/01/2026 DLP was amended on 27/03/2024 PSUSA/00010425/202808 Roxana Stefania Udrescu Romania NAP
10426 isavuconazole 06/09/2015 3 years 06/09/2027 05/12/2027 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00010426/202709 Adam Przybylkowski Poland CAP
10427 linagliptin, linagliptin / metformin 24/08/2011 3 years 02/05/2027 31/07/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010427/202705 Bianca Mulder Netherlands CAP NAP
10428 sterculia, frangula / sterculia 01/12/1955 10 years 28/02/2034 29/05/2034 No 31/07/2018 New active substances added to the entry on 31/07/2018
New Active Substance was added on 21/12/2015. PSUSA/00010428/203402 Guðrún Stefánsdóttir Iceland NAP
10429 levofloxacin (Inhalation use) 26/03/2015 5 years 26/05/2030 24/08/2030 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010429/203005 Maria del Pilar Rayon Spain CAP
10430 phenylephrine / tropicamide Not available* 5 years 08/11/2025 06/02/2026 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00010430/202511 Karin Erneholm Denmark NAP
10431 amlodipine / atorvastatin / perindopril, amlodipine / atorvastatin / ramipril 31/07/2015 5 years 22/10/2030 20/01/2031 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010431/203010 Veronika Macurová Czech Republic NAP
10432 timolol (systemic use) 06/12/1990 7 years 13/10/2031 11/01/2032 No 12/09/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010432/203110 Veronika Macurová Czech Republic NAP
10433 horse anti-T lymphocyte immunoglobulin for human use 17/11/1981 5 years 16/11/2027 14/02/2028 No 05/03/2025 Active substance name was amended on 05/03/2025
Next DLP was updated on 26/07/2023 PSUSA/00010433/202711 Zane Neikena Latvia NAP
10434 amlodipine / rosuvastatin, amlodipine / perindopril / rosuvastatin, rosuvastatin / perindopril / indapamide, rosuvastatin / perindopril, rosuvastatin / ramipril 29/07/2015 5 years 29/07/2029 27/10/2029 No 22/10/2025 Active substance name was amended on 22/10/2025
PSUR frequency amended and DLP updated on 02/04/2025 PSUSA/00010434/202907 Melinda Palfi Hungary NAP
10435 idarucizumab 16/10/2015 3 years 15/10/2027 13/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00010435/202710 Bianca Mulder Netherlands CAP
10438 sacubitril / valsartan 07/07/2015 2 years 31/07/2026 29/10/2026 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00010438/202607 Karin Erneholm Denmark CAP
10439 timolol (eye preparations) 01/12/1981 5 years 31/07/2026 29/10/2026 No 30/03/2022 DLP was updated on 30/03/2022
Next DLP was amended on 26/04/2017
EURD and DLP were amended on 07/04/2016
Active substance name was amended on 04/02/2016
Lead MS and PRAC Rapporteur name updated on 04/02/2016 PSUSA/00010439/202607 Dennis Lex Germany NAP
10440 estradiol (except cream/balm/emulsion for application in female genital area) 01/01/1946 5 years 31/08/2026 29/11/2026 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00010440/202608 Bianca Mulder Netherlands NAP
10441 estradiol, estradiol /prednisolone (only cream/balm/emulsion for application in the female genital area) Not available* 3 years 24/04/2026 23/07/2026 Yes 05/08/2025 DLP was amended on 20/12/2023 PSUSA/00010441/202604 Lina Seibokiene Lithuania NAP
10442 levonorgestrel / ethinylestradiol, ethinylestradiol (combination pack) 29/01/2015 5 years 13/01/2029 13/04/2029 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00010442/202901 Zoubida Amimour France NAP
10443 dienogest / estradiol (HRT indication) 13/12/2000 5 years 13/06/2029 11/09/2029 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010443/202906 Bianca Mulder Netherlands NAP
10444 dienogest / estradiol (contraception indication) 03/11/2008 5 years 08/09/2028 07/12/2028 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010444/202809 Bianca Mulder Netherlands NAP
10445 asparaginase (centrally authorised product) 14/01/2016 3 years 14/01/2027 14/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010445/202701 Jan Neuhauser Austria CAP
10446 birch bark extract (centrally authorised products) 14/01/2016 1 year 14/01/2026 25/03/2026 14/01/2027 25/03/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010446/202601 PSUSA/00010446/202701 Zane Neikena Latvia CAP
10447 brivaracetam 14/01/2016 3 years 14/01/2027 14/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010447/202701 Adam Przybylkowski Poland CAP
10448 carfilzomib 20/07/2012 3 years 19/07/2026 17/10/2026 No 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 PSUSA/00010448/202607 Barbara Kovacic Bytyqi Croatia CAP
10449 cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide 05/11/2015 3 years 04/11/2027 02/02/2028 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010449/202711 Amelia Cupelli Italy CAP
10450 cobimetinib 24/08/2015 3 years 23/08/2026 21/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010450/202608 Bianca Mulder Netherlands CAP
10451 efmoroctocog alfa 06/06/2014 1 year 05/06/2026 14/08/2026 05/06/2027 14/08/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010451/202606 PSUSA/00010451/202706 Sonja Radowan Austria CAP
10454 glycerol phenylbutyrate 01/02/2013 3 years 31/01/2027 01/05/2027 No 27/07/2022 PRAC representative was updated on 27/07/2022
DLP and PSUR frequency were updated on 22/09/2021
DLP was updated on 23/09/2020
DLP and PRAC representative were updated on 25/09/2019
DLP and PRAC Representative updated on 04/07/2018
European Union reference date and Next DLP were updated on 07/05/2018
PSUR frequency amended and DLP updated on 31/01/2018
Next DLP was amended on 27/06/2017
Next DLP was amended on 30/01/2017
New CAP authorised on 27/11/2015 PSUSA/00010454/202701 Amelia Cupelli Italy CAP
10455 lumacaftor / ivacaftor 19/11/2015 3 years 19/05/2028 17/08/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010455/202805 Eamon O Murchu Ireland CAP
10456 mepolizumab 02/12/2015 3 years 23/09/2028 22/12/2028 No 29/04/2026 PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00010456/202809 Dirk Mentzer Germany CAP
10457 pegaspargase (centrally authorised product) 14/01/2016 5 years 14/07/2030 12/10/2030 No 02/06/2026 PSUSA/00010457/203007 Jenny-Maria Jönsson Sweden CAP
10458 susoctocog alfa 11/11/2015 3 years 11/11/2025 09/02/2026 No 06/10/2025 PSUR frequency amended and DLP updated on 28/06/2023 PSUSA/00010458/202511 Dirk Mentzer Germany CAP
10459 talimogene laherparepvec 27/10/2015 3 years 26/10/2026 24/01/2027 No 06/10/2025 PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00010459/202610 Dirk Mentzer Germany CAP
10460 blinatumomab 03/12/2014 3 years 02/12/2025 02/03/2026 No 12/09/2025 PRAC Rapporteur name was amended on 26/07/2023
Next DLP was updated on 26/07/2023 PSUSA/00010460/202512 Veronika Macurova Czech Republic CAP
10461 diclofenac / omeprazole Not available* 5 years 30/09/2026 29/12/2026 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00010461/202609 Karin Erneholm Denmark NAP
10462 bisoprolol / perindopril 09/11/2015 7 years 22/10/2032 20/01/2033 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
PRAC representative was updated on 22/12/2021
DLP was updated on 30/06/2021
PRAC representative and LMS were added on 01/04/2020
European Union reference date updated on 07/05/2018
New entry added on 04/03/2016 PSUSA/00010462/203210 Jana Pecherova Slovakia NAP
10463 fosinopril, fosinopril / hydrochlorothiazide 03/07/1990 5 years 02/07/2026 30/09/2026 No 02/03/2022 PRAC Representative updated on 16/11/2022
PSUR frequency and DLP were updated on 02/03/2022
Next DLP was updated on 06/03/2019
PRAC Representative updated on 26/09/2018
New merged entry added on 07/04/2016
Next DLP was amended on 07/04/2016 PSUSA/00010463/202607 Maria del Pilar Rayon Spain NAP
10464 thiocolchicoside, paracetamol / thiocolchicoside 04/07/1956 3 years 04/07/2027 02/10/2027 No 05/03/2025 DLP was amended on 05/03/2025 PSUSA/00010464/202707 Amelia Cupelli Italy NAP
10465 allergen for therapy: Dactylis Glomerata L., Phleum Pratense L., Anthoxanthum Odoratum L., Lolium Perenne L., Poa Pratensis L. (sublingual tablet) 10/08/2004 3 years 24/12/2025 24/03/2026 No 06/10/2025 Active substance name was amended on 28/02/2024
Active substance name was amended on 20/12/2023
DLP amended on 20/09/2023 PSUSA/00010465/202512 Dirk Mentzer Germany NAP
10466 allergen for diagnostic: grass pollen, tree pollen, house dust mites, moulds, weed pollen, vertebrates, animal epithelia (except for hymenoptera venoms) single or mixes, positive and negative controls 26/06/1983 10 years 31/10/2026 29/01/2027 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00010466/202610 Karin Erneholm Denmark NAP
10467 cinchocaine hydrochloride / prednisolone caproate, cinchocaine hydrochloride / fluocortolone caproate / fluocortolone pivalate Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00010467/202911 NAP
10469 diphtheria / tetanus / pertussis (acellular, component) / hepatitis B (rDNA) / poliomyelitis (inactivated) / haemophilus type b conjugate vaccine (adsorbed) 15/02/2016 3 years 15/02/2026 16/05/2026 No 06/10/2025 Next DLP was updated on 18/10/2023 PSUSA/00010469/202602 Dirk Mentzer Germany CAP
10472 osimertinib 13/11/2015 3 years 12/11/2026 10/02/2027 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00010472/202611 Bianca Mulder Netherlands CAP
10473 varicella vaccine (live) 17/10/1994 3 years 16/03/2028 14/06/2028 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010473/202803 Jean-Michel Dogné Belgium NAP
10474 meloxicam 08/05/1995 5 years 09/07/2027 07/10/2027 No 05/04/2023 PSUR frequency amended and DLP updated on 05/04/2023
PRAC representative was updated on 26/05/2021
DLP was updated on 01/04/2020
PRAC Representative updated on 26/09/2018
PRAC Rapporteur name updated on 21/07/2017
DLP was updated on 28/03/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016
New active substance added on 07/04/2016 PSUSA/00010474/202707 Tiphaine Vaillant France NAP
10475 allergen for therapy: Phleum Pratense (oromucosal use, product authorised via mutually recognition procedure) 14/03/2006 5 years 13/03/2027 11/06/2027 No 02/06/2026 PSUSA/00010475/202703 Karin Bolin Sweden NAP
10476 ferric maltol 18/02/2016 3 years 18/02/2027 19/05/2027 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00010476/202702 Adam Przybylkowski Poland CAP
10477 diflucortolone valerate / chlorquinaldol Not available* 13 years 30/09/2027 29/12/2027 No 07/04/2016 New active substance added on 07/04/2016 PSUSA/00010477/202709 NAP
10478 diflucortolone valerate / salicylic acid Not available* 13 years 04/04/2027 03/07/2027 No 07/04/2016 New active substance added on 07/04/2016 PSUSA/00010478/202704 NAP
10479 carbidopa / levodopa (for centrally authorised product) 19/11/2015 6 months 01/10/2026 10/12/2026 01/04/2027 10/06/2027 No 27/05/2026 Entry re-activated on 27/05/2026
New CAP authorised on 27/04/2026
Entry deleted as CAP surrendered 30/11/2019
PRAC Rapporteur name was amended on 31/07/2018
Next DLP was amended on 27/06/2017
PSUR Frequency amended and DLP updated on 20/12/2016
New CAP authorised on 19/11/2015 PSUSA/00010479/202610 PSUSA/00010479/202704 Barbara Kovacic Bytyqi Croatia CAP
10480 dexamethasone (centrally authorised product indicated in symptomatic multiple myeloma) 16/03/2016 3 years 16/09/2026 15/12/2026 No 05/06/2024 PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00010480/202609 Tiphaine Vaillant France CAP
10481 human coagulation factor X 16/03/2016 3 years 16/03/2027 14/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010481/202703 Bianca Mulder Netherlands CAP
10482 rhubarb extract / salicylic acid Not available* 15 years 30/09/2030 29/12/2030 No 03/05/2016 New entry added on 03/05/2016 PSUSA/00010482/203009 NAP
10483 phenylpropanolamine 29/11/2005 5 years 10/06/2029 08/09/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010483/202906 Eva Jirsová Czech Republic NAP
10484 methoxyflurane 18/05/2015 3 years 17/05/2028 15/08/2028 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010484/202805 Karin Bolin Sweden NAP
10486 tauroselcholic [75Se] acid 25/06/1991 5 years 31/01/2028 30/04/2028 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00010486/202801 Melinda Palfi Hungary NAP
10488 isotretinoin (oral formulations) 07/05/1982 1 year 06/05/2026 15/07/2026 06/05/2027 15/07/2027 Yes 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010488/202605 PSUSA/00010488/202705 Maia Uusküla Estonia NAP
10489 olodaterol / tiotropium 20/05/2015 5 years 19/05/2029 17/08/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010489/202905 Bianca Mulder Netherlands NAP
10490 pitolisant 31/03/2016 3 years 30/09/2027 29/12/2027 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00010490/202709 Terhi Lehtinen Finland CAP
10491 azithromycin (systemic use formulations) 04/04/1991 3 years 30/04/2026 29/07/2026 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00010491/202604 Kimmo Jaakkola Finland NAP
10492 azithromycin (ocular use formulations) Not available* 5 years 30/04/2028 29/07/2028 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00010492/202804 Kimmo Jaakkola Finland NAP
10493 ixekizumab 22/03/2016 3 years 22/03/2027 20/06/2027 No 06/10/2025 DLP was amended on 20/11/2024 PSUSA/00010493/202703 Dirk Mentzer Germany CAP
10494 calcium chloride / glucose / magnesium chloride / sodium chloride / sodium lactate, calcium chloride / glucose / magnesium chloride / sodium chloride / sodium lactate/ sodium bicarbonate, calcium chloride / amino acids blend / magnesium chloride / sodium chloride / sodium lactate, calcium chloride / icodextrin / magnesium chloride / sodium chloride / sodium lactate (peritoneal dialysis solutions) Not available* 15 years 01/01/2027 01/04/2027 No 03/06/2016 New entry added on 03/06/2016 PSUSA/00010494/202701 NAP
10495 immunocyanine 25/03/1997 15 years 30/06/2030 28/09/2030 No 03/06/2016 New active substance added on 03/06/2016 PSUSA/00010495/203006 NAP
10496 delapril / manidipine, delapril / indapamide 17/01/1989 5 years 30/06/2027 28/09/2027 No 01/03/2023 DLP was updated on 01/03/2023
PRAC representative was updated on 17/11/2021
PRAC representative was updated on 30/06/2021
PRAC Rapporteur name amended on 04/07/2018
DLP was updated on 27/03/2018
Lead MS and PRAC Rapporteur name was added on 20/12/2016
Entry 'delapril / manidipine' replaced with 'delapril / manidipine, delapril / indapamide' on 03/06/2016 PSUSA/00010496/202706 Amelia Cupelli Italy NAP
10497 albutrepenonacog alfa 26/01/2016 3 years 26/01/2027 26/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010497/202701 Bianca Mulder Netherlands CAP
10498 daratumumab 16/11/2015 2 years 15/11/2026 13/02/2027 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010498/202611 Carla Torre Portugal CAP
10499 eftrenonacog alfa 20/03/2014 3 years 19/03/2026 17/06/2026 No 06/10/2025 DLP was amended on 15/11/2023 PSUSA/00010499/202603 Dirk Mentzer Germany CAP
10500 elotuzumab 30/11/2015 3 years 29/11/2027 27/02/2028 No 06/10/2025 DLP was amended on 30/07/2025 PSUSA/00010500/202711 Dirk Mentzer Germany CAP
10501 pandemic influenza vaccine (H5N1) (live attenuated, nasal) 20/05/2016 6 months 20/05/2026 29/07/2026 20/11/2026 29/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010501/202605 PSUSA/00010501/202611 Sonja Radowan Austria CAP
10502 pitavastatin 17/07/2003 5 years 16/07/2030 14/10/2030 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00010502/203007 Bianca Mulder Netherlands NAP
10503 selexipag 21/12/2015 3 years 20/12/2026 20/03/2027 Yes 02/04/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 02/04/2025
DLP was amended on 25/09/2024 PSUSA/00010503/202612 Zoubida Amimour France CAP
10504 ascorbic acid / rutoside, ascorbic acid / rutoside / alfatocopherol Not available* 8 years 01/12/2025 01/03/2026 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00010504/202512 Adam Przybylkowski Poland NAP
10505 autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence 26/05/2016 3 years 25/11/2025 23/02/2026 No 26/07/2023 PSUR frequency amended and DLP updated on 26/07/2023 PSUSA/00010505/202511 Liana Martirosyan Netherlands CAP
10506 dutasteride, dutasteride / tamsulosine 20/11/2001 5 years 19/11/2027 17/02/2028 No 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00010506/202711 Melinda Palfi Hungary NAP
10507 migalastat 26/05/2016 3 years 26/05/2027 24/08/2027 No 02/06/2026 PSUSA/00010507/202705 Karin Bolin Sweden CAP
10508 metronidazole / neomycin / nystatin 02/05/1997 5 years 02/09/2030 01/12/2030 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010508/203009 Zoubida Amimour France NAP
10509 pyridoxine / thiamine, arginine / pyridoxine / thiamine Not available* 9 years 03/05/2032 01/08/2032 No 11/06/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010509/203205 Guðrún Stefánsdóttir Iceland NAP
10510 beta-alanine 23/09/1991 3 years 23/01/2026 23/04/2026 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00010510/202601 Barbara Kovacic Bytyqi Croatia NAP
10511 budesonide / salmeterol 23/07/2015 3 years 23/07/2027 21/10/2027 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00010511/202707 Bianca Mulder Netherlands NAP
10512 amlodipine / losartan 06/01/2014 5 years 05/01/2029 05/04/2029 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010512/202901 Melinda Palfi Hungary NAP
10513 ceftazidime / avibactam 25/02/2015 3 years 24/02/2026 25/05/2026 No 18/10/2023 PSUR frequency amended and DLP updated on 18/10/2023 PSUSA/00010513/202602 Rugile Pilviniene Lithuania CAP
10514 emtricitabine / rilpivirine / tenofovir alafenamide 01/03/2016 3 years 28/02/2026 29/05/2026 No 15/11/2023 DLP was amended on 15/11/2023 PSUSA/00010514/202602 Ana Sofia Diniz Martins Portugal CAP
10515 emtricitabine / tenofovir alafenamide 04/04/2016 3 years 03/04/2026 02/07/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00010515/202604 Ana Sofia Diniz Martins Portugal CAP
10516 opicapone 24/06/2016 3 years 24/06/2027 22/09/2027 No 05/03/2025 DLP was amended on 05/03/2025 PSUSA/00010516/202706 Maria del Pilar Rayon Spain CAP
10517 trifluridine / tipiracil 24/03/2014 3 years 24/03/2026 22/06/2026 No 02/06/2026 PSUSA/00010517/202603 Jenny-Maria Jönsson Sweden CAP
10519 elbasvir / grazoprevir 19/01/2016 5 years 18/01/2030 18/04/2030 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00010519/203001 Ana Sofia Diniz Martins Portugal CAP
10521 technetium (99mTc) edda / hynic-octreotide 03/06/2016 15 years 02/06/2032 31/08/2032 Yes 25/09/2019 Active substance name corrected on 02/02/2022
PSUR frequency and DLP were updated on 25/09/2019
Entry name, PSUR frequency amended and DLP updated on 31/01/2018
Lead MS and PRAC Rapporteur name was added on 26/04/2017
New active substance added on 20/12/2016 PSUSA/00010521/203206 Adam Przybylkowski Poland NAP
10523 reslizumab 16/08/2016 3 years 16/02/2027 17/05/2027 No 06/10/2025 PRAC representative was updated on 01/03/2023
PSUR frequency and DLP were amended on 20/10/2021
DLP was updated on 21/10/2020
DLP was updated on 25/09/2019
PSUR frequency amended and DLP updated on 03/04/2019
DLP was updated on 26/09/2018
DLP was updated on 27/03/2018
DLP was updated on 17/10/2017
New CAP authorised on 22/09/2016 PSUSA/00010523/202702 Dirk Mentzer Germany CAP
10524 sofosbuvir / velpatasvir 28/06/2016 5 years 27/06/2030 25/09/2030 No 01/04/2026 DLP was corrected on 01/04/2026
PSUR frequency amended and DLP updated on 04/03/2026 PSUSA/00010524/203006 Ana Sofia Diniz Martins Portugal CAP
10525 deoxycholic acid 29/04/2015 3 years 29/04/2027 28/07/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010525/202704 Karin Bolin Sweden NAP
10526 dequalinium, dequalinium / cinchocaine, dequalinium / lidocaine, dequalinium / enoxolone / tyrothricin/ hydrocortisone / lidocaine 01/06/1962 11 years 03/07/2039 01/10/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010526/203907 Amelia Cupelli Italy NAP
10527 diphenhydramine, ammonium chloride / diphenhydramine hydrochloride, diphenhydramine hydrochloride / levomenthol, ammonium chloride / diphenhydramine hydrochloride / levomenthol 05/03/1974 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010527/203503 Rhea Fitzgerald Ireland NAP
10529 glycopyrronium (indicated for the treatment of severe sialorhoea) 15/09/2016 3 years 14/09/2027 13/12/2027 Yes 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00010529/202709 Zane Neikena Latvia CAP NAP
10532 lisinopril, lisinopril / hydrochlorothiazide 24/09/1987 5 years 23/09/2030 22/12/2030 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00010532/203009 Carla Torre Portugal NAP
10533 etelcalcetide 11/11/2016 3 years 10/11/2027 08/02/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010533/202711 Amelia Cupelli Italy CAP
10534 irinotecan (liposomal formulations) 22/10/2015 3 years 22/10/2028 20/01/2029 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010534/202810 David Olsen Norway CAP
10535 ixazomib 20/11/2015 2 years 19/11/2025 17/02/2026 No 02/06/2026 PSUSA/00010535/202511 Jenny-Maria Jönsson Sweden CAP
10536 lactic acid / urea, urea 21/11/1969 10 years 02/09/2034 01/12/2034 No 30/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010536/203409 Polona Golmajer Slovenia NAP
10537 mesoglycan 22/12/1978 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00010537/202811 NAP
10539 empagliflozin / linagliptin 11/11/2016 3 years 10/11/2026 08/02/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010539/202611 Maria del Pilar Rayon Spain CAP
10540 olanzapine 27/09/1996 3 years 31/03/2028 29/06/2028 No 21/12/2022 DLP was updated on 21/12/2022
DLP was updated on 18/12/2019
New entry created on 20/12/2016 PSUSA/00010540/202803 Kimmo Jaakkola Finland CAP NAP
10542 sulfogaiacol, sodium benzoate / sulfogaiacol, codeine / sodium benzoate, codeine sulfogaiacol, codeine / sulfogaiacol / grindelia soft extract 12/08/1996 5 years 31/12/2027 30/03/2028 No 27/03/2024 Active substance name was amended on 27/03/2024
PRAC Rapporteur updated on 15/11/2023 PSUSA/00010542/202712 Petar Mas Croatia NAP
10544 palbociclib 03/02/2015 3 years 02/08/2026 31/10/2026 No 27/03/2024 PSUR frequency amended and DLP updated on 27/03/2024 PSUSA/00010544/202608 Marie Louise Schougaard Christiansen Denmark CAP
10545 ascorbic acid / calcium, ascorbic acid / calcium / lysine Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00010545/202905 Roxana Dondera Romania NAP
10546 benzalkonium chloride / cetrimide, cetrimide / dimeticone Not available* 9 years 03/06/2029 01/09/2029 Yes 23/10/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 23/10/2024
PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00010546/202906 Rhea Fitzgerald Ireland NAP
10547 alfa-tocopherol / vaccinium myrtillus anthocyanosides, betacarotene / vaccinium myrtillus anthocyanosides Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00010547/202903 Maia Uusküla Estonia NAP
10549 morphine, morphine / cyclizine 14/04/1969 5 years 14/10/2027 12/01/2028 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00010549/202710 Karin Erneholm Denmark NAP
10550 mycophenolate mofetil, mycophenolic acid 03/05/1995 3 years 02/05/2028 31/07/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010550/202805 Karin Erneholm Denmark CAP NAP
10551 mesterolone 25/05/1967 5 years 31/01/2030 01/05/2030 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00010551/203001 Petar Mas Croatia NAP
10552 edotreotide 08/12/2016 3 years 07/12/2025 07/03/2026 Yes 17/12/2025 Reference to NAP added on 17/12/2025
Reference to NAP removed on 28/05/2025
PSUR frequency amended and DLP updated on 26/07/2023 PSUSA/00010552/202512 Rhea Fitzgerald Ireland CAP NAP
10554 follitropin delta 12/12/2016 3 years 30/11/2026 28/02/2027 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00010554/202611 Bianca Mulder Netherlands CAP
10556 venetoclax 05/12/2016 3 years 04/12/2027 03/03/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010556/202712 Eva Jirsová Czech Republic CAP
10557 carbasalate calcium / metoclopramide, lysine acetylsalicylic acid / metoclopramide, paracetamol / metoclopramide 16/07/1981 15 years 16/07/2027 14/10/2027 No 30/01/2017 New entry added on 30/01/2017 PSUSA/00010557/202707 NAP
10558 cidofovir 23/04/1997 3 years 10/06/2027 08/09/2027 Yes 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010558/202706 Rugile Pilviniene Lithuania NAP
10559 lonoctocog alfa 04/01/2017 1 year 03/01/2026 14/03/2026 03/01/2027 14/03/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010559/202601 PSUSA/00010559/202701 Sonja Radowan Austria CAP
10561 sulfamethizole 15/06/1955 10 years 15/06/2032 13/09/2032 Yes 01/03/2023 PSUR frequency and DLP were updated on 01/03/2023
PRAC Rapporteur name was amended on 28/04/2022
PRAC Rapporteur name was amended on 21/11/2018
DLP was updated on 28/02/2018
Lead MS and PRAC Rapporteur name was added on 26/04/2017
New entry added on 30/01/2017
PRAC Rapporteur name updated on 05/11/2018 PSUSA/00010561/203206 Marie Louise Schougaard Christiansen Denmark NAP
10563 calcium glycerophosphate / magnesium gluconate, calcium glycerophosphate / manganese glycerophosphate / potassium glycerophosphate / sodium glycerophosphate / thiamine 14/09/1959 11 years 03/05/2039 01/08/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010563/203905 NAP
10564 cetrimide, cetyltrimethylammonium naproxenate 07/12/1976 15 years 28/02/2030 29/05/2030 No 19/12/2017 Entry name amended on 19/12/2017
New active substance added on 28/02/2017 PSUSA/00010564/203002 NAP
10565 amino acid combinations / glucose / triglyceride combinations (e.g. olive oil, soya bean oil, fish oil)/ with or without electrolytes/ mineral compounds (i.v. application) - except the combination with procedure number 00010190 (drug Numeta) Not available* 5 years 03/06/2026 01/09/2026 No 02/02/2022 DLP was updated on 02/02/2022
PRAC representative and LMS were added on 23/09/2020
New active substance added on 28/02/2017 PSUSA/00010565/202606 Melinda Palfi Hungary NAP
10566 amino acid combinations/ glucose/ with or without electrolytes / mineral compounds (i.v. application) Not available* 5 years 03/06/2026 01/09/2026 No 02/02/2022 DLP was updated on 02/02/2022
PRAC representative was updated on 28/07/2021
PRAC representative was updated on 28/04/2021
PRAC representative and LMS were added on 23/09/2020
New active substance added on 28/02/2017 PSUSA/00010566/202606 Polona Golmajer Slovenia NAP
10569 Camellia sinensis, Leaf, Dry extract refined (derived from Camellia sinensis, L. O.KUNTZE) (topical use) 31/08/2009 5 years 31/12/2029 31/03/2030 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00010569/202912 Adam Przybylkowski Poland NAP
10570 landiolol 03/08/2016 3 years 02/02/2026 03/05/2026 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00010570/202602 Bianca Mulder Netherlands NAP
10571 naphazoline, naphazoline / zinc sulphate 16/10/1946 12 years 31/07/2036 29/10/2036 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00010571/203607 Karin Erneholm Denmark NAP
10572 nitrous oxide, nitrous oxide / oxygen Not available* 3 years 23/06/2028 21/09/2028 Yes 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010572/202806 John Joseph Borg Malta NAP
10573 mercaptamine (treatment of nephropathic cystinosis) 23/06/1997 5 years 23/10/2030 21/01/2031 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010573/203010 Maria Martinez Gonzalez Spain CAP
10574 mercaptamine (Indicated for the treatment of corneal cystine crystal deposit only) 19/01/2017 3 years 18/01/2027 18/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010574/202701 Maria del Pilar Rayon Spain CAP
10575 tenofovir alafenamide 10/11/2016 3 years 09/11/2027 07/02/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010575/202711 Amelia Cupelli Italy CAP
10576 bezlotoxumab 21/10/2016 5 years 20/10/2030 18/01/2031 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
PSUR frequency amended and DLP updated on 31/05/2023
DLP was updated on 29/06/2022
DLP was updated on 30/06/2021
DLP was updated on 16/12/2020
PSUR frequency and DLP were updated on 03/06/2020
DLP was updated on 20/11/2019
DLP was updated on 05/06/2019
DLP was updated on 21/11/2018
DLP was updated on 06/06/2018
DLP was updated on 19/12/2017
EURD and DLP amended on 26/04/2017
New CAP authorised on 18/01/2017 PSUSA/00010576/203010 Adam Przybylkowski Poland CAP
10577 insulin glargine / lixisenatide 11/01/2017 3 years 21/11/2026 19/02/2027 No 03/07/2024 PSUR frequency amended and DLP updated on 03/07/2024 PSUSA/00010577/202611 Bianca Mulder Netherlands CAP
10578 baricitinib 13/02/2017 1 year 13/02/2026 24/04/2026 13/02/2027 24/04/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010578/202602 PSUSA/00010578/202702 Adam Przybylkowski Poland CAP
10579 citrulline malate 31/10/1991 13 years 12/03/2034 10/06/2034 No 02/02/2022 Correction to PSUR frequency and DLP on 02/02/2022
DLP was updated on 17/11/2021
DLP was updated on 21/11/2018
PRAC representative and Lead Member State were added on 21/07/2017
New entry added on 28/03/2017 PSUSA/00010579/203403 Eva Jirsová Czech Republic NAP
10581 alectinib 04/07/2014 3 years 03/07/2028 01/10/2028 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010581/202807 Veronika Macurova Czech Republic CAP
10582 allergen for therapy: dermatophagoides pteronyssinus / dermatophagoides farina (oromucosal use, products authorised via mutually recognition procedure and decentralised procedure) 23/09/2015 3 years 22/09/2028 21/12/2028 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00010582/202809 Dirk Mentzer Germany NAP
10583 bendroflumethiazide, bendroflumethiazide / potassium chloride 28/02/1960 6 years 01/01/2030 01/04/2030 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010583/203001 Eva Jirsová Czech Republic NAP
10584 benzyl nicotinate / camphor / dimethyl sulfoxide / nonivamide / turpentine oil, Nicoboxil/ Nonivamide 01/01/1994 5 years 31/03/2028 29/06/2028 No 20/12/2023 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00010584/202803 Zane Neikena Latvia NAP
10585 budesonide / formoterol 25/08/2000 5 years 24/08/2030 22/11/2030 No 27/05/2026 DLP was corrected on 27/05/2026
PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00010585/203008 Marie Louise Schougaard Christiansen Denmark CAP NAP
10587 chlormethine 23/08/2013 3 years 22/08/2027 20/11/2027 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00010587/202708 Tiphaine Vaillant France CAP
10588 tofacitinib 06/11/2012 3 years 05/11/2027 03/02/2028 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010588/202711 Liana Martirosyan Netherlands CAP
10590 chenodeoxycholic acid (inborn error in primary bile acid synthesis, xanthomatosis - centrally authorised products only) 10/04/2017 1 year 09/10/2026 18/12/2026 09/10/2027 18/12/2027 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00010590/202610 PSUSA/00010590/202710 Adam Przybylkowski Poland CAP
10593 sulfametrole / trimethoprim, sulfadiazine / trimethoprim, sulfamethoxazole / trimethoprim (co-trimoxazole) 01/04/1969 8 years 31/03/2027 29/06/2027 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00010593/202703 Barbara Kovacic Bytyqi Croatia NAP
10594 fluciclovine (18F) 27/05/2016 3 years 27/05/2026 25/08/2026 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00010594/202605 Rugile Pilviniene Lithuania CAP
10595 nusinersen 30/05/2017 3 years 30/05/2027 28/08/2027 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010595/202705 Karin Bolin Sweden CAP
10596 cerliponase alfa 27/04/2017 3 years 26/04/2027 25/07/2027 No 02/06/2026 PSUSA/00010596/202704 Karin Bolin Sweden CAP
10597 dinutuximab beta 08/05/2017 1 year 08/11/2026 17/01/2027 08/11/2027 17/01/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010597/202611 PSUSA/00010597/202711 Dirk Mentzer Germany CAP
10598 lactobacillus all subspecies and combinations of subspecies (oral and vaginal use) 14/07/1954 10 years 13/07/2034 11/10/2034 No 28/05/2025 PSUR frequency corrected and DLP corrected on 28/05/2025
PSUR frequency amended and DLP updated on 02/04/2025 PSUSA/00010598/203407 Dennis Lex Germany NAP
10599 choline alfoscerate 27/07/1987 8 years 30/08/2030 28/11/2030 No 03/05/2023 DLP was amended on 03/05/2023
Lead MS and PRAC Rapporteur name added on 29/06/2022
New active substance added on 27/06/2017 PSUSA/00010599/203008 Rugile Pilviniene Lithuania NAP
10600 deproteinised hemoderivative of calf blood, deproteinised hemoderivative of calf blood / macrogol 400 03/01/1957 8 years 31/03/2031 29/06/2031 No 12/09/2025 DLP was amended on 20/12/2023 PSUSA/00010600/203103 Veronika Macurová Czech Republic NAP
10601 irbesartan, irbesartan / hydrochlorothiazide 12/08/1997 5 years 12/08/2026 10/11/2026 No 28/04/2022 PRAC Representative updated on 16/11/2022
DLP was updated on 28/04/2022
Correction of active substance name on 30/03/2022
PRAC Representative updated on 26/09/2018
European Union reference date, DLP and Submission date were updated on 28/02/2018
New combination of active substances added following merge on 27/06/2017
*for irbesartan containing products the next PSUR (PSUSA/00010601/202109) will cover period of 6 years, form 12/08/2015 to 30/09/2021 PSUSA/00010601/202608 Maria del Pilar Rayon Spain CAP NAP
10603 benzocaine / chlorhexidine, benzocaine / chlorhexidine / tyrothricin Not available* 18 years 01/01/2030 01/04/2030 No 21/07/2017 New entry added on 21/07/2017 PSUSA/00010603/203001 NAP
10604 chlorhexidine / tetracaine 22/12/1969 8 years 22/12/2033 22/03/2034 No 23/10/2024 PSUR frequency amended and DLP updated on 23/10/2024
Active substance name was amended on 23/10/2024
Active substance amended on 19/12/2017
New entry added on 21/07/2017 PSUSA/00010604/203312 Miroslava Gocova Slovakia NAP
10605 human plasma proteins with no less than 95% albumin 01/07/1950 5 years 01/07/2029 29/09/2029 Yes 06/10/2025 DLP was amended on 05/03/2025 PSUSA/00010605/202907 Dirk Mentzer Germany NAP
10606 itopride 30/06/1995 5 years 30/06/2028 28/09/2028 Yes 04/03/2026 PSUR frequency amended and DLP updated on 04/03/2026 PSUSA/00010606/202806 Rugile Pilviniene Lithuania NAP
10607 meningococcal group B vaccine (recombinant, adsorbed) 29/10/2014 3 years 28/10/2027 26/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00010607/202710 Jean-Michel Dogné Belgium CAP
10608 nonacog beta pegol 31/05/2017 3 years 31/05/2026 29/08/2026 No 06/10/2025 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00010608/202605 Dirk Mentzer Germany CAP
10609 sarilumab 12/01/2017 3 years 12/01/2026 12/04/2026 No 19/09/2025 DLP and PSUR frequency amended on 20/09/2023 PSUSA/00010609/202601 Maria Martinez Gonzalez Spain CAP
10610 shark liver oil / yeast extract, yeast extract (excluding saccharomyces boulardii) 01/01/1957 15 years 31/12/2031 30/03/2032 No 17/12/2025 Active substance name was amended on 17/12/2025
New entry added on 21/07/2017 PSUSA/00010610/203112 none NAP
10611 tripelennamine 04/04/1984 10 years 31/10/2026 29/01/2027 No 27/02/2026 New entry added on 21/07/2017 PSUSA/00010611/202610 Zane Neikena Latvia NAP
10612 sodium oxybate (oral use) 13/06/1961 1 year 12/10/2026 21/12/2026 12/10/2027 21/12/2027 Yes 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00010612/202610 PSUSA/00010612/202710 Ana Sofia Diniz Martins Portugal CAP NAP
10613 sodium oxybate (intravenous use) 13/06/1961 5 years 12/10/2029 10/01/2030 No 25/06/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/06/2025
PSUR frequency amended and DLP updated on 25/06/2025
DLP was updated on 25/05/2022
PSUR frequency and DLP were updated on 05/06/2019
DLP was updated on 06/06/2018
PRAC representative added on 17/10/2017
New entry added on 21/07/2017 PSUSA/00010613/202910 Ana Sofia Diniz Martins Portugal NAP
10614 pentosan polysulfate sodium (for centrally authorised product) 02/06/2017 3 years 01/06/2027 30/08/2027 Yes 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010614/202706 Ana Sofia Diniz Martins Portugal CAP
10616 brodalumab 17/07/2017 3 years 16/07/2027 14/10/2027 No 19/09/2025 DLP was amended on 02/04/2025 PSUSA/00010616/202707 Maria Martinez Gonzalez Spain CAP
10617 beclometasone / formoterol / glycopyrronium bromide 17/07/2017 1 year 16/07/2026 24/09/2026 16/07/2027 24/09/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010617/202607 PSUSA/00010617/202707 Jan Neuhauser Austria CAP
10618 patiromer 21/10/2015 3 years 20/10/2026 18/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010618/202610 Terhi Lehtinen Finland CAP
10619 sofosbuvir / velpatasvir / voxilaprevir 18/07/2017 5 years 17/07/2030 15/10/2030 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00010619/203007 Ana Sofia Diniz Martins Portugal CAP
10620 glecaprevir / pibrentasvir 26/07/2017 5 years 25/07/2030 23/10/2030 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00010620/203007 Ana Sofia Diniz Martins Portugal CAP
10621 bismuth / lidocaine / zinc oxide, lidocaine / zinc oxide Not available* 8 years 01/01/2028 31/03/2028 Yes 23/09/2020 DLP was updated on 23/09/2020
LMS and PRAC representative were added on 31/07/2019
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 06/02/2019
New entry introduced on 25/09/2017 PSUSA/00010621/202801 Rugile Pilviniene Lithuania NAP
10622 calcium chloride dihydrate / magnesium chloride hexahydrate / malic acid / sodium acetate trihydrate / sodium chloride / potassium chloride, calcium chloride dihydrate / sodium chloride / sodium lactate / potassium chloride, calcium chloride / sodium chloride / potassium chloride Not available* 13 years 01/01/2036 31/03/2036 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00010622/203601 Polona Golmajer Slovenia NAP
10623 cariprazine 13/07/2017 3 years 05/10/2027 03/01/2028 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010623/202710 Ana Sofia Diniz Martins Portugal CAP
10624 cenegermin 06/07/2017 1 year 05/07/2026 13/09/2026 05/07/2027 13/09/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010624/202607 PSUSA/00010624/202707 Jan Neuhauser Austria CAP
10625 mucopolysaccharide polysulfuric acid ester (chondroitin), mucopolysaccharide polysulfuric acid ester (chondroitin)/salicylic acid, mucopolysaccharide polysulfuric acid ester (chondroitin)/salicylic acid/flufenamic acid, mucopolysaccharide polysulfuric acid ester (chondroitin)/salicylic acid/suprarenal extract [cutaneous use] Not available* 9 years 02/12/2031 01/03/2032 No 23/10/2024 PSUR frequency amended and DLP updated on 23/10/2024
Active substance name was amended on 23/10/2024
New active sustance combination added following merge on 25/09/2017 PSUSA/00010625/203112 none NAP
10626 mucopolysaccharide polysulfuric acid ester (chondroitin), mucopolysaccharide polysulfuric acid ester (chondroitin)/ glucosamine [oral and intramuscular use] Not available* 9 years 02/12/2031 01/03/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010626/203112 NAP
10627 benzyl benzoate / disulfiram 22/10/1982 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00010627/202812 Sweden NAP
10628 gentamicin (implant) 28/02/1973 5 years 31/03/2027 29/06/2027 No 21/12/2022 DLP was updated on 21/12/2022
PRAC representative was updated on 19/10/2022
PRAC representative was updated on 27/07/2022
LMS and PRAC representative were added on 20/10/2021
New active substance added on 25/09/2017 PSUSA/00010628/202703 Amelia Cupelli Italy NAP
10629 hamamelis water Not available* 13 years 01/01/2040 31/03/2040 No 25/09/2017 New active substance added on 25/09/2017 PSUSA/00010629/204001 NAP
10630 spheroids of human autologous matrix-associated chondrocytes 10/07/2017 3 years 09/07/2027 07/10/2027 No 06/10/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00010630/202707 Dirk Mentzer Germany CAP
10631 testosterone (all formulations apart from topical use) 01/07/1978 3 years 31/12/2027 30/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010631/202712 Maia Uusküla Estonia NAP
10632 zinc oxide, zinc oxide/calamine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010632/203211 Dennis Lex Germany NAP
10633 ribociclib 13/03/2017 3 years 12/03/2028 10/06/2028 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00010633/202803 Marie Louise Schougaard Christiansen Denmark CAP
10634 cladribine (multiple sclerosis) 08/07/2010 3 years 07/07/2027 05/10/2027 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00010634/202707 Carla Torre Portugal CAP
10635 avelumab 23/03/2017 3 years 22/03/2026 20/06/2026 No 15/11/2023 PSUR frequency amended and DLP updated on 15/11/2023 PSUSA/00010635/202603 Karin Erneholm Denmark CAP
10636 tivozanib 24/08/2017 3 years 23/02/2028 23/05/2028 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010636/202802 Rugile Pilviniene Lithuania CAP
10637 trientine 05/09/2017 3 years 05/09/2028 04/12/2028 No 27/05/2026 DLP was corrected on 27/05/2026
PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00010637/202809 Ana Sofia Diniz Martins Portugal CAP NAP
10638 midostaurin 28/04/2017 5 years 27/10/2029 25/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010638/202910 Carla Torre Portugal CAP
10639 telotristat 28/02/2017 3 years 27/02/2027 28/05/2027 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00010639/202702 Adam Przybylkowski Poland CAP
10640 benzalkonium chloride / isopropyl myristate / paraffin liquid, benzalkonium chloride / chlorhexidine / isopropyl myristate / paraffin liquid Not available* 8 years 01/12/2025 01/03/2026 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00010640/202512 Rhea Fitzgerald Ireland NAP
10641 eucalyptus oil Not available* 13 years 01/01/2030 01/04/2030 No 17/10/2017 New entry added on 17/10/2017 PSUSA/00010641/203001 NAP
10643 lutetium (177Lu) oxodotreotide 26/09/2017 3 years 19/12/2025 19/03/2026 No 26/07/2023 PSUR frequency amended and DLP updated on 26/07/2023 PSUSA/00010643/202512 Adam Przybylkowski Poland CAP
10644 atezolizumab 18/05/2016 2 years 17/05/2027 15/08/2027 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010644/202705 Carla Torre Portugal CAP
10645 dupilumab 28/03/2017 1 year 28/03/2026 06/06/2026 28/03/2027 06/06/2027 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010645/202603 PSUSA/00010645/202703 Kimmo Jaakkola Finland CAP
10646 darunavir / cobicistat / emtricitabine / tenofovir alafenamide 21/09/2017 3 years 20/09/2027 19/12/2027 No 28/04/2022 PSUR frequency and DLP were updated on 28/04/2022
DLP was updated on 28/04/2021
DLP was updated on 06/05/2020
PSUR frequency amended on 20/11/2019
DLP was updated on 23/10/2019
DLP was updated on 30/04/2019
Lead MS and PRAC Rapporteur name updated on 23/10/2018
DLP was updated on 23/10/2018
New CAP authorised on 21/09/2017 PSUSA/00010646/202709 Ana Sofia Diniz Martins Portugal CAP
10647 dimethyl fumarate (psoriasis) 23/06/2017 3 years 23/03/2028 21/06/2028 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00010647/202803 Karin Bolin Sweden CAP
10648 triglyceride combinations (e.g. olive oil, soya bean oil, fish oil)/ with or without mineral compounds/electrolytes (i.v. application) 06/02/2014 5 years 03/06/2026 01/09/2026 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00010648/202606 Petar Mas Croatia NAP
10649 ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus), ibuprofen / caffeine 19/02/1969 3 years 18/02/2026 19/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00010649/202602 John Joseph Borg Malta NAP
10650 clodronic acid, clodronic acid / lidocaine 13/02/1985 5 years 28/02/2027 29/05/2027 Yes 16/11/2022 DLP was updated on 16/11/2022
PRAC Representative amended on 28/04/2022
New entry added following merge on 15/11/2017 PSUSA/00010650/202702 Jean-Michel Dogné Belgium NAP
10651 ozenoxacin 19/05/2017 5 years 18/05/2030 16/08/2030 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010651/203005 Maria Martinez Gonzalez Spain NAP
10652 guselkumab 13/07/2017 1 year 12/07/2026 20/09/2026 12/07/2027 20/09/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010652/202607 PSUSA/00010652/202707 Dirk Mentzer Germany CAP
10653 fluticasone furoate / umeclidinium / vilanterol 18/09/2017 3 years 17/03/2027 15/06/2027 No 02/06/2026 PSUSA/00010653/202703 Karin Bolin Sweden CAP
10654 padeliporfin 10/11/2017 3 years 09/11/2025 07/02/2026 No 28/06/2023 PSUR frequency amended and DLP updated on 28/06/2023 PSUSA/00010654/202511 Maia Uusküla Estonia CAP
10655 niraparib 27/03/2017 1 year 26/03/2026 04/06/2026 26/03/2027 04/06/2027 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010655/202603 PSUSA/00010655/202703 Jan Neuhauser Austria CAP
10656 methohexital 24/01/1977 5 years 01/01/2027 01/04/2027 No 21/09/2022 DLP was updated on 21/09/2022
PRAC representative and LMS were added on 26/05/2021
New entry added on 19/17/2017 PSUSA/00010656/202701 Liana Martirosyan Netherlands NAP
10657 naloxone (for use in non-medical settings) 06/06/2016 2 years 09/05/2026 07/08/2026 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010657/202605 Liana Martirosyan Netherlands CAP NAP
10658 methyl salicylate,
menthol / methyl salicylate,
menthol / methyl salicylate / camphor,
methyl salicylate/ camphor, methyl salicylate / menthol / camphor / tocopherol,
methyl salicylate / camphor / menthol / turpentine (essence, oil),
methyl salicylate / menthol / camphor / hydroxyethyl salicylate,
methyl salicylate / menthol / camphor / hydroxyethyl salicylate / benzyl nicotinate 23/06/1989 5 years 20/04/2027 19/07/2027 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00010658/202704 Carla Torre Portugal NAP
10659 inotuzumab ozogamicin 29/06/2017 1 year 28/12/2025 08/03/2026 28/12/2026 08/03/2027 No 06/10/2025 DLP was amended on 30/07/2025 PSUSA/00010659/202512 PSUSA/00010659/202612 Dirk Mentzer Germany CAP
10660 letermovir 01/11/2017 3 years 01/11/2027 30/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00010660/202711 Terhi Lehtinen Finland CAP
10661 benralizumab 14/11/2017 3 years 13/11/2025 11/02/2026 No 28/06/2023 PSUR frequency amended and DLP updated on 28/06/2023 PSUSA/00010661/202511 David Olsen Norway CAP
10662 ocrelizumab 28/03/2017 3 years 27/03/2027 25/06/2027 No 06/10/2025 DLP was amended on 20/11/2024 PSUSA/00010662/202703 Dirk Mentzer Germany CAP
10663 rurioctocog alfa pegol 13/11/2018 3 years 12/11/2027 10/02/2028 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010663/202711 Bianca Mulder Netherlands CAP
10664 budesonide (for centrally authorised products indicated for eosinophilic esophagitis only) 08/01/2018 3 years 07/07/2028 05/10/2028 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026
DLP was amended on 04/03/2026 PSUSA/00010664/202807 Zane Neikena Latvia CAP
10665 loperamide, loperamide / simeticone 31/05/1973 5 years 31/05/2029 29/08/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010665/202905 Adam Przybylkowski Poland NAP
10667 pseudoephedrine, acetylsalicylic acid / pseudoephedrine 01/02/1986 3 years 28/06/2026 26/09/2026 No 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 PSUSA/00010667/202606 Maia Uusküla Estonia NAP
10668 emicizumab 16/11/2017 3 years 15/11/2027 13/02/2028 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010668/202711 Amelia Cupelli Italy CAP
10669 burosumab 19/02/2018 1 year 18/02/2026 29/04/2026 18/02/2027 29/04/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010669/202602 PSUSA/00010669/202702 Dirk Mentzer Germany CAP
10670 opium 01/10/1986 7 years 30/09/2031 29/12/2031 Yes 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00010670/203109 Marie Louise Schougaard Christiansen Denmark NAP
10671 semaglutide (all other indications) 05/12/2017 2 years 31/05/2027 29/08/2027 No 02/06/2026 PSUSA/00010671/202705 Karin Bolin Sweden CAP
10672 prasterone (vaginal use/Pessary) 16/11/2016 2 years 15/11/2025 13/02/2026 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00010672/202511 Bianca Mulder Netherlands CAP
10673 sitagliptin, metformin / sitagliptin 21/03/2007 3 years 03/08/2026 01/11/2026 No 30/07/2025 Active substance name was amended on 30/07/2025
DLP was amended on 30/04/2024 PSUSA/00010673/202608 Bianca Mulder Netherlands CAP NAP
10674 hydrocortisone (centrally authorised products for adrenal insufficiency, paediatric use only) 09/02/2018 3 years 08/08/2026 06/11/2026 No 27/03/2024 PSUR frequency amended and DLP updated on 27/03/2024 PSUSA/00010674/202608 Karin Bolin Sweden CAP
10675 sodium zirconium cyclosilicate 22/03/2018 3 years 21/03/2028 19/06/2028 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010675/202803 Terhi Lehtinen Finland CAP
10677 velmanase alfa 23/03/2018 3 years 22/03/2028 20/06/2028 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00010677/202803 Jan Neuhauser Austria CAP
10678 herpes zoster vaccine (recombinant, adjuvanted) 13/10/2017 1 year 12/10/2026 21/12/2026 12/10/2027 21/12/2027 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00010678/202610 PSUSA/00010678/202710 Sonja Radowan Austria CAP
10683 Krypton (81 mKr) 31/01/1995 10 years 30/01/2026 30/04/2026 No 20/06/2025 New active substance added on 06/06/2018 PSUSA/00010683/202601 Zane Neikena Latvia NAP
10684 coal tar, distilled coal tar, coconut oil / distilled coal tar / salicylic acid, coal tar solution / salicylic acid / sulfur, coal tar / salicylic acid, coal tar / menthol 16/02/1989 8 years 16/02/2033 17/05/2033 No 23/10/2024 PSUR frequency amended and DLP updated on 23/10/2024
Active substance name was amended on 23/10/2024
EURD added on 23/10/2024
New entry added on 06/06/2018 PSUSA/00010684/203302 Liana Martirosyan Netherlands NAP
10685 lisinopril / torasemide 12/12/2017 5 years 11/12/2028 11/03/2029 Yes 13/08/2025 DLP was amended on 31/07/2024 PSUSA/00010685/202812 Veronika Macurová Czech Republic NAP
10686 enterococcus faecium 27/07/1955 10 years 26/07/2026 24/10/2026 No 18/11/2025 New active substance added on 06/06/2018 PSUSA/00010686/202607 Polona Golmajer Slovenia NAP
10688 gemtuzumab ozogamicin 17/05/2000 3 years 16/05/2026 14/08/2026 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00010688/202605 Carla Torre Portugal CAP
10689 dolutegravir / rilpivirine 16/05/2018 3 years 15/05/2028 13/08/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010689/202805 Zoubida Amimour France CAP
10690 glibenclamide (for centrally authorised products only) 24/05/2018 3 years 23/05/2028 21/08/2028 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010690/202805 Maria del Pilar Rayon Spain CAP
10691 heparin / zinc sulphate 30/11/1998 12 years 29/11/2027 27/02/2028 No 31/07/2018 New combination of active substances added on 31/07/2018 PSUSA/00010691/202711 NAP
10693 allergen for therapy: Ambrosia Artemisiifolia (302) (sublingual use, products authorised via decentralised procedure)” 10/04/2014 3 years 09/04/2027 08/07/2027 No 06/10/2025 DLP was amended on 18/12/2024 PSUSA/00010693/202704 Dirk Mentzer Germany NAP
10694 rucaparib 19/12/2016 2 years 19/12/2025 19/03/2026 No 02/06/2026 PSUSA/00010694/202512 Jenny-Maria Jönsson Sweden CAP
10695 bictegravir / emtricitabine / tenofovir alafenamide 07/02/2018 3 years 06/02/2028 06/05/2028 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010695/202802 Liana Martirosyan Netherlands CAP
10696 iron dextran Not available* 3 years 01/01/2027 01/04/2027 Yes 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010696/202701 Zane Neikena Latvia NAP
10697 inotersen 06/07/2018 2 years 05/07/2027 03/10/2027 No 27/05/2026 DLP was corrected on 27/05/2026
PSUR frequency amended and DLP updated on 29/04/2026
DLP was amended on 04/03/2026 PSUSA/00010697/202707 Rhea Fitzgerald Ireland CAP
10698 brexpiprazole 10/07/2015 3 years 09/07/2027 07/10/2027 No 05/03/2025 DLP was amended on 05/03/2025 PSUSA/00010698/202707 Miroslava Gocova Slovakia CAP
10699 erenumab 17/05/2018 3 years 16/05/2027 14/08/2027 No 18/12/2024 PSUR frequency amended and DLP updated on 18/12/2024 PSUSA/00010699/202705 Terhi Lehtinen Finland CAP
10700 metreleptin 25/03/2013 1 year 24/01/2026 04/04/2026 24/01/2027 04/04/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010700/202601 PSUSA/00010700/202701 Adam Przybylkowski Poland CAP
10701 daunorubicin / cytarabine 03/08/2017 3 years 02/08/2028 31/10/2028 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00010701/202808 Carla Torre Portugal CAP
10702 tisagenlecleucel 30/08/2017 1 year 12/08/2026 21/10/2026 12/08/2027 21/10/2027 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00010702/202608 PSUSA/00010702/202708 Dirk Mentzer Germany CAP
10703 axicabtagene ciloleucel 18/10/2017 1 year 17/10/2026 26/12/2026 17/10/2027 26/12/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010703/202610 PSUSA/00010703/202710 Karin Erneholm Denmark CAP
10706 sodium fluoride (18F) 14/11/1994 5 years 13/11/2027 11/02/2028 Yes 26/07/2023 PSUR frequency amended and DLP updated on 26/07/2023 PSUSA/00010706/202711 Kimmo Jaakkola Finland NAP
10707 soybean phospholipids (oral use) 02/10/1957 5 years 01/10/2026 30/12/2026 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00010707/202610 Petar Mas Croatia NAP
10708 fluorocholine (18F) 02/04/2010 3 years 01/04/2026 30/06/2026 No 23/08/2023 DLP was amended on 23/08/2023
DLP updated on 02/02/2022
LMS and PRAC representative were added on 25/09/2019
New entry added on 26/09/2018 PSUSA/00010708/202604 Eva Jirsová Czech Republic NAP
10709 vestronidase alfa 15/11/2017 3 years 14/11/2026 12/02/2027 No 03/07/2024 PSUR frequency amended and DLP updated on 03/07/2024 PSUSA/00010709/202611 Maria del Pilar Rayon Spain CAP
10710 alitretinoin (oral use) Not available* 1 year 18/01/2026 29/03/2026 18/01/2027 29/03/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010710/202601 PSUSA/00010710/202701 Jan Neuhauser Austria NAP
10712 neratinib 17/07/2017 3 years 16/07/2026 14/10/2026 No 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 PSUSA/00010712/202607 Bianca Mulder Netherlands CAP
10713 caplacizumab 31/08/2018 1 year 30/08/2026 08/11/2026 30/08/2027 08/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010713/202608 PSUSA/00010713/202708 Jan Neuhauser Austria CAP
10714 vonicog alfa 08/12/2015 3 years 31/12/2026 31/03/2027 No 02/06/2026 PSUSA/00010714/202612 Karin Bolin Sweden CAP
10715 patisiran 10/08/2018 2 years 09/08/2027 07/11/2027 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00010715/202708 Rhea Fitzgerald Ireland CAP
10716 Symphytum officinale L., radix (comfrey root) 07/01/1966 13 years 31/12/2027 30/03/2028 No 23/10/2018 New active substance added on 23/10/2018 PSUSA/00010716/202712 NAP
10717 binimetinib 27/06/2018 3 years 26/06/2028 24/09/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010717/202806 Carla Torre Portugal CAP
10718 eravacycline 27/08/2018 3 years 26/08/2027 24/11/2027 No 02/04/2025 PSUR frequency amended and DLP updated on 02/04/2025 PSUSA/00010718/202708 Adam Przybylkowski Poland CAP
10719 encorafenib 27/06/2018 3 years 26/06/2028 24/09/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010719/202806 Rugile Pilviniene Lithuania CAP
10720 tildrakizumab 20/03/2018 1 year 19/03/2026 28/05/2026 19/03/2027 28/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010720/202603 PSUSA/00010720/202703 Adam Przybylkowski Poland CAP
10721 allergen for diagnostic and/or therapy: Vespula SPP. (802) (with or without adjuvant), Wasp venom 03/07/1980 5 years 02/07/2027 30/09/2027 No 02/06/2026 PSUSA/00010721/202707 Karin Bolin Sweden NAP
10722 allergen for diagnostic and/or therapy: Apis mellifera (801) (with or without adjuvant), Apis mellifera venom 03/07/1980 5 years 02/07/2027 30/09/2027 No 02/06/2026 DLP was updated on 01/03/2023
PRAC Rapporteur name was amended on 22/09/2022
DLP was updated on 31/03/2021
PRAC representative and LMS were added on 18/11/2020
New active substance added on 21/11/2018 PSUSA/00010722/202707 Karin Bolin Sweden NAP
10723 durvalumab 01/05/2017 1 year 30/04/2026 09/07/2026 30/04/2027 09/07/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010723/202604 PSUSA/00010723/202704 David Olsen Norway CAP
10724 abemaciclib 28/09/2017 3 years 28/09/2027 27/12/2027 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010724/202709 Carla Torre Portugal CAP
10725 interferon beta-1a (intramuscular use) 13/03/1997 5 years 03/05/2029 01/08/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010725/202905 Maria del Pilar Rayon Spain CAP
10726 interferon beta-1a (subcutaneous use) 04/05/1998 5 years 03/05/2026 01/08/2026 No 02/06/2026 PSUSA/00010726/202605 Karin Bolin Sweden CAP
10727 meropenem / vaborbactam 29/08/2017 3 years 28/08/2026 26/11/2026 No 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00010727/202608 Maria del Pilar Rayon Spain CAP
10728 brigatinib 28/04/2017 3 years 27/04/2026 26/07/2026 No 20/12/2023 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00010728/202604 Carla Torre Portugal CAP
10729 doravirine 30/08/2018 5 years 29/08/2030 27/11/2030 No 27/05/2026 DLP was corrected on 27/05/2026
PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00010729/203008 Ana Sofia Diniz Martins Portugal CAP
10730 tezacaftor / ivacaftor 12/02/2018 1 year 11/02/2026 22/04/2026 11/02/2027 22/04/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010730/202602 PSUSA/00010730/202702 Eamon O Murchu Ireland CAP
10731 doravirine / lamivudine / tenofovir disoproxil 30/08/2018 5 years 29/08/2030 27/11/2030 No 27/05/2026 DLP was corrected on 27/05/2026
PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00010731/203008 Ana Sofia Diniz Martins Portugal CAP
10732 damoctocog alfa pegol 29/08/2018 2 years 28/08/2027 26/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010732/202708 Bianca Mulder Netherlands CAP
10733 galcanezumab 27/09/2018 3 years 27/09/2026 26/12/2026 No 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00010733/202609 Terhi Lehtinen Finland CAP
10734 ceftobiprole 20/11/2013 3 years 19/11/2027 17/02/2028 No 02/06/2026 PSUSA/00010734/202711 Jenny Jönsson Sweden NAP
10735 valsartan / rosuvastatin 12/10/2016 3 years 11/10/2028 09/01/2029 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010735/202810 Polona Golmajer Slovenia NAP
10736 activated attapulgite mormoiron,
activated attapulgite / aluminium / pectin 30/03/1956 10 years 31/12/2026 31/03/2027 No 19/12/2018 New entry added on 19/12/18 PSUSA/00010736/202612 NAP
10737 influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 12/12/2018 1 year 15/03/2026 24/05/2026 15/03/2027 24/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010737/202603 PSUSA/00010737/202703 Dirk Mentzer Germany CAP
10738 mexiletine (centrally authorised products only) 18/12/2018 3 years 17/12/2025 17/03/2026 No 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00010738/202512 Eva Jirsová Czech Republic CAP
10739 glycopyrronium bromide / formoterol 25/04/2016 3 years 24/04/2026 23/07/2026 No 20/12/2023 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00010739/202604 Jan Neuhauser Austria CAP
10741 mogamulizumab 30/03/2012 3 years 29/03/2026 27/06/2026 No 15/11/2023 PSUR frequency amended and DLP updated on 15/11/2023 PSUSA/00010741/202603 Marie Louise Schougaard Christiansen Denmark CAP
10742 voretigene neparvovec 19/12/2017 1 year 23/07/2026 01/10/2026 23/07/2027 01/10/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010742/202607 PSUSA/00010742/202707 Dirk Mentzer Germany CAP
10743 lanadelumab 23/08/2018 3 years 22/08/2026 20/11/2026 No 27/03/2024 PSUR frequency amended and DLP updated on 27/03/2024 PSUSA/00010743/202608 Terhi Lehtinen Finland CAP
10744 isopropyl alcohol , isopropyl alcohol (covers other synonymous terms such as 2-propanol) / benzalkonium 03/12/1982 10 years 02/12/2029 02/03/2030 No 04/02/2026 Active substance name was amended on 04/02/2026
Entry name updated on 22/10/2025
Entry name updated on 30/07/2025
New entry introduced on 06/03/2019 PSUSA/00010744/202912 none NAP
10745 apalutamide 14/02/2018 3 years 13/02/2028 13/05/2028 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00010745/202802 Tiphaine Vaillant France CAP
10746 macimorelin 11/01/2019 5 years 10/01/2030 10/04/2030 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00010746/203001 Liana Martirosyan Netherlands CAP NAP
10747 calcium dobesilate / lidocaine, 'calcium dobesilate / dexamethasone / lidocaine 30/12/1975 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010747/203503 NAP
10748 octenidine 18/07/2018 10 years 17/07/2035 15/10/2035 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00010748/203507 Petar Mas Croatia NAP
10749 argipressin 01/04/1979 3 years 31/03/2027 29/06/2027 Yes 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010749/202703 Terhi Lehtinen Finland NAP
10750 magnesium / pyridoxine 24/07/1991 13 years 23/07/2026 21/10/2026 No 18/11/2025 New entry introduced on 06/03/2019 PSUSA/00010750/202607 Guðrún Stefánsdóttir Iceland NAP
10753 naldemedine 23/03/2017 2 years 22/03/2026 20/06/2026 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010753/202603 Eamon O Murchu Ireland CAP
10754 amidotrizoic acid and combination 05/03/1956 11 years 01/12/2036 01/03/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010754/203612 Karin Erneholm Denmark NAP
10755 lusutrombopag 28/09/2015 3 years 27/09/2026 26/12/2026 No 02/06/2026 PSUSA/00010755/202609 Mari Thorn Sweden CAP
10756 ropeginterferon alfa-2b 15/02/2019 3 years 14/02/2026 15/05/2026 No 18/10/2023 PSUR frequency amended and DLP updated on 18/10/2023 PSUSA/00010756/202602 Carla Torre Portugal CAP
10757 dacomitinib 27/09/2018 3 years 26/09/2027 25/12/2027 No 03/05/2023 PSUR frequency amended and DLP updated on 03/05/2023
DLP was updated on 25/05/2022
DLP was updated on 17/11/2021
PSUR frequency and DLP were updated on 26/05/2021
DLP was updated on 18/11/2020
DLP was updated on 06/05/2020
New CAP authorised on 02/04/2019 PSUSA/00010757/202709 Bianca Mulder Netherlands CAP
10758 fremanezumab 14/09/2018 3 years 13/09/2026 12/12/2026 No 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00010758/202609 Terhi Lehtinen Finland CAP
10759 infliximab 16/11/2000 3 years 23/08/2028 21/11/2028 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010759/202808 Karin Bolin Sweden CAP
10760 lorlatinib 21/09/2018 1 year 20/09/2026 29/11/2026 20/09/2027 29/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010760/202609 PSUSA/00010760/202709 Barbara Kovacic Bytyqi Croatia CAP
10761 pegvaliase 24/05/2018 3 years 23/05/2028 21/08/2028 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010761/202805 Rhea Fitzgerald Ireland CAP
10762 volanesorsen 03/05/2019 6 months 02/05/2026 11/07/2026 02/11/2026 11/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010762/202605 PSUSA/00010762/202611 Dennis Lex Germany CAP
10763 zanamivir (centrally authorised products only) 09/02/1999 3 years 31/01/2027 01/05/2027 No 02/06/2026 PSUSA/00010763/202701 Karin Bolin Sweden CAP
10764 andexanet alfa 26/04/2019 6 months 25/04/2026 04/07/2026 25/10/2026 03/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010764/202604 PSUSA/00010764/202610 Bianca Mulder Netherlands CAP
10765 risankizumab 26/03/2019 5 years 25/03/2030 23/06/2030 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00010765/203003 Liana Martirosyan Netherlands CAP
10767 levofloxacin (intravenous and oral use) 01/10/1993 3 years 01/10/2026 30/12/2026 No 05/06/2024 PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00010767/202610 Dennis Lex Germany NAP
10768 levofloxacin (ocular use) 01/10/1993 5 years 01/10/2028 30/12/2028 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00010768/202810 Dennis Lex Germany NAP
10771 anthrax vaccine 06/01/1994 3 years 31/12/2027 30/03/2028 No 06/10/2025 DLP was amended on 24/09/2025 PSUSA/00010771/202712 Dirk Mentzer Germany NAP
10772 metergoline 15/01/1990 5 years 31/08/2028 29/11/2028 No 03/07/2019 Lead MS and PRAC reperesentative were updated on 21/12/2022
New entry added on 03/07/2019 PSUSA/00010772/202808 Amelia Cupelli Italy NAP
10774 amlodipine / ramipril, amlodipine / hydrochlorothiazide / ramipril, hydrochlorothiazide / ramipril 31/03/2012 3 years 31/03/2027 29/06/2027 No 22/10/2025 Active substance name was amended on 22/10/2025
DLP was amended on 18/12/2024 PSUSA/00010774/202703 Jan Neuhauser Austria NAP
10775 ursodeoxycholic acid, tauroursodeoxycholic acid 27/11/1979 10 years 30/11/2026 28/02/2027 No 08/04/2026 Entry name updated on 03/07/2019 PSUSA/00010775/202611 Benjamin Micallef Malta NAP
10776 pramocaine, hydrocortisone / pramocaine 12/12/1965 11 years 02/12/2039 01/03/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010776/203912 NAP
10777 treosulfan (for centrally authorised product) 20/06/2019 3 years 19/06/2026 17/09/2026 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00010777/202606 Julia Pallos Hungary CAP
10779 avatrombopag 21/05/2018 3 years 20/05/2027 18/08/2027 No 19/09/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010779/202705 Maria Martinez Gonzalez Spain CAP
10780 cemiplimab 28/09/2018 2 years 27/09/2026 26/12/2026 No 03/05/2023 PSUR frequency amended and DLP updated on 03/05/2023
PSUR frequency corrected on 21/12/2022
DLP was updated on 25/05/2022
PSUR frequency corrected on 30/03/2022
DLP was updated on 17/11/2021
PSUR frequency and DLP were updated on 26/05/2021
DLP was updated on 18/11/2020
DLP was updated on 06/05/2020
New CAP authorised on 28/06/2019 PSUSA/00010780/202609 Bianca Mulder Netherlands CAP
10781 talazoparib 16/10/2018 3 years 15/10/2027 13/01/2028 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00010781/202710 Carla Torre Portugal CAP
10782 turoctocog alfa pegol 20/06/2019 3 years 19/06/2027 17/09/2027 No 06/10/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010782/202706 Dirk Mentzer Germany CAP
10783 adalimumab 08/09/2003 3 years 31/12/2025 31/03/2026 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00010783/202512 Karin Bolin Sweden CAP
10784 ertugliflozin / metformin, ertugliflozin / sitagliptin, ertugliflozin 19/12/2017 2 years 18/12/2025 18/03/2026 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010784/202512 Bianca Mulder Netherlands CAP
10785 angiotensin II 21/12/2017 2 years 20/12/2025 20/03/2026 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00010785/202512 Bianca Mulder Netherlands CAP
10786 l-lysine hydrochloride / l-arginine hydrochloride 25/07/2019 3 years 24/07/2026 22/10/2026 Yes 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 PSUSA/00010786/202607 Adam Przybylkowski Poland CAP
10787 ravulizumab 01/01/2019 3 years 31/12/2027 30/03/2028 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00010787/202712 Kimmo Jaakkola Finland CAP
10788 technetium (99mtc) N,N'-ethylene-(L,L)-dicysteine 28/09/2010 15 years 27/09/2033 26/12/2033 Yes 25/09/2019 New entry added on 25/09/2019 PSUSA/00010788/203309 NAP
10789 technetium (99mtc) 3,3-diphosphono-1,2-propanedicarboxylic acid 31/01/1995 15 years 30/01/2032 29/04/2032 Yes 25/09/2019 New entry added on 25/09/2019 PSUSA/00010789/203201 NAP
10790 aniracetam 20/08/1993 10 years 19/08/2031 17/11/2031 No 12/09/2025 PSUR frequency and DLP were updated on 28/04/2022
PRAC representative and LMS were added on 03/02/2021
New entry added on 25/09/2019 PSUSA/00010790/203108 Veronika Macurová Czech Republic NAP
10791 bovine lung phospholipid 22/12/1989 5 years 30/06/2026 28/09/2026 Yes 28/10/2025 PSUR frequency and DLP were updated on 02/03/2022
PRAC representative and LMS were added on 18/11/2020
New entry added on 25/09/2019 PSUSA/00010791/202606 Kimmo Jaakkola Finland NAP
10792 cod-liver oil (oral and parental use) Not available* 15 years 01/01/2034 01/04/2034 Yes 25/09/2019 New entry added on 25/09/2019 PSUSA/00010792/203401 NAP
10793 cod-liver oil (topical use), cod-liver oil/zinc oxide Not available* 15 years 01/01/2034 01/04/2034 Yes 25/09/2019 New entry added on 25/09/2019 PSUSA/00010793/203401 NAP
10794 ispaghula husk, ispaghula husk / ispaghula seed, ispaghula husk / ispaghula seed / senna Tinnervelly pod, psyllium, psyllium husk, psyllium seed 13/09/1954 10 years 12/09/2034 11/12/2034 No 27/05/2026 Entry re-activated on 27/05/2026
Active substance name was updated on 21/10/2020
New entry added on 25/09/2019 PSUSA/00010794/203409 none NAP
10795 etanercept 03/02/2000 5 years 02/02/2028 02/05/2028 No 19/09/2025 New CAP authorised on 23/04/2026
PSUR frequency amended and DLP updated on 18/10/2023 PSUSA/00010795/202802 Maria Martinez Gonzalez Spain CAP
10796 botulinum toxin type A (for centrally authorised products only) 01/02/2019 3 years 31/01/2027 01/05/2027 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00010796/202701 Adam Przybylkowski Poland CAP
10798 cannabidiol (for centrally authorised products only) 25/06/2018 3 years 24/06/2027 22/09/2027 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010798/202706 Ana Sofia Diniz Martins Portugal CAP
10799 larotrectinib 26/11/2018 6 months 25/05/2026 03/08/2026 25/11/2026 03/02/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010799/202605 PSUSA/00010799/202611 Rugile Pilviniene Lithuania CAP
10800 ethanol extracts of: Iberis amara L., planta tota recens / Angelica archangelica L., radix / Matricaria recutita L., flos / Carum carvi L., fructus / Silybum marianum (L.) Gaertn., fructus / Melissa officinalis L., folium / Mentha piperita L., folium / Chelidonium majus L., herba / Glycyrrhiza glabra L., radix 23/01/1968 3 years 30/11/2026 28/02/2027 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00010800/202611 Dennis Lex Germany NAP
10801 poliovirus type 1 / poliovirus type 2 / poliovirus type 3 vaccine (oral, live, attenuated), poliovirus type 1 / poliovirus type 3 vaccine (oral, live, attenuated),poliovirus type 1 (oral, live, attenuated) vaccine, poliovirus type 2 (oral, live, attenuated) vaccine,poliovirus type 3 (oral, live, attenuated) vaccine 01/01/1964 3 years 26/07/2028 24/10/2028 Yes 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00010801/202807 Jean-Michel Dogné Belgium NAP
10802 highly refined fish oil / glycerol / purified egg phosphatide 30/03/1998 5 years 29/03/2029 27/06/2029 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010802/202903 Polona Golmajer Slovenia NAP
10803 copper chloride dihydrate / manganese chloride tetrahydrate / potassium iodide / sodium fluoride / sodium selenite anhydrous / zinc chloride 05/02/1993 8 years 03/08/2033 01/11/2033 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00010803/203308 Rugile Pilviniene Lithuania NAP
10805 docusate, docusate/sorbitol 01/01/1976 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010805/203503 Zoubida Amimour France NAP
10806 rubidium (82Rb) chloride 22/11/2016 3 years 31/10/2026 29/01/2027 No 05/06/2024 PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00010806/202610 Dennis Lex Germany NAP
10807 thiamine / riboflavin/ pyridoxine / ascorbic acid / nicotinamide / glucose, thiamine / riboflavin / pyridoxine / ascorbic acid / nicotinamide, ascorbic acid / biotin / cyanocobalamin / folic acid / nicotinamide / pantothenic acid / pyridoxine hydrochloride / riboflavin / thiamine, riboflavin / thiamine / calcium folinate / cyanocobalamin / nicotinamide, calcium pantothenate / nicotinamide / pyridoxine / riboflavin / thiamine, dexpanthenol / nicotinamide / pyridoxine / riboflavin / thiamine, biotin / calcium pantothenate / cyanocobalamin / nicotinamide / pyridoxine / riboflavin / thiamine 27/09/1968 10 years 27/09/2027 26/12/2027 No 30/07/2025 Active substance name was amended on 30/07/2025
Active substance amended on 28/04/2022
Entry name was amended on 03/06/2020
EURD ID corrected on 05/02/2020
New entry following merge on 20/11/2019 PSUSA/00010807/202709 none NAP
10808 erythromycin (systemic use) 11/03/1954 3 years 11/03/2028 09/06/2028 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010808/202803 Eamon O'Murchu Ireland NAP
10809 erythromycin (topical use) 11/03/1954 5 years 11/03/2029 09/06/2029 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010809/202903 Eamon O'Murchu Ireland NAP
10810 lavender oil 26/06/2009 5 years 27/04/2028 26/07/2028 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00010810/202804 Guðrún Stefánsdóttir Iceland NAP
10811 valine / histidine / isoleucine / leucine / lysine / methionine / phenylalanine / threonine / tyrosine / tryptophan 19/04/1991 10 years 01/08/2028 30/10/2028 No 05/02/2020 New entry added on 05/02/2020 PSUSA/00010811/202808 NAP
10812 sodium thiosulfate (except centrally authorised products) 11/11/2003 10 years 30/09/2027 29/12/2027 No 28/06/2023 Active substance name was amended on 28/06/2023
New entry added on 05/02/2020 PSUSA/00010812/202709 none NAP
10813 inactivated leptospire vaccine 04/04/1979 5 years 30/11/2027 28/02/2028 No 19/09/2024 PSUSA/00010813/202711 Zoubida Amimour France NAP
10814 aviptadil / phentolamine mesilate 10/07/1998 5 years 28/02/2027 29/05/2027 No 16/11/2022 DLP was updated on 16/11/2022
PRAC Rapporteur name was amended on 28/04/2022
LMS and PRAC representative were added on 28/07/2021
New entry added on 05/02/2020 PSUSA/00010814/202702 Marie Louise Schougaard Christiansen Denmark NAP
10815 allergen for therapy: betula verrucosa (sublingual use) 02/07/2019 3 years 02/07/2026 30/09/2026 No 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 PSUSA/00010815/202607 Terhi Lehtinen Finland NAP
10816 lactic acid/oxalic acid / nitric acid / cupric nitrate/ acetic acid 27/09/1985 10 years 26/09/2029 25/12/2029 No 05/02/2020 New entry added on 05/02/2020 PSUSA/00010816/202909 NAP
10817 polatuzumab vedotin 10/06/2019 1 year 09/06/2026 18/08/2026 09/06/2027 18/08/2027 No 02/06/2026 PSUSA/00010817/202606 PSUSA/00010817/202706 Jenny-Maria Jönsson Sweden CAP
10818 siponimod 26/03/2019 3 years 25/03/2027 23/06/2027 No 20/11/2024 PSUR frequency amended and DLP updated on 20/11/2024 PSUSA/00010818/202703 Maria del Pilar Rayon Spain CAP
10819 fostamatinib 17/04/2018 3 years 16/04/2028 15/07/2028 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00010819/202804 Bianca Mulder Netherlands CAP
10820 osilodrostat 09/01/2020 3 years 08/01/2027 08/04/2027 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00010820/202701 Maria del Pilar Rayon Spain CAP
10822 delafloxacin 19/06/2017 2 years 18/06/2026 16/09/2026 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010822/202606 Petar Mas Croatia CAP
10823 upadacitinib 16/08/2019 3 years 15/08/2028 13/11/2028 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00010823/202808 Petar Mas Croatia CAP
10824 romosozumab 08/01/2019 1 year 07/01/2026 18/03/2026 07/01/2027 18/03/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010824/202601 PSUSA/00010824/202701 Tiphaine Vaillant France CAP
10825 esketamine (for centrally authorised product only) 05/03/2019 3 years 04/03/2027 02/06/2027 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00010825/202703 Terhi Lehtinen Finland CAP
10826 glucagon (for centrally authorised product only) 24/07/2019 1 year 24/07/2026 02/10/2026 24/07/2027 02/10/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010826/202607 PSUSA/00010826/202707 Rhea Fitzgerald Ireland CAP
10827 levonorgestrel (for emergency contraception only) 09/05/1990 5 years 08/05/2030 06/08/2030 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010827/203005 Dennis Lex Germany NAP
10828 levonorgestrel (all indications except emergency contraception) 09/05/1990 3 years 08/05/2026 06/08/2026 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00010828/202605 Dennis Lex Germany NAP
10829 brolucizumab 07/10/2019 1 year 06/10/2026 15/12/2026 06/10/2027 15/12/2027 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00010829/202610 PSUSA/00010829/202710 Dirk Mentzer Germany CAP
10830 imipenem / cilastatin / relebactam 16/07/2019 3 years 15/07/2027 13/10/2027 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00010830/202707 Adam Przybylkowski Poland CAP
10831 solriamfetol 20/03/2019 3 years 19/03/2028 17/06/2028 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00010831/202803 Julia Pallos Hungary CAP NAP
10832 gilteritinib 21/09/2018 3 years 20/09/2027 19/12/2027 No 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00010832/202709 Dennis Lex Germany CAP
10833 enoxaparin 15/09/2016 3 years 03/04/2027 02/07/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010833/202704 Bianca Mulder Netherlands CAP NAP
10834 recombinant vesicular stomatitis virus - zaire ebolavirus vaccine (live) 11/11/2019 3 years 10/05/2028 08/08/2028 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00010834/202805 Liana Martirosyan Netherlands CAP
10835 allergen products for treatment: grass pollen, tree pollen, house dust mites, moulds, weed pollen, vertebrates, animal epithelia (except for hymenoptera venoms) single or mixes (subcutaneous use) 29/06/1984 8 years 31/07/2027 29/10/2027 No 01/04/2020 New entry added on 01/04/2020 PSUSA/00010835/202707 NAP
10836 human serum albumin (medical dilution) 25/11/1980 15 years 02/07/2035 30/09/2035 No 01/04/2020 New entry due to split on 01/04/2020 PSUSA/00010836/203507 NAP
10837 calcium carbonate/
magnesium carbonate/
simeticone 28/01/1988 10 years 01/01/2029 01/04/2029 No 01/04/2020 New entry added on 01/04/2020 PSUSA/00010837/202901 NAP
10839 givosiran 20/11/2019 1 year 19/05/2026 28/07/2026 19/05/2027 28/07/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010839/202605 PSUSA/00010839/202705 Dennis Lex Germany CAP
10840 remdesivir (Veklury) 07/05/2020 3 years 06/05/2028 04/08/2028 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00010840/202805 Eva Jirsová Czech Republic CAP
10841 bempedoic acid, bempedoic acid / ezetimibe 21/02/2020 3 years 20/02/2028 20/05/2028 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00010841/202802 Kimmo Jaakkola Finland CAP
10843 darolutamide 30/07/2019 1 year 30/07/2026 08/10/2026 30/07/2027 08/10/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010843/202607 PSUSA/00010843/202707 Jan Neuhauser Austria CAP
10844 dronabinol/cannabidiol 15/04/2005 5 years 14/04/2028 13/07/2028 No 20/12/2023 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00010844/202804 Liana Martirosyan Netherlands NAP
10847 lidocaine hydrochloride / neomycin sulfate / polymyxin b, lidocaine hydrochloride monohydrate / fludrocortisone acetate / neomycin sulfate / polymyxin b Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010847/202611 Tiphaine Vaillant France NAP
10848 onasemnogene abeparvovec 24/05/2019 1 year 23/05/2026 01/08/2026 23/05/2027 01/08/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010848/202605 PSUSA/00010848/202705 Karin Bolin Sweden CAP
10849 cefiderocol 14/11/2019 3 years 13/11/2027 11/02/2028 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010849/202711 Dennis Lex Germany CAP
10850 indacaterol / mometasone furoate 30/05/2020 1 year 29/05/2026 07/08/2026 29/05/2027 07/08/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010850/202605 PSUSA/00010850/202705 Jan Neuhauser Austria CAP
10851 isatuximab 02/03/2020 2 years 01/03/2027 30/05/2027 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010851/202703 Maria Martinez Gonzalez Spain CAP
10852 ozanimod 20/05/2020 3 years 19/05/2028 17/08/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010852/202805 Maria del Pilar Rayon Spain CAP
10853 drospirenone 12/11/2019 3 years 12/11/2027 10/02/2028 No 02/06/2026 PSUSA/00010853/202711 Jenny Jönsson Sweden NAP
10854 dexamethasone / netilmicin 08/04/2006 5 years 08/04/2026 07/07/2026 No 22/12/2021 DLP was updated on 22/12/2021
PRAC representative and LMS were added on 23/09/2020
New entry added on 29/07/2020 PSUSA/00010854/202604 Dennis Lex Germany NAP
10855 hydrocortisone (systemic formulations except for products indicated in adrenal insufficiency in a modified release tablet formulation and except for centrally authorised products for adrenal insufficiency in paediatric use only) 05/08/1952 5 years 31/08/2029 29/11/2029 No 25/06/2025 Active substance name was corrected on 25/06/2025
DLP was amended on 30/04/2025 PSUSA/00010855/202908 Barbara Kovacic Bytyqi Croatia NAP
10856 hydrocortisone (all formulations apart from systemic use) 05/08/1952 5 years 31/08/2029 29/11/2029 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00010856/202908 Barbara Kovacic Bytyqi Croatia NAP
10857 ebola vaccine (Ad26.ZEBOV-GP [recombinant], MVA-BN-Filo [recombinant]) 27/09/2019 1 year 26/09/2026 05/12/2026 26/09/2027 05/12/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010857/202609 PSUSA/00010857/202709 Jean-Michel Dogné Belgium CAP
10859 glasdegib 21/11/2018 3 years 20/11/2027 18/02/2028 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010859/202711 Bianca Mulder Netherlands CAP
10860 luspatercept 25/06/2020 1 year 24/06/2026 02/09/2026 24/06/2027 02/09/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010860/202606 PSUSA/00010860/202706 Jo Robays Belgium CAP
10861 indacaterol / glycopyrronium / mometasone 03/07/2020 1 year 02/07/2026 10/09/2026 02/07/2027 10/09/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010861/202607 PSUSA/00010861/202707 Jan Neuhauser Austria CAP
10862 cholera vaccine, oral, live 10/06/2016 3 years 09/06/2028 07/09/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010862/202806 Jean-Michel Dogné Belgium CAP
10863 pretomanid 14/08/2019 1 year 13/08/2026 22/10/2026 13/08/2027 22/10/2027 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00010863/202608 PSUSA/00010863/202708 Liana Martirosyan Netherlands CAP
10864 iron sucrose (parenteral use) 06/12/1949 3 years 01/01/2027 01/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010864/202701 Zane Neikena Latvia NAP
10865 ferric carboxymaltose (parenteral use) 06/12/1949 3 years 01/01/2027 01/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010865/202701 Zane Neikena Latvia NAP
10866 ferric derisomaltose (parenteral use) 06/12/1949 3 years 01/01/2027 01/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010866/202701 Zane Neikena Latvia NAP
10867 sodium iron gluconate (parenteral use) 06/12/1949 3 years 01/01/2027 01/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010867/202701 Zane Neikena Latvia NAP
10868 ivacaftor / tezacaftor / elexacaftor 21/10/2019 1 year 20/10/2026 29/12/2026 20/10/2027 29/12/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010868/202610 PSUSA/00010868/202710 Dennis Lex Germany CAP
10869 belantamab mafodotin 17/04/2025 6 months 16/04/2026 25/06/2026 16/10/2026 25/12/2026 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010869/202604 PSUSA/00010869/202610 Ulla Wändel Liminga Sweden CAP
10870 imlifidase 25/08/2020 6 months 25/02/2026 06/05/2026 25/08/2026 03/11/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00010870/202602 PSUSA/00010870/202608 Bianca Mulder Netherlands CAP
10871 alpelisib 24/05/2019 3 years 23/05/2028 21/08/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010871/202805 Bianca Mulder Netherlands CAP
10872 lefamulin 19/08/2019 3 years 18/08/2028 16/11/2028 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00010872/202808 Eva Jirsová Czech Republic CAP
10873 bulevirtide 31/07/2020 1 year 30/07/2026 08/10/2026 30/07/2027 08/10/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010873/202607 PSUSA/00010873/202707 Adam Przybylkowski Poland CAP
10874 entrectinib 18/06/2019 6 months 17/12/2025 25/02/2026 17/06/2026 26/08/2026 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010874/202512 PSUSA/00010874/202606 Bianca Mulder Netherlands CAP
10875 sodium oleate 06/09/1956 13 years 01/01/2033 01/04/2033 No 21/10/2020 New entry added on 21/10/2020 PSUSA/00010875/203301 NAP
10876 amlodipine/irbesartan 14/06/2020 5 years 14/06/2030 12/09/2030 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010876/203006 Maia Uusküla Estonia NAP
10877 leuprorelin (depot formulations) 31/07/1984 2 years 31/07/2027 29/10/2027 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00010877/202707 Amelia Cupelli Italy CAP NAP
10878 avapritinib 09/01/2020 6 months 08/01/2026 19/03/2026 08/07/2026 16/09/2026 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010878/202601 PSUSA/00010878/202607 Bianca Mulder Netherlands CAP
10879 filgotinib 24/09/2020 1 year 23/09/2026 02/12/2026 23/09/2027 02/12/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010879/202609 PSUSA/00010879/202709 Petar Mas Croatia CAP
10881 levofloxacin/dexamethasone (ocular use) 13/06/2020 3 years 12/06/2028 10/09/2028 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010881/202806 Amelia Cupelli Italy NAP
10882 amikacin (centrally authorised product only) 28/09/2018 1 year 27/09/2026 06/12/2026 27/09/2027 06/12/2027 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00010882/202609 PSUSA/00010882/202709 Jean-Michel Dogné Belgium CAP
10883 carvedilol / ivabradine 25/04/2005 3 years 25/04/2028 24/07/2028 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00010883/202804 Bianca Mulder Netherlands NAP
10884 lumasiran 19/11/2020 2 years 18/11/2026 16/02/2027 No 02/06/2026 PSUSA/00010884/202611 Karin Bolin Sweden CAP
10886 quadrivalent influenza vaccine (recombinant, prepared in cell culture) 16/01/2013 1 year 15/01/2026 26/03/2026 15/01/2027 26/03/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010886/202601 PSUSA/00010886/202701 Zoubida Amimour France CAP
10887 acalabrutinib 31/10/2017 1 year 30/10/2026 08/01/2027 30/10/2027 08/01/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010887/202610 PSUSA/00010887/202710 Barbara Kovacic Bytyqi Croatia CAP
10889 bupivacaine (liposomal formulations) 28/10/2011 1 year 27/10/2026 05/01/2027 27/10/2027 05/01/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010889/202610 PSUSA/00010889/202710 Eamon O Murchu Ireland CAP
10890 serenoa repens 26/06/1981 5 years 26/06/2026 24/09/2026 No 28/10/2025 New entry added on 03/02/2021 PSUSA/00010890/202606 Gudrun Stefansdottir Iceland NAP
10891 methacholine 31/10/1986 5 years 31/10/2028 29/01/2029 No 12/09/2025 DLP was amended on 03/07/2024 PSUSA/00010891/202810 Veronika Macurová Czech Republic NAP
10892 ascorbic acid / acid folic / alfa-tocopherol / biotin / cholecalciferol / cyanocobalamin / nicotinamide / pantothenic acid / pyridoxine hydrochloride / retinol / riboflavin / thiamine 22/01/2001 8 years 22/01/2029 22/04/2029 No 28/04/2022 Active substance and DLP amended on 28/04/2022
New entry added on 03/02/2021 PSUSA/00010892/202901 NAP
10893 acetylsalicylic acid/rosuvastatin 26/06/2020 5 years 26/06/2028 24/09/2028 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00010893/202806 Polona Golmajer Slovenia NAP
10894 trastuzumab deruxtecan 20/12/2019 6 months 19/12/2025 27/02/2026 19/06/2026 28/08/2026 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010894/202512 PSUSA/00010894/202606 Carla Torre Portugal CAP
10895 baloxavir marboxil 23/02/2018 3 years 22/02/2028 22/05/2028 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00010895/202802 Sonja Radowan Austria CAP
10896 tagraxofusp 21/12/2018 2 years 20/12/2025 20/03/2026 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024
DLP was amended on 31/07/2024 PSUSA/00010896/202512 Bianca Mulder Netherlands CAP
10897 COVID-19 mRNA vaccine (Spikevax) 18/12/2020 2 years 17/12/2026 17/03/2027 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00010897/202612 Marie Louise Schougaard Christiansen Denmark CAP
10898 COVID-19 mRNA vaccine (Comirnaty) 19/12/2020 2 years 18/12/2026 18/03/2027 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00010898/202612 Liana Martirosyan Netherlands CAP
10899 atidarsagene autotemcel 17/12/2020 3 years 16/12/2027 15/03/2028 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025
DLP was amended on 30/07/2025 PSUSA/00010899/202712 Dirk Mentzer Germany CAP
10900 cabotegravir (for treatment of human immunodeficiency virus type 1 (HIV-1) 18/03/2020 1 year 17/03/2026 26/05/2026 17/03/2027 26/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010900/202603 PSUSA/00010900/202703 Dennis Lex Germany CAP
10901 rilpivirine (for intramuscular use) 18/03/2020 1 year 17/03/2026 26/05/2026 17/03/2027 26/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010901/202603 PSUSA/00010901/202703 Liana Martirosyan Netherlands CAP
10902 defatted powder of Arachis hypogaea L., semen (peanuts) 31/01/2020 3 years 30/01/2028 29/04/2028 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00010902/202801 Terhi Lehtinen Finland CAP
10903 brexucabtagene autoleucel 24/07/2020 6 months 23/01/2026 03/04/2026 23/07/2026 01/10/2026 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010903/202601 PSUSA/00010903/202607 Bianca Mulder Netherlands CAP
10904 inclisiran 09/12/2020 1 year 31/12/2025 11/03/2026 31/12/2026 11/03/2027 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010904/202512 PSUSA/00010904/202612 Kimmo Jaakkola Finland CAP
10905 latanoprost / netarsudil 07/01/2021 3 years 17/06/2028 15/09/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010905/202806 Adam Przybylkowski Poland CAP
10906 pertuzumab / trastuzumab 29/06/2020 1 year 28/06/2026 06/09/2026 28/06/2027 06/09/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010906/202606 PSUSA/00010906/202706 Dirk Mentzer Germany CAP
10907 fenfluramine 25/06/2020 2 years 24/06/2027 22/09/2027 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010907/202706 Dennis Lex Germany CAP
10908 formoterol fumarate dihydrate / glycopyrronium bromide / budesonide 18/06/2019 1 year 17/06/2026 26/08/2026 17/06/2027 26/08/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010908/202606 PSUSA/00010908/202706 Jan Neuhauser Austria CAP
10909 fedratinib 16/08/2019 1 year 15/02/2026 26/04/2026 15/02/2027 26/04/2027 No 29/04/2026 PSUR frequency amended and DLP updated on 29/04/2026
DLP was amended on 01/04/2026 PSUSA/00010909/202602 PSUSA/00010909/202702 Sonja Radowan Austria CAP
10911 fostemsavir 04/02/2021 3 years 03/02/2027 04/05/2027 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00010911/202702 Liana Martirosyan Netherlands CAP
10913 oxytocin (systemic use) 02/06/1955 3 years 30/06/2026 28/09/2026 Yes 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00010913/202606 Karen Pernille Harg Norway NAP
10914 oxytocin (nasal spray) 02/06/1955 3 years 30/06/2026 28/09/2026 Yes 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00010914/202606 Karen Pernille Harg Norway NAP
10915 Rosuvastatin/ Omega-3-acid ethyl esters 15/01/2020 5 years 14/01/2030 14/04/2030 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010915/203001 Bianca Mulder Netherlands NAP
10917 selpercatinib 08/05/2020 6 months 08/05/2026 17/07/2026 08/11/2026 17/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010917/202605 PSUSA/00010917/202611 Bianca Mulder Netherlands CAP
10918 tucatinib 17/04/2020 1 year 16/04/2026 25/06/2026 16/04/2027 25/06/2027 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010918/202604 PSUSA/00010918/202704 Jean-Michel Dogné Belgium CAP
10919 hepatitis B surface antigen, CpG 1018 adjuvant 09/11/2017 3 years 08/11/2027 06/02/2028 No 06/10/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010919/202711 Dirk Mentzer Germany CAP
10920 somapacitan 28/08/2020 3 years 31/08/2027 29/11/2027 No 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00010920/202708 Dennis Lex Germany CAP
10921 cenobamate 21/11/2019 1 year 26/09/2026 05/12/2026 26/09/2027 05/12/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010921/202609 PSUSA/00010921/202709 Jo Robays Belgium CAP
10922 icosapent ethyl 26/07/2012 3 years 25/07/2027 23/10/2027 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00010922/202707 Bianca Mulder Netherlands CAP
10923 pemigatinib 17/04/2020 1 year 16/04/2026 25/06/2026 16/04/2027 25/06/2027 No 17/12/2025 DLP was amended on 17/12/2025
DLP was amended on 19/11/2025 PSUSA/00010923/202604 PSUSA/00010923/202704 Bianca Mulder Netherlands CAP
10924 remimazolam 23/01/2020 1 year 22/07/2026 30/09/2026 22/07/2027 30/09/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010924/202607 PSUSA/00010924/202707 Eamon O Murchu Ireland CAP
10925 risdiplam 07/08/2020 1 year 06/08/2026 15/10/2026 06/08/2027 15/10/2027 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00010925/202608 PSUSA/00010925/202708 Jan Neuhauser Austria CAP
10926 selinexor 26/03/2021 3 years 25/03/2028 23/06/2028 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00010926/202803 Bianca Mulder Netherlands CAP
10927 ofatumumab 26/03/2021 1 year 25/09/2026 04/12/2026 25/09/2027 04/12/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010927/202609 PSUSA/00010927/202709 Amelia Cupelli Italy CAP
10928 salmeterol / fluticasone propionate (for centrally authorised products) 27/01/2017 3 years 27/01/2028 26/04/2028 No 19/11/2025 Correction of DLP on 19/11/2025
PSUR frequency amended and DLP updated on 22/10/2025
DLP was amended on 24/09/2025 PSUSA/00010928/202801 Amelia Cupelli Italy CAP
10929 trifarotene 04/10/2019 3 years 03/10/2027 01/01/2028 No 29/06/2022 Next DLP was updated on 31/05/2023 PSUSA/00010929/202710 Karin Bolin Sweden NAP
10930 berotralstat 03/12/2020 3 years 02/12/2027 01/03/2028 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00010930/202712 Julia Pallos Hungary CAP
10931 dostarlimab 21/04/2021 1 year 20/04/2026 29/06/2026 20/04/2027 29/06/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010931/202604 PSUSA/00010931/202704 Carla Torre Portugal CAP
10932 potassium citrate / potassium hydrogen carbonate 30/04/2021 3 years 29/04/2028 28/07/2028 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00010932/202804 Adam Przybylkowski Poland CAP
10933 lidocaine (topical use) 01/10/1948 8 years 30/09/2028 29/12/2028 No 30/06/2021 New active substance added on 30/06/2021 following split of previous entry PSUSA/00010933/202809 NAP
10934 lidocaine (systemic use) 01/10/1948 8 years 30/09/2028 29/12/2028 No 30/06/2021 New active substance added on 30/06/2021 following split of previous entry PSUSA/00010934/202809 NAP
10936 selumetinib 10/04/2020 6 months 09/04/2026 18/06/2026 09/10/2026 18/12/2026 No 02/06/2026 PSUSA/00010936/202604 PSUSA/00010936/202610 Karin Bolin Sweden CAP
10937 tralokinumab 17/06/2021 1 year 16/12/2025 24/02/2026 16/12/2026 24/02/2027 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010937/202512 PSUSA/00010937/202612 Kimmo Jaakkola Finland CAP NAP
10938 drospirenone / estetrol 19/05/2021 1 year 19/05/2026 28/07/2026 19/05/2027 28/07/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010938/202605 PSUSA/00010938/202705 Dennis Lex Germany CAP
10940 ponesimod 18/03/2021 2 years 17/03/2027 15/06/2027 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00010940/202703 Karin Erneholm Denmark CAP
10941 setmelanotide 25/11/2020 1 year 24/11/2026 02/02/2027 24/11/2027 02/02/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010941/202611 PSUSA/00010941/202711 Miroslava Gocova Slovakia CAP
10942 relugolix / estradiol / norethisterone acetate 26/05/2021 3 years 25/05/2028 23/08/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010942/202805 Dennis Lex Germany CAP
10943 tirbanibulin 14/12/2020 1 year 13/12/2025 21/02/2026 13/12/2026 21/02/2027 No 17/02/2026 DLP was amended on 30/07/2025 PSUSA/00010943/202512 PSUSA/00010943/202612 Jana Pecherova Slovakia CAP
10944 satralizumab (for centrally authorised products) 01/06/2020 1 year 31/05/2026 09/08/2026 31/05/2027 09/08/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010944/202605 PSUSA/00010944/202705 Jan Neuhauser Austria CAP
10945 evinacumab 11/02/2021 1 year 11/02/2026 22/04/2026 11/02/2027 22/04/2027 No 02/06/2026 DLP was amended on 24/09/2025 PSUSA/00010945/202602 PSUSA/00010945/202702 Karin Bolin Sweden CAP
10946 glycerol / urea 18/03/2021 13 years 17/03/2034 15/06/2034 No 28/07/2021 New entry added on 28/07/2021 PSUSA/00010946/203403 NAP
10947 telmisartan / indapamide 08/02/2021 5 years 07/02/2026 08/05/2026 No 20/06/2025 New entry added on 28/07/2021 PSUSA/00010947/202602 Carla Torre Portugal NAP
10949 odevixibat 16/07/2021 1 year 15/07/2026 23/09/2026 15/07/2027 23/09/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010949/202607 PSUSA/00010949/202707 Adam Przybylkowski Poland CAP NAP
10950 vericiguat 19/01/2021 1 year 18/01/2026 29/03/2026 18/01/2027 29/03/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010950/202601 PSUSA/00010950/202701 Kimmo Jaakkola Finland CAP
10951 tafasitamab 31/07/2020 6 months 30/01/2026 10/04/2026 30/07/2026 08/10/2026 No 02/06/2026 PSUSA/00010951/202601 PSUSA/00010951/202607 Jenny-Maria Jönsson Sweden CAP
10952 vosoritide 26/08/2021 1 year 25/08/2026 03/11/2026 25/08/2027 03/11/2027 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00010952/202608 PSUSA/00010952/202708 Zane Neikena Latvia CAP
10953 bimekizumab 20/08/2021 3 years 19/08/2027 17/11/2027 No 02/04/2025 PSUR frequency amended and DLP updated on 02/04/2025 PSUSA/00010953/202708 Liana Martirosyan Netherlands CAP
10954 idecabtagene vicleucel 26/03/2021 1 year 25/03/2026 03/06/2026 25/03/2027 03/06/2027 No 02/06/2026 PSUSA/00010954/202603 PSUSA/00010954/202703 Jenny-Maria Jönsson Sweden CAP
10955 roxadustat 17/12/2018 1 year 16/12/2025 24/02/2026 16/12/2026 24/02/2027 No 17/02/2026 DLP was amended on 30/07/2025 PSUSA/00010955/202512 PSUSA/00010955/202612 Jana Pecherova Slovakia CAP
10956 phentermine/ topiramate 17/07/2012 3 years 17/07/2027 15/10/2027 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00010956/202707 Karin Bolin Sweden NAP
10957 mometasone furoate/olopatadine 26/04/2021 3 years 25/04/2026 24/07/2026 No 02/06/2026 PSUSA/00010957/202604 Karin Bolin Sweden NAP
10958 artesunate 23/06/2020 2 years 22/06/2027 20/09/2027 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010958/202706 Dennis Lex Germany CAP
10959 sacituzumab govitecan 22/04/2020 3 years 21/04/2028 20/07/2028 No 18/12/2024 PSUR frequency amended and DLP updated on 18/12/2024
DLP was amended on 20/12/2023 PSUSA/00010959/202804 Bianca Mulder Netherlands CAP
10960 zanubrutinib 14/11/2019 1 year 13/11/2026 22/01/2027 13/11/2027 22/01/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010960/202611 PSUSA/00010960/202711 Bianca Mulder Netherlands CAP
10962 ripretinib 15/05/2020 1 year 14/05/2026 23/07/2026 14/05/2027 23/07/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010962/202605 PSUSA/00010962/202705 Barbara Kovacic Bytyqi Croatia CAP
10965 dexamethasone / tobramycin (systemic formulations) Not available* 5 years 31/03/2026 29/06/2026 No 19/10/2022 PRAC representative was updated on 19/10/2022
PRAC representative was updated on 27/07/2022
New entry due to splitting of entries on 22/12/2021 PSUSA/00010965/202603 Amelia Cupelli Italy NAP
10966 eptinezumab 21/02/2020 3 years 20/02/2028 20/05/2028 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00010966/202802 Liana Martirosyan Netherlands CAP
10967 avacopan 27/09/2021 1 year 26/09/2026 05/12/2026 26/09/2027 05/12/2027 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00010967/202609 PSUSA/00010967/202709 Liana Martirosyan Netherlands CAP
10968 glucarpidase 17/01/2012 3 years 16/07/2028 14/10/2028 No 01/04/2026 DLP was corrected on 01/04/2026
PSUR frequency amended and DLP updated on 04/03/2026 PSUSA/00010968/202807 Dennis Lex Germany CAP
10969 lonapegsomatropin 25/08/2021 3 years 25/08/2028 23/11/2028 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00010969/202808 Dennis Lex Germany CAP
10970 sotorasib 28/05/2021 6 months 27/05/2026 05/08/2026 27/11/2026 05/02/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010970/202605 PSUSA/00010970/202611 Marie Louise Schougaard Christiansen Denmark CAP
10971 tecovirimat 13/07/2018 1 year 12/01/2026 23/03/2026 12/01/2027 23/03/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010971/202601 PSUSA/00010971/202701 Dennis Lex Germany CAP
10972 COVID-19 Vaccine (recombinant, adjuvanted) (Nuvaxovid) 20/12/2021 1 year 19/12/2025 27/02/2026 19/12/2026 27/02/2027 No 01/07/2026 Active substance name was amended on 01/07/2026
DLP was amended on 30/07/2025 PSUSA/00010972/202512 PSUSA/00010972/202612 Dirk Mentzer Germany CAP
10974 pegcetacoplan 14/05/2021 1 year 13/11/2026 22/01/2027 13/11/2027 22/01/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010974/202611 PSUSA/00010974/202711 Kimmo Jaakkola Finland CAP
10975 pneumococcal polysaccharide conjugate vaccine (15 valent, adsorbed) 16/07/2021 1 year 15/01/2026 26/03/2026 15/01/2027 26/03/2027 No 06/10/2025 DLP was amended on 24/09/2025 PSUSA/00010975/202601 PSUSA/00010975/202701 Dirk Mentzer Germany CAP
10976 abrocitinib 08/09/2021 1 year 07/09/2026 16/11/2026 07/09/2027 16/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010976/202609 PSUSA/00010976/202709 Petar Mas Croatia CAP
10977 amivantamab 21/05/2021 1 year 20/05/2026 29/07/2026 20/05/2027 29/07/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010977/202605 PSUSA/00010977/202705 Dirk Mentzer Germany CAP
10978 finerenone 09/07/2021 1 year 08/07/2026 16/09/2026 08/07/2027 16/09/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010978/202607 PSUSA/00010978/202707 Bianca Mulder Netherlands CAP
10979 tepotinib 25/03/2020 1 year 24/03/2026 02/06/2026 24/03/2027 02/06/2027 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010979/202603 PSUSA/00010979/202703 Bianca Mulder Netherlands CAP
10980 anifrolumab 30/07/2021 1 year 29/07/2026 07/10/2026 29/07/2027 07/10/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010980/202607 PSUSA/00010980/202707 Liana Martirosyan Netherlands CAP
10981 pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) 08/06/2021 1 year 07/12/2025 15/02/2026 07/06/2026 16/08/2026 No 04/02/2026 PRAC Rapporteur name was amended on 04/02/2026
DLP was amended on 30/07/2025 PSUSA/00010981/202512 PSUSA/00010981/202606 Jean-Michel Dogné Belgium CAP
10982 somatrogon 26/10/2021 3 years 26/10/2027 24/01/2028 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010982/202710 Liana Martirosyan Netherlands CAP
10983 voxelotor 14/02/2022 6 months 13/02/2026 24/04/2026 13/08/2026 22/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00010983/202602 PSUSA/00010983/202608 Jo Robays Belgium CAP
10984 nirmatrelvir / ritonavir 31/12/2021 1 year 30/12/2025 10/03/2026 30/12/2026 10/03/2027 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010984/202512 PSUSA/00010984/202612 Dennis Lex Germany CAP
10986 sodium citrate (extracorporeal use) 22/10/1990 8 years 31/01/2031 01/05/2031 Yes 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00010986/203101 Polona Golmajer Slovenia NAP
10987 myristalkonium, benzalkonium (vaginal use only) 17/02/1986 13 years 01/01/2038 01/04/2038 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010987/203801 Lina Šeibokienė Lithuania NAP
10988 ascorbic acid / magnesium aspartate / leucine L / lysine L / phenylalanine L / valine L 09/11/2007 10 years 28/10/2034 26/01/2035 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010988/203410 Guðrún Stefánsdóttir Iceland NAP
10989 enfortumab vedotin 18/12/2019 1 year 17/12/2025 25/02/2026 17/12/2026 25/02/2027 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010989/202512 PSUSA/00010989/202612 Eva Jirsová Czech Republic CAP
10990 lisocabtagene maraleucel / lisocabtagene maraleucel 05/02/2021 1 year 04/02/2026 15/04/2026 04/02/2027 15/04/2027 No 06/10/2025 DLP was amended on 24/09/2025 PSUSA/00010990/202602 PSUSA/00010990/202702 Dirk Mentzer Germany CAP
10991 tebentafusp 25/01/2022 1 year 24/01/2026 04/04/2026 24/01/2027 04/04/2027 No 05/03/2025 Next DLP was updated on 05/03/2025
PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00010991/202601 PSUSA/00010991/202701 Bianca Mulder Netherlands CAP
10993 daridorexant 07/01/2022 1 year 06/01/2026 17/03/2026 06/01/2027 17/03/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010993/202601 PSUSA/00010993/202701 Ana Sofia Diniz Martins Portugal CAP
10994 relugolix 08/01/2019 1 year 07/01/2026 18/03/2026 07/01/2027 18/03/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010994/202601 PSUSA/00010994/202701 Karin Erneholm Denmark CAP
10995 difelikefalin 23/08/2021 2 years 22/08/2027 20/11/2027 No 02/06/2026 PSUSA/00010995/202708 Karin Bolin Sweden CAP
10996 inebilizumab 11/06/2020 1 year 10/06/2026 19/08/2026 10/06/2027 19/08/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010996/202606 PSUSA/00010996/202706 Amelia Cupelli Italy CAP
10997 rimegepant 27/02/2021 1 year 26/02/2026 07/05/2026 26/02/2027 07/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010997/202602 PSUSA/00010997/202702 Karin Erneholm Denmark CAP
10998 linzagolix choline 14/06/2022 1 year 05/05/2026 14/07/2026 05/05/2027 14/07/2027 No 30/07/2025 DLP was corrected on 30/07/2025
PSUR frequency amended and DLP updated on 25/06/2025
DLP was amended on 18/12/2024 PSUSA/00010998/202605 PSUSA/00010998/202705 Dennis Lex Germany CAP
10999 mosunetuzumab 03/06/2022 6 months 02/12/2025 10/02/2026 02/06/2026 11/08/2026 No 02/06/2026 PSUSA/00010999/202512 PSUSA/00010999/202606 Jenny-Maria Jönsson Sweden CAP
11000 ciltacabtagene autoleucel 28/02/2022 1 year 27/02/2026 08/05/2026 27/02/2027 08/05/2027 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00011000/202602 PSUSA/00011000/202702 Jo Robays Belgium CAP
11002 avalglucosidase alfa 06/08/2021 3 years 06/08/2027 04/11/2027 No 02/04/2025 PSUR frequency amended and DLP updated on 02/04/2025 PSUSA/00011002/202708 Liana Martirosyan Netherlands CAP
11003 olipudase alfa 28/03/2022 1 year 28/03/2026 06/06/2026 28/03/2027 06/06/2027 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00011003/202603 PSUSA/00011003/202703 Dennis Lex Germany CAP
11004 eladocagene exuparvovec 18/07/2022 1 year 16/06/2026 25/08/2026 16/06/2027 25/08/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00011004/202606 PSUSA/00011004/202706 Dirk Mentzer Germany CAP
11005 lonafarnib 20/11/2020 1 year 19/11/2026 28/01/2027 19/11/2027 28/01/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011005/202611 PSUSA/00011005/202711 Adam Przybylkowski Poland CAP
11006 eptacog beta (activated) 15/07/2022 2 years 14/07/2027 12/10/2027 No 29/04/2026 Correction of DLP on 29/04/2026
PSUR frequency amended and DLP updated on 04/03/2026 PSUSA/00011006/202707 Bianca Mulder Netherlands CAP
11007 budesonide (for centrally authorised products indicated for primary immunoglobulin A nephropathy only) 15/12/2021 1 year 14/12/2025 22/02/2026 14/12/2026 22/02/2027 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00011007/202512 PSUSA/00011007/202612 Marie Louise Schougaard Christiansen Denmark CAP
11008 asciminib 29/10/2021 1 year 28/04/2026 07/07/2026 28/04/2027 07/07/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00011008/202604 PSUSA/00011008/202704 Eva Jirsová Czech Republic CAP
11010 teclistamab 23/08/2022 6 months 22/02/2026 03/05/2026 22/08/2026 31/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011010/202602 PSUSA/00011010/202608 Veronika Macurova Czech Republic CAP
11011 lasmiditan 11/10/2019 1 year 11/10/2026 20/12/2026 11/10/2027 20/12/2027 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00011011/202610 PSUSA/00011011/202710 Jana Pecherova Slovakia CAP
11012 lenacapavir 17/08/2022 1 year 16/08/2026 25/10/2026 16/08/2027 25/10/2027 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011012/202608 PSUSA/00011012/202708 Ana Sofia Diniz Martins Portugal CAP
11013 melphalan, melphalan flufenamide 06/02/2022 3 years 06/02/2028 06/05/2028 No 01/07/2026 Active substance name was amended on 01/07/2026
Reference to CAP added on 27/05/2026
Reference to NAP added on 01/04/2026
Active substance name was amended on 01/04/2026
PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00011013/202802 Dennis Lex Germany CAP NAP
11014 efgartigimod alfa 17/12/2021 1 year 16/12/2025 24/02/2026 16/12/2026 24/02/2027 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00011014/202512 PSUSA/00011014/202612 Rhea Fitzgerald Ireland CAP
11015 tezepelumab 17/12/2021 1 year 16/12/2025 24/02/2026 16/12/2026 24/02/2027 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00011015/202512 PSUSA/00011015/202612 Eva Jirsová Czech Republic CAP
11016 faricimab 28/01/2022 1 year 27/01/2026 07/04/2026 27/01/2027 07/04/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00011016/202601 PSUSA/00011016/202701 Carla Torre Portugal CAP
11017 fosdenopterin 26/02/2021 1 year 25/02/2026 06/05/2026 25/02/2027 06/05/2027 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00011017/202602 PSUSA/00011017/202702 Dennis Lex Germany CAP
11018 nivolumab / relatlimab 18/03/2022 1 year 17/03/2026 26/05/2026 17/03/2027 26/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00011018/202603 PSUSA/00011018/202703 Dirk Mentzer Germany CAP
11019 tirzepatide 13/05/2022 1 year 13/05/2026 22/07/2026 13/05/2027 22/07/2027 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025
DLP was amended on 18/12/2024 PSUSA/00011019/202605 PSUSA/00011019/202705 Bianca Mulder Netherlands CAP
11020 voclosporin 22/01/2021 1 year 21/01/2026 01/04/2026 21/01/2027 01/04/2027 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025
DLP was amended on 05/03/2025 PSUSA/00011020/202601 PSUSA/00011020/202701 Adam Przybylkowski Poland CAP
11021 vutrisiran 13/06/2022 1 year 12/06/2026 21/08/2026 12/06/2027 21/08/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00011021/202606 PSUSA/00011021/202706 Liana Martirosyan Netherlands CAP
11022 capmatinib 06/05/2020 1 year 05/05/2026 14/07/2026 05/05/2027 14/07/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00011022/202605 PSUSA/00011022/202705 Carla Torre Portugal CAP
11023 sutimlimab 04/02/2022 1 year 04/02/2026 15/04/2026 04/02/2027 15/04/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00011023/202602 PSUSA/00011023/202702 Jan Neuhauser Austria CAP
11024 maribavir 23/11/2021 1 year 22/11/2026 31/01/2027 22/11/2027 31/01/2028 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00011024/202611 PSUSA/00011024/202711 Adam Przybylkowski Poland CAP
11025 mitapivat 17/02/2022 1 year 16/02/2026 27/04/2026 16/02/2027 27/04/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00011025/202602 PSUSA/00011025/202702 Adam Przybylkowski Poland CAP
11026 nirsevimab 31/10/2022 1 year 30/04/2026 09/07/2026 30/04/2027 09/07/2027 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025
DLP was amended on 18/12/2024 PSUSA/00011026/202604 PSUSA/00011026/202704 Kimmo Jaakkola Finland CAP
11027 loncastuximab tesirine 23/04/2021 6 months 22/04/2026 01/07/2026 22/10/2026 31/12/2026 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011027/202604 PSUSA/00011027/202610 Eva Jirsová Czech Republic CAP
11028 tabelecleucel 16/12/2022 1 year 15/12/2025 23/02/2026 15/12/2026 23/02/2027 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00011028/202512 PSUSA/00011028/202612 Amelia Cupelli Italy CAP
11029 abaloparatide 28/04/2017 1 year 27/04/2026 06/07/2026 27/04/2027 06/07/2027 No 01/04/2026 Correction of PSUR frequency on 01/04/2026
Correction of DLP on 04/02/2026
DLP was amended on 25/06/2025 PSUSA/00011029/202604 PSUSA/00011029/202704 Karin Erneholm Denmark CAP
11030 gozetotide 23/03/2022 1 year 22/03/2026 31/05/2026 22/03/2027 31/05/2027 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00011030/202603 PSUSA/00011030/202703 John Joseph Borg Malta CAP NAP
11031 lutetium (177LU) vipivotide tetraxetan 23/03/2022 1 year 22/03/2026 31/05/2026 22/03/2027 31/05/2027 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00011031/202603 PSUSA/00011031/202703 John Joseph Borg Malta CAP
11032 maralixibat 29/09/2021 6 months 28/03/2026 06/06/2026 28/09/2026 07/12/2026 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00011032/202603 PSUSA/00011032/202609 Adam Przybylkowski Poland CAP
11033 spesolimab 01/09/2022 6 months 01/03/2026 10/05/2026 01/09/2026 10/11/2026 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011033/202603 PSUSA/00011033/202609 Zoubida Amimour France CAP
11034 dengue tetravalent vaccine (live, attenuated) 19/08/2022 1 year 18/08/2026 27/10/2026 18/08/2027 27/10/2027 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011034/202608 PSUSA/00011034/202708 Liana Martirosyan Netherlands CAP
11036 octreotide (for centrally authorised products) 30/06/2025 6 months 01/12/2025 09/02/2026 01/06/2026 10/08/2026 No 24/09/2025 Correction of DLP on 24/09/2025
New CAP authorised on 30/06/2025 PSUSA/00011036/202512 PSUSA/00011036/202606 Eamon O Murchu Ireland CAP
11037 etranacogene dezaparvovec 22/11/2022 6 months 21/05/2026 30/07/2026 21/11/2026 30/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011037/202605 PSUSA/00011037/202611 Bianca Mulder Netherlands CAP
11038 tremelimumab 21/10/2022 1 year 30/04/2026 09/07/2026 30/04/2027 09/07/2027 No 28/05/2025 PSUR frequency amended and DLP updated on 28/05/2025
DLP was amended on 18/12/2024 PSUSA/00011038/202604 PSUSA/00011038/202704 David Olsen Norway CAP
11039 donepezil / memantine 27/07/2020 5 years 26/07/2028 24/10/2028 No 12/09/2025 DLP was amended on 27/03/2024 PSUSA/00011039/202807 Veronika Macurová Czech Republic NAP
11041 ramipril / bisoprolol 11/05/2022 7 years 22/10/2032 20/01/2033 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
New entry added on 03/05/2023 PSUSA/00011041/203210 Jana Pecherova Slovakia NAP
11042 meldonium 14/04/2003 8 years 13/04/2031 12/07/2031 Yes 03/05/2023 New entry added on 03/05/2023 PSUSA/00011042/203104 none NAP
11043 nifedipine / lidocaine 01/02/2004 10 years 03/03/2035 01/06/2035 Yes 03/05/2023 New entry added on 03/05/2023 PSUSA/00011043/203503 none NAP
11044 ipidacrine 12/05/2008 8 years 11/05/2031 09/08/2031 Yes 03/05/2023 New entry added on 03/05/2023 PSUSA/00011044/203105 none NAP
11045 COVID-19 Vaccine (recombinant, adjuvanted) (Bimervax) 30/03/2023 1 year 29/03/2026 07/06/2026 29/03/2027 07/06/2027 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00011045/202603 PSUSA/00011045/202703 Zane Neikena Latvia CAP
11046 deucravacitinib 09/09/2022 1 year 08/09/2026 17/11/2026 08/09/2027 17/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011046/202609 PSUSA/00011046/202709 Liana Martirosyan Netherlands CAP
11047 cipaglucosidase alfa 20/03/2023 1 year 19/03/2026 28/05/2026 19/03/2027 28/05/2027 No 02/06/2026 DLP was amended on 22/10/2025 PSUSA/00011047/202603 PSUSA/00011047/202703 Karin Bolin Sweden CAP
11048 ivosidenib 04/05/2023 1 year 03/05/2026 12/07/2026 03/05/2027 12/07/2027 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025
DLP was amended on 18/12/2024 PSUSA/00011048/202605 PSUSA/00011048/202705 Marie Louise Schougaard Christiansen Denmark CAP
11049 pegunigalsidase alfa 04/05/2023 3 years 03/11/2027 01/02/2028 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00011049/202711 Liana Martirosyan Netherlands CAP
11050 vadadustat 29/06/2020 1 year 28/12/2025 08/03/2026 28/06/2026 06/09/2026 No 04/03/2026 PSUR frequency corrected on 04/03/2026
DLP was amended on 04/02/2026 PSUSA/00011050/202512 PSUSA/00011050/202606 Eva Jirsová Czech Republic CAP
11051 niraparib / abiraterone acetate 19/04/2023 6 months 19/04/2026 28/06/2026 19/10/2026 28/12/2026 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011051/202604 PSUSA/00011051/202610 Jan Neuhauser Austria CAP
11052 ruxolitinib (for non-segmental vitiligo) 21/09/2021 1 year 20/09/2026 29/11/2026 20/09/2027 29/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011052/202609 PSUSA/00011052/202709 Adam Przybylkowski Poland CAP
11053 Insulin icodec 01/03/2024 6 months 28/02/2026 09/05/2026 28/08/2026 06/11/2026 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011053/202602 PSUSA/00011053/202608 Sonja Hrabcik Austria CAP
11054 iptacopan 05/12/2023 6 months 04/12/2025 12/02/2026 04/06/2026 13/08/2026 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00011054/202512 PSUSA/00011054/202606 Lina Seibokiene Lithuania CAP
11055 aztreonam / avibactam 22/04/2024 6 months 21/04/2026 30/06/2026 21/10/2026 30/12/2026 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011055/202604 PSUSA/00011055/202610 Lina Seibokiene Lithuania CAP
11056 danicopan 18/01/2024 1 year 17/01/2026 28/03/2026 17/01/2027 28/03/2027 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025
DLP was amended on 05/03/2025 PSUSA/00011056/202601 PSUSA/00011056/202701 Dennis Lex Germany CAP
11057 pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures), prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures) 31/01/2020 6 months 31/01/2026 11/04/2026 31/07/2026 09/10/2026 No 02/06/2026 PSUSA/00011057/202601 PSUSA/00011057/202607 Jenny Jönsson Sweden CAP
11058 chikungunya vaccine (live) 09/11/2023 6 months 08/05/2026 17/07/2026 08/11/2026 17/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011058/202605 PSUSA/00011058/202611 Dirk Mentzer Germany CAP
11059 retifanlimab 22/03/2023 6 months 21/03/2026 30/05/2026 21/09/2026 30/11/2026 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011059/202603 PSUSA/00011059/202609 Dirk Mentzer Germany CAP
11060 sparsentan 17/02/2023 1 year 16/02/2026 27/04/2026 16/02/2027 27/04/2027 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00011060/202602 PSUSA/00011060/202702 Dennis Lex Germany CAP
11061 capivasertib 16/11/2023 6 months 15/05/2026 24/07/2026 15/11/2026 24/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011061/202605 PSUSA/00011061/202611 Sonja Hrabcik Austria CAP
11062 efanesoctocog alfa 22/02/2023 1 year 22/02/2026 03/05/2026 22/02/2027 03/05/2027 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00011062/202602 PSUSA/00011062/202702 Amelia Cupelli Italy CAP
11063 dantrolene sodium hemiheptahydrate 29/05/2024 1 year 28/05/2026 06/08/2026 28/05/2027 06/08/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00011063/202605 PSUSA/00011063/202705 Liana Martirosyan Netherlands CAP NAP
11064 tofersen 25/04/2023 1 year 24/04/2026 03/07/2026 24/04/2027 03/07/2027 No 01/07/2026 New CAP authorised on 29/05/2024 PSUSA/00011064/202604 PSUSA/00011064/202704 Kimmo Jaakkola Finland CAP
11065 bevacizumab gamma 27/05/2024 1 year 26/05/2026 04/08/2026 26/05/2027 04/08/2027 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
DLP was amended on 04/02/2026 PSUSA/00011065/202605 PSUSA/00011065/202705 Karin Erneholm Denmark CAP
11066 dopamine hydrochloride 27/05/2024 6 months 26/05/2026 04/08/2026 26/11/2026 04/02/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011066/202605 PSUSA/00011066/202611 Maia Uusküla Estonia CAP
11067 aprocitentan 19/03/2024 1 year 18/03/2026 27/05/2026 18/03/2027 27/05/2027 No 29/04/2026 PSUR frequency amended and DLP updated on 29/04/2026
DLP was amended on 22/10/2025 PSUSA/00011067/202603 PSUSA/00011067/202703 Maria del Pilar Rayon Spain CAP
11068 vibegron 21/09/2018 6 months 20/03/2026 29/05/2026 20/09/2026 29/11/2026 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011068/202603 PSUSA/00011068/202609 Jan Neuhauser Austria CAP
11069 fruquintinib 04/09/2018 1 year 03/09/2026 12/11/2026 03/09/2027 12/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011069/202609 PSUSA/00011069/202709 Bianca Mulder Netherlands CAP
11071 crovalimab 06/02/2024 6 months 05/02/2026 16/04/2026 05/08/2026 14/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011071/202602 PSUSA/00011071/202608 Bianca Mulder Netherlands CAP
11072 erdafitinib 12/04/2019 1 year 11/04/2026 20/06/2026 11/04/2027 20/06/2027 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00011072/202604 PSUSA/00011072/202704 Bianca Mulder Netherlands CAP
11073 flortaucipir (18F) 28/05/2020 6 months 28/11/2025 06/02/2026 28/05/2026 06/08/2026 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00011073/202511 PSUSA/00011073/202605 Adam Przybylkowski Poland CAP
11074 odronextamab 22/08/2024 6 months 21/02/2026 02/05/2026 21/08/2026 30/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011074/202602 PSUSA/00011074/202608 Veronika Macurová Czech Republic CAP
11075 respiratory syncytial virus mRNA vaccine 31/05/2024 6 months 29/11/2025 07/02/2026 29/05/2026 07/08/2026 No 01/07/2026 Active substance name was amended on 01/07/2026
Next DLP was updated on 27/05/2026
DLP was amended on 04/02/2026 PSUSA/00011075/202511 PSUSA/00011075/202605 Jean-Michel Dogné Belgium CAP
11076 sotatercept 26/03/2024 6 months 25/03/2026 03/06/2026 25/09/2026 04/12/2026 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011076/202603 PSUSA/00011076/202609 Zoubida Amimour France CAP
11077 rADAMTS13 09/08/2024 1 year 08/05/2026 17/07/2026 08/05/2027 17/07/2027 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
DLP was amended on 25/06/2025 PSUSA/00011077/202605 PSUSA/00011077/202705 Maia Uusküla Estonia CAP
11080 sugemalimab 20/12/2021 6 months 19/12/2025 27/02/2026 19/06/2026 28/08/2026 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00011080/202512 PSUSA/00011080/202606 Petar Mas Croatia CAP
11081 epinephrine (for nasal use) 09/08/2024 6 months 08/02/2026 19/04/2026 08/08/2026 17/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011081/202602 PSUSA/00011081/202608 Terhi Lehtinen Finland CAP
11082 polihexanide 22/08/2024 6 months 21/02/2026 02/05/2026 21/08/2026 30/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011082/202602 PSUSA/00011082/202608 Adam Przybylkowski Poland CAP
11083 fluoroethyltyrosine (18F) 23/12/2015 3 years 23/12/2027 22/03/2028 Yes 25/09/2024 New entry added on 25/09/2024 PSUSA/00011083/202712 not yet assigned none NAP
11084 dienogest / ethinylestradiol (prolonged-release tablet) 13/03/2024 1 year 15/03/2026 24/05/2026 15/03/2027 24/05/2027 No 02/06/2026 PSUSA/00011084/202603 PSUSA/00011084/202703 Jenny Jönsson Sweden NAP
11085 valsartan / indapamide 10/05/2024 5 years 10/05/2029 08/08/2029 No 25/09/2024 New entry added on 25/09/2024 PSUSA/00011085/202905 not yet assigned none NAP
11086 isothipendyl 12/08/2011 10 years 12/08/2034 10/11/2034 No 25/09/2024 PSUSA/00011086/203408 not yet assigned none NAP
11087 methylprednisolone (topical use) 18/12/1957 5 years 30/11/2028 28/02/2029 No 25/09/2024 New entry added on 25/09/2024 PSUSA/00011087/202811 not yet assigned none NAP
11088 nifurtimox 08/01/1970 3 years 08/01/2026 08/04/2026 No 26/05/2025 New entry added on 23/10/2024 PSUSA/00011088/202601 Maria del Pilar Rayon Spain NAP
11089 allergen for therapy: Dactylis Glomerata L., Phleum Pratense L., Anthoxanthum Odoratum L., Lolium Perenne L., Poa Pratensis L. Salsola Kali L., Blomia Tropicalis, Zea Mays L., Fraxinus Excelsior L., Arrhenatherum Elatius, Cynodon Dactylon (L.) pers., latex, Festuca Pratensis Hudson, Parietaria Officinalis L., Cat Epithelia, Dog Epithelia, Triticum Aestivum, Dermatophagoides Farinae, Juniperus Ashei Buchholz, Hordeum Vulgare L., Alnus Glutinosa L., Agrostis Capillaris L., Corylus Avellana L., Secale Cereale L., Avena Fatua whole., Holcus Lanatus, Artemisia Vulgaris L., Olea Europaea L., Ambrosia Artemisiifolia, Dermatophagoides Pteronyssinus, Carpinus Betulus L., Avena Sativa L., Bromus Inermis whole, Parietaria Judaica L., Betula single or mixes (Staloral) 10/08/2004 8 years 10/08/2033 08/11/2033 No 23/10/2024 New entry added on 23/10/2024 PSUSA/00011089/203308 not yet assigned none NAP
11090 macitentan / tadalafil 14/10/2024 1 year 13/10/2026 22/12/2026 13/10/2027 22/12/2027 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00011090/202610 PSUSA/00011090/202710 Maria del Pilar Rayon Spain CAP
11091 delgocitinib 23/01/2020 1 year 22/01/2026 02/04/2026 22/01/2027 02/04/2027 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025
Reference to NAP added on 05/03/2025
New CAP authorised on 19/09/2024 PSUSA/00011091/202601 PSUSA/00011091/202701 Liana Martirosyan Netherlands CAP NAP
11092 elafibranor 10/06/2024 6 months 09/12/2025 17/02/2026 09/06/2026 18/08/2026 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00011092/202512 PSUSA/00011092/202606 Rugile Pilviniene Lithuania CAP
11094 toripalimab 17/12/2018 1 year 16/12/2025 24/02/2026 16/12/2026 24/02/2027 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026
DLP was amended on 30/07/2025 PSUSA/00011094/202512 PSUSA/00011094/202612 Karin Erneholm Denmark CAP
11095 zolbetuximab 26/03/2024 1 year 25/03/2026 03/06/2026 25/03/2027 03/06/2027 No 17/12/2025 DLP was amended on 17/12/2025
PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00011095/202603 PSUSA/00011095/202703 Bianca Mulder Netherlands CAP
11097 mirvetuximab soravtansine 14/11/2022 1 year 13/11/2026 22/01/2027 13/11/2027 22/01/2028 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
Correction of DLP on 18/12/2024
New CAP authorised on 14/11/2024 PSUSA/00011097/202611 PSUSA/00011097/202711 Maria del Pilar Rayon Spain CAP
11098 furazidine 24/10/2025 5 years 28/02/2026 29/05/2026 Yes 05/08/2025 New entry added on 18/12/2024 PSUSA/00011098/202602 Polona Golmajer Slovenia NAP
11099 magnesium chloride Not available* 20 years 02/09/2044 01/12/2044 Yes 18/12/2024 New entry added on 18/12/2024 PSUSA/00011099/204409 not yet assigned none NAP
11100 sodium acetate Not available* 20 years 02/09/2044 01/12/2044 Yes 18/12/2024 New entry added on 18/12/2024 PSUSA/00011100/204409 not yet assigned none NAP
11101 marstacimab 11/10/2024 1 year 10/04/2026 19/06/2026 10/04/2027 19/06/2027 No 01/07/2026 Correction of DLP on 01/07/2026
PSUR frequency amended and DLP updated on 27/05/2026
DLP was amended on 19/11/2025 PSUSA/00011101/202604 PSUSA/00011101/202704 Marie Louise Schougaard Christiansen Denmark CAP
11102 repotrectinib 15/11/2023 6 months 14/05/2026 23/07/2026 14/11/2026 23/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011102/202605 PSUSA/00011102/202611 Barbara Kovacic Bytyqi Croatia CAP
11103 vilobelimab 04/04/2023 1 year 03/04/2026 12/06/2026 03/04/2027 12/06/2027 No 27/05/2026 PSUR frequency amended and DLP updated on 27/05/2026
DLP was amended on 19/11/2025 PSUSA/00011103/202604 PSUSA/00011103/202704 Liana Martirosyan Netherlands CAP
11104 rdESAT-6 / rCFP-10 09/05/2022 6 months 08/05/2026 17/07/2026 08/11/2026 17/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011104/202605 PSUSA/00011104/202611 Sonja Hrabcik Austria CAP
11105 concizumab 10/03/2023 1 year 30/03/2026 08/06/2026 10/04/2027 19/06/2027 No 01/07/2026 Next DLP was updated on 01/07/2026
PSUR frequency amended and DLP updated on 27/05/2026
DLP was amended on 19/11/2025 PSUSA/00011105/202603 PSUSA/00011105/202704 Marie Louise Schougaard Christiansen Denmark CAP
11106 acoramidis 22/11/2024 6 months 21/05/2026 30/07/2026 21/11/2026 30/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011106/202605 PSUSA/00011106/202611 Rhea Fitzgerald Ireland CAP
11107 belzutifan 13/08/2021 6 months 12/02/2026 23/04/2026 12/08/2026 21/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011107/202602 PSUSA/00011107/202608 Dennis Lex Germany CAP
11108 catumaxomab 10/02/2025 6 months 09/02/2026 20/04/2026 09/08/2026 18/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011108/202602 PSUSA/00011108/202608 Bianca Mulder Netherlands CAP
11109 garadacimab 14/01/2025 6 months 13/01/2026 24/03/2026 13/07/2026 21/09/2026 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00011109/202601 PSUSA/00011109/202607 Marie Louise Schougaard Christiansen Denmark CAP
11110 lazertinib 21/05/2021 6 months 20/05/2026 29/07/2026 20/11/2026 29/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011110/202605 PSUSA/00011110/202611 Petar Mas Croatia CAP
11111 nemolizumab 28/03/2022 1 year 27/09/2026 06/12/2026 27/09/2027 06/12/2027 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00011111/202609 PSUSA/00011111/202709 Liana Martirosyan Netherlands CAP
11112 serplulimab 22/03/2022 6 months 21/03/2026 30/05/2026 21/09/2026 30/11/2026 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011112/202603 PSUSA/00011112/202609 Jan Neuhauser Austria CAP
11113 sipavibart 27/12/2024 1 year 26/12/2025 06/03/2026 26/12/2026 06/03/2027 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026
New CAP authorised on 20/01/2025 PSUSA/00011113/202512 PSUSA/00011113/202612 Kimmo Jaakkola Finland CAP
11114 tiratricol 12/02/2025 6 months 11/02/2026 22/04/2026 11/08/2026 20/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011114/202602 PSUSA/00011114/202608 Zoubida Amimour France CAP
11115 COVID-19 sa-mRNA Vaccine (Kostaive) 28/11/2023 1 year 27/11/2026 05/02/2027 27/11/2027 05/02/2028 No 01/07/2026 Active substance name was amended on 01/07/2026
DLP was amended on 04/02/2026 PSUSA/00011115/202611 PSUSA/00011115/202711 Dirk Mentzer Germany CAP
11117 imetelstat 06/06/2024 6 months 05/12/2025 13/02/2026 05/06/2026 14/08/2026 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00011117/202512 PSUSA/00011117/202606 Bianca Mulder Netherlands CAP
11118 chikungunya vaccine (recombinant, adsorbed) 14/02/2025 6 months 13/02/2026 24/04/2026 13/08/2026 22/10/2026 No 01/04/2026 DLP was amended on 01/04/2026
Active substance name was amended on 01/04/2026
Correction of EURD and DLP on 30/04/2025
New CAP authorised on 28/02/2025 PSUSA/00011118/202602 PSUSA/00011118/202608 Liana Martirosyan Netherlands CAP
11119 seladelpar lysine dihydrate 14/08/2024 6 months 13/02/2026 24/04/2026 13/08/2026 22/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011119/202602 PSUSA/00011119/202608 Amelia Cupelli Italy CAP
11120 eplontersen 21/12/2023 6 months 20/12/2025 28/02/2026 20/06/2026 29/08/2026 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00011120/202512 PSUSA/00011120/202606 Jan Neuhauser Austria CAP
11121 pneumococcal polysaccharide conjugate vaccine (21-valent) 17/06/2024 6 months 16/12/2025 24/02/2026 16/06/2026 25/08/2026 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00011121/202512 PSUSA/00011121/202606 Jean-Michel Dogné Belgium CAP
11122 indigo carmine 11/11/2003 13 years 10/11/2035 08/02/2036 Yes 02/04/2025 New entry added on 02/04/2025 PSUSA/00011122/203511 not yet assigned none NAP
11123 paraffin liquid / paraffin yellow soft 01/08/1977 12 years 28/12/2032 28/03/2033 Yes 25/06/2025 Active substance name was corrected on 25/06/2025
New entry added on 02/04/2025 PSUSA/00011123/203212 not yet assigned none NAP
11124 lactobacillus all subspecies and combinations of subspecies (intramuscular use) 14/07/1954 5 years 13/07/2029 11/10/2029 No 28/05/2025 PSUR frequency and DLP corrected on 28/05/2025
New entry added on 30/04/2025 PSUSA/00011124/202907 Dirk Mentzer Germany NAP
11127 tisotumab vedotin 20/09/2021 6 months 19/03/2026 28/05/2026 19/09/2026 28/11/2026 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011127/202603 PSUSA/00011127/202609 Jo Robays Belgium CAP
11129 datopotamab deruxtecan 27/12/2024 6 months 26/12/2025 06/03/2026 26/06/2026 04/09/2026 No 02/06/2026 PSUSA/00011129/202512 PSUSA/00011129/202606 Jenny Jönsson Sweden CAP
11130 linvoseltamab 23/04/2025 6 months 22/04/2026 01/07/2026 22/10/2026 31/12/2026 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011130/202604 PSUSA/00011130/202610 Veronika Macurová Czech Republic CAP
11131 beremagene geperpavec 19/05/2023 6 months 18/05/2026 27/07/2026 18/11/2026 27/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011131/202605 PSUSA/00011131/202611 Liana Martirosyan Netherlands CAP
11132 lecanemab 06/01/2023 6 months 05/01/2026 16/03/2026 05/07/2026 13/09/2026 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00011132/202601 PSUSA/00011132/202607 Eva Jirsová Czech Republic CAP
11133 CARBO VEGETABILIS C4, RESINA PICEAE C4, ROBINIA PSEUDOACACIA C4, STRYCHNOS NUX-VOMICA C4 19/12/2005 18 years 18/12/2043 17/03/2044 Yes 28/05/2025 New active substance added on 28/05/2025 PSUSA/00011133/204312 none none NAP
11134 cinitapride 13/12/1989 13 years 12/12/2036 12/03/2037 Yes 28/05/2025 New active substance added on 28/05/2025 PSUSA/00011134/203612 none none NAP
11135 magnesium sulfate heptahydrate, potassium chloride, xylitol, procaine hydrochloride 04/04/2024 3 years 03/04/2027 02/07/2027 No 28/05/2025 New entry added on 28/05/2025 PSUSA/00011135/202704 none none NAP
11136 ATROPA BELLA-DONNA C6 / VIBURNUM OPULUS C6 / CHELIDONIUM MAJUS C6 / ACONITUM NAPELLUS C6 / CALENDULA OFFICINALIS C6 / ABRUS PRECATORIUS C6 11/07/2008 18 years 10/07/2044 08/10/2044 Yes 28/05/2025 New active substance added on 28/05/2025 PSUSA/00011136/204407 None none NAP
11137 papain / trypsin / chymotrypsin 25/11/2013 10 years 24/11/2035 22/02/2036 No 28/05/2025 New entry added on 28/05/2025 PSUSA/00011137/203511 none none NAP
11138 populi cortex et folium, extractum / fraxini cortex, extractum / european goldenrod extract 12/03/2015 13 years 11/03/2035 09/06/2035 No 28/05/2025 New entry added on 28/05/2025 PSUSA/00011138/203503 none none NAP
11139 bencyclane 23/11/1966 13 years 22/11/2035 20/02/2036 No 28/05/2025 New entry added on 28/05/2025 PSUSA/00011139/203511 none none NAP
11140 ferric citrate coordination complex 11/06/2025 6 months 10/12/2025 18/02/2026 10/06/2026 19/08/2026 No 01/04/2026 Reference to NAP added on 01/04/2026
New CAP authorised on 25/06/2025 PSUSA/00011140/202512 PSUSA/00011140/202606 Kimmo Jaakkola Finland CAP NAP
11141 givinostat 20/12/2024 6 months 20/12/2025 28/02/2026 20/06/2026 29/08/2026 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00011141/202512 PSUSA/00011141/202606 Liana Martirosyan Netherlands CAP
11142 atropine (myopia indication) 31/08/1945 1 year 31/08/2026 09/11/2026 31/08/2027 09/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011142/202608 PSUSA/00011142/202708 Dennis Lex Germany CAP NAP
11143 candesartan / indapamide 11/09/2024 5 years 10/09/2029 09/12/2029 No 30/07/2025 New entry added on 30/07/2025 PSUSA/00011143/202909 not yet assigned none NAP
11144 amino acid combinations (only combinations of pure amino acids or combination of amino acids with mineral compounds / electrolytes, oral use) 18/10/2006 7 years 17/10/2026 15/01/2027 No 27/02/2026 New entry added on 30/07/2025 PSUSA/00011144/202610 Polona Golmajer Slovenia NAP
11145 sepiapterin 19/06/2025 6 months 19/12/2025 27/02/2026 19/06/2026 28/08/2026 No 30/07/2025 New CAP authorised on 19/06/2025 PSUSA/00011145/202512 PSUSA/00011145/202606 David Olsen Norway CAP
11146 deutivacaftor / tezacaftor / vanzacaftor 20/12/2024 6 months 19/12/2025 27/02/2026 19/06/2026 28/08/2026 No 30/07/2025 New CAP authorised on 30/06/2025 PSUSA/00011146/202512 PSUSA/00011146/202606 Dennis Lex Germany CAP
11147 zanidatamab 20/11/2024 6 months 19/05/2026 28/07/2026 19/11/2026 28/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011147/202605 PSUSA/00011147/202611 Jenny Jönsson Sweden CAP
11148 teprotumumab 21/01/2020 6 months 20/01/2026 31/03/2026 20/07/2026 28/09/2026 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00011148/202601 PSUSA/00011148/202607 Sonja Radowan Austria CAP
11149 Glycine / L-ALANINE / L-ARGININE / L-ASPARTIC ACID / L-CYSTEINE HYDROCHLORIDE MONOHYDRATE / L-HISTIDINE / L-METHIONINE / L-PHENYLALANINE / L-PROLINE / L-SERINE / L-THREONINE / L-TRYPTOPHAN / L-TYROSINE / L-glutamic acid / L-lysine monohydrate / Taurine 28/07/2025 6 months 27/01/2026 07/04/2026 27/07/2026 05/10/2026 Yes 22/10/2025 DLP was amended on 22/10/2025
New CAP authorised on 28/07/2025 PSUSA/00011149/202601 PSUSA/00011149/202607 Amelia Cupelli Italy CAP
11150 diflunisal (for centrally authorised products) 03/11/2025 3 years 03/11/2028 01/02/2029 No 24/09/2025 PSUSA/00011150/202811 Karin Bolin Sweden CAP
11151 dorocubicel / allogeneic umbilical cord-derived CD34- cells, non-expanded 25/08/2025 6 months 24/02/2026 05/05/2026 24/08/2026 02/11/2026 No 02/06/2026 PSUSA/00011151/202602 PSUSA/00011151/202608 Karin Bolin Sweden CAP
11152 sargramostim 05/03/1991 6 months 04/03/2026 13/05/2026 04/09/2026 13/11/2026 No 02/06/2026 PSUSA/00011152/202603 PSUSA/00011152/202609 Jenny Jönsson Sweden CAP
11153 erysimum 12/11/1999 8 years 12/11/2030 10/02/2031 No 22/10/2025 New entry added on 22/10/2025 PSUSA/00011153/203011 not yet assigned none NAP
11154 sebetralstat 03/07/2025 6 months 02/01/2026 13/03/2026 02/07/2026 10/09/2026 No 22/10/2025 New CAP authorised on 17/09/2025 PSUSA/00011154/202601 PSUSA/00011154/202607 Zane Neikena Latvia CAP
11155 olezarsen 19/12/2024 6 months 18/12/2025 26/02/2026 18/06/2026 27/08/2026 No 22/10/2025 New CAP authorised on 17/09/2025 PSUSA/00011155/202512 PSUSA/00011155/202606 Kimmo Jaakkola Finland CAP
11156 vimseltinib 14/02/2025 6 months 13/02/2026 24/04/2026 13/08/2026 22/10/2026 No 22/10/2025 New CAP authorised on 17/09/2025 PSUSA/00011156/202602 PSUSA/00011156/202608 Karin Erneholm Denmark CAP
11157 vorasidenib 06/08/2024 6 months 05/02/2026 16/04/2026 05/08/2026 14/10/2026 No 19/11/2025 EURD and DLP updated on 19/11/2025
New CAP authorised on 17/09/2025 PSUSA/00011157/202602 PSUSA/00011157/202608 Jo Robays Belgium CAP
11158 zuranolone 04/08/2023 6 months 03/02/2026 14/04/2026 03/08/2026 12/10/2026 No 22/10/2025 New CAP authorised on 17/09/2025 PSUSA/00011158/202602 PSUSA/00011158/202608 Guðrún Stefánsdóttir Iceland CAP
11159 resmetirom 14/03/2024 6 months 13/03/2026 22/05/2026 13/09/2026 22/11/2026 No 22/10/2025 New CAP authorised on 18/08/2025 PSUSA/00011159/202603 PSUSA/00011159/202609 Lina Seibokiene Lithuania CAP
11160 obecabtagene autoleucel 08/11/2024 6 months 07/05/2026 16/07/2026 07/11/2026 16/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011160/202605 PSUSA/00011160/202611 Karin Erneholm Denmark CAP
11161 mirdametinib 11/02/2025 6 months 10/02/2026 21/04/2026 10/08/2026 19/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011161/202602 PSUSA/00011161/202608 Bianca Mulder Netherlands CAP
11162 clascoterone 17/10/2025 6 months 16/04/2026 25/06/2026 16/10/2026 25/12/2026 No 19/11/2025 New CAP authorised on 17/10/2025 PSUSA/00011162/202604 PSUSA/00011162/202610 Zane Neikena Latvia CAP
11163 nirogacestat 27/11/2023 6 months 27/05/2026 05/08/2026 27/11/2026 05/02/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011163/202605 PSUSA/00011163/202611 Terhi Lehtinen Finland CAP
11164 inavolisib 10/10/2024 6 months 09/04/2026 18/06/2026 09/10/2026 18/12/2026 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00011164/202604 PSUSA/00011164/202610 Bianca Mulder Netherlands CAP
11165 donanemab 02/07/2024 6 months 02/01/2026 13/03/2026 02/07/2026 10/09/2026 No 04/02/2026 DLP was amended on 04/02/2026
New CAP authorised on 24/09/2025 PSUSA/00011165/202601 PSUSA/00011165/202607 Amelia Cupelli Italy CAP
11166 thiamine / cyanocobalamine / riboflavin / pyridoxine 27/09/1999 3 years 03/06/2028 01/09/2028 Yes 26/05/2026 PSUR frequency amended and DLP updated on 26/05/2026
New entry added on 17/12/2025 PSUSA/00011166/202806 not yet assigned none NAP
11167 gentian root / verbena herb / common sorrel herb / primula flower with calyx / sambucus nigra flower 27/06/2007 13 years 26/06/2036 24/09/2036 No 17/12/2025 New entry added 17/12/2025 PSUSA/00011167/203606 not yet assigned none NAP
11168 nipocalimab 29/04/2025 6 months 28/04/2026 07/07/2026 28/10/2026 06/01/2027 No 17/12/2025 New CAP authorised on 28/11/2025 PSUSA/00011168/202604 PSUSA/00011168/202610 Dirk Mentzer Germany CAP
11169 insulin icodec / semaglutide 05/12/2017 6 months 04/06/2026 13/08/2026 04/12/2026 12/02/2027 No 17/12/2025 New CAP authorised on 18/11/2025 PSUSA/00011169/202606 PSUSA/00011169/202612 Petar Mas Croatia CAP
11170 brensocatib 12/08/2025 6 months 11/02/2026 22/04/2026 11/08/2026 20/10/2026 No 17/12/2025 New CAP authorised on 18/11/2025 PSUSA/00011170/202602 PSUSA/00011170/202608 Zane Neikena Latvia CAP
11171 elinzanetant 08/07/2025 6 months 07/01/2026 18/03/2026 07/07/2026 15/09/2026 No 17/12/2025 New CAP authorised on 17/11/2025 PSUSA/00011171/202601 PSUSA/00011171/202607 Guðrún Stefánsdóttir Iceland CAP
11172 donidalorsen 21/08/2025 6 months 20/02/2026 01/05/2026 20/08/2026 29/10/2026 No 04/02/2026 New CAP authorised on 19/01/2026 PSUSA/00011172/202602 PSUSA/00011172/202608 Julia Pallos Hungary CAP
11173 etuvetidigene autotemcel 09/01/2026 6 months 08/07/2026 16/09/2026 08/01/2027 19/03/2027 No 04/02/2026 New CAP authorised on 09/01/2026 PSUSA/00011173/202607 PSUSA/00011173/202701 Jo Robays Belgium CAP
11174 levacetylleucine 24/09/2024 6 months 23/03/2026 01/06/2026 23/09/2026 02/12/2026 No 04/02/2026 New CAP authorised on 19/01/2026 PSUSA/00011174/202603 PSUSA/00011174/202609 Dennis Lex Germany CAP
11175 imlunestrant 25/09/2025 6 months 25/03/2026 03/06/2026 25/09/2026 04/12/2026 No 02/06/2026 DLP updated on 04/03/2026
New CAP authorised on 09/01/2026 PSUSA/00011175/202603 PSUSA/00011175/202609 Jenny Jönsson Sweden CAP
11176 pertussis vaccine (recombinant, acellular, component, adsorbed) 30/09/2016 6 months 29/03/2026 07/06/2026 29/09/2026 08/12/2026 No 04/02/2026 New CAP authorised on 09/01/2026 PSUSA/00011176/202603 PSUSA/00011176/202609 Amelia Cupelli Italy CAP
11177 deutetrabenazine 08/01/2026 1 year 31/03/2026 09/06/2026 31/03/2027 09/06/2027 No 01/04/2026 PSUR frequency corrected on 01/04/2026
New CAP authorised on 08/01/2026 PSUSA/00011177/202603 PSUSA/00011177/202703 Liana Martirosyan Netherlands CAP
11178 teplizumab 17/11/2022 6 months 16/05/2026 25/07/2026 16/11/2026 25/01/2027 No 04/02/2026 New CAP authorised on 08/01/2026 PSUSA/00011178/202605 PSUSA/00011178/202611 Terhi Lehtinen Finland CAP
11179 rilzabrutinib 19/06/2025 6 months 18/06/2026 27/08/2026 18/12/2026 26/02/2027 No 04/02/2026 New CAP authorised on 22/12/2025 PSUSA/00011179/202606 PSUSA/00011179/202612 Dennis Lex Germany CAP
11180 depemokimab 29/08/2017 6 months 28/02/2026 09/05/2026 28/08/2026 06/11/2026 No 04/03/2026 New CAP authorised on 12/02/2026 PSUSA/00011180/202602 PSUSA/00011180/202608 Dirk Mentzer Germany CAP
11181 aficamten 16/12/2025 6 months 15/06/2026 24/08/2026 15/12/2026 23/02/2027 No 04/03/2026 New CAP authorised on 12/02/2026 PSUSA/00011181/202606 PSUSA/00011181/202612 Eva Jirsová Czech Republic CAP
11182 aumolertinib 17/03/2020 6 months 16/03/2026 25/05/2026 16/09/2026 25/11/2026 No 04/03/2026 New CAP authorised on 12/02/2026 PSUSA/00011182/202603 PSUSA/00011182/202609 Bianca Mulder Netherlands CAP
11183 COVID-19 mRNA vaccine (mNEXSPIKE) 30/05/2025 1 year 29/05/2027 07/08/2027 29/05/2028 07/08/2028 No 01/07/2026 Active substance name was amended on 01/07/2026
Correction of PSUR frequency and DLP on 01/04/2026
New CAP authorised on 12/02/2026 PSUSA/00011183/202705 PSUSA/00011183/202805 Marie Louise Schougaard Christiansen Denmark CAP
11184 standardised bacterial culture suspension, standardised bacterial culture suspension / hydrocortisone, inactivated E. coli, inactivated E. coli / hydrocortisone 16/09/2008 15 years 16/09/2034 15/12/2034 No 01/04/2026 New entry added on 01/04/2026 PSUSA/00011184/203409 not yet assigned none NAP
11185 povidone, polyvinyl alcohol / povidone, dextran 70 / hypromellose, white soft paraffin / white soft paraffin combinations (ocular indications) 01/01/1981 13 years 30/06/2040 28/09/2040 No 01/04/2026 New entry added on 01/04/2026 PSUSA/00011185/204006 not yet assigned none NAP
11186 chlorhexidine / hydrocortisone 05/08/1952 8 years 03/03/2033 01/06/2033 Yes 01/04/2026 New entry added on 01/04/2026 PSUSA/00011186/203303 not yet assigned none NAP
11187 efinaconazole 19/03/2025 5 years 19/03/2029 17/06/2029 No 01/04/2026 New entry added on 01/04/2026 PSUSA/00011187/202903 not yet assigned none NAP
11188 penfluridol 05/11/2018 3 years 05/11/2027 03/02/2028 Yes 01/04/2026 New entry added on 01/04/2026 PSUSA/00011188/202711 not yet assigned none NAP
11189 ezetimibe / pitavastatin 17/04/2025 5 years 16/07/2030 14/10/2030 No 01/04/2026 New entry added on 01/04/2026 PSUSA/00011189/203007 not yet assigned none NAP
11190 anamirta cocculus / strychnos nux-vomica / petroleum / nicotiana tabacum 19/12/2001 18 years 19/12/2028 19/03/2029 Yes 01/04/2026 New entry added on 01/04/2026 PSUSA/00011190/202812 not yet assigned none NAP
11191 fenofibrate / rosuvastatin 26/08/2013 5 years 06/11/2027 04/02/2028 No 01/04/2026 New entry added on 01/04/2026 PSUSA/00011191/202711 not yet assigned none NAP
11192 ginkgo biloba L., folium (ginkgo leaf) 26/06/1986 10 years 25/06/2034 23/09/2034 No 01/04/2026 New entry added on 01/04/2026 PSUSA/00011192/203406 not yet assigned none NAP
11193 primaquine 12/04/1972 5 years 12/04/2031 11/07/2031 Yes 01/04/2026 New entry added on 01/04/2026 PSUSA/00011193/203104 not yet assigned none NAP
11194 nogapendekin alfa inbakicept 04/07/2025 6 months 03/07/2026 11/09/2026 03/01/2027 14/03/2027 No 01/04/2026 New CAP added on 01/04/2026 PSUSA/00011194/202607 PSUSA/00011194/202701 Jean-Michel Dogné Belgium CAP
11195 clesrovimab 09/06/2025 6 months 08/06/2026 17/08/2026 08/12/2026 16/02/2027 No 27/05/2026 DLP was amended on 27/05/2026
New CAP authorised on 15/04/2026 PSUSA/00011195/202606 PSUSA/00011195/202612 Dirk Mentzer Germany CAP
11196 doxecitine / doxribtimine 03/11/2025 6 months 02/05/2026 11/07/2026 02/11/2026 11/01/2027 No 29/04/2026 New CAP authorised on 26/03/2026 PSUSA/00011196/202605 PSUSA/00011196/202611 Barbara Kovacic Bytyqi Croatia CAP
11197 estetrol 26/03/2026 6 months 25/09/2026 04/12/2026 25/03/2027 03/06/2027 No 29/04/2026 New CAP authorised on 26/03/2026 PSUSA/00011197/202609 PSUSA/00011197/202703 Sonja Radowan Austria CAP
11198 belumosudil 16/07/2021 6 months 15/07/2026 23/09/2026 15/01/2027 26/03/2027 No 27/05/2026 DLP was corrected on 27/05/2026
New CAP authorised on 24/03/2026 PSUSA/00011198/202607 PSUSA/00011198/202701 Karin Erneholm Denmark CAP
11199 trivalent influenza vaccine (recombinant, prepared in cell culture) 30/03/2026 6 months 29/09/2026 08/12/2026 29/03/2027 07/06/2027 No 29/04/2026 New CAP authorised on 30/03/2026 PSUSA/00011199/202609 PSUSA/00011199/202703 Zoubida Amimour France CAP
11200 semaglutide (treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis with liver fibrosis) 26/03/2026 6 months 25/09/2026 04/12/2026 25/03/2027 03/06/2027 No 03/06/2026 New CAP authorised on 26/03/2026 PSUSA/00011200/202609 PSUSA/00011200/202703 Karin Bolin Sweden CAP
11201 secale cereale L., phleum pratense, zea mays L. single or mixes (genitourinary therapy) 28/10/2004 5 years 28/10/2030 26/01/2031 No 27/05/2026 New entry added 27/05/2026 PSUSA/00011201/203010 not yet assigned none NAP
11202 salicylic acid (ocular use) Not available* 6 years 02/12/2029 02/03/2030 No 27/05/2026 New entry added on 27/05/2026 PSUSA/00011202/202912 not yet assigned none NAP
11203 viperae beri venenum / camphor / salicylic acid / turpentine oil Not available* 6 years 02/12/2029 02/03/2030 No 27/05/2026 New entry added on 27/05/2026 PSUSA/00011203/202912 not yet assigned none NAP
11204 tovorafenib 23/04/2024 6 months 22/10/2026 31/12/2026 22/04/2027 01/07/2027 No 27/05/2026 New CAP authorised on 20/04/2026 PSUSA/00011204/202610 PSUSA/00011204/202704 Marie Louise Schougaard Christiansen Denmark CAP
11205 influenza mRNA vaccine / COVID-19 mRNA vaccine (mCombriax) 20/04/2026 6 months 19/10/2026 28/12/2026 19/04/2027 28/06/2027 No 01/07/2026 Active substance name was amended on 01/07/2026
New CAP authorised on 20/04/2026 PSUSA/00011205/202610 PSUSA/00011205/202704 Georgia Gkegka Greece CAP
11206 remibrutinib 30/09/2025 6 months 29/09/2026 08/12/2026 29/03/2027 07/06/2027 No 27/05/2026 New CAP authorised on 23/04/2026 PSUSA/00011206/202609 PSUSA/00011206/202703 Terhi Lehtinen Finland CAP
11207 paltusotine 25/09/2025 6 months 31/08/2026 09/11/2026 28/02/2027 09/05/2027 No 27/05/2026 New CAP authorised on 23/04/2026 PSUSA/00011207/202608 PSUSA/00011207/202702 Liana Martirosyan Netherlands CAP
11208 mavorixafor 15/05/2015 6 months 14/05/2026 23/07/2026 14/11/2026 23/01/2027 No 27/05/2026 New CAP authorised on 27/04/2026 PSUSA/00011208/202605 PSUSA/00011208/202611 Karin Erneholm Denmark CAP
11210 lurbinectedin 15/06/2020 6 months 14/12/2026 22/02/2027 14/06/2027 23/08/2027 No 01/07/2026 New CAP authorised on 29/05/2026 PSUSA/00011210/202612 PSUSA/00011210/202706 Jenny-Maria Jönsson Sweden CAP
11211 tarlatamab 16/05/2024 6 months 15/11/2026 24/01/2027 15/05/2027 24/07/2027 No 01/07/2026 New CAP authorised on 29/05/2026 PSUSA/00011211/202611 PSUSA/00011211/202705 Sonja Radowan Austria CAP
11212 nadofaragene firadenovec 16/12/2025 6 months 15/06/2026 24/08/2026 15/12/2026 23/02/2027 No 01/07/2026 New CAP authorised on 28/05/2026 PSUSA/00011212/202606 PSUSA/00011212/202612 Amelia Cupelli Italy CAP
11213 leniolisib 24/03/2023 6 months 23/09/2026 02/12/2026 23/03/2027 01/06/2027 No 01/07/2026 New CAP authorised on 21/05/2026 PSUSA/00011213/202609 PSUSA/00011213/202703 Petar Mas Croatia CAP
11214 plozasiran 18/11/2025 6 months 31/07/2026 09/10/2026 31/01/2027 11/04/2027 No 01/07/2026 New CAP authorised on 19/06/2026 PSUSA/00011214/202607 PSUSA/00011214/202701 Terhi Lehtinen Finland CAP
107800 levodopa 21/12/2018 1 year 20/12/2025 28/02/2026 20/12/2026 28/02/2027 No 01/04/2026 Reference to NAP added on 01/04/2026
DLP was amended on 30/07/2025 PSUSA/00107800/202512 PSUSA/00107800/202612 Barbara Kovacic Bytyqi Croatia CAP NAP
107812 netarsudil 18/12/2017 3 years 17/06/2027 15/09/2027 No 04/03/2026 PSUR frequency amended and DLP updated on 04/03/2026 PSUSA/00107812/202706 Maria del Pilar Rayon Spain CAP
&"Calibri"&11&K000000&"Verdana,Regular"&6© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged._x000D_&1#&"Verdana"&7&K737373 Classified as internal/staff & contractors by the Europ &"Verdana,Regular"&9Page &P / &N
An agency of the European Union
https://www.ema.europa.eu/documents/template-form/template-request-amendments-addition-active-substances-combinations-active-substances-european-union_en-1.docxhttps://www.ema.europa.eu/documents/other/timetable-periodic-safety-update-report-psur-psur-single-assessment-psusa_en.pdfhttp://www.ema.europa.eu/ema/index.jsp?curl=pages/contacts/PRAC/people_listing_000112.jsp&mid=WC0b01ac058058f328https://www.ema.europa.eu/documents/other/introductory-cover-note-list-european-union-reference-dates-frequency-submission-periodic-safety_en.pdf
Removed entries
Active substances and combinations of active substances removed from the EURD list Comments Month removed
aminosalicylic acid Entry removed as only authorised in 1 MS Jun-26
cocaine Entry deleted due to no products in scope Jun-26
ergometrine Entry deleted due to no products in scope Jun-26
fludrocortisone / gramicidin / neomycin Entry deleted due to no products in scope Jun-26
furazolidone Entry deleted due to no products in scope Jun-26
plasma protein fraction Entry removed as only authorised in 1 MS Jun-26
glutaral Entry deleted due to no products in scope Jun-26
chloroquine phosphate / proguanil hydrochloride Entry deleted due to no products in scope Jun-26
insulin degludec / liraglutide Entry deleted due to merge (See EURD ID: 1892) Jun-26
tilmanocept Entry deleted due to no products in scope Jun-26
ivabradine / metoprolol Entry deleted due to no products in scope Jun-26
sodium benzoate / grindelia tincture / polygala syrup Entry deleted due to no products in scope Jun-26
parathyroid hormone Entry deleted as Natpar (CAP) withdrawn Jun-26
hydroxyprogesterone caproate Entry deleted due to no products in scope Jun-26
dasiglucagon Entry deleted as Zegalogue (CAP) withdrawn Jun-26
melphalan Entry deleted due to merge (see EURD ID: 11013) May-26
copper sulfate / zinc oxide Entry removed as only authorised in 1 MS May-26
calcium carbonate / sodium alginate / sodium bicarbonate, sodium alginate / sodium bicarbonate, sodium alginate/ potassium hydrogen carbonate, sodium alginate/magnesium alginate Entry deleted due to merge (see entry ID 123 and/or 500) May-26
duvelisib Entry deleted as Copiktra (CAP) withdrawn May-26
casirivimab / imdevimab (Ronapreve) Entry deleted as Ronapreve (CAP) withdrawn May-26
valoctocogene roxaparvovec Entry deleted as Roctavian (CAP) withdrawn May-26
clotrimazole / zinc oxide Entry removed as only authorised in 1 MS Apr-26
codeine / erysimum Entry removed as only authorised in 1 MS Apr-26
codeine / ethylmorphine hydrochloride Entry removed as only authorised in 1 MS Apr-26
disodium phosphate dodecahydrate / sodium dihydrogen phosphate dihydrate Entry deleted - Art 57 has no products/products covered by other entry (See EURD ID: 2737) Apr-26
ibritumomab tiuxetan Entry deleted as Zevalin (CAP) expired Apr-26
levamisole Entry deleted due to revocation of all levamisole-containing products from the EU market Apr-26
bendroflumethiazide / timolol maleate Entry removed as only authorised in 1 MS Apr-26
chymotrypsin / trypsin Entry deleted - Art 57 has no products Apr-26
benzocaine / tyrothricin Entry removed as only authorised in 1 MS Apr-26
bromelain Entry removed as only authorised in 1 MS Apr-26
acetic acid Entry removed as only authorised in 1 MS Mar-26
atropine sulfate / hyoscine hydrobromide / hyoscyamine sulfate / phenobarbital Entry deleted - Art 57 has no products Mar-26
benzoxonium chloride Entry removed as only authorised in 1 MS Mar-26
carbutamide Entry deleted - Art 57 has no products Mar-26
dextran 70 / hypromellose Entry deleted due to merge (See EURD IDs 11185 or 9280) Mar-26
dextromethorphan hydrobromide / pseudoephedrine hydrochloride Entry deleted - Art 57 has no products Mar-26
dichlorobenzyl alcohol Entry deleted - Art 57 has no products Mar-26
dropropizine Entry removed as only authorised in 1 MS Mar-26
doederlein bacillus selected strain (lactobacillus casei ssp rhamnosus) / estriol / progesterone Entry removed as only authorised in 1 MS Mar-26
melarsoprol Entry removed as only authorised in 1 MS Mar-26
panthenol Entry deleted - Art 57 has no products Mar-26
dicyclomine hydrochloride / paracetamol Entry deleted due to active substance(s) already covered by EURD ID 1051 Mar-26
sodium chromate (51cr) Entry deleted - Art 57 has no products Mar-26
salicylate / triethanolamine Entry deleted - Art 57 has no products Mar-26
arginine glutamate Entry deleted - Art 57 has no products Mar-26
ascorbic acid / cyanocobalamin / folic acid / nicotinamide Entry removed as only authorised in 1 MS Mar-26
gentamicin sulfate / indometacin Entry removed as only authorised in 1 MS Mar-26
chlorpheniramine / dextromethorphan / paracetamol / pseudoephedrine Entry removed as only authorised in 1 MS Mar-26
ascorbic acid / potassium bicarbonate Entry removed as only authorised in 1 MS Mar-26
fluorescein sodium / proxymetacaine hydrochloride Entry deleted - Art 57 has no products Mar-26
sargramostim Entry deleted - Art 57 has no products Mar-26
cinacalcet Entry removed as Mimpara (CAP) withdrawn Feb-26
idebenone (non centrally authorised products) Entry removed as only authorised in 1 MS Feb-26
mometasone / salicylic acid Entry removed as only authorised in 1 MS Feb-26
pranoprofen Entry removed as only authorised in 1 MS Feb-26
aluminium phosphate Entry deleted as other entry covers same products (See EURD ID: 500) Feb-26
ocriplasmin Entry removed as Jetrea (CAP) withdrawn Feb-26
rabbit anti-human thymocyte immunoglobulin Entry deleted due to merge (see EURD ID: 10252) Feb-26
phenylephrine / ketorolac Entry removed as Omidria (CAP) withdrawn Feb-26
atorvastatin / perindopril Entry deleted - Art 57 has no products Feb-26
13C-methacetin Entry deleted - Art 57 has no products Feb-26
sotrovimab Entry removed as XEVUDY (CAP) withdrawn Feb-26
eptifibatide Entry removed as Integrilin (CAP) withdrawn Jan-26
lixisenatide Entry deleted - Art 57 has no products Jan-26
cytidine / uridine triphosphate sodium Entry deleted - Art 57 has no products Dec-25
trandolapril / verapamil Entry deleted due to merge (see EURD ID: 3004) Nov-25
dengue tetravalent vaccine (live, attenuated) [Chimeric yellow fever dengue virus serotype 1 (live, attenuated) / Chimeric yellow fever dengue virus serotype 2 (live, attenuated) / Chimeric yellow fever dengue virus serotype 3 (live, attenuated) / Chimeric yellow fever dengue virus serotype 4 (live, attenuated)] Entry removed as Dengavia (CAP) withdrawn Nov-25
dirithromycin Entry deleted - Art 57 has no products Oct-25
etofylline Entry deleted due to merge (see EURD ID: 1329) Oct-25
moexipril Entry deleted - Art 57 has no products Oct-25
nisoldipine Entry deleted - Art 57 has no products Oct-25
parnaparin Entry removed as only authorised in 1 MS Oct-25
dihydroergocristine / etofylline Entry deleted due to merge (see EURD ID: 1329) Oct-25
ephedrine hydrochloride / resorcinol Entry deleted - Art 57 has no products Oct-25
amlexanox Entry deleted - Art 57 has no products Oct-25
rosuvastatin/ perindopril /indapamide Entry removed due to merge (see EURD ID:10434) Oct-25
tixagevimab / cilgavimab (Evusheld) Entry deleted as Evusheld (CAP) withdrawn Oct-25
rosuvastatin / ramipril Entry removed due to merge (see EURD ID:10434) Sep-25
gemeprost Entry deleted - Art 57 has no products Sep-25
human leucocyte interferon-alfa Entry deleted as there are no products in Art 57 Sep-25
ascorbic acid / paracetamol / pheniramine hydrogenomaleate / phenylephrine hydrochloride Entry removed as only authorised in 1 MS Sep-25
dexketoprofen / tramadol Entry removed due to merge (see EURD ID: 997) Sep-25
cefotiam Entry deleted as there are no products in Art 57 Jul-25
cefpirome Entry deleted as there are no products in Art 57 Jul-25
codeine / diclofenac Entry deleted as there are no products in Art 57 Jul-25
etizolam Entry removed as only authorised in 1 MS Jul-25
methocarbamol / paracetamol Entry deleted due to merge (see EURD ID: 2011) Jul-25
nizatidine Entry removed as only authorised in 1 MS Jul-25
propyphenazone Entry deleted as there are no products in Art 57 Jul-25
sulfafurazole Entry removed as only authorised in 1 MS Jul-25
buprenorphine (implant) Entry deleted due to Sixmo (CAP) withdrawal Jul-25
josamycin Entry removed as only authorised in 1 MS Jun-25
pralsetinib Entry deleted due to product(s) withdrawn Jun-25
alverine / simeticone Entry deleted due to merge (see EURD ID: 124) May-25
amylmetacresol / dichlorobenzyl alcohol Entry deleted due to merge (see EURD ID: 204) May-25
cyanocobalamin / folic acid Entry deleted due to merge (see EURD ID: 892) May-25
dextromethorphan / guaifenesin Entry deleted due to merge (see EURD ID: 1009) May-25
ammonium chloride / codeine phosphate hemihydrate / guaifenesin / thyme oil Entry deleted due to merge (see EURD ID: 1576) May-25
isoniazid / pyridoxine hydrochloride Entry deleted due to merge (see EURD ID: 1789) May-25
isoniazid / rifampicin Entry deleted due to merge (see EURD ID: 1789) May-25
bromelain / trypsin Entry deleted as there are no products in Art 57 May-25
isoniazid / pyrazinamide / rifampicin, ethambutol / isoniazid / pyrazinamide / rifampicin Entry deleted due to merge (see EURD ID: 1789) May-25
dapagliflozin / metformin Entry deleted due to merge (see EURD ID: 10029) May-25
saxagliptin / dapagliflozin Entry deleted due to merge (see EURD ID: 10029) May-25
fidanacogene elaparvovec Entry deleted due to BEQVEZ (CAP) withdrawal May-25
cocarboxylase Entry deleted as there are no products in Art 57 Apr-25
dextromethorphan hydrobromide / dichlorobenzyl alcohol Entry removed as only authorised in 1 MS Apr-25
diethylstilbestrol Entry removed as only authorised in 1 MS Apr-25
dimethyl sulfoxide Entry removed as only authorised in 1 MS Apr-25
diphenhydramine hydrochloride / zinc oxide Entry deleted as there are no products in Art 57 Apr-25
misoprostol / naproxen Entry deleted as there are no products in Art 57 Apr-25
oxaprozin Entry removed as only authorised in 1 MS Apr-25
guaifenesin / oxolamine citrate Entry deleted as there are no products in Art 57 Apr-25
pentobarbital Entry deleted as there are no products in Art 57 Apr-25
phenindione Entry removed as only authorised in 1 MS Apr-25
codeine phosphate hemihydrate / fenpiverinium bromide / paracetamol / pitofenone hydrochloride Entry deleted as there are no products in Art 57 Apr-25
magnesium chloride hexahydrate / potassium chloride / procaine hydrochloride Entry removed as only authorised in 1 MS Apr-25
ephedrine hydrochloride / sulfathiazole Entry removed as only authorised in 1 MS Apr-25
nitrofural / phenazone / tetracaine hydrochloride Entry removed as only authorised in 1 MS Apr-25
shingles (herpes zoster) vaccine (live) Entry deleted due to Zostavax (CAP) withdrawal Apr-25
regdanvimab (Regkirona) Entry deleted due to Regkirona(CAP) withdrawal Apr-25
nifurtimox Entry deleted due to duplicate entry (see EURD ID: 11088) Apr-25
dectaflur / olaflur / sodium fluoride Entry deleted due to merge (See EURD ID: 863) Mar-25
enflurane Entry deleted as there are no products in Art 57 Mar-25
etynodiol Entry deleted as there are no products in Art 57 Mar-25
hydrocortisone / propanocaine Entry removed as only authorised in 1 MS Mar-25
norgestimate Entry deleted as there are no products in Art 57 Mar-25
phenylephrine / zinc sulfate Entry deleted as there are no products in Art 57 Mar-25
pidotimod Entry removed as only authorised in 1 MS Mar-25
epinephrine / prilocaine hydrochloride Entry removed as only authorised in 1 MS Mar-25
doxylamine hydrogen succinate / paracetamol / pseudoephedrine hydrochloride Entry removed as only authorised in 1 MS Mar-25
trifluridine Entry removed as only authorised in 1 MS Mar-25
octreotide (for centrally authorised products) Entry deleted as Mycapssa (CAP) is withdrawn Mar-25
allantoin / aminoacridine / peru balsam / prednisolone Entry deleted as there are no products in Art 57 Feb-25
dextromethorphan hydrobromide / triprolidine hydrochloride Entry deleted as there are no products in Art 57 Feb-25
latanoprost (products with paediatric indication) Entry deleted due to merge with EURD ID: 1832 Feb-25
allantoin / aminoacridine / hydrocortisone hemisuccinate / lidocaine hydrochloride Entry deleted as there are no products in Art 57 Feb-25
mequitazine Entry removed as only authorised in 1 MS Feb-25
phenylephrine hydrochloride / prednisolone acetate Entry deleted as there are no products in Art 57 Feb-25
meningococcal group A, B, C, W and Y vaccine Entry deleted as Penbraya (CAP) is withdrawn Feb-25
quinidine Entry (EURD ID 2595) deleted as there is a duplicate entry EURD ID: 1688 "quinidine, hydroquinidine" Jan-25
obeticholic acid Entry deleted as the marketing authorisation for Ocaliva is revoked by the Commission Implementing Decision of 30 August Jan-25
darvadstrocel Entry deleted as Alofisel (CAP) is withdrawn Jan-25
azacitidine (oral formulations) Entry (EURD ID: 10935) deleted due to merge with EURD ID: 274 Jan-25
chlortalidone / metoprolol Entry removed as only authorised in 1 MS Dec-24
dextromethorphan hydrobromide / mepyramine maleate Entry deleted as there are no products in Art 57 Dec-24
dextromethorphan hydrobromide / guaifenesin / mepyramine maleate Entry deleted as there are no products in Art 57 Dec-24
dextromethorphan hydrobromide / guaifenesin / mepyramine maleate / phenylephrine hydrochloride Entry deleted as there are no products in Art 57 Dec-24
magnesium oxide Entry deleted due to merge (See EURD ID: 1929) Dec-24
pixantrone Entry deleted as Pixuvri (CAP) withdrawn Nov-24
pralsetinib Entry deleted as Gavreto (CAP) withdrawn Nov-24
acetylsalicylic acid / calcium carbonate Entry deleted as there are no products in Art 57 Oct-24
amitriptyline hydrochloride / chlordiazepoxide Entry deleted due to merge (See EURD ID: 661) Oct-24
ascorbic acid / dextromethorphan / paracetamol / pseudoephedrine Entry deleted due to merge (See EURD ID: 2307) Oct-24
alum / benzalkonium chloride Entry removed as only authorised in 1 MS Oct-24
benzalkonium chloride / dimethicone Entry deleted as there are no products in Art 57 Oct-24
benzalkonium chloride / dimethicone / hydrocortisone / nystatin Entry deleted as there are no products in Art 57 Oct-24
benzalkonium chloride / hexylresorcinol Entry deleted due to merge (See EURD ID: 332) Oct-24
benzalkonium chloride / lidocaine Entry removed as only authorised in 1 MS Oct-24
benzalkonium chloride / tolnaftate Entry removed as only authorised in 1 MS Oct-24
chlorhexidine / neomycin Entry removed as only authorised in 1 MS Oct-24
chlorocresol combinations Entry removed as only authorised in 1 MS Oct-24
acetylsalicylic acid / ascorbic acid / caffeine / chlorphenamine maleate Entry removed as only authorised in 1 MS Oct-24
cinchocaine hydrochloride / esculin / framycetin sulfate / hydrocortisone acetate Entry deleted as there are no products in Art 57 Oct-24
clopamide / pindolol Entry removed as only authorised in 1 MS Oct-24
clopamide / reserpine Entry deleted as there are no products in Art 57 Oct-24
codeine polysulfonate / phenyltoloxamine polysulfonate Entry removed as only authorised in 1 MS Oct-24
dextromethorphan / paracetamol Entry deleted due to merge (See EURD ID 2307) Oct-24
dextromethorphan hydrobromide / paracetamol / pseudoephedrine hydrochloride Entry deleted due to merge (See EURD ID 2307) Oct-24
caffeine / codeine phosphate / doxylamine succinate / paracetamol Entry removed as only authorised in 1 MS Oct-24
guaifenesin / pseudoephedrine Entry deleted due to merge (See EURD ID: 1580) Oct-24
measles vaccine (live attenuated) Entry deleted as there are no products in Art 57 Oct-24
menadiol Entry deleted due to merge (See EURD ID: 2400) Oct-24
miglitol Entry deleted as there are no products in Art 57 Oct-24
neomycin sulfate / polymyxin b sulfate Entry removed as only authorised in 1 MS Oct-24
orphenadrine Entry deleted due to merge (See EURD ID: 2224) Oct-24
acetylsalicylic acid / caffeine / codeine / paracetamol Entry deleted due to merge (See EURD ID: 2312) Oct-24
caffeine / codeine / paracetamol Entry deleted due to merge (See EURD ID: 448) Oct-24
quinidine / verapamil hydrochloride Entry deleted as there are no products in Art 57 Oct-24
acetylsalicylic acid / citric acid / sodium hydrogen carbonate Entry deleted due to merge (See EURD ID: 241) Oct-24
ketoprofen / sucralfate Entry removed as only authorised in 1 MS Oct-24
zaleplon Entry removed as only authorised in 1 MS Oct-24
acetylsalicylic acid / codeine phosphate / paracetamol Entry deleted due to merge (See EURD ID: 448) Oct-24
dihydrocodeine / paracetamol Entry removed as only authorised in 1 MS Oct-24
ferrimanitol ovoalbumin Entry removed as only authorised in 1 MS Oct-24
neomycin sulphate / polymyxin b sulfate / prednisolone acetate Entry deleted as there are no products in Art 57 Oct-24
calcium folinate / iron succinyl-protein complex Entry deleted due to merge (See EURD ID 10234) Oct-24
macrogol 3350 combinations (oral use) Entry deleted due to merge (See EURD ID: 1924) Oct-24
dasabuvir, ombitasvir / paritaprevir / ritonavir Entry deleted as Exviera & Viekirax (CAPs) withdrawn on 25/09/2024 Oct-24
dibromotyrosine Entry deleted as there are no products in Art 57 Sep-24
dihydroxyaluminum sodium carbonate Entry deleted due to merge (see EURD ID: 1098) Sep-24
hydrocortisone / oxytetracycline Entry deleted due to merge (see EURD ID: 2262) Sep-24
hydrocortisone acetate / oxytetracycline hydrochloride / polymyxin b Entry deleted due to merge (see EURD ID: 2262) Sep-24
sodium citrate / sodium lauryl sulfoacetate Entry deleted due to merge (see EURD ID: 2735) Sep-24
dibromotyrosine / thiamazole Entry deleted as there are no products in Art 57 Sep-24
magnesium citrate / magnesium lactate Entry deleted dut to merge (see EURD ID 1928) Sep-24
ulipristal acetate (treatment of moderate to severe symptoms of uterine fibroids) Entry deleted as CAP (Esmya) withdrawn on 18/07/2024
Sep-24
obiltoxaximab Entry deleted as CAP (NYXTHRACIS) withdrawn on 02/08/2024
Sep-24
COVID-19 vaccine (Ad26.COV2-S [recombinant]) (JCOVDEN) Entry deleted as CAP (JCOVDEN) withdrawn on 26/07/2024
Sep-24
ethambutol / isoniazid / pyrazinamide / rifampicine Entry deleted as there are no products in Art 57 Jul-24
amifostine Entry deleted as there are no products in Art 57 Jul-24
clemastine / dexamethasone Entry removed as only authorised in 1 MS Jul-24
azidamfenicol Entry removed as only authorised in 1 MS Jun-24
benzalkonium chloride / benzyl alcohol / chlorhexedine Entry removed as only authorised in 1 MS Jun-24
benzododecinium / polysorbate 80, benzododecinium Entry removed as only authorised in 1 MS Jun-24
beractant Entry removed as only authorised in 1 MS Jun-24
chloroxylenol / edetic acid / triclosan Entry deleted as there are no products in Art 57 Jun-24
eberconazole Entry removed as only authorised in 1 MS Jun-24
fluocortolone Entry deleted as there are no products in Art 57 Jun-24
lofexidine Entry deleted as there are no products in Art 57 Jun-24
talinolol Entry deleted as there are no products in Art 57 Jun-24
tiopronin Entry removed as only authorised in 1 MS Jun-24
lamivudine / tenofovir disoproxil Entry removed as only authorised in 1 MS Jun-24
citric acid / potassium / sodium Entry deleted as there are no products in Art 57 May-24
dexamethasone / neomycin Entry deleted due to merge (See EURD ID: 977) May-24
dexamethasone acetate / hydroxyethyl salicylate / salicylamide Entry deleted as there are no products in Art 57 May-24
piretanide Entry deleted due to merge (See EURD ID: 2434) May-24
proguanil Entry deleted as there are no products in Art 57 May-24
tazarotene Entry deleted as there are no products in Art 57 May-24
dexamethasone sodium / framycetin sulfate Entry removed as only authorised in 1 MS May-24
caffeine / chlorphenamine maleate / paracetamol Entry removed as only authorised in 1 MS Apr-24
acetylsalicylic acid / ascorbic acid / chlorphenamine maleate / phenylephrine hydrochloride Entry deleted as there are no products in Art 57 Apr-24
biclotymol / chlorphenamine maleate / phenylephrine hydrochloride Entry deleted as there are no products in Art 57 Apr-24
chlorphenamine / paracetamol / phenylephrine Entry deleted due to merge (See EURD ID: 693) Apr-24
chlorphenamine maleate / codeine phosphate / pseudoephedrine hydrochloride Entry deleted as there are no products in Art 57 Apr-24
acetic acid glacial / dexamethasone / neomycin Entry removed as only authorised in 1 MS Apr-24
mephenesin Entry deleted as there are no products in Art 57 Apr-24
mephenesin / methyl nicotinate Entry deleted as there are no products in Art 57 Apr-24
naloxone / tilidine Entry removed as only authorised in 1 MS Apr-24
glucose anhydrous / nikethamide Entry removed as only authorised in 1 MS Apr-24
chlorphenamine / phenylephrine Entry deleted due to merge (See EURD ID: 710) Apr-24
pirenzepine Entry removed as only authorised in 1 MS Apr-24
propantheline Entry removed as only authorised in 1 MS Apr-24
acetylsalicylic acid / ascorbic acid / chlorphenamine / colae semen Entry deleted as there are no products in Art 57 Apr-24
caffeine / chlorphenamine / paracetamol / phenylephrine Entry removed as only authorised in 1 MS Apr-24
belantamab mafodotin Entry deleted as Blenrep (CAP) expired Apr-24
COVID-19 Vaccine (ChAdOx1-S [recombinant]) (Vaxzevria) Entry deleted as Vaxzevria (CAP) withdrawn Apr-24
benzathine benzylpenicillin, benzathine benzylpenicillin / lidocaine Entry deleted due to merge with EURD ID: 383 Mar-24
cetylpyridinium / menthol Entry deleted as there are no products in Art 57 Mar-24
ciprofloxacin hydrochloride / dexamethasone acetate Entry deleted as already covered under EURD ID: 10012 Mar-24
homatropine Entry removed as only authorised in 1 MS Mar-24
lauromacrogol / lidocaine / matricariae tinctura Entry removed as only authorised in 1 MS Mar-24
mezlocillin Entry deleted as there are no products in Art 57 Mar-24
orciprenaline Entry deleted as there are no products in Art 57 Mar-24
procaine benzylpenicillin Entry deleted due to merge with EURD ID: 383 Mar-24
sulfogaiacol Entry deleted due to merge with EURD ID: 10542 Mar-24
codeine phosphate / sulfogaiacol Entry deleted due to merge with EURD ID: 10542 Mar-24
SARS-CoV-2, B.1.351 variant, prefusion Spike delta TM protein, recombinant Entry deleted as Vidprevtyn Beta (CAP) withdrawn on 11 March 2024 Mar-24
ascorbic acid / caffeine citrate / chlorphenamine maleate / dextromethorphan hydrobromide / paracetamol Entry removed as only authorised in 1 MS Mar-24
chlorphenamine maleate / diphenhydramine hydrochloride / phenylephrine hydrochloride Entry removed as only authorised in 1 MS Mar-24
chlortalidone / clonidine hydrochloride Entry removed as only authorised in 1 MS Mar-24
calcium pantothenate / cystine / keratin / p-aminobenzoic acid / thiamine / yeast Entry deleted as there are no products in Art 57 Mar-24
demoxytocin Entry removed as only authorised in 1 MS Mar-24
diclofenamide Entry deleted as there are no products in Art 57 Mar-24
pandemic influenza vaccine (H5N1) (whole virion, Vero cell derived, inactivated) Entry deleted as there are no products in Art 57 Mar-24
dichlorobenzyl alcohol / sodium benzoate Entry removed as only authorised in 1 MS Mar-24
dextropropoxyphene hydrochloride Entry removed as only authorised in 1 MS Mar-24
benzododecinium bromide Entry deleted due to merge with EURD ID: 369 Feb-24
chorionic gonadotrophin Entry deleted due to merge with EURD ID: 736 Feb-24
dihydralazine Entry deleted due to merge with EURD ID: 1646 Feb-24
dihydralazine / hydrochlorothiazide / reserpine Entry deleted as there are no products in Art 57 Feb-24
dimethoxanate Entry deleted as there are no products in Art 57 Feb-24
framycetin sulfate / lidocaine hydrochloride / salicylates / triamcinolone acetonide Entry deleted as there are no products in Art 57 Feb-24
hydralazine hydrochloride / hydrochlorothiazide / metoprolol tartrate Entry deleted as there are no products in Art 57 Feb-24
chlortalidone / hydralazine hydrochloride / oxprenolol hydrochloride Entry deleted as there are no products in Art 57 Feb-24
hydralazine hydrochloride / propranolol hydrochloride Entry deleted as there are no products in Art 57 Feb-24
polyvinyl alcohol / povidone Entry 2477 deleted due to merge with EURD ID: 2475 Feb-24
reteplase Entry deleted as Rapilysin (CAP) withdrawn on 26 Jan 2024 Feb-24
copper (64Cu) chloride Entry deleted as Cuprymina (CAP) withdrawn on 25 Jan 2024 Feb-24
estradiol / medroxyprogesterone acetate
Entry deleted due to merge with EURD ID: 582 Jan-24
ornithine Entry deleted due to merge with EURD ID: 10187 Jan-24
perazine
Entry deleted due to merge with EURD ID: 2426 & 2536 Jan-24
thiethylperazine
Entry deleted due to merge with EURD ID: 2426 & 2536 Jan-24
trifluoperazine
Entry deleted due to merge with EURD ID: 2426 & 2536 Jan-24
caffeine / indomethacin / proclorperazine maleate Entry removed as no products identified in Art 57 Jan-24
acetylsalicylic acid / dipyridamole Entry removed as only authorised in 1 MS Jan-24
abciximab Entry removed as no products identified in Art 57 Dec-23
acrivastine / pseudoephedrine Deletion of entry due to merge with EURD ID 54 Dec-23
altretamine Entry removed as only authorised in 1 MS Dec-23
aluminium hydroxide gel / calcium carbonate Entry removed as no products identified in Art 57 Dec-23
amiloride Deletion due to merge entries EURD ID: 145, 146, 147, 149 and 151 with entry EURD ID: 148 Dec-23
amiloride / bumetanide Deletion due to merge entries EURD ID: 145, 146, 147, 149 and 151 with entry EURD ID: 148 Dec-23
amiloride / chlortalidone Deletion due to merge entries EURD ID: 145, 146, 147, 149 and 151 with entry EURD ID: 148 Dec-23
amiloride / hydrochlorthiazide Deletion due to merge entries EURD ID: 145, 146, 147, 149 and 151 with entry EURD ID: 148 Dec-23
amiloride / hydrochlorthiazide / timolol Deletion due to merge entries EURD ID: 145, 146, 147, 149 and 151 with entry EURD ID: 148 Dec-23
amitriptyline hydrochloride / medazepam Entry removed as only authorised in 1 MS Dec-23
bacitracin / neomycin Entry deleted due to merge all the bacitracin containing entries (EURD ID: 288, 289, 291, 292 and 9072) in a single one (EURD ID: 285) Dec-23
bacitracin / hydrocortisone / neomycin Entry deleted due to merge all the bacitracin containing entries (EURD ID: 288, 289, 291, 292 and 9072) in a single one (EURD ID: 285) Dec-23
bacitracin zinc / cystein / glycine / neomycin sulfate / threonine Entry deleted due to merge all the bacitracin containing entries (EURD ID: 288, 289, 291, 292 and 9072) in a single one (EURD ID: 285) Dec-23
bacitracin zinc / neomycin sulfate / polymyxin b sulfate Entry deleted due to merge all the bacitracin containing entries (EURD ID: 288, 289, 291, 292 and 9072) in a single one (EURD ID: 285) Dec-23
bisacodyl combinations Entry deleted due to merge with EURD ID: 416 Dec-23
canrenone Entry removed as only authorised in 1 MS Dec-23
chloroxine Entry removed as only authorised in 1 MS Dec-23
colecalciferol Entry deleted due to merge entries EURD ID: 862, 1249 and 9089 with entry EURD ID: 10386 Dec-23
cyanamide Entry removed as no products identified in Art 57 Dec-23
caffeine / cyclizine / ergotamine Entry removed as only authorised in 1 MS Dec-23
dimemorfan Entry removed as no products identified in Art 57 Dec-23
efavirenz / emtricitabine / tenofovir
Entry removed as Atripla (CAP) surrendered Dec-23
ergocalciferol Entry deleted due to merge entries EURD ID: 862, 1249 and 9089 with entry EURD ID: 10386 Dec-23
lomefloxacin Entry removed as only authorised in 1 MS Dec-23
neostigmine Entry deleted due to merge with EURD ID: 1557 Dec-23
nilvadipine Entry removed as only authorised in 1 MS Dec-23
pneumococcal polysaccharide conjugate vaccine (adsorbed) - 7 valent
Entry removed as Prevenar (CAP) surrendered Dec-23
quazepam Entry removed as no products identified in Art 57 Dec-23
cinchonidine / cinchonine / quinidine / quinine Entry removed as only authorised in 1 MS Dec-23
saquinavir
Entry removed as Invirase (CAP) surrendered Dec-23
bacitracin / polymyxine Entry deleted due to merge all the bacitracin containing entries (EURD ID: 288, 289, 291, 292 and 9072) in a single one (EURD ID: 285) Dec-23
calcium / ergocalciferol Entry deleted due to merge entries EURD ID: 862, 1249 and 9089 with entry EURD ID: 10386 Dec-23
bupivacaine/meloxicam
Entry removed as Zynrelef (CAP) withdrawn on 05.10.23 Nov-23
chlorphenamine maleate / pholcodine Entry removed due to referral 107i/1521 adopted in Dec 2022:
CMDh AR conclusions: The Committee, as a consequence, considers that the benefit-risk balance of pholcodine-containing medicinal products is not favourable.
Therefore, pursuant to Article 116 of Directive 2001/83/EC, the Committee recommends the revocation of the marketing authorisations for pholcodine-containing medicinal products. Nov-23
paracetamol / pholcodine / pseudoephedrine Entry removed due to referral 107i/1521 adopted in Dec 2022:
CMDh AR conclusions: The Committee, as a consequence, considers that the benefit-risk balance of pholcodine-containing medicinal products is not favourable.
Therefore, pursuant to Article 116 of Directive 2001/83/EC, the Committee recommends the revocation of the marketing authorisations for pholcodine-containing medicinal products. Nov-23
pholcodine / biclotymol / chlorphenamine maleate Entry removed due to referral 107i/1521 adopted in Dec 2022:
CMDh AR conclusions: The Committee, as a consequence, considers that the benefit-risk balance of pholcodine-containing medicinal products is not favourable.
Therefore, pursuant to Article 116 of Directive 2001/83/EC, the Committee recommends the revocation of the marketing authorisations for pholcodine-containing medicinal products. Nov-23
SARS-CoV-2 virus, strain wuhan hCoV-19/Italy/INMI1-isl/2020, inactivated (Valneva) Entry removed as COVID-19 Vaccine (inactivated, adjuvanted) Valneva was withdrawn on 12.10.23 Nov-23
dimenhydrinate Entry removed due to merge (See EURD ID: 1088) Oct-23
hydrochlorothiazide / propranolol / triamterene Entry removed due to merge (See EURD ID: 1644) Oct-23
metildigoxin Entry removed due to merge (See EURD ID: 1065) Oct-23
nitrofurantoin / pyridoxine hydrochloride Entry removed due to merge (See EURD ID: 2174) Oct-23
pancreatic enzymes, pancreatic extracts, pancreatin (except for the centrally authorised product) Entry removed due to merge (See EURD ID: 2705) Oct-23
pancreatin / simeticone Entry removed due to merge (See EURD ID: 2705) Oct-23
dimethicone / pancreatin Entry removed due to merge (See EURD ID: 2705) Oct-23
selenite sodium Entry removed due to merge (See EURD ID: 2690) Oct-23
hydrochlorothiazide / triamterene / verapamil hydrochloride Entry removed due to merge (See EURD ID: 3107) Oct-23
xipamide Entry removed due to merge (See EURD ID: 3133) Oct-23
crizanlizumab
Entry for deletion as Adakveo (CAP) is revoked Oct-23
iodohippurate sodium (123i) Entry removed as no products identified in Art 57 Sep-23
elivaldogene autotemcel
Entry for deletion as Skysona (CAP) is withdrawn Sep-23
naphazoline nitrate / prednisolone Entry removed as only authorised in 1 MS Aug-23
dextromethorphan hydrobromide / quinidine sulfate Entry removed as no products identified in Art 57 Aug-23
neridronic acid Entry removed as no products identified in Art 57 Aug-23
penfluridol Entry removed as only authorised in 1 MS Aug-23
chlorphenoxamine Entry removed as only authorised in 1 MS Aug-23
acrivastine / pseudoephedrine Entry removed due to merge with EURD ID 54 “Acrivastine, acrivastine / pseudoephedrine” Jul-23
pholcodine Entry removed due to products' revocation (following Referral procedure) Jul-23
rufloxacin Entry removed as only authorised in 1 MS Jul-23
risperidone (centrally authorised products only) Entry removed due to merge with EURD ID: 2649 Jul-23
iodohippurate sodium (123i) Entry removed as no products identified in Art 57 Jun-23
betamethasone / diprophylline / guaifenesin Entry removed as only authorised in 1 MS Jun-23
ioxaglic acid Entry removed as no products identified in Art 57 Jun-23
lysine acetylsalicylate Entry removed due to merge with EURD ID: 39 (acetylsalicylic acid) Jun-23
lidocaine / norepinephrine Entry removed as only authorised in 1 MS Jun-23
sodium benzoate / grindelia tincture / polygala syrup Entry removed as only authorised in 1 MS Jun-23
calcium chloride / glucose monohydrate / magnesium chloride hexahydrate Entry removed due to merge (see EURD ID: 10424) Apr-23
piretanide Entry removed due to merge (see EURD ID: 2434) Apr-23
peppermint oil Entry removed as no longer fulfils requirements for inclusion in EURD list Apr-23
nilvadipine Entry removed as only authorised in 1 MS Mar-23
sulbactam Entry removed as only authorised in 1 MS Mar-23
xenon Entry removed as only authorised in 1 MS Mar-23
indinavir Entry removed as Crixivan (CAP) was withdrawn Jan-23
metformin / saxagliptin Entry removed due to merge with EURD ID: 2685 (saxagliptin) Jan-23
telbivudine Entry removed as Sebivo (CAP) was withdrawn Jan-23
telithromycin Entry removed as Ketek (CAP) was withdrawn Jan-23
ibalizumab Entry removed as Trogarzo (CAP) was withdrawn Jan-23
equine tetanus immunoglobulin Entry removed as no products identified in Art 57 Jan-23
adefovir Entry removed as Hepsera (CAP) was withdrawn Dec-22
peginterferon alpha-2b Entry removed as PegIntron & ViraferonPeg (CAP) were withdrawn Dec-22
botulinum toxin type b Entry removed as NeuroBloc (CAP) was withdrawn Dec-22
aminotridecane adipate Entry removed as no products identified in Art 57 Nov-22
strontium [89sr] chloride Entry removed as only authorised in 1 MS Nov-22
atenolol / nifedipine Entry removed as only authorised in 1 MS Nov-22
diphtheria / tetanus / pertussis (acellular, component) / haemophilus type b conjugate vaccine (adsorbed) Entry removed as no products identified in Art 57 Oct-22
leuprorelin (except for depot formulations) Entry removed as only authorised in 1 MS Oct-22
hydrochlorothiazide / moexipril Entry removed as only authorised in 1 MS Oct-22
halofantrine Entry removed as no products identified in Art 57 Sep-22
ertugliflozin Entry ID removed due to merge (see entry ID: 10784) Sep-22
ceftibuten Entry removed as only authorised in 1 MS Jul-22
interferon alpha-2a Entry removed as only authorised in 1 MS Jul-22
calcium chloride / glucose / magnesium chloride hexahydrate / sodium chloride / sodium hydrogen carbonate Entry removed as no products identified in Art 57 (Products covered/moved to EURD ID: 2724) Jul-22
cloxazolam Entry removed as only authorised in 1 MS Jul-22
sotagliflozin Entry removed as Zynquista (CAP) was withdrawn Jun-22
nateglinide Entry removed as Starlix (CAP) was withdrawn May-22
moxetumomab pasudotox Entry removed as Lumoxiti (CAP) was withdrawn May-22
cefodizime Entry removed as only authorised in 1 MS May-22
benzalkonium chloride (incl ocular) Entry removed due to merge. See EURD ID: 10987 Apr-22
sodium aurothiomalate Entry removed as no products identified in Art 57 Apr-22
calcium pantothenate / nicotinamide / pyridoxine / riboflavin / thiamine Entry removed due to merge. See EURD ID: 10807 Apr-22
dicobalt edetate Entry removed as only authorised in 1 MS Apr-22
betibeglogene autotemcel Entry removed as Zynteglo (CAP) was withdrawn Apr-22
flubendazole Entry removed as only authorised in 1 MS Mar-22
oxatomide Entry removed as only authorised in 1 MS Mar-22
pergolide Entry removed as only authorised in 1 MS Mar-22
lesinurad Entry removed as Zurampic (CAP) was withdrawn Mar-22
naltrexone Entry removed as only authorised in 1 MS Feb-22
crisaborole Entry removed as Staquis (CAP) was withdrawn Feb-22
didanosine Entry removed as no products identified in Art 57 Jan-22
fenoterol (obsteric indications) Entry removed as only authorised in 1 MS Jan-22
influenza vaccine (split virion, inactivated, prepared in cell cultures) Entry removed as no products identified in Art 57 Jan-22
benzoyl peroxide hydrous / potassium hydroxyquinoline sulphate Entry removed as only authorised in 1 MS Jan-22
allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2) Entry removed as Zalmoxis (CAP) was withdrawn Jan-22
allopurinol / lesinurad Entry removed as no products identified in Art 57 Jan-22
cinoxacin Entry removed as only authorised in 1 MS Dec-21
enoxacin Entry removed as no products identified in Art 57 Dec-21
fluocinolone acetonide / framycetin Entry ID removed due to merge (see entry ID: 1952) Dec-21
fluocinolone acetonide / ketocaine hydrochloride Entry ID removed due to merge (see entry ID: 1952) Dec-21
interferon alpha-2b Entry removed as IntronA (CAP) was withdrawn Dec-21
erythromycin / isotretinoin, isotretinoin (topical formulations) Entry removed as only authorised in 1 MS Dec-21
nalidixic acid Entry removed as no products identified in Art 57 Dec-21
pipemidic acid Entry removed as no products identified in Art 57 Dec-21
dihydroergocryptine Entry removed as no products identified in Art 57 Oct-21
dihydroergotoxine Entry removed as only authorised in 1 MS Oct-21
ispaghula husk, ispaghula husk/ ispaghula seed, ispaghula husk/ispaghula seed/senna Tinnervelly pod, psyllium, psyllium husk, psyllium seed Entry removed as GPAG outcome adopted by PRAC Oct-21
senna glycosides standardised 60% Entry removed as GPAG outcome adopted by PRAC Oct-21
eluxadoline Entry removed due to Truberzi (CAP) surrendered Aug-21
necitumumab Entry removed due to Portrazza (CAP) expiry of MA Jul-21
lidocaine Entry removed due to split (see entry ID: 10933 and 10934) Jun-21
collagenase clostridium histolyticum (treatment of Dupuytren’s contracture and treatment of Peyronie’s disease) Entry removed due to Xiapex (CAP) withdrawal Jun-21
methionine Entry removed as only authorised in 1 MS May-21
meningococcal group a and c polysaccharide vaccine Entry removed as only authorised in 1 MS May-21
benzathine benzylpenicillin / procaine benzylpenicillin Entry removed as only products authorised under WEU May-21
furosemide / ramipril Entry removed as only authorised in 1 MS Apr-21
cholic acid (CTX, AMACR or cholesterol 7α-hydroxylase deficiency indication) Entry removed as Kolbam was withdrawn Mar-21
meningococcal group a, c, w135, y polysaccharide vaccine Entry removed as no products identified in Art 57 Mar-21
alendronate / alfacalcidol Entry removed as only authorised in 1 MS Mar-21
peramivir Entry removed as Alpivab was withdrawn Mar-21
alitretinoin (cutaneous use) Entry removed as Panretin was withdrawn Feb-21
oxytocin Entry removed due to split (see entry ID: 10913 and 10914) Feb-21
indoramin Entry removed as only authorised in 1 MS Jan-21
quizartinib Entry removed as no products identified in Art 57 Jan-21
fluticasone / salmeterol (for centrally authorised products) Entry removed as product no longer authrorised Jan-21
ivabradine Entry ID removed due to merge (see entry ID: 10883) Dec-20
carvedilol / ivabradine Entry ID removed due to merge (see entry ID: 10883) Dec-20
strontium ranelate Entry removed as Protelos and Osseor were withdrawn in April 2020 Nov-20
benzocain / neomycin sulfate Entry removed as only authorised in 1 MS Oct-20
stavudine Entry removed as Zerit was withdrawn in June 2020 Sep-20
iron (parenteral preparations, except for iron dextran) Entry removed due to split (see entry ID: 10864, 10865, 10866 and 10867) Sep-20
ingenol mebutate Entry removed as product no longer authrorised Jul-20
hydrocortisone (except for products indicated in adrenal insufficiency in a modified release tablet formulation) Entry removed due to split (See entries ID: 10855, 10856) Jul-20
rubella vaccine (live, attenuated) Entry removed as only authorised in 1 MS Jun-20
technetium (99mtc) tiatide Entry removed as no products identified in Art 57 Jun-20
rolapitant Entry removed as Varuby was withdrawn in Jan 2020 Jun-20
rimexolone Entry removed as no products identified in Art 57 May-20
ferric citrate coordination complex Entry removed as product no longer authrorised May-20
chlorpropamide Entry removed as no products identified in Art 57 May-20
lidocaine hydrochloride monohydrate / fludrocortisone acetate / neomycin sulfate / polymyxin b Entry removed due to merge (See entry ID: 10847) May-20
lidocaine / paraformaldehyde Entry removed as no products identified in Art 57 May-20
lidocaine / pentosan polysulfate sodium / triamcinolone,
lidocaine / triamcinolone Entry removed as no products identified in Art 57 May-20
lidocaine hydrochloride / neomycin sulfate / polymyxin b Entry removed due to merge (See entry ID: 10847) May-20
pheniramine maleate / tetryzoline hydrochloride Entry removed as only authorised in 1 MS May-20
ergocalciferol / retinol acetate Entry removed as no products identified in Art 57 May-20
a-tocopherol / ergocalciferol / phytomenadion / retinol palmitate Entry removed as no products identified in Art 57 May-20
calcium carbonate / sodium alginate / sodium bicarbonate Entry removed due to merge (See entry ID: 10845) May-20
sodium alginate / sodium bicarbonate Entry removed due to merge (See entry ID: 10845) May-20
sulfanilamide Entry removed as no products identified in Art 57 May-20
adenosine 5' triphosphate / disodium salt Entry removed as only authorised in 1 MS Apr-20
125i-human serum albumin Entry removed as only authorised in 1 MS Mar-20
acetyldigoxin combinations Entry removed as only authorised in 1 MS Mar-20
adenosine / cytochrome c / nicotinamide / sodium succinate / sorbitol Entry removed as no products identified in Art 57 Mar-20
adenosine 5' triphosphate / disodium salt / glycine Entry removed as no products identified in Art 57 Mar-20
alpha amylase / bacitracin Entry removed as no products identified in Art 57 Mar-20
alpha chymotrypsin Entry removed as no products identified in Art 57 Mar-20
aluminium / calcium / sodium Entry removed as no products identified in Art 57 Mar-20
aminocaproic acid / esculina / hesperidina metil chalcona / menadiona / menadione sodium bisulfite Entry removed as no products identified in Art 57 Mar-20
amylsalicylate / levomenthol / methylnicotinate Entry removed as no products identified in Art 57 Mar-20
anatoxin staphylococcal native mixed alpha / beta and delta Entry removed as no products identified in Art 57 Mar-20
benzalkonium chloride / oxymetazoline Entry removed as no products identified in Art 57 Mar-20
benzylnicotinate / hydroxyethyl salicylate Entry removed as no products identified in Art 57 Mar-20
dihydroergocristine / esculinum / rutoside Entry removed as only authorised in 1 MS Mar-20
dihydroergocristine mesilate / raubasine Entry removed as no products identified in Art 57 Mar-20
caffeine / dihydroergotamine / propyphenazone Entry removed as no products identified in Art 57 Mar-20
dihydroergotoxin / hydrochlorothiazide / reserpine Entry removed as no products identified in Art 57 Mar-20
anthracene glycosides / glycosides hidroxiantracénicos / iodine Entry removed due to merge (See entry ID: 10838) Mar-20
lidocaine / matricariae extract Entry removed as no products identified in Art 57 Mar-20
potassium / sodium / triclosan Entry removed as no products identified in Art 57 Mar-20
codeine phosphate / promethazine hydrochloride Entry removed as no products identified in Art 57 Mar-20
ascorbic acid / calcium hydrogenphosphate / calcium panthotenate / colecalciferol / cyanocobalamin / folic acid / nicotinamide / pyridoxine hydrochloride / retinol / riboflavine / thiamin nitrate, ascorbic acid / cyanocobalamin / ergocalciferol / nicotinamide / pyridoxine / retinol / riboflavin / thiamine hydrochloride, ascorbic acid / colecalciferol / dexpanthenol / nicotinamide / pyridoxine / retinol / riboflavin / thiamine Entry removed as only authorised in 1 MS Mar-20
a-tocopheryl acetate / retinol acetate Entry removed as only authorised in 1 MS Mar-20
pyridoxine hydrochloride / retinol acetate / tocopheryl acetate Entry removed as no products identified in Art 57 Mar-20
a-tocoferol acetate / aurantii aetheroleum / citri aetheroleum / retinol palmitate / terpineol Entry removed as no products identified in Art 57 Mar-20
sacarose / trioxymethylene Entry removed as no products identified in Art 57 Mar-20
saccharomyces cerevisiae / sodium sulfate Entry removed as no products identified in Art 57 Mar-20
sulfabenzamide / sulfacetamide / sulfathiazole Entry removed as no products identified in Art 57 Mar-20
pyrimethamine / sulfalene Entry removed as only authorised in 1 MS Mar-20
aminopropylone / sulodexide Entry removed as no products identified in Art 57 Mar-20
sulphur / triclosan Entry removed as no products identified in Art 57 Mar-20
oxydation product / terebenthin essential oil Entry removed as no products identified in Art 57 Mar-20
calcium carbonate / magnesium carbonate / sodium bicarbonate Entry removed due to merge (See entry ID: 10837) Mar-20
allethrin (isomers and mixtures of isomers) / piperonyl butoxide Entry removed as only authorised in 1 MS Mar-20
cibenzoline Entry removed as only authorised in 1 MS Feb-20
formaldehyde Entry removed as only authorised in 1 MS Feb-20
pristinamycin Entry removed as only authorised in 1 MS Feb-20
guanosine / inosine / miconazole nitrate / vitamin f Entry removed due to merge (See entry ID: 10425) Jan-20
levonorgestrel Entry removed due to split (See entry ID: 107831 and 107832) Jan-20
nilvadipine Entry removed as it no longer fulfills the criteria for remaining on the list Jan-20
phentermine Entry removed as it no longer fulfills the criteria for remaining on the list Jan-20
charcoal activated / sodium thiosulphate Entry removed due to merge (See entry ID: 107816) Jan-20
androstanolone Entry removed as only authorised in 1 MS Dec-19
acetyldigoxin Entry removed as only authorised in 1 MS Nov-19
allobarbital / aminophenazone Entry removed as no products identified in Art 57 Nov-19
allopurinol / benzbromarone Entry removed as only authorised in 1 MS Nov-19
ambucetamide Entry removed as no products identified in Art 57 Nov-19
amiloride / hydrochlorthiazide / methyldopa Entry removed as no products identified in Art 57 Nov-19
aminaftone Entry removed as only authorised in 1 MS Nov-19
amlodipine / benazepril Entry removed as no products identified in Art 57 Nov-19
amoxicillin / metronidazole Entry removed as no products identified in Art 57 Nov-19
amoxicillin trihydrate / clarithromycin / lansoprazole Entry removed as no products identified in Art 57 Nov-19
amphetamine Entry removed as no products identified in Art 57 Nov-19
amphetamine / dextroamfetamine Entry removed as no products identified in Art 57 Nov-19
ascorbic acid / biotin / cyanocobalamin / folic acid / niacinamide / pantothenic acid / pyridoxine hydrochloride / riboflavin / thiamine mononitrate, biotine / cyanocobalamin / nicotinamide / pantothenic acid / pyridoxine / riboflavin / thiamine Entry removed due to merge (See entry ID: 107808) Nov-19
auranofin Entry removed as only authorised in 1 MS Nov-19
azepentacene polysulfonate sodium Entry removed as no products identified in Art 57 Nov-19
bacitracin / neomycin / prednisolone Entry removed as no products identified in Art 57 Nov-19
benfotiamine / biotin / cyanocobalamin / pantothenic acid / pyridoxine / retinol Entry removed as no products identified in Art 57 Nov-19
benfotiamine / cyanocobalamin Entry removed as only authorised in 1 MS Nov-19
benfotiamine / cyanocobalamin / pyridoxine Entry removed as only authorised in 1 MS Nov-19
benfotiamine / caffeine / codeine / paracetamol / propyphenazone Entry removed as no products identified in Art 57 Nov-19
benfotiamine / pyridoxine Entry removed as only authorised in 1 MS Nov-19
benidipine Entry removed as no products identified in Art 57 Nov-19
benzalkonium chloride / chloroxylenol / disodium edetate Entry removed as no products identified in Art 57 Nov-19
benzatropine Entry removed as no products identified in Art 57 Nov-19
benzonatate Entry removed as no products identified in Art 57 Nov-19
brompheniramine maleate / codeine phosphate / guaifenesin Entry removed as no products identified in Art 57 Nov-19
buclizine hydrochloride / cyanocobalamin / lysine hydrochloride / pyridoxine hydrochloride / tryptophan Entry removed as no products identified in Art 57 Nov-19
bupranolol Entry removed as no products identified in Art 57 Nov-19
buprenorphine hydrochloride / salicylic acid Entry removed as no products identified in Art 57 Nov-19
butalbital / paracetamol Entry removed as no products identified in Art 57 Nov-19
butalbital / caffeine / paracetamol Entry removed as no products identified in Art 57 Nov-19
butalbital / caffeine / codeine phosphate / paracetamol Entry removed as no products identified in Art 57 Nov-19
butenafine Entry removed as no products identified in Art 57 Nov-19
butriptyline Entry removed as no products identified in Art 57 Nov-19
cafedrine Entry removed as no products identified in Art 57 Nov-19
calamine Entry removed as no products identified in Art 57 Nov-19
calcium / magnesium / phosphorus Entry removed as only authorised in 1 MS Nov-19
cannabidiol (except for centrally authorised product) Entry removed as no products identified in Art 57 Nov-19
carbenicillin Entry removed as no products identified in Art 57 Nov-19
carbimide Entry removed as no products identified in Art 57 Nov-19
carbinoxamine maleate / phenylephrine hydrochloride Entry removed as no products identified in Art 57 Nov-19
carmellose (except for eye preparation) Entry removed as no products identified in Art 57 Nov-19
adenine / benfotiamine / carnitine orotate / fructose / nicotinamide / pantothenic acid / potassium orotate / pyridoxine / riboflavin / xanthine Entry removed as no products identified in Art 57 Nov-19
cefcapene Entry removed as no products identified in Art 57 Nov-19
cefpiramide Entry removed as no products identified in Art 57 Nov-19
cefsulodin Entry removed as no products identified in Art 57 Nov-19
cefteram Entry removed as no products identified in Art 57 Nov-19
ceftezole Entry removed as no products identified in Art 57 Nov-19
cefapirin Entry removed as no products identified in Art 57 Nov-19
cerivastatin Entry removed as no products identified in Art 57 Nov-19
benzoyl peroxide / cetylpyridinium chloride Entry removed as no products identified in Art 57 Nov-19
chlormadinone / estradiol Entry removed as no products identified in Art 57 Nov-19
chlornitrofenol Entry removed as no products identified in Art 57 Nov-19
chlorobutanol / levomenthol / pine oils / terpineol / thymol Entry removed as only authorised in 1 MS Nov-19
chlorothiazide Entry removed as no products identified in Art 57 Nov-19
chloroxylenol / disodium edetate Entry removed as no products identified in Art 57 Nov-19
chlorphenamine maleate / hydrocodone bitartrate / phenylephrine hydrochloride Entry removed as no products identified in Art 57 Nov-19
chlorphenamine maleate / hydrocodone polistirex Entry removed as no products identified in Art 57 Nov-19
chlorphenamine maleate / paracetamol / phenylephrine hydrochloride / phenyltoloxamine citrate Entry removed as no products identified in Art 57 Nov-19
chlorproethazine Entry removed as no products identified in Art 57 Nov-19
chlortetracycline / demeclocycline / tetracycline Entry removed as no products identified in Art 57 Nov-19
chlorxylenol / cinchocaine Entry removed as no products identified in Art 57 Nov-19
chlorzoxazone / paracetamol Entry removed as no products identified in Art 57 Nov-19
cilastatin Entry removed as no products identified in Art 57 Nov-19
bismuth subgallate / cinchocaine hydrochloride / oxidised cellulose calcium salt Entry removed as no products identified in Art 57 Nov-19
clofibrate Entry removed as no products identified in Art 57 Nov-19
clorazepate / pyridoxine Entry removed as no products identified in Art 57 Nov-19
codeine / creosote Entry removed as no products identified in Art 57 Nov-19
codeine / diphenhydramine Entry removed as no products identified in Art 57 Nov-19
codeine / ephedrine hydrochloride / guaifenesin Entry removed as no products identified in Art 57 Nov-19
codeine polysulfonate / guaifenesin / phenyltoloxamine Entry removed as no products identified in Art 57 Nov-19
codeine polysulfonate / guaifenesin / phenyltoloxamine / thyme Entry removed as no products identified in Art 57 Nov-19
codeine polysulfonate resin Entry removed as no products identified in Art 57 Nov-19
cyanocobalamin / folic acid / nicotinamide / pantothenic acid / pyridoxine hydrochloride / riboflavin / thiamine nitrate Entry deleted due to merge (see Entry ID: 107808) Nov-19
cyproheptadine hydrochloride / dimethylaminoethanol acetylglutamate / metoclopramide hydrochloride Entry removed as no products identified in Art 57 Nov-19
dantrone / poloxamer Entry removed as no products identified in Art 57 Nov-19
delavirdine Entry removed as no products identified in Art 57 Nov-19
dexbudesonide Entry removed as no products identified in Art 57 Nov-19
dexetimide Entry removed as no products identified in Art 57 Nov-19
dextranomer Entry removed as no products identified in Art 57 Nov-19
dextromethorphan hydrobromide / phenylpropanolamine hydrochloride Entry removed as no products identified in Art 57 Nov-19
dextromethorphan hydrobromide / guaifenesin / pseudoephedrine hydrochloride Entry removed as no products identified in Art 57 Nov-19
dextromethorphan hydrobromide / guaifenesin / paracetamol / pseudoephedrine hydrochloride Entry removed as only authorised in 1 MS Nov-19
chlorphenamine / dextromethorphan hydrochloride / phenylephrine hydrochloride Entry removed as no products identified in Art 57 Nov-19
dibenzepine Entry removed as no products identified in Art 57 Nov-19
diclofenac / gentamicin Entry removed as no products identified in Art 57 Nov-19
diclofenac / tobramycin Entry removed as no products identified in Art 57 Nov-19
diclofenac sodium / lidocaine Entry removed as no products identified in Art 57 Nov-19
dipivefrine Entry removed as no products identified in Art 57 Nov-19
dipivefrine hydrochloride / guanethidine Entry removed as no products identified in Art 57 Nov-19
docusate Entry deleted due to merge (See Entry ID: 107806) Nov-19
doxercalciferol Entry removed as no products identified in Art 57 Nov-19
erythromycin Entry removed due to split (See entry ID: 10808 and 10809) Nov-19
ethambutol / isoniazid Entry removed as no products identified in Art 57 Nov-19
ethambutol / isoniazid / rifampicine Entry removed as no products identified in Art 57 Nov-19
etoperidone Entry removed as no products identified in Art 57 Nov-19
etynodiol / mestranol Entry removed as no products identified in Art 57 Nov-19
fenbufen Entry removed as no products identified in Art 57 Nov-19
fendiline Entry removed as no products identified in Art 57 Nov-19
flurithromycin Entry removed as no products identified in Art 57 Nov-19
guaifenesin / hydrocodone Entry removed as no products identified in Art 57 Nov-19
guaifenesin / pentoxyverine Entry removed as no products identified in Art 57 Nov-19
hyaluronate zinc Entry removed as no products identified in Art 57 Nov-19
hydrochlorothiazide / methyldopa Entry removed as no products identified in Art 57 Nov-19
hydrochlorothiazide / reserpine / triamterene Entry removed as no products identified in Art 57 Nov-19
hydrocodone Entry removed as no products identified in Art 57 Nov-19
homatropine methylbromide / hydrocodone bitartrate Entry removed as no products identified in Art 57 Nov-19
hydrocodone bitartrate / ibuprofen Entry removed as no products identified in Art 57 Nov-19
hydrocodone bitartrate / paracetamol Entry removed as no products identified in Art 57 Nov-19
guaifenesin / hydrocodone bitartrate / phenylephrine hydrochloride Entry removed as no products identified in Art 57 Nov-19
hydrocodone bitartrate / phenyltoloxamine citrate Entry removed as no products identified in Art 57 Nov-19
escherichia coli / hydrocortisone acetate Entry removed as no products identified in Art 57 Nov-19
atropine / hydromorphone Entry removed as no products identified in Art 57 Nov-19
calcium oxide / ichthammol / potassium aluminium sulfate / salicylic acid / sodium perborate Entry removed as no products identified in Art 57 Nov-19
iodamide Entry removed as no products identified in Art 57 Nov-19
acidum malicum levogirum / calcium chloride dihydrate / glucose monohydrate / glycine / l proline / l-alanine / l-arginine / l-histidine / l-isoleucine / l-leucine / l-lysine hydrochloride / l-methionine / l-phenylalanine / l-threonine / l-tryptophane / l-valine / magnesium chloride hexahydrate / potassium chloride / sodium chloride / sodium glycerophosphate pentahydrate / zinc chloride Entry removed as no products identified in Art 57 Nov-19
lovastatin / nicotinic acid Entry removed as no products identified in Art 57 Nov-19
lumiracoxib Entry removed as no products identified in Art 57 Nov-19
meclofenamate Entry removed as no products identified in Art 57 Nov-19
mepenzolate Entry removed as no products identified in Art 57 Nov-19
mesuximide Entry removed as it no longer fulfills the criteria for remaining on the list Nov-19
methenamine / methylene blue Entry removed as no products identified in Art 57 Nov-19
methenamine / phenazopyridine Entry removed as no products identified in Art 57 Nov-19
acetylsalicylic acid / methocarbamol Entry removed as no products identified in Art 57 Nov-19
methyl diethylacetylsalicylate Entry removed as no products identified in Art 57 Nov-19
methylprednisolone acetate / neomycin sulfate Entry removed as no products identified in Art 57 Nov-19
metipamide Entry removed as no products identified in Art 57 Nov-19
metizoline Entry removed as no products identified in Art 57 Nov-19
metronidazole / minocycline / nystatine Entry removed as no products identified in Art 57 Nov-19
mitiglinide Entry removed as no products identified in Art 57 Nov-19
mofebutazone Entry removed as no products identified in Art 57 Nov-19
morphine sulfate / naltrexone hydrochloride Entry removed as no products identified in Art 57 Nov-19
nafcillin Entry removed as no products identified in Art 57 Nov-19
naloxone hydrochloride / pentazocine hydrochloride Entry removed as no products identified in Art 57 Nov-19
neomycin / phenylephrine / polymyxin b Entry removed as no products identified in Art 57 Nov-19
norfenefrine Entry removed as no products identified in Art 57 Nov-19
nystatin / triamcinolone Entry removed as no products identified in Art 57 Nov-19
oxiglutatione Entry removed as no products identified in Art 57 Nov-19
parethoxycaine Entry removed as no products identified in Art 57 Nov-19
pentosan polyester / phenylephrine Entry removed as no products identified in Art 57 Nov-19
pentoxyverine hydrogen citrate / terpine hydrate Entry removed as no products identified in Art 57 Nov-19
phenazone / tetracaine Entry removed as no products identified in Art 57 Nov-19
oxytetracycline / phenazopyridine hydrochloride / sulfamethizole Entry removed as no products identified in Art 57 Nov-19
phendimetrazine Entry removed as no products identified in Art 57 Nov-19
glibenclamide / phenformin hydrochloride Entry removed as no products identified in Art 57 Nov-19
guaifenesin / phenylephrine hydrochloride Entry removed as no products identified in Art 57 Nov-19
isoprenaline / phenylephrine hydrochloride Entry removed as no products identified in Art 57 Nov-19
phenylephrine hydrochloride / promethazine hydrochloride Entry removed as no products identified in Art 57 Nov-19
phenylsalicylate Entry removed as only authorised in 1 MS Nov-19
paracetamol / phenyltoloxamine citrate Entry removed as no products identified in Art 57 Nov-19
phosphorus (32p) sodium phosphate / sodium carbonate Entry removed as no products identified in Art 57 Nov-19
betaxolol / pilocarpine Entry removed as no products identified in Art 57 Nov-19
poliovirus type 1 (oral, live, attenuated) vaccine Entry deleted due to merge (see Entry ID: 107802) Nov-19
poliovirus type 1 / poliovirus type 2 / poliovirus type 3 vaccine (oral, live, attenuated) Entry deleted due to merge (see Entry ID: 107802) Nov-19
poliovirus type 2 (oral, live, attenuated) vaccine Entry deleted due to merge (see Entry ID: 107802) Nov-19
poliovirus type 3 (oral, live, attenuated) vaccine Entry deleted due to merge (see Entry ID: 107802) Nov-19
pranlukast Entry removed as no products identified in Art 57 Nov-19
prenoxdiazine Entry removed as no products identified in Art 57 Nov-19
progabide Entry removed as no products identified in Art 57 Nov-19
quinaprilat Entry removed as no products identified in Art 57 Nov-19
rebamipide Entry removed as no products identified in Art 57 Nov-19
reserpine Entry removed as no products identified in Art 57 Nov-19
rofecoxib Entry removed as no products identified in Art 57 Nov-19
rokitamycin Entry removed as no products identified in Art 57 Nov-19
rosoxacin Entry removed as no products identified in Art 57 Nov-19
sermorelin Entry removed as no products identified in Art 57 Nov-19
streptodornase Entry removed as no products identified in Art 57 Nov-19
tegaserod Entry removed as no products identified in Art 57 Nov-19
thenoate sodium Entry removed as no products identified in Art 57 Nov-19
teprenone Entry removed as no products identified in Art 57 Nov-19
terconazole Entry removed as no products identified in Art 57 Nov-19
terguride Entry removed as no products identified in Art 57 Nov-19
thyroglobulin Entry removed as no products identified in Art 57 Nov-19
tiotixene Entry removed as no products identified in Art 57 Nov-19
tolazamide Entry removed as no products identified in Art 57 Nov-19
tolmetin Entry removed as no products identified in Art 57 Nov-19
vidarabine Entry removed as no products identified in Art 57 Nov-19
boceprevir Entry for removal: Victrelis (CAP) surrendered. No other products in Art 57. Nov-19
carbidopa / levodopa (for centrally authorised product) Entry deleted as Numient (CAP) surrendered Nov-19
olaratumab Entry deleted as Lartruvo (CAP) revoked following Referral in July 2019 Nov-19
enoxaparin (biosimilars) Entry deleted due to merge (see Entry ID: 107810) Nov-19
enoxaparin (except for biosimilars) Entry deleted due to merge (see Entry ID: 107810) Nov-19
poliovirus type 1 / poliovirus type 3 (oral, live, attenuated) vaccine Entry deleted due to merge (see Entry ID: 107802) Nov-19
F(ab’)2 fragments of equine antirabies immunoglobulin Entry to be removed: produtcts authorised in only 1 MS Sep-19
fenspiride Entry to be removed as no products identified in Art 57 Sep-19
benzathine phenoxymethylpenicillin Entry deleted as medicinal products containing ‘benzathine phenoxymethylpenicillin’ are covered by the ‘phenoxymethylpenicillin’ entry Sep-19
daclatasvir Entry to be removed due to MA expiry Sep-19
dihydroergotamine / etilefrine Entry to be removed as no products identified in Art 57 Sep-19
etanercept (except for biosimilars) Entry deleted due to merge Sep-19
ertugliflozin / metformin Entry deleted due to merge Sep-19
ertugliflozin / sitagliptin Entry deleted due to merge Sep-19
etanercept (biosimilars) Entry deleted due to merge Sep-19
zafirlukast Entry to be removed as no products identified in Art 57 Sep-19
adalimumab (biosimilars) Entry deleted due to merge Jul-19
adalimumab (except for biosimilars) Entry deleted due to merge Jul-19
ursodeoxycholic acid Entry to be removed as no products identified in Art 57 Jun-19
pramocaine Entry deleted due to merge Jun-19
amlodipine besilate / ramipril Entry deleted due to merge Jun-19
chenodeoxycholic acid (for gallstone dissolution) Entry deleted due to merge Jun-19
dasabuvir
Entry deleted due to merge Jun-19
hydrochlorothiazide / ramipril Entry deleted due to merge Jun-19
hydrocortisone acetate / pramocaine hydrochloride Entry deleted due to merge Jun-19
malathion / permethrin / piperonyl butoxide Entry to be removed as no products identified in Art 57 Jun-19
ombitasvir / paritaprevir / ritonavir Entry deleted due to merge Jun-19
tauroursodeoxycholic acid Entry deleted due to merge Jun-19
antithrombin alpha Entry to be removed due to MA withdrawal May-19
ethinylestradiol / gestodene (transdermal application) Entry removed from the EURD list since products containing this active substance are authorised only in one MS May-19
levofloxacin (except for the centrally authorised product) Entry deleted due to merge May-19
ofatumumab Entry to be removed due to MA withdrawal May-19
acetylcysteine / tuaminoheptane Entry deleted due to merge Apr-19
colchicine / dicycloverine hydrochloride GPAG outcome adopted by PRAC April 2019 entry removed Apr-19
colchicine / probenecid GPAG outcome adopted by PRAC April 2019 entry removed Apr-19
dicycloverine hydrochloride / metochalcone / procaine hydrochloride GPAG outcome adopted by PRAC April 2019 entry removed Apr-19
aluminium oxide hydrated / dicycloverine hydrochloride / magnesium oxide light / simeticone GPAG outcome adopted by PRAC April 2019 entry removed Apr-19
fluorometholone / tetryzoline GPAG outcome adopted by PRAC April 2019 entry removed Apr-19
fluorometholone / urea GPAG outcome adopted by PRAC April 2019 entry removed Apr-19
retapamulin Entry removed due to withdrawal of CAP (only authorisation) Apr-19
infliximab (biosimilars) Entry merged with 'infliximab (except biosimilars). New entry named "Infliximab". Apr-19
infliximab (except for biosimilars) Entry merged with 'infliximab (biosimilars). New entry named "Infliximab". Apr-19
lubiprostone Entry removed: no products in the procedure Apr-19
amidotrizoic acid Entry to be removed because covered by "amidotrizoic acid and combination" Feb-19
aluminium salicylate / sulfaguanidine Entry removed since no products have been identified containing this combination of active substances Feb-19
amfetamine aspartate / amfetamine sulfate / dexamfetamine saccharate / dexamfetamine sulfate Entry removed since no products have been identified containing this combination of active substances Feb-19
biodastase / dehydrocholic acid / lipase / papain / procaine hydrochloride Entry removed since no products have been identified containing this combination of active substances Feb-19
calcium / dexamethasone / lidocaine Entry to be removed: duplicate of "calcium dobesilate / dexamethasone / lidocaine" Feb-19
calcium / lidocaine Entry to be removed: duplicate of "calcium dobesilate / lidocaine" Feb-19
calcium carbonate / simeticone Entry removed since no products have been identified containing this combination of active substances Feb-19
calcium dobesilate / dexamethasone / lidocaine Entry removed because merged with "calcium dobesilate / lidocaine" Feb-19
calcium dobesilate / lidocaine Entry removed because merged with "calcium dobesilate / dexamethasone / lidocaine" Feb-19
pegaptanib Entry to be removed due to MA withdrawal Feb-19
ibuprofen / isopropyl myristate Entry removed since no products have been identified containing this combination of active substances Feb-19
lysine amidotrizoate / sodium amidotrizoate Entry removed because covered by "amidotrizoic acid and combination" Feb-19
meglumine amidotrizoate / sodium amidotrizoate Entry removed because covered by "amidotrizoic acid and combination" Feb-19
metaxalone Entry removed since no products have been identified containing this active substance Feb-19
metoxybutropate Entry removed since no products have been identified containing this active substance Feb-19
pipobroman Entry removed from the EURD list since product containing this active substance is authorised only in one MS Feb-19
polycarbophil Entry removed since no products have been identified containing this combination of active substances Feb-19
acetylsalicylic acid / magnesium hydroxide Entry removed since no products have been identified containing this active substance Jan-19
albiglutide Entry removed since no products have been identified containing this active substance Jan-19
amrinone Entry removed since no products have been identified containing this active substance Jan-19
calcium pantothenate / dimeticone / magnesium polygalacturonate Entry removed since no products have been identified containing this active substance Jan-19
chloramphenicol / medroxyprogesterone / tetryzoline Entry removed since no products have been identified containing this active substance Jan-19
chloramphenicol / methyluracil Entry removed from the EURD list since products containing this active substance are authorised only in one MS Jan-19
choline magnesium trisalicylate Entry removed since no products have been identified containing this active substance Jan-19
coprecipitate of aluminium hydroxide / magnesium carbonate Entry to be removed because covered by "antacids: combinations or monocomponents of aluminium / calcium / magnesium / potassium / sodium salts" Jan-19
cromoglicate sodium / tetryzoline hydrochloride Entry removed since no products have been identified containing this active substance Jan-19
dienestrol Entry removed since no products have been identified containing this active substance Jan-19
diphenhydramine hydrochloride / naphazoline hydrochloride / neomycin sulfate Entry removed from the EURD list since products containing this active substance are authorised only in one MS Jan-19
estradiol / gestodene Entry removed since no products have been identified containing this active substance Jan-19
estrogen / methyltestosterone Entry removed since no products have been identified containing this active substance Jan-19
estrone sodium sulfate Entry removed since no products have been identified containing this active substance Jan-19
ethinylestradiol / etynodiol Entry removed since no products have been identified containing this active substance Jan-19
ethinylestradiol / lynestrenol Entry removed since no products have been identified containing this active substance Jan-19
ethinylestradiol / norgestrel Entry removed since no products have been identified containing this active substance Jan-19
fluorometholone / gentamicin Entry removed since no products have been identified containing this active substance Jan-19
fluorometholone / miconazole nitrate / neomycin sulfate Entry removed since no products have been identified containing this active substance Jan-19
fluorometholone acetate / tobramycin Entry removed since no products have been identified containing this active substance Jan-19
heptaminol Entry removed from the EURD list since products containing this active substance are authorised only in one MS Jan-19
magnesium peroxide Entry removed since no products have been identified containing this active substance Jan-19
mebhydroline Entry removed since no products have been identified containing this active substance Jan-19
medroxyprogesterone acetate / tetryzoline hydrochloride Entry removed since no products have been identified containing this active substance Jan-19
metipranolol Entry removed since no products have been identified containing this active substance Jan-19
metipranolol hydrochloride / pilocarpine hydrochloride Entry removed since no products have been identified containing this active substance Jan-19
oxamniquine Entry removed since no products have been identified containing this active substance Jan-19
oxandrolone Entry removed since no products have been identified containing this active substance Jan-19
oxymetholone Entry removed since no products have been identified containing this active substance Jan-19
pegademase Entry removed since no products have been identified containing this active substance Jan-19
pimethixene Entry removed from the EURD list since products containing this active substance are authorised only in one MS Jan-19
polyestradiol Entry removed since no products have been identified containing this active substance Jan-19
polythiazide Entry removed since no products have been identified containing this active substance Jan-19
polythiazide / reserpine Entry removed since no products have been identified containing this active substance Jan-19
pramocaine hydrochloride / zinc sulfate Entry removed since no products have been identified containing this active substance Jan-19
prednisolone acetate / sulfacetamide sodium Entry removed since no products have been identified containing this active substance Jan-19
sodium bicarbonate / sodium citrate / sodium fluoride Entry removed since no products have been identified containing this active substance Jan-19
sodium bromide Entry removed from the EURD list since products containing this active substance are authorised only in one MS Jan-19
ribavirin (aerosol application) Entry to be removed: no products authorised in Art.57.
The last product which was authorised, Virazole in Spain, was withdrawn on 19/10/2018. Dec-18
fentanyl (transdermal system - centrally authorised product) Entry to be removed: no products authorised , as the CAP Ionsys belonging to the procedure has now been withdrawn. Dec-18
aluminium lactate / benzydamine Entry removed since no products have been identified containing this active substance Nov-18
bacitracin / colistimethate sodium / hydrocortisone acetate Entry removed from the EURD list since products containing this active substance are authorised only in one MS Nov-18
cobamamide / cyproheptadine Entry removed from the EURD list since products containing this active substance are authorised only in one MS Nov-18
copper acetate / lactic acid / salicylic acid Entry removed from the EURD list since products containing this active substance are authorised only in one MS Nov-18
olpadronic acid Entry removed since no products have been identified containing this active substance Nov-18
ticarcillin Entry removed from the EURD list since products containing this active substance are authorised only in one MS Nov-18
amyl nitrite Entry removed since no products have been identified containing this active substance Oct-18
chloramphenicol / collagenase Entry removed from the EURD list since products containing this active substance are authorised only in one MS Oct-18
chlorcyclizine hydrochloride / cinnarizine Entry removed from the EURD list since products containing this active substance are authorised only in one MS Oct-18
cilnidipine Entry removed since no products have been identified containing this active substance Oct-18
clemastine fumarate / phenylpropanolamine hydrochloride Entry removed since no products have been identified containing this active substance Oct-18
clocinizine / phenylpropanolamine hydrochloride Entry removed from the EURD list since products containing this active substance are authorised only in one MS Oct-18
co-danthrusate Entry removed from the EURD list since products containing this active substance are authorised only in one MS Oct-18
desipramine Entry removed since no products have been identified containing this active substance Oct-18
eptotermin alpha Entry removed since no products have been identified containing this active substance Oct-18
fructose Entry removed since no products have been identified containing this active substance Oct-18
ibacitabine Entry removed from the EURD list since products containing this active substance are authorised only in one MS Oct-18
influenza vaccine (split virion, inactivated) (centrally authorised products only) The marketing authorisation has expired on 1 July 2018. Oct-18
acebutolol / mefruside Entry removed since no products have been identified containing this active substance Sep-18
acebutolol / nifedipine Entry removed since no products have been identified containing this active substance Sep-18
acepromazine / aceprometazine / clorazepate dipotassium Entry removed since no products have been identified containing this active substance Sep-18
acetylsalicylic acid / carisoprodol Entry removed since no products have been identified containing this active substance Sep-18
actinoquinol / oxedrine tartrate Entry removed since no products have been identified containing this active substance Sep-18
activated attapulgite / attapulgite / morphine hydrochloride Entry removed since no products have been identified containing this active substance Sep-18
aluminium hydroxide / attapulgite / kaolin / pectin Entry removed since no products have been identified containing this active substance Sep-18
amineptine Entry removed since no products have been identified containing this active substance Sep-18
amylocaine hydrochloride / dodeclonium bromide Entry removed since no products have been identified containing this active substance Sep-18
avobenzone / ensulizole / octisalate Entry removed since no products have been identified containing this active substance Sep-18
azintamide / hyoscine Entry removed since no products have been identified containing this active substance Sep-18
benzalkonium chloride / furazolidone Entry removed since no products have been identified containing this active substance Sep-18
bile-dispert / pancreatin Entry removed since no products have been identified containing this active substance Sep-18
bretylium Entry removed since no products have been identified containing this active substance Sep-18
broxaterol Entry removed since no products have been identified containing this active substance Sep-18
buformin Entry removed since no products have been identified containing this active substance Sep-18
butorphanol Entry removed since no products have been identified containing this active substance Sep-18
buzepide metiodide / haloperidol Entry removed since no products have been identified containing this active substance Sep-18
caffeine / carisoprodol / diclofenac sodium / paracetamol Entry removed since no products have been identified containing this active substance Sep-18
calcium pidolate Entry removed since no products have been identified containing this active substance Sep-18
camostat Entry removed since no products have been identified containing this active substance Sep-18
carisoprodol Entry removed since no products have been identified containing this active substance Sep-18
carisoprodol / paracetamol Entry removed since no products have been identified containing this active substance Sep-18
carmofur Entry removed since no products have been identified containing this active substance Sep-18
carmoisine Entry removed since no products have been identified containing this active substance Sep-18
carmoisine / paracetamol Entry removed since no products have been identified containing this active substance Sep-18
centella extract / hydrocortisone acetate / neomycine Entry removed since no products have been identified containing this active substance Sep-18
cetylpyridinium / dequalinium chloride Entry removed since no products have been identified containing this active substance Sep-18
cevimeline Entry removed since no products have been identified containing this active substance Sep-18
chymopapain Entry removed since no products have been identified containing this active substance Sep-18
cinnarizine / heptaminol acefylline Entry removed since no products have been identified containing this active substance Sep-18
corticotropin Entry removed since no products have been identified containing this active substance Sep-18
cyanocobalamin / hydroxocobalamin Entry removed since no products have been identified containing this active substance Sep-18
cyclandelate Entry removed since no products have been identified containing this active substance Sep-18
d,l-1-(p-hydroxyphenyl)-propylamine hydroiodide / muramidase hydrochloride / thonzylamine hydrochloride Entry removed since no products have been identified containing this active substance Sep-18
dalfopristin / quinupristin Entry removed since no products have been identified containing this active substance Sep-18
denileukin diftitox Entry removed since no products have been identified containing this active substance Sep-18
deslanoside Entry removed since no products have been identified containing this active substance Sep-18
dextromoramide Entry removed since no products have been identified containing this active substance Sep-18
dimefline Entry removed since no products have been identified containing this active substance Sep-18
diphemanil Entry removed since no products have been identified containing this active substance Sep-18
dipivefrine hydrochloride / pilocarpine hydrochloride Entry removed since no products have been identified containing this active substance Sep-18
dipotassium clorazepate / gabob / pyridoxine hydrochloride Entry removed since no products have been identified containing this active substance Sep-18
diprophylline / oxidation product / terebenthin essential oil Entry removed since no products have been identified containing this active substance Sep-18
diprophylline / proxyphylline / theophylline Entry removed since no products have been identified containing this active substance Sep-18
disodium inosinate Entry removed since no products have been identified containing this active substance Sep-18
dixyrazine Entry removed since no products have been identified containing this active substance Sep-18
domiphen Entry removed since no products have been identified containing this active substance Sep-18
drofenine / propyphenazone Entry removed since no products have been identified containing this active substance Sep-18
dronabinol Entry removed since no products have been identified containing this active substance Sep-18
eledoisin Entry removed since no products have been identified containing this active substance Sep-18
embramine Entry removed since no products have been identified containing this active substance Sep-18
emetine Entry removed since no products have been identified containing this active substance Sep-18
epervudine Entry removed since no products have been identified containing this active substance Sep-18
equilin sulfate sodium / estrone sodium sulfate Entry removed since no products have been identified containing this active substance Sep-18
estropipate Entry removed since no products have been identified containing this active substance Sep-18
eszopiclone Entry removed since no products have been identified containing this active substance Sep-18
ethylmorphine hydrochloride / indometacin Entry removed since no products have been identified containing this active substance Sep-18
etofylline / hexobendine Entry removed since no products have been identified containing this active substance Sep-18
etretinate Entry removed since no products have been identified containing this active substance Sep-18
fluocortin Entry removed since no products have been identified containing this active substance Sep-18
framycetin sulfate / oxedrine / polymyxin b sulphate Entry removed since no products have been identified containing this active substance Sep-18
fursultiamine / riboflavin Entry removed since no products have been identified containing this active substance Sep-18
gastric mucin Entry removed since no products have been identified containing this active substance Sep-18
glibornuride Entry removed since no products have been identified containing this active substance Sep-18
gramicidin / neomycin Entry removed since no products have been identified containing this active substance Sep-18
gramicidin s / framycetin sulfate / polymyxin b sulfate Entry removed since no products have been identified containing this active substance Sep-18
ibudilast Entry removed since no products have been identified containing this active substance Sep-18
iopanoic acid Entry removed since no products have been identified containing this active substance Sep-18
edrophonium Entry removed since no products have been identified containing this active substance Sep-18
prenoxdiazine Entry removed since no products have been identified containing this active substance Sep-18
propacetamol Entry removed since no products have been identified containing this active substance Sep-18
proscillaridin Entry removed since no products have been identified containing this active substance Sep-18
quinfamide Entry removed since no products have been identified containing this active substance Sep-18
resorcinol / sulphur Entry removed since no products have been identified containing this active substance Sep-18
sibutramine Entry removed since no products have been identified containing this active substance Sep-18
sivelestat Entry removed since no products have been identified containing this active substance Sep-18
sodium aurothiosulfate Entry removed since no products have been identified containing this active substance Sep-18
sodium bromebrate Entry removed since no products have been identified containing this active substance Sep-18
sodium medronate / stannous fluoride Entry removed since no products have been identified containing this active substance Sep-18
sodium pidolate Entry removed since no products have been identified containing this active substance Sep-18
stannous fluoride Entry removed since no products have been identified containing this active substance Sep-18
sulesomab Entry removed since no products have been identified containing this active substance Sep-18
tedisamil Entry removed since no products have been identified containing this active substance Sep-18
tinidazole / tioconazole Entry removed since no products have been identified containing this active substance Sep-18
ascorbic acid / macrogol 3350 / potassium chloride / sodium ascorbate / sodium chloride / sodium sulphate Entry was merged with "macrogol 3350 combinations (oral use)", therefore it had to be deleted from the list Sep-18
hydroxocobalamin (except for products for chemical poisoning) Entry was merged with "cobamamide"ID 838 due to the similarity in therapeutical indication, therefore it had to be deleted from the list Sep-18
macrogol 3350 / potassium chloride / sodium bicarbonate / sodium chloride Entry was merged with "macrogol 3350 combinations (oral use)", therefore it had to be deleted from the list Sep-18
macrogol 3350 / potassium chloride / sodium sulphate anhydrous / sodium chloride / sodium hydrogen carbonate Entry was merged with "macrogol 3350 / potassium chloride / sodium bicarbonate / sodium chloride ; ascorbic acid / macrogol 3350 / potassium chloride / sodium ascorbate / sodium chloride / sodium sulphate"
in new entry "macrogol 3350 combinations (oral use)", therefore it had to be deleted from the list Sep-18
retigabine Entry removed due to product withdrawal on 19 July 2018 Sep-18
sodium fluoride Entry removed because this substance is covered by the general "fluoride" entry Sep-18
amylocaine hydrochloride / sodium benzoate Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
catalase Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
catalase / neomycin Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
cellulase Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
cetalkonium / lidocaine Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
chlorquinaldol / hydrocortisone butyrate Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
cicletanine Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
clofoctol Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
desoxycortone acetate Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
dimecrotate magnesium Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
eperisone Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
ephedrine hydrochloride / naphazoline nitrate Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
ethionamide Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
fenoldopam Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
fluoride sodium / strontium acetate hemihydrate Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
gramicidin / naphazoline / neomycin / phenylephrine Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
halcinonide Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
hydroxocobalamin / pyridoxine / thiamine Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
ibopamine Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
metixene Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
naphazoline nitrate / thonzylamine hydrochloride Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
procaterol Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
rociverine Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
takadiastase Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
alitretinoin Entry removed from the EURD list due to splitting existing entry into two separate entries: alitretinoin (cutaneous use) and alitretinoin (oral use) Sep-18
rabbit anti-human T-lymphocyte immunoglobulin (powder for solution for infusion) Entry removed from the EURD list due to procedure scope change and merging with "rabbit anti-humanT-lymphocyte immunoglobulin (concentrate for solution for infusion)" entry. New entry: "rabbit anti-humanT-lymphocyte immunoglobulin". Sep-18
acetylaminonitropropoxybenzene Entry to be removed since no products have been identified containing this active substance Jul-18
acetylleucine Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Jul-18
aconitine / histamine disalicylate Entry to be removed since no products have been identified containing this combination of active substances Jul-18
acriflavinium chloride / menthol / resorcinol Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. Jul-18
algeldrate, algeldrate / magnesium hydroxide Removal from EURD list; Entry: "antacids: combinations or monocomponents of aluminium / calcium / magnesium / potassium / sodium salts" to be followed (PSUSA/00000500) Jul-18
alibendole Entry to be removed since no products have been identified containing this active substance Jul-18
altizide Entry to be removed since no products have been identified containing this active substance Jul-18
amezinium Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Jul-18
amilomer Entry to be removed since no products have been identified containing this active substance Jul-18
aminoglutethimide Entry to be removed since no products have been identified containing this active substance Jul-18
aminohippurate Entry to be removed since no products have been identified containing this active substance Jul-18
aminotridecane undecylenate Entry to be removed since no products have been identified containing this active substance Jul-18
ampicillin / flucloxacillin Entry to be removed from the EURD list since only products in one MS identified containing this combination of active substances. Jul-18
azulenolum Entry to be removed since no products have been identified containing this active substance Jul-18
barbexaclone Entry to be removed since no products have been identified containing this active substance Jul-18
benexate Entry to be removed since no products have been identified containing this active substance Jul-18
benorilate Entry to be removed since no products have been identified containing this active substance Jul-18
bopindolol Entry to be removed since no products have been identified containing this active substance Jul-18
buclizine Entry to be removed since no products have been identified containing this active substance Jul-18
cadralazine Entry to be removed since no products have been identified containing this active substance Jul-18
calcium carbonate / magnesium carbonate Removal from EURD list; Entry: "antacids: combinations or monocomponents of aluminium / calcium / magnesium / potassium / sodium salts" to be followed (PSUSA/00000500) Jul-18
cortivazol Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Jul-18
detajmium Entry to be removed since no products have been identified containing this active substance Jul-18
ditazole Entry to be removed since no products have been identified containing this active substance Jul-18
flavodate Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Jul-18
glycol salicylate / methyl nicotinate Entry to be removed from the EURD list since only products in one MS identified containing this combination of active substances. Jul-18
idrocilamide Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Jul-18
iotrolan Entry to be removed since no products have been identified containing this active substance Jul-18
lidoflazine Entry to be removed since no products have been identified containing this active substance Jul-18
limaprost Entry to be removed since no products have been identified containing this active substance Jul-18
linsidomine Entry to be removed since no products have been identified containing this active substance Jul-18
mabuprofen Entry to be removed since no products have been identified containing this active substance Jul-18
matrix-applied characterised autologous cultured chondrocytes The marketing authorisation has expired on 1 July 2018, therefore this entry is deleted. Jul-18
mitoguazone Entry to be removed since no products have been identified containing this active substance Jul-18
nimorazole Entry to be removed since no products have been identified containing this active substance Jul-18
nitrogen Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Jul-18
nonivamide Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Jul-18
oxilofrine Entry to be removed since no products have been identified containing this active substance Jul-18
oxitropium Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Jul-18
oxymetazoline hydrochloride / prednisolone sodium phosphate Entry to be removed from the EURD list since only products in one MS identified containing this combination of active substances. Jul-18
pemoline Entry to be removed since no products have been identified containing this active substance Jul-18
pipazetate Entry to be removed since no products have been identified containing this active substance Jul-18
pipotiazine Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Jul-18
pitofenone Entry to be removed since no products have been identified containing this active substance Jul-18
ramelteon Entry to be removed since no products have been identified containing this active substance Jul-18
stanozolol Entry to be removed since no products have been identified containing this active substance Jul-18
thioproperazine Entry to be removed since no products have been identified containing this active substance Jul-18
triclabendazole Entry to be removed since no products have been identified containing this active substance Jul-18
trimethobenzamide Entry to be removed from the EURD list since only products in one MS identified containing this combination of active substances. Jul-18
tropatepine Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Jul-18
troxipide Entry to be removed since no products have been identified containing this active substance Jul-18
tulobuterol Entry to be removed since no products have been identified containing this active substance Jul-18
unoprostone Entry to be removed since no products have been identified containing this active substance Jul-18
valethamate Entry to be removed since no products have been identified containing this active substance Jul-18
vasopressin Entry to be removed since no products have been identified containing this active substance Jul-18
viloxazine Entry to be removed since no products have been identified containing this active substance Jul-18
viminol Entry to be removed from the EURD list since only products in one MS identified containing this combination of active substances. Jul-18
voglibose Entry to be removed since no products have been identified containing this active substance Jul-18
vorinostat Entry to be removed since no products have been identified containing this active substance Jul-18
xantinol nicotinate Entry to be removed from the EURD list since only products in one MS identified containing this combination of active substances. Jul-18
zalcitabine Entry to be removed since no products have been identified containing this active substance Jul-18
simeprevir Product was withdrawn on 05/03/2018, therefore entry is deleted Jun-18
flupirtine Marketing authorisations for flupirtine containing priducts have been revoked with the CMDh position dated 21 March 2018, therefore entry to be removed Jun-18
acetylsalicylic acid / ibuprofen Entry to be removed since no products have been identified containing this combination of active substances Jun-18
benzathine benzylpenicillin / lidocaine hydrochloride Entry to be removed since no products have been identified containing this combination of active substances Jun-18
cefonicid / lidocaine hydrochloride Entry to be removed since no products have been identified containing this combination of active substances Jun-18
cetylpyridinium chloride / dichlorobenzyl alcohol / lidocaine hydrochloride Entry to be removed since no products have been identified containing this combination of active substances Jun-18
indometacin / methocarbamol Entry to be removed since no products have been identified containing this combination of active substances Jun-18
lidocaine hydrochloride / metacresol / paraformaldehyde Entry to be removed since no products have been identified containing this combination of active substances Jun-18
lidocaine hydrochloride / phenylbutazone Entry to be removed since no products have been identified containing this combination of active substances Jun-18
lidocaine hydrochloride / phenylephrine hydrochloride / sodium propionate Entry to be removed since no products have been identified containing this combination of active substances Jun-18
lidocaine hydrochloride / piperacillin sodium Entry to be removed since no products have been identified containing this combination of active substances Jun-18
lidocaine hydrochloride / tolperisone hydrochloride Entry to be removed since no products have been identified containing this combination of active substances Jun-18
pheniramine Entry to be removed since no products have been identified containing this combination of active substances Jun-18
acediasulfone Entry to be removed since no products have been identified containing this active substance May-18
acediasulfone / cinchocaine / dihydroxymethyl carbamide Entry to be removed since no products have been identified containing this active substance May-18
alfoscerate olamine Entry to be removed since no products have been identified containing this active substance May-18
aloxiprin Entry to be removed since no products have been identified containing this active substance May-18
benzethonium chloride Entry to be removed since no products have been identified containing this active substance May-18
benzfetamine Entry to be removed since no products have been identified containing this active substance May-18
calcium phosphate / cyanocobalamin / cyproheptadine hydrochloride Entry to be removed since no products have been identified containing this combination of active substances May-18
coal tar, distilled coal tar Removal from EURD list following merge. Entry: "coal tar, distilled coal tar, distilled coal tar / lecithin, coconut oil / distilled coal tar / salicylic acid, coal tar solution / salicylic acid / sulfur, coal tar / salicylic acid, coal tar / menthol, coal tar solution / salicylic acid / benzalkonium chloride solution / polyoxyethylene 4 lauryl ether / polyoxyethylene 23 lauryl ether" to be followed (PSUSA/00010684) May-18
coal tar / menthol Removal from EURD list following merge. Entry: "coal tar, distilled coal tar, distilled coal tar / lecithin, coconut oil / distilled coal tar / salicylic acid, coal tar solution / salicylic acid / sulfur, coal tar / salicylic acid, coal tar / menthol, coal tar solution / salicylic acid / benzalkonium chloride solution / polyoxyethylene 4 lauryl ether / polyoxyethylene 23 lauryl ether" to be followed (PSUSA/00010684) May-18
coconut oil / distilled coal tar / salicylic acid, coal tar solution / salicylic acid / sulfur Removal from EURD list following merge. Entry: "coal tar, distilled coal tar, distilled coal tar / lecithin, coconut oil / distilled coal tar / salicylic acid, coal tar solution / salicylic acid / sulfur, coal tar / salicylic acid, coal tar / menthol, coal tar solution / salicylic acid / benzalkonium chloride solution / polyoxyethylene 4 lauryl ether / polyoxyethylene 23 lauryl ether" to be followed (PSUSA/00010684) May-18
cholecalciferol concentrate / sodium fluoride Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. May-18
colchicine / opium / tiemonium Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. May-18
delapril Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. May-18
distilled coal tar / lecithin Removal from EURD list following merge. Entry: "coal tar, distilled coal tar, distilled coal tar / lecithin, coconut oil / distilled coal tar / salicylic acid, coal tar solution / salicylic acid / sulfur, coal tar / salicylic acid, coal tar / menthol, coal tar solution / salicylic acid / benzalkonium chloride solution / polyoxyethylene 4 lauryl ether / polyoxyethylene 23 lauryl ether" to be followed (PSUSA/00010684) May-18
mebutizide Entry to be removed since no products have been identified containing this active substance May-18
reviparin Entry to be removed since no products have been identified containing this active substance May-18
trilostane Entry to be removed since no products have been identified containing this active substance May-18
abarelix Entry to be removed since no products have been identified containing this active substance Apr-18
peramivir Entry to be removed since no products have been identified containing this active substance Apr-18
prasterone Products currently authorised only in PL, therefore entry is deleted Apr-18
tiemonium Entry to be removed since no products have been identified containing this active substance Apr-18
telavancin Product was withdrawn on 23/03/2018, therefore entry is deleted Apr-18
ipecacuanha / potassium sulfoguaiacolate / promethazine Products currently authorised only in NL and as generic, therefore entry is deleted Apr-18
nesiritide Entry to be removed since no products have been identified containing this active substance Apr-18
aceclidine Entry to be removed since no products have been identified containing this active substance Apr-18
ammonium chloride / dextromethorphan hydrobromide / diphenhydramine hydrochloride / pseudoephedrine hydrochloride Entry to be removed since no products have been identified containing this active substance Apr-18
benzocaine / chlorobutanol Entry to be removed since no products have been identified containing this active substance Apr-18
caffeine / propyphenazone Products currently authorised only in ES and under WEU, therefore entry is deleted Apr-18
calcium carbonate / vitamin d / zinc Entry to be removed since no products have been identified containing this active substance Apr-18
chlorphenamine maleate / hyoscine methobromide / pseudoephedrine hydrochloride Entry to be removed since no products have been identified containing this active substance Apr-18
cimetidine / sodium alginate Entry to be removed since no products have been identified containing this active substance Apr-18
cineole / codeine phosphate Product currently authorised only in FR, therefore entry is deleted Apr-18
cineole / thymol Entry to be removed since no products have been identified containing this active substance Apr-18
clorprenaline / codeine / pseudoephedrine Entry to be removed since no products have been identified containing this active substance Apr-18
colistimethate sodium / erythromycin lactobionate Entry to be removed since no products have been identified containing this active substance Apr-18
daclizumab Entry should be removed as the Marketing Authorisation has been withdrawn on 27 March 2018 Apr-18
caffeine (apnea, centrally authorised product only) Removal from EURD list; Entry: "caffeine (apnea)" to be followed (PSUSA/0000482) Mar-18
estradiol (17-beta) / trimegestone Entry to be removed since no products have been identified containing this active substance combination Mar-18
lactobacillus acidophilus Removal from EURD list; Entry: "lactobacillus all subspecies and combinations of subspecies" to be followed (PSUSA/00010598) Mar-18
metformin hydrochloride / sitagliptin Removal from EURD list following merge. Entry: "sitagliptin, metformin hydrochloride / sitagliptin" to be followed (PSUSA/00010673) Mar-18
sitagliptin Removal from EURD list following merge. Entry: "sitagliptin, metformin hydrochloride / sitagliptin" to be followed (PSUSA/00010673) Mar-18
triglyceride combinations (e.g. olive oil, soya bean oil, fish oil)/ with or without mineral compounds/electrolytes (i.v. application) Removal from EURD list; Entry: "triglyceride combinations (e.g. olive oil, soya bean oil, fish oil)/ with or without mineral compounds/electrolytes (i.v. application) to be followed (PSUSA/00010648) Mar-18
acetylsalicylic acid / pseudoephedrine hydrochloride Entry was merged with "pseudoephedrine" and "acetylsalicylic acid / pseudoephedrine hydrochloride" entries, therefore it had to be deleted from the list Feb-18
pseudoephedrine MERGED with "pseudoephedrine" and "acetylsalicylic acid / pseudoephedrine hydrochloride" in a new entry, therefore entry is deleted Feb-18
a-tocopherol / ascorbic acid / cupric oxide / sodium selenate / vitamin a / zinc oxide Entry to be removed since no products have been identified containing this active substance combination. Feb-18
boric acid / guaiazulen / ichthammol / zinc oxide Entry to be removed since no products have been identified containing this active substance combination. Feb-18
brompheniramine / pseudoephedrine Entry to be removed since no products have been identified containing this active substance combination. Feb-18
calcium levomefolate / mecobalamin / pyridoxal phosphate Entry to be removed since no products have been identified containing this active substance combination. Feb-18
carbethopendecinium bromide / ephedrine hydrochloride Entry to be removed since no products have been identified containing this active substance combination. Feb-18
carbinoxamine maleate / pseudoephedrine hydrochloride Entry to be removed since no products have been identified containing this active substance combination. Feb-18
cefdinir Entry to be removed since no products have been identified containing this active substance combination. Feb-18
clocortolone hexanoate / clocortolone pivalate Entry to be removed since no products have been identified containing this active substance combination. Feb-18
estradiol / norgestimate Entry to be removed since no products have been identified containing this active substance combination. Feb-18
glaucine hydrobromide / pseudoephedrine hydrochloride Entry to be removed since no products have been identified containing this active substance combination. Feb-18
insulin porcine Products currently authorised only in UK and under WEU, therefore entry is deleted Feb-18
iotalamic acid Entry to be removed since no products have been identified containing this active substance combination. Feb-18
lisuride Product authorised in 1 MS (FR), therefore should be deleted Feb-18
loperamide MERGED with "loperamide hydrochloride/simeticon" in a new entry, therefore entry is deleted Feb-18
loperamide hydrochloride / simeticone MERGED with "loperamide" in a new entry, therefore entry is deleted Feb-18
macrogol 3350 / potassium chloride / sodium chloride / sodium bicarbonate / potassium sulfate Entry to be removed since no products have been identified containing this active substance combination. Feb-18
chlorphenesin Entry to be removed since no products have been identified containing this active substance combination. Feb-18
adenosine / allopurinol / glutathione / lactobionic acid / magnesium sulphate / poly (0-2-hydroxyethyl) starch (pentafraction) / potassium dihydrogen phosphate / potassium hydroxide / raffinose / sodium hydroxide Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. Jan-18
azoximer bromide Entry to be removed from the EURD list since only one product in one MS identified containing this active substances. Jan-18
brompheniramine Entry to be removed from the EURD list since only one product in one MS identified containing this active substances. Jan-18
dolasetron Entry to be removed from the EURD list since only one product in one MS identified containing this active substances. Jan-18
ketanserin Entry to be removed from the EURD list since only one product in one MS identified containing this active substances. Jan-18
methyl salicylate / levomenthol Removal from EURD list following merge: Entry: "menthol / methyl salicylate / camphor, menthol / methyl salicylate" to be followed (PSUSA/00010658) Jan-18
methyl salicylate / levomenthol / DL-camphor Removal from EURD list following merge: Entry: "menthol / methyl salicylate / camphor, menthol / methyl salicylate" to be followed (PSUSA/00010658) Jan-18
catumaxomab Entry should be removed as the Marketing Authorisation has been withdrawn on 2nd June 2017. Dec-17
desirudin Entry should be removed as the Marketing Authorisation was withdrawn on 29/07/2014. Dec-17
alipogene tiparvovec Entry should be removed as the marketing authorisation expired on 25/10/2017. No additional PSURs are required to be submitted. Dec-17
gadoversetamide Entry should be removed as the marketing authorisation has expired on has expired on 23/07/2017. Dec-17
influenza vaccine (surface antigen, inactivated, prepared in cell cultures) Entry should be removed as the marketing authorisation has expired on has expired on 01/06/2017. Dec-17
influenza vaccine (surface antigen, inactivated, virosome) Entry should be removed as no products are currently authorised in EU with this active substance. Dec-17
mestranol / norethisterone Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. Dec-17
hepatitis A vaccine (inactivated, virosome) Entry to be removed from the EURD list as there are currently no products authorised in the EU Dec-17
dihydroergocristine Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Nov-17
bemetizide / triamterene Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. Nov-17
ebastine / pseudoephedrine Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. Nov-17
fish oil / olive oil / soybean oil / triglycerides medium-chain Removal from EURD list following merge: Entry: "triglyceride combinations (e.g. olive oil, soya bean oil, fish oil)/ with or without mineral compounds/electrolytes (i.v. application)" to be followed (PSUSA/00010648) Nov-17
clodronic acid Removal from EURD list following merge: Entry: "clodronic acid, clodronic acid / lidocaine" to be followed (PSUSA/00010650) Nov-17
ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus) Removal from EURD list following merge: Entry: "ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus), ibuprofen / caffeine" to be followed (PSUSA/00010649) Nov-17
vorapaxar Product withdrawn, therefore entry should be removed. Nov-17
roxatidine Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Oct-17
tiludronic acid Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Oct-17
eucalyptol Entry "eucalyptol" is deleted as there a no products authorised in Art 57. New entry "eucalyptus oil" is created as per MAH request Oct-17
tropisetron Only 1 valid generic product identified in ES. Products in FR expired due to sunset clause, products in other MSs are withdrawn. Therefore entry is deleted. Oct-17
calcium chloride dihydrate / lactic acid / magnesium chloride hexahydrate / sodium chloride / sodium hydrogen carbonate All Products currently authorised in EU are authorised under WEU, therefore entry is deleted Oct-17
benzalkonium chloride / isopropyl myristate / paraffin liquid The entry will be merged with 'benzalkonium chloride / chlorhexidine / isopropyl myristate / paraffin liquid' therfore the current entry is deleted Oct-17
pancreas powder (centrally authorised product only) Product withdrawn on 27 July 2017, therefore entry should be removed. Oct-17
buflomedil Entry removed, as only 2 generic products identified in Art. 57 DB. No submissions have been received. Oct-17
influenza vaccine (H1N1)ν (split virion, inactivated, adjuvanted) Entry removed, as this medicine is withdrawn from use in the European Union Oct-17
alcium chloride dihydrate / magnesium chloride hexahydrate / malic acid / sodium acetate trihydrate / sodium chloride / potassium chloride Removal from EURD list following merge: Entry: "calcium chloride dihydrate / magnesium chloride hexahydrate / malic acid / sodium acetate trihydrate / sodium chloride / potassium chloride, calcium chloride dihydrate / sodium chloride / sodium lactate / potassium chloride" to be followed (PSUSA/00010622) Sep-17
bismuth subnitrate / lidocaine / zinc oxide Removal from EURD list following merge: Entry: "bismuth / lidocaine / zinc oxide, lidocaine / zinc oxide" to be followed (PSUSA/00010621) Sep-17
cefminox Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Sep-17
chondroitin Removal from EURD list following merge: Entries to be followed: PSUSA/00010625 or PSUSA/00010626 accordingly Sep-17
chondroitin / glucosamine Removal from EURD list following merge: Entries to be followed PSUSA/00010625 or PSUSA/00010626 accordingly Sep-17
D-camphor / hydroxyethyl salicylate / levomenthol / methyl salicylate Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Sep-17
dornase alpha / fibrinolysin Entry to be removed since no products have been identified containing this active substance combination. Sep-17
fructose / glycerin Entry to be removed since no products have been identified containing this active substance combination. Sep-17
glycerine Entry to be removed from the EURD list due to duplication with "glycerol" entry. Sep-17
hexamidine / tetravacaine Entry to be removed since no products have been identified containing this active substance. Sep-17
icodextrin Entry to be removed since no products have been identified containing this active substance. Sep-17
methysergide Entry to be removed since no products have been identified containing this active substance. Sep-17
testosterone undecanoate (injection) Removal from EURD list: Entry: "testosterone (all formulations apart from topical use)" to be followed (PSUSA/00010631) Sep-17
testosterone (all formulations apart from topical use and testosterone undecanoate injection) Removal from EURD list: Entry: "testosterone (all formulations apart from topical use)" to be followed (PSUSA/00010631) Sep-17
tetrazepam Entry to be removed from the EURD list following suspension of the products. Sep-17
zinc oxide Removal from EURD list following merge: Entry: "zinc oxide, zinc oxide/calamine" to be followed (PSUSA/00010632) Sep-17
caffeine / ephedrine sulfate / promethazine hydrochloride Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. Jul-17
sodium oxybate Removal from EURD list: Entry deleted due to merging of sodium oxybate (oral use) and sodium oxybate (intravenous use) Jul-17
acetic acid / calcium chloride / glucose anhydrous / magnesium chloride / potassium chloride / sodium chloride Entry to be removed since no products have been identified containing this active substance combination. Jul-17
acetic acid glacial / calcium chloride dihydrate / glucose monohydrate / magnesium chloride hexahydrate / potassium chloride / sodium chloride / sodium dihydrogen phosphate dihydrate / sodium hydrogen carbonate Entry to be removed since only 2 WEU products in CZ identified. Jul-17
acetylsalicylic acid / pravastatin Entry to be removed since no products have been identified containing this active substance combination. Jul-17
arsenic trioxide / ephedrine hydrochloride / lidocaine Entry to be removed since no products are authorised containing this active substance combination. Jul-17
benzocaine / chlorhexidine Removal from EURD list: Entry deleted due to merging 'benzocaine / chlorhexidine' with 'benzocaine / chlorhexidine / tyrothricin'. Jul-17
benzocaine / chlorhexidine / tyrothricin Removal from EURD list: Entry deleted due to merging 'benzocaine / chlorhexidine' with 'benzocaine / chlorhexidine / tyrothricin'. Jul-17
calcium chloride / glucose / potassium chloride / sodium chlorid / sodium lactate / sodium saccharin Entry to be removed since no products are authorised containing this active substance combination. Jul-17
chlorhexidine gluconate / oxybuprocaine hydrochloride Removal from EURD list: Entry deleted due to merging ‘chlorhexidine gluconate / oxybuprocaine hydrochloride’ with ‘chlorhexidine gluconate / tetracaine hydrochloride'. Jul-17
chlorhexidine gluconate / tetracaine hydrochloride Removal from EURD list: Entry deleted due to merging ‘chlorhexidine gluconate / oxybuprocaine hydrochloride’ with ‘chlorhexidine gluconate / tetracaine hydrochloride'. Jul-17
chondroitin sulphate sodium / sodium hyaluronate Entry to be removed since no products are authorised containing this active substance combination. Jul-17
fexofenadine combinations Entry to be removed since no products are authorised containing this active substance combination. Jul-17
glucosamine / lidocaine Entry to be removed since product is only authorised in 1 MS (PL). Jul-17
human albumin solution Entry to be removed. The products of this entry will fall into the scope of the newly introduced entry "human plasma proteins with not less than 95% albumin". Jul-17
human plasma proteins with not less than 96% albumin Entry to be removed. The products of this entry will fall into the scope of the newly introduced entry "human plasma proteins with not less than 95% albumin". Jul-17
mangafodipir Product withdrawn on 21 June 2012, therefore entry should be removed. Jul-17
methyl salicylate bp / octafonium chloride / phenol / zinc oxide Entry to be removed since no products have been identified containing this active substance combination. Jul-17
lactobacillus rhamnosus Removal from EURD list: Entry: "lactobacillus all subspecies and combinations of subspecies" to be followed (PSUSA/00010598) Jun-17
lactobacillus acidophilus Removal from EURD list: Entry: "lactobacillus all subspecies and combinations of subspecies" to be followed (PSUSA/00010598) Jun-17
lactobacillus fermentum / lactobacillus rhamnosus / lactobacillus salivarius / lactobacillus vaginalis Removal from EURD list: Entry: "lactobacillus all subspecies and combinations of subspecies" to be followed (PSUSA/00010598) Jun-17
guaifenesin / salbutamol sulfate Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. Jun-17
hydrochlorothiazide / irbesartan Removal from EURD list: Entry: "hydrochlorothiazide / irbesartan, irbesartan" to be followed (PSUSA/00010601) Jun-17
irbesartan Removal from EURD list: Entry: "hydrochlorothiazide / irbesartan, irbesartan" to be followed (PSUSA/00010601) Jun-17
propiomazine Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. Jun-17
sulfametrole / trimethoprim, sulfadiazine trimethoprim New entry was created by merging 'sulfametrole / trimethoprim, sulfadiazine / trimethoprim’ with ‘sulfamethoxazole / trimethoprim (co-trimoxazole), therefore entry for “'sulfametrole / trimethoprim, sulfadiazine / trimethoprim” should be deleted. May-17
palifermin Product withdrawn on 24.02.2016, therefore entry is removed. May-17
hetastarch / sodium chloride The entry removed from the list as a duplicate (to 1694 'hydroxyethyl starch'). May-17
elvitegravir Product withdrawn on 03.11.2016, therefore entry is removed. May-17
co-trimoxazole New entry was created by merging 'sulfametrole / trimethoprim, sulfadiazine / trimethoprim’ with ‘sulfamethoxazole / trimethoprim (co-trimoxazole), therefore entry for “co-trimoxazole” should be deleted. May-17
bendroflumethiazide / hydralazine / propanolol Entry to be removed since only one product identified in Art. 57 DB in one MSs (DE). Entry to be deleted. May-17
clarithromycin / lansoprazole / tinidazole Entry to be removed since only one generic product identified in Art. 57 DB in one MSs (LV). May-17
amyleine / chlorhexidine Entry to be removed since no products have been identified containing this active substance combination. Apr-17
bacitracin / chlorhexidine Entry to be removed since no products have been identified containing this active substance combination. Apr-17
bendroflumethiazide Removal from EURD list: New entry: "bendroflumethiazide, bendroflumethiazide / potassium chloride" to be followed (PSUSA/00010583) Apr-17
benzalkonium chloride / chlorhexidine dihydrochloride / isopropyl myristate / paraffin liquid Entry to be removed from the EURD list since products in only one MS identified containing this combination of active substances. Apr-17
collagen Entry to be removed since no products have been identified containing this active substance combination. Apr-17
collagenase clostridium histolyticum (all indications except for treatment of Dupuytren’s contracture and Peyronie’s disease) Entry to be removed since no products have been identified containing this active substance combination. Apr-17
characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins Entry to be removed following withdrawal of marketing authorisation Apr-17
benzylnicotine / camphora / dimethyl sulphate / turpentine oil Entry to be removed since no products have been identified containing this active substance combination. Apr-17
dinutuximab Entry to be removed following withdrawal of marketing authorisation Apr-17
budesonide / formoterol (apart from centrally authorised products) Removal from EURD list: New entry: "budesonide / formoterol" to be followed (PSUSA/00010585) Apr-17
budesonide / formoterol (only centrally authorised products) Removal from EURD list: New entry: "budesonide / formoterol" to be followed (PSUSA/00010585) Apr-17
chlorhexidine / hydrocortisone Entry to be removed since no products have been identified containing this active substance combination. Apr-17
chlorhexidine / sodium fluoride Entry to be removed since no products have been identified containing this active substance combination. Apr-17
chlorhexidine / tolnaftate Entry to be removed since no products have been identified containing this active substance combination. Apr-17
chlorhexidine hydrochloride / hydrocortisone acetate / nystatin Entry to be removed since no products have been identified containing this active substance combination. Apr-17
chlorhexidine hydrochloride / nystatin Entry to be removed since no products have been identified containing this active substance combination. Apr-17
mycobacterium bovis Removal from EURD list: Entry: "BCG vaccine (freeze-dried)" to be followed (PSUSA/00000304) Apr-17
dextromethorphan hydrobromide / salbutamol sulfate Entry to be removed since no products have been identified containing this fixed dose active substance combination. Mar-17
oagulation factor ii / human coagulation factor ix / human coagulation factor vii / human coagulation factor x / protein c Entry to be removed since no products are authorised in EU containing this fixed dose active substance combination. Mar-17
calcium carbonate / etidronate disodium Entry to be removed since no products have been identified containing this fixed dose active substance combination. Mar-17
chelidonium majus L., herba Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. Mar-17
cyanocobalamin / dexamethasone / lidocaine hydrochloride / thiamine Entry to be removed from the EURD list since this fixed dose combination is authorised only in one Member State. Mar-17
dehydrocholic acid / homatropine / papaverine Entry to be removed from the EURD list since this fixed dose combination is authorised only in one Member State. Mar-17
ferucarbotran Entry to be removed since no products have been identified containing this active substance. Mar-17
fusafungine Entry to be removed since no products are authorised in EU containing this active substance. Mar-17
rimantadine Entry to be removed as all products containing this active substance are authorised under Article 10(a). Mar-17
nicotinic acid Entry to be removed from the EURD list since products with this active substance are authorised only in one Member State. Mar-17
oxedrine Entry to be removed from the EURD list since products with this active substance are authorised only in one Member State. Mar-17
oxybuprocaine hydrochloride / tetracaine hydrochloride Entry to be removed from the EURD list since only one WEU product is authorised in only one Member State. Mar-17
penamecillin Entry to be removed from the EURD list since products with this active substance are authorised only in one Member State. Mar-17
phenolphthalein Entry to be removed from the EURD list since products with this active substance are authorised only in one Member State. Mar-17
poliovirus type 1 / poliovirus type 3 (oral, live, attenuated) vaccine Entry to be removed since no products have been identified containing this fixed dose active substance combination. Mar-17
sulfamethoxazole Entry to be removed since no products have been identified containing this combination of active substances. Mar-17
aluminium oxide / hydrated / magnesium hydroxide / oxetacaine Entry to be removed since the combination of active substances is only authorised in 1 MS Feb-17
antazoline phosphate / naphazoline hydrochloride / zinc sulfate Entry to be removed since no products have been identified containing this active substance combination. Feb-17
biclotymol / cineole / pholcodine Entry to be removed since no products have been identified containing this active substance combination. Feb-17
charcoal activated / magnesium hydroxide Entry to be removed since the combination of active substances is only authorised in 1 MS Feb-17
chlorhexidine gluconate / oxedrine tartrate Entry to be removed since no products have been identified containing this active substance combination. Feb-17
chlorhexidine hydrochloride / phenobarbital / valerian extract Entry to be removed since no products have been identified containing this active substance combination. Feb-17
enterococcus faecalis / escherichia coli / klebsiella pneumoniae / morganella morganii / proteus mirabilis Entry to be removed since the combination of active substances is only authorised in 1 MS Feb-17
ethanolic extracts of camellia sinensis (L.) kuntze, non fermentatum folium Entry to be removed since no products have been identified containing this active substance combination. Feb-17
influenza vaccine (H1N1)ν (split virion, inactivated) Entry to be removed following withdrawal of marketing authorisation Feb-17
meprobamate Entry to be removed since the combination of active substances is only authorised in 1 MS Feb-17
mercaptamine Removal from EURD list: Entry split to two entries: "mercaptamine (treatment of nephropathic cystinosis)" to be followed (PSUSA/00010573) Feb-17
oxetacaine Entry to be removed since no products have been identified containing this active substance. Feb-17
influenza vaccine (H1N1)ν (whole virion, inactivated, prepared in cell culture) Entry removed from the list due to withdrawal of the product. Feb-17
nitrous oxide Removal from EURD list: Entry merged with combination of active substances containing nitrous oxide / oxygen. New entry: "nitrous oxide, nitrous oxide/oxygen" to be followed (PSUSA/00010572) Feb-17
naphazoline hydrochloride / pheniramine maleate Entry to be removed since no products have been identified containing this active substance combination. Feb-17
naphazoline Removal from EURD list: Entry merged with combination of active substances containing naphazoline/zinc sulphate. New entry: "naphazoline, naphazoline/zinc sulphate" to be followed (PSUSA/00010571) Feb-17
methotrexate (for centrally authorised product) Removal from EURD list: This entry was wrongly updated in the previous version of the EURDlist Jan-17
calcium glycerophosphate / magnesium gluconate Removal from EURD list: Entry merged with an existing entry “calcium glycerophosphate / magnesium gluconate”, therefore entry for “calcium glycerophosphate / magnesium gluconate” is deleted Jan-17
carbasalate calcium / metoclopramide Removal from EURD list: Entry merged with with other combination of active substances containing metoclopramide Jan-17
enoxaparin Removal from EURD list: Entry split to two entries: one entry only for biosimilar products and another entry for all products except for biosimilars. Jan-17
lysine acetylsalicylic acid / metoclopramide Removal from EURD list: Entry merged with with other combination of active substances containing metoclopramide Jan-17
sulfametrole / trimethoprim Removal from EURD list: Entry to be removed following merging with sulfadiazine trimethoprim Jan-17
phenothrin / piperonyl butoxide Removal from EURD list: Entry to be removed from the EURD list since no products have been identified containing this active substance combination. Dec-16
betamethasone sodium phosphate / framycetin sulfate Removal from EURD list: Entry to be removed from the EURD list since no products have been identified containing this active substance combination. Dec-16
sulpiride Removal from EURD list: substance was merged with levosulpiride, in line with the principles set in the EURDlist introductory cover note. Entry: "levosulpiride, sulpiride" to be followed (PSUSA/00001859) Dec-16
mycophenolate mofetil Removal from the EURD List: New entry "'mycophenolate mofetil, mycophenolic acid" to be followed (PSUSA/00010550) Dec-16
mycophenolic acid (apart from mycophenolate mofetil) Removal from the EURD List: New entry "'mycophenolate mofetil, mycophenolic acid" to be followed (PSUSA/00010550) Dec-16
morphine Removal from the EURD List: New entry "morphine, morphine / cyclizine" to be followed (PSUSA/00010549) Dec-16
ascorbic acid / calcium Removal from EURD list: ascorbic acid / calcium / lysine” was merged with the entry “ascorbic acid / calcium”, therefore the existing entry “ascorbic acid / calcium” should be deleted. Dec-16
benzalkonium chloride / cetrimide Removal from EURD list: “cetrimide/dimeticone” was merged with an existing entry “benzalkonium chloride/cetrimide”, therefore entry for “benzalkonium chloride/cetrimide” should be deleted. Dec-16
betacarotene / vaccinium myrtillus anthocyanosides Removal from EURD list: New entry: "alpha-tocopherol / vaccinium myrtillus anthocyanosides, betacarotene / vaccinium myrtillus anthocyanosides" to be followed (PSUSA/00010547) Dec-16
factor x / human coagulation factor ix / human coagulation factor vii / protein c / protein s / prothrombin Removal from EURD list: Entry: “human prothrombin complex" to be followed (PSUSA/00001638) Dec-16
ferumoxsil (siloxane coated superparamagnetic ironoxide) Entry to be removed since the active substance is only authorised in 1 MS Dec-16
itopride Entry to be removed from the EURD list since only one product authorised in 1 MS has been identified. Dec-16
olanzapine Removal from EURD list: olanzapine and olanzapine pamoate entries were merged. New entry to be followed: "olanzapine" (PSUSA/0010540) Dec-16
olanzapine pamoate Removal from EURD list: olanzapine and olanzapine pamoate entries were merged. Entry to be followed: "olanzapine" (PSUSA/0010540) Dec-16
coconut oil / distilled coal tar / salicylic acid Removal from EURD list: New entry: coconut oil / distilled coal tar / salicylic acid, coal tar solution / salicylic acid / sulfur to be followed (PSUSA/00010548) Dec-16
diazepam / sulpiride Entry to be removed from the EURD list since only one product authorised in 1 MS has been identified. Dec-16
urea Removal from the EURD List: New entry "'lactic acid / urea, urea" to be followed (PSUSA/00010536) Dec-16
lisinopril Removal from EURD list: merge of lisonopril with lisinopril / hydrochlorothiazide Nov-16
pegloticase Removal from EURD list: the product has not been renewed and Rapporteur notified us that no more PSUR are expected for this product. Nov-16
hydrochlorothiazide / lisinopril Removal from EURD list: merge of lisonopril with lisinopril / hydrochlorothiazide Nov-16
telaprevir Removal from EURD list: entry to be removed from the EURD List following PRAC AR in October 2016 and the MAH's wish to not renew the MA Nov-16
acidic acid / nitric acid / oxolinic acid / zinc nitrate Entry to be removed since no products have been identified containing this active substance combination. Oct-16
ajmaline Entry to be removed from the EURD list since only one product authorised in 1 MS has been identified. Oct-16
ammonium chloride / diphenhydramine hydrochloride Entry removed and merged with diphenhydramine, diphenhydramine hydrochloride / levomenthol. Entry to be followed: "diphenhydramine, ammonium chloride / diphenhydramine hydrochloride, diphenhydramine hydrochloride / levomenthol, ammonium chloride / diphenhydramine hydrochloride / levomenthol" Oct-16
borax / calcium carbonate / cholecalciferol / copper oxide / magnesium oxide / manganese sulfate / zinc oxide Entry to be removed since no products have been identified containing this active substance combination. Oct-16
calcium levulinate / cetylpyridinium chloride / diphenhydramine hydrochloride / essential sage oil / panthenol / phenylephrine hydrochloride Entry to be removed since no products have been identified containing this active substance combination. Oct-16
cineole / gaiacol / pholcodine Entry to be removed since no products have been identified containing this active substance combination. Oct-16
codeine phosphate / ibuprofen / paracetamol Entry to be removed since no products have been identified containing this active substance combination. Oct-16
hypericin Entry to be removed since no products have been identified containing this active substance.
Additionally, a duplicate entry "hypericum perforatum L., herba" has been identified. Oct-16
lidocaine / zinc oxide Entry to be removed since no products have been identified containing this active substance combination. Oct-16
nicotinic acid / simvastatin Entry to be removed since no products have been identified containing this active substance combination. Oct-16
tegafur / uracil Entry to be removed since no products have been identified containing this active substance combination. Oct-16
dequalinium Removal from EURD list: new entry "dequalinium, dequalinium / cinchocaine, dequalinium / lidocaine" (PSUSA/00010526) should be followed Oct-16
dequalinium chloride / lidocaine Removal from EURD list: new entry "dequalinium, dequalinium / cinchocaine, dequalinium / lidocaine" (PSUSA/00010526) should be followed Oct-16
diphenhydramine Removal from EURD list: new entry "diphenhydramine, ammonium chloride / diphenhydramine hydrochloride, diphenhydramine hydrochloride / levomenthol, ammonium chloride / diphenhydramine hydrochloride / levomenthol" (PSUSA/00010527) should be followed Oct-16
diphenhydramine hydrochloride / levomenthol Removal from EURD list: new entry "diphenhydramine, ammonium chloride / diphenhydramine hydrochloride, diphenhydramine hydrochloride / levomenthol, ammonium chloride / diphenhydramine hydrochloride / levomenthol" (PSUSA/00010527) should be followed Oct-16
levobunolol Removal from EURD list: entry "levobunolol (ophthalmic indication)" (PSUSA/00010109) should be followed Oct-16
magnesium / potassium / sodium / water for injection Entry to be removed since no products have been identified containing this active substance combination. Jul-16
spirapril Entry to be removed from the EURD list since only one product authorised in 1 MS has been identified. Jul-16
dutasteride / tamsulosin hydrochloride Entry removed due to merging the entries for dutasteride and dutasteride/tamsulosine Jun-16
sodium molybdate [99mo] / sodium pertechnetate [99mtc] Entry removed due to it being duplicate to entry 'technetium (99mTc) pertechnetate' Jun-16
pyridoxin / thiamine Entry removed from the EURD List following the merging with another combination of active substances Jun-16
dutasteride Entry removed due to merging the entries for dutasteride and dutasteride/tamsulosine Jun-16
ascorbic acid / rutoside This product is only authorised in France under Article 8(3) of Directive 2001/83/EC, therefore it should be removed from the list Jun-16
artemether / lumefantrin (dispersible tablet) Product authorised only in 1 Member State, therefore it should be removed from the list Jun-16
delapril / manidipine Removal from EURD list: new entry 'delapril / manidipine, delapril / indapamide' (PSUSA/00010496) should be followed. May-16
calcium chloride / icodextrin / magnesium chloride / sodium chloride / sodium lactate Entry removed and merged with 3 other combinations of active substances for peritoneal dialysis.
New entry: 'calcium chloride / glucose / magnesium chloride / sodium chloride / sodium lactate, calcium chloride / glucose / magnesium chloride / sodium chloride / sodium lactate/ sodium bicarbonate, calcium chloride / amino acids blend / magnesium chloride / sodium chloride / sodium lactate, calcium chloride / icodextrin / magnesium chloride / sodium chloride / sodium lactate’ to be followed May-16
azithromycin Removal from EURD list: new entries “azithromycin (systemic use formulations)”(PSUSA/00010491/) and azithromycin (ocular use formulations)” (PSUSA/00010492) should be followed. May-16
ambroxol / doxycycline Entry to be removed since products identified in Art. 57 are only authorised in 1 MS (DE) Apr-16
ascorbic acid / cyanocobalamin / ergocalciferol / nicotinamide / pyridoxine / retinol / riboflavin / thiamine hydrochloride This entry should be removed from the EURD List since this combination of active substance is already covered by the following entry:
'ascorbic acid / calcium hydrogenphosphate / calcium panthotenate / colecalciferol / cyanocobalamin / folic acid / nicotinamide / pyridoxine hydrochloride / retinol / riboflavine / thiamin nitrate, ascorbic acid / cyanocobalamin / ergocalciferol / nicotinamide / pyridoxine / retinol / riboflavin / thiamine hydrochloride, ascorbic acid / colecalciferol / dexpanthenol / nicotinamide / pyridoxine / retinol / riboflavin / thiamine Apr-16
bromhexine / oxymetazoline Entry to be removed since products identified in Art. 57 are only authorised in 1 MS (HU) Apr-16
citric acid / epoetin alpha / human albumin / sodium chloride / sodium citrate Entry to be removed since no products containing this particular combination have been identified in the Article 57 database Apr-16
histrelin Entry to be removed from the EURD list as no products containing the active substance histrelin have been identified in article 57. In addition, no submissions were received during the reconcilliation process for PSUSA/00001611/201511 Apr-16
human coagulation factor xiii / human fibrinogen Entry to be removed since no authorised products were identified in Article 57 Apr-16
influenza vaccine (H1N1)ν (surface antigens, inactivated, adjuvanted) Entry to be removed following withdrawal of marketing authorisation for CAP Focetria on 11/02/2016 Apr-16
influenza vaccine (H1N1)ν (surface antigens, inactivated, prepared in cell cultures, adjuvanted) Entry to be removed since only the product Celtura (authorised in DE) was identified in Article 57 Apr-16
lansoprazole / metronidazole / tetracycline Entry to be removed since no authorised products were identified in Article 57 Apr-16
leucocytes dialysate Entry to be removed since no authorised products were identified in Article 57 Apr-16
selenomethionine (75Se) Entry to be removed since no authorised products were identified in Article 57 Apr-16
thrombin Entry to be removed since no products were identified in Article 57 referencing “thrombin” as standalone active substance, apart from 2 products containing bovine thrombin (only authorised in PL)) Apr-16
almagate Removal from EURD List: only authorised in one Member State (ES). Therefore the active substance almagate should be removed from the EURDlist. Apr-16
erythromycin / isotretinoin Removal from EURD list: new entries “erythromycin / isotretinoin, isotretinoin (topical formulations)”(PSUSA/00010487/) and “isotretinoin (oral formulations)” (PSUSA/00010488) should be followed. Apr-16
isotretinoin Removal from EURD list: new entries “erythromycin / isotretinoin, isotretinoin (topical formulations)”(PSUSA/00010487/) and “isotretinoin (oral formulations)” (PSUSA/00010488) should be followed. Apr-16
dextromethorphan hydrobromide / quinidine sulfate (treatment of pseudobulbar affect (PBA)) CAP Nuedexta no longer authorised. MA has been withdrawn on 02/03/2016 Mar-16
fosinopril Entry "fosinopril, fosinopril / hydrochlorothiazide" should be followed Mar-16
fosinopril / hydrochlorothiazide Entry "fosinopril, fosinopril / hydrochlorothiazide" should be followed Mar-16
thiocolchicoside Entry "thiocolchicoside, paracetamol / thiocolchicoside" should be followed Mar-16
paracetamol / thiocolchicoside Entry "thiocolchicoside, paracetamol / thiocolchicoside" should be followed Mar-16
metopimazine Not authorised in EEA or in more than 1 Member state. Mar-16
estradiol The estradiol entry has been split into the following 2 new entries:
-estradiol (without cream/balm/emulsion for application in the female genital area)
-estradiol, estradiol / prednisolone (only cream/balm/emulsion for application in the female genital area) Feb-16
terfenadine Not authorised in EEA or in more than 1 Member state. Feb-16
parathyroid hormone (rdna) CAP Preotact no longer authorised. MA has been withdrawn on 16/05/2014. Feb-16
dienogest / estradiol Entry dienogest / estradiol split into 2 new entries with a different scope based on the different indication. The 2 new entries to be followed are:
dienogest / estradiol (HRT indication)
dienogest / estradiol (contraception indication) Feb-16
alfatradiol Not authorised in EEA or in more than 1 Member state Jan-16
almitrine Not authorised in EEA or in more than 1 Member state Dec-15
betamethasone / dexchlorpheniramine maleate Not authorised in EEA or in more than 1 Member state Dec-15
butizide / spironolactone Not authorised in EEA or in more than 1 Member state Dec-15
calcium chloride dihydrate / glucose / potassium chloride / sodium chloride Entry "glucose (apart from glucose1- phosphate) / glucose in combination with calcium chloride and/or sodium chloride and/or magnesium chloride and/or sodium citrate and/or potassium chloride (intravenous or parenteral use)" should be followed. Dec-15
calcium chloride dihydrate / glucose monohydrate Entry "glucose (apart from glucose1- phosphate) / glucose in combination with calcium chloride and/or sodium chloride and/or magnesium chloride and/or sodium citrate and/or potassium chloride (intravenous or parenteral use)" should be followed. Dec-15
calcium chloride dihydrate / glucose monohydrate / sodium chloride Entry "glucose (apart from glucose1- phosphate) / glucose in combination with calcium chloride and/or sodium chloride and/or magnesium chloride and/or sodium citrate and/or potassium chloride (intravenous or parenteral use)" should be followed. Dec-15
calcium chloride dihydrate / potassium chloride / sodium chloride Entry "glucose (apart from glucose1- phosphate) / glucose in combination with calcium chloride and/or sodium chloride and/or magnesium chloride and/or sodium citrate and/or potassium chloride (intravenous or parenteral use)" should be followed. Dec-15
chlortalidone / spironolactone Not authorised in EEA or in more than 1 Member state Dec-15
'dexbrompheniramine / pseudoephedrine Not authorised in EEA or in more than 1 Member state Dec-15
dexchlorpheniramine / guaiafenesin / pseudoephedrine Not authorised in EEA or in more than 1 Member state Dec-15
dexchlorpheniramine / pseudoephedrine Not authorised in EEA or in more than 1 Member state Dec-15
galactose Not authorised in EEA or in more than 1 Member state Dec-15
glucose Entry "glucose (apart from glucose1- phosphate) / glucose in combination with calcium chloride and/or sodium chloride and/or magnesium chloride and/or sodium citrate and/or potassium chloride (intravenous or parenteral use)" should be followed. Dec-15
glucose / potassium chloride Entry "glucose (apart from glucose1- phosphate) / glucose in combination with calcium chloride and/or sodium chloride and/or magnesium chloride and/or sodium citrate and/or potassium chloride (intravenous or parenteral use)" should be followed. Dec-15
glucose / potassium chloride / sodium chloride / sodium citrate Entry "glucose (apart from glucose1- phosphate) / glucose in combination with calcium chloride and/or sodium chloride and/or magnesium chloride and/or sodium citrate and/or potassium chloride (intravenous or parenteral use)" should be followed. Dec-15
glucose / sodium chloride Entry "glucose (apart from glucose1- phosphate) / glucose in combination with calcium chloride and/or sodium chloride and/or magnesium chloride and/or sodium citrate and/or potassium chloride (intravenous or parenteral use)" should be followed. Dec-15
linagliptin Entry "linagliptin, linagliptin / metformin" should be followed. Dec-15
linagliptin / metformin Entry "linagliptin, linagliptin / metformin" should be followed. Dec-15
dibrompropamidine Entry "dibrompropamidine , propamidine" should be followed. Nov-15
trapidil Not authorised in EEA or in more than 1 Member state Nov-15
empagliflozin Entry "empagliflozin, empagliflozin / metformin" should be followed. Nov-15
tacrolimus (systemic formulations) - for CAP Envarsus Entry "tacrolimus (systemic formulations)" should be followed. Nov-15
tocopherol / tretinoin Not authorised in EEA or in more than 1 Member state Oct-15
tioconazole Entry "tioconazole, tioconazole / hydrocortisone" should be followed. Oct-15
phenylephrine Entry divided according to indication. Entry "phenylephrine (IV, nasal or oral formulations )" or "phenylephrine (ophthalmic formulations)" should be followed. Oct-15
nystatin / tinidazole Entry "tinidazole / nystatin, tinidazole" should be followed Oct-15
tinidazole Entry "tinidazole / nystatin, tinidazole" should be followed Oct-15
beclometasone dipropionate / formoterol fumarate Entry "beclometasone / formoterol (inhalative application)" should be followed Sep-15
calcium carbonate / colecalciferol Entry "calcium salts / colecalciferol" should be followed Sep-15
calcium phosphate / colecalciferol Entry "calcium salts / colecalciferol" should be followed Sep-15
macrogol 4000 Entry "macrogol 4000 and combinations (systemic use)" to be followed Sep-15
'macrogol 4000 and combinations Entry "macrogol 4000 and combinations (systemic use)" to be followed Sep-15
macrogol 4000 / potassium chloride / sodium bicarbonate / sodium chloride / sodium sulfate anhydrous Entry "macrogol 4000 and combinations (systemic use)" to be followed Sep-15
rosiglitazone Not authorised in EEA or in more than 1 Member state Sep-15
valsartan Entry "valsartan, hydrochlorothiazide / valsartan" to be followed Sep-15
hydrochlorothiazide / valsartan Entry "valsartan,/ hydrochlorothiazide / valsartan" to be followed Sep-15
budipine Not authorised in EEA or in more than 1 Member state Jul-15
cidofovir Not authorised in EEA or in more than 1 Member state Jul-15
ferumoxytol Not authorised in EEA or in more than 1 Member state Jul-15
floctafenine Not authorised in EEA or in more than 1 Member state Jul-15
human fibrinogen / human thrombin (all pharmaceutical dose forms except for sealant matrix) Entry "human fibrinogen / human thrombin" should be followed Jul-15
raltegravir Entry "raltegravir, lamivudine / raltegravir " should be followed Jul-15
amitriptyline Entry "amitriptyline, amitriptyline / amitriptylinoxide, amitriptylinoxide" should be followed Jun-15
amitriptylinoxide Entry "amitriptyline, amitriptyline / amitriptylinoxide, amitriptylinoxide" should be followed Jun-15
amitriptyline / amitriptylinoxide Entry "amitriptyline, amitriptyline / amitriptylinoxide, amitriptylinoxide" should be followed Jun-15
colestilan Not authorised in EEA or in more than 1 Member state Jun-15
bacterial lysate Entry “bacterial lysates” removed and more specific entries are introduced Jun-15
allergen diagnostics: all prick and provocation tests of all species; intracutan tests (allergens) Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergen products for treatment: epithelia and feathers, single or mixes (parenteral preparations) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergen products for treatment: grass and cereal pollen, single or mixes (oral preparations, solid forms) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergen products for treatment: grass and cereal pollen, single or mixes (parenteral preparations) allergoid Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergen products for treatment: grass and cereal pollen, single or mixes (parenteral preparations) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergen products for treatment: insects venoms (parenteral preparations) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergen products for treatment: mites, single or mixes (oral presentation- liquid and semi-solid forms) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergen products for treatment: mites, single or mixes (parenteral preparations) allergoid Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergen products for treatment: mites, single or mixes (parenteral preparations) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergen products for treatment: moulds, single or mixes (parenteral preparations) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergen products for treatment: tree pollen, single or mixes (oral presentation – liquid and semi-solid forms) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergen products for treatment: tree pollen, single or mixes (parenteral preparations) allergoid Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergen products for treatment: tree pollen, single or mixes (parenteral preparations) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergen products for treatment: weed pollen, single or mixes (oral presentation – liquid) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergen products for treatment: weed pollen, single or mixes (parenteral preparations) allergoid Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergen products for treatment: weed pollen, single or mixes (parenteral preparations) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergens from vertebrates, single or mixes (parenteral presentations) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
products used in connection with allergen diagnostics: products for positive and negative control for allergy prick tests and negative control for allergy provocation tests; diluents (no active substance) for prick test and treatment products; positive and negative control for intracutan tests Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
guanfacine Not authorised in EEA or in more than 1 Member state May-15
dimethyl fumarate / ethyl fumarate calcium / ethyl fumarate magnesium / ethyl fumarate zinc Not authorised in EEA or in more than 1 Member state May-15
autologous peripheral-blood mononuclear cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor (sipuleucel-T) Not authorised in EEA or in more than 1 Member state May-15
amlodipine / indapamide Entry "'amlodipine / indapamide, amlodipine / indapamide / perindopril" should be followed May-15
amlodipine / indapamide / perindopril Entry "'amlodipine / indapamide, amlodipine / indapamide / perindopril" should be followed May-15
budipine Not authorised in EEA or in more than 1 Member state May-15
adrafinil Not authorised in EEA or in more than 1 Member state May-15
human fibrinogen / human thrombin (sealant matrix) Entry "human fibrinogen / human thrombin" should be followed Apr-15
phloroglucinol / trimethylphloroglucinol Entry "phloroglucinol, phloroglucinol / trimethylphloroglucinol" should be followed Apr-15
phloroglucinol Entry "phloroglucinol, phloroglucinol / trimethylphloroglucinol" should be followed Apr-15
niaprazine Not authorised in EEA or in more than 1 Member state Apr-15
misoprostol (gynaecological indication) Entries "misoprostol (gynaecological indication - labor induction)" and "misoprostol (gynaecological indication - termination of pregnancy)" should be followed accordingly Apr-15
mazindol Not authorised in EEA or in more than 1 Member state Apr-15
human spongiosa Not authorised in EEA or in more than 1 Member state Apr-15
human fascia lata collagen Not authorised in EEA or in more than 1 Member state Apr-15
ferumoxtran-10 (superparamagnetic ironoxide) Not authorised in EEA or in more than 1 Member state Apr-15
ferumoxides Not authorised in EEA or in more than 1 Member state Apr-15
chlorphenamine / dexchlorpheniramine / pseudoephedrine Not authorised in EEA or in more than 1 Member state Apr-15
carmustine Entries "carmustine (powder and solvent for solution for infusion)" and "carmustine (implant)" should be followed accordingly Apr-15
caffeine / dexchlorpheniramine / dextromethorphan Not authorised in EEA or in more than 1 Member state Apr-15
atorvastatin (paediatric indication) Entry "atorvastatin" should be followed Apr-15
atorvastatin (adult indication) Entry "atorvastatin" should be followed Apr-15
aprotinin / human fibrinogen / thrombin (calcium chloride) Entry "aprotinin / calcium chloride / human factor xiii / human fibrinogen / human thrombin, aprotinin / fibrinogen / fibronectin / human coagulation factor XIII / plasma protein fraction / plasminogen / thrombin, aprotinin / human fibrinogen / thrombin (calcium chloride)" should be followed Apr-15
aprotinin / fibrinogen / fibronectin / human coagulation factor XIII / plasma protein fraction / plasminogen / thrombin Entry "aprotinin / calcium chloride / human factor xiii / human fibrinogen / human thrombin, aprotinin / fibrinogen / fibronectin / human coagulation factor XIII / plasma protein fraction / plasminogen / thrombin, aprotinin / human fibrinogen / thrombin (calcium chloride)" should be followed Apr-15
aprotinin / calcium chloride / human factor xiii / human fibrinogen / human thrombin Entry "aprotinin / calcium chloride / human factor xiii / human fibrinogen / human thrombin, aprotinin / fibrinogen / fibronectin / human coagulation factor XIII / plasma protein fraction / plasminogen / thrombin, aprotinin / human fibrinogen / thrombin (calcium chloride)" should be followed Apr-15
codergocrine mesilate Entry "dihydroergotoxine" should be followed Mar-15
ibuprofen lysine Entry "ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus)" should be followed Mar-15
ibuprofen Entry "ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus)" should be followed Mar-15
sodium bicarbonate Entry "'sodium hydrogen carbonate" should be followed Mar-15
diclofenac (ophtalmic formulations) Entry "diclofenac (topical formulations)" should be followed Mar-15
diclofenac (cutaneous formulations) Entry "diclofenac (topical formulations)" should be followed Mar-15
amlodipine / valsartan Entry "'amlodipine / valsartan, amlodipine / hydrochlorothiazide, valsartan" should be followed Mar-15
amlodipine / hydrochlorothiazide / valsartan Entry "'amlodipine / valsartan, amlodipine / hydrochlorothiazide, valsartan" should be followed Mar-15
aluminium / calcium or aluminium / magnesium Not authorised in EEA or in more than 1 Member state Feb-15
acidic acid / nitric acid / oxalic acid / zinc nitrate Not authorised in EEA or in more than 1 Member state Feb-15
pegaspargase Entry "asparaginase" should be followed Jan-15
crisantaspase (erwinia L-asparaginase) Entry "asparaginase" should be followed Jan-15
cilazapril / hydrochlorothiazide Entry "'cilazapril, cilazapril / hydrochlorothiazide" should be followed Jan-15
bromhexine / ephedrine Not authorised in EEA or in more than 1 Member state Jan-15
anise oil / bromhexine / fennel oil / levomenthol Not authorised in EEA or in more than 1 Member state Jan-15
ambroxol hydrochloride / theophylline Not authorised in EEA or in more than 1 Member state Jan-15
canagliflozin / metformin Entry "'canagliflozin, canagliflozin / metformin" should be followed Dec-14
acethylthyrosine / acetylcysteine / alanine / arginine / asparagine monohydrate / aspartic acid / glutamic acid / glycine / histidine / isoleucine / leucine / lysine acetate / methionine / ornithine hydrochloride / phenylalanine / proline / serine / threonine / tryptophane / valine Entry "'amino acid combinations (only combinations of pure amino acids or combination of amino acids with mineral compounds/electrolytes, i.v. application)" should be followed Dec-14
metformin / vildagliptin Entry "'vildagliptin, metformin / vildagliptin" should be followed Nov-14
caffeine / opium / paracetamol Not authorised in EEA or in more than 1 Member state Nov-14
hydroxyzine Entry removed as duplicate to "hydroxyzine chloride / hydroxyzine pamoate and all fixed combination, hydroxyzine" Nov-14
doripenem Not authorised in EEA or in more than 1 Member state Nov-14
camphor / eucalyptus oil / menthol / thymol / turpentine oil Entry "'camphor, camphor and other terpene derivates" should be followed Nov-14
camphor / eucalyptus oil / menthol / turpentine oil Entry "'camphor, camphor and other terpene derivates" should be followed Nov-14
camphor / menthol Entry "'camphor, camphor and other terpene derivates" should be followed Nov-14
camphor / ichtamol Entry "'camphor, camphor and other terpene derivates" should be followed Nov-14
sodium salt of gamma-hydroxybutyric acid Entry "sodium oxybate" should be followed Oct-14
bendroflumethiazide / spironolactone Not authorised in EEA or in more than 1 Member state Sep-14
nelfinavir Not authorised in EEA or in more than 1 Member state Sep-14
chlorazepate Entry clorazepate in the EURD list to be followed Sep-14
cetylpyridinium chloride / muramidase hydrochloride Entry cetylpyridinium, lysozyme in the EURD list to be followed Sep-14
calcium pantothenate / dl-methionine / l-cystine / pa / pyridoxine hcl / thiamine hcl Not authorised in EEA or in more than 1 Member state Sep-14
benztropine mesylate Entry benztropine in the EURD list to be followed Sep-14
benfotiamine / calcium hydrogen phosphate dihydrate / magnesium estearate Entry benfotiamine in the EURD list to be followed Sep-14
benfotiamine / calcium hydrogen phosphate dihydrate / cyanocobalamin / magnesium estearate / pyridoxine Entry benfotiamine, cyanocobalamin, pyridoxine in the EURD list to be followed Sep-14
ammonium salt / glycine / glycyrrhizic acid / l-station sun cysteine hydrochloride hydrate Not authorised in EEA or in more than 1 Member state Sep-14
aluminium hydroxide dried / magnesium hydroxide / simeticone Entry aluminium oxide, magnesium hydroxide, simeticone in the EURD list to be followed Sep-14
benzalkonium chloride / potassium alum Entry alum, benzalkonium chloride in the EURD list to be followed Sep-14
sodium ferrous citrate Entry iron, oral preparations in the EURD list to be followed Jul-14
sodium ferric gluconate complex Entry iron, parenteral preparations in the EURD list to be followed Jul-14
iron / sodium feredetate Entry sodium feredetate in the EURD list to be followed Jul-14
folic acid / iron Entry iron in combination with folic acid and other substances in the EURD list to be followed Jul-14
ferrous sulphate / folic acid Entry iron in combination with folic acid and other substances in the EURD list to be followed Jul-14
ferrous sulfate / serine Entry iron in combination with folic acid and other substances in the EURD list to be followed Jul-14
ferrous sulfate Entry iron, oral preparations in the EURD list to be followed Jul-14
ferrous salts Entry iron, oral preparations in the EURD list to be followed Jul-14
ferrous lactate Entry iron, oral preparations in the EURD list to be followed Jul-14
ferrous glycine sulfate Entry iron, oral preparations in the EURD list to be followed Jul-14
ferrous gluconate Entry iron, oral preparations in the EURD list to be followed Jul-14
ferrous fumarate Entry iron, oral preparations in the EURD list to be followed Jul-14
ferrous aspartate Entry iron, oral preparations in the EURD list to be followed Jul-14
ferric polymaltose / folic acid Entry iron in combination with folic acid and other substances in the EURD list to be followed Jul-14
ferric hydroxide sucrose complex Entry iron, parenteral preparations in the EURD list to be followed Jul-14
dextriferron Entry iron, parenteral preparations in the EURD list to be followed Jul-14
cyanocobalamin / ferrous sulfate / folic acid Entry iron in combination with folic acid and other substances in the EURD list to be followed Jul-14
cyanocobalamin / dl-serine / ferrous sulfate / folic acid Entry iron in combination with folic acid and other substances in the EURD list to be followed Jul-14
copper gluconate / ferrous gluconate / manganese gluconate Entry iron in any combination including one or more of the following: multivitamins, minerals, aminoacids, herbal extracts, lecithine (except for combinations with folic acid)to be followed Jul-14
chromium trichloride hexahydrate / copper chloride dihydrate / ferric chloride hexahydrate / manganese chloride tetrahydrate / potassium iodide / sodium fluoride / sodium molybdate dihydrate / sodium selenite / water for injection / zinc chloride Entry iron in any combination including one or more of the following: multivitamins, minerals, aminoacids, herbal extracts, lecithine (except for combinations with folic acid)to be followed Jul-14
calcium panthotenate / copper / d /l-methionine / faex medicinalis / iron / l-cystine / milium semen extract / paraaminobenzoic acid / pyridoxine hydrochloride / thiamine hydrochloride / triticum germs extract / zinc Entry iron in any combination including one or more of the following: multivitamins, minerals, aminoacids, herbal extracts, lecithine (except for combinations with folic acid)to be followed Jul-14
calcium folinate / iron protein succinylate Entry calcium folinate, iron succinyl-protein complex in the EURD list to be followed Jul-14
ascorbic acid / ferrous sulfate Entry iron in any combination including one or more of the following: multivitamins, minerals, aminoacids, herbal extracts, lecithine (except for combinations with folic acid)to be followed Jul-14
ascorbic acid / calcium hydrogenphosphate / calcium panthotenate / colecalciferol / copper sulfate / cyanocobalamin / ferrous fumarate / folic acid / magnesium lactate / manganese sulfate / nicotinamide / pyridoxine hydrochloride / retinol / riboflavine / sodium molybdenate / thiamin nitrate / tocopherol acetate / zinc sulfate Entry iron in combination with folic acid and other substances in the EURD list to be followed Jul-14
ascorbic acid / betacarotene / biotine / calcium hydrogenphosphate / colecalciferol / copper sulfate / cyanocobalamin / ferrous sulfate / folic acid / ginseng radix extract / magnesium oxide / manganese sulfate / nicotinamide / pyridoxine hydrochloride / riboflavine / sodium selenate / thiamin nitrate / tocopherol alpha dl acetate / zinc sulfate Entry iron in combination with folic acid and other substances in the EURD list to be followed Jul-14
ascorbic acid / calcium hydrogenphosphate / calcium lactate / calcium panthotenate / colecalciferol / cyanocobalamin / ferrous fumarate / folic acid / nicotinamide / pyridoxine hydrochloride / retinol palmitate / riboflavine / thiamin nitrate / tocoferol acetate Entry iron in combination with folic acid and other substances in the EURD list to be followed Jul-14
ascorbic acid / calcium fluoride / calcium hydrogenphosphate / calcium panthotenate / copper sulfate / cyanocobalamin / deanol hydrogentartrate / ergocalciferol / ferrous sulfate / ginseng radix extract / lecithine / magnesium sulfate / manganese sulfate / nicotinamide / potassium sulfate / pyridoxine hydrochloride / retinol palmitate / riboflavine / rutoside / soy lecithine / thiamine nitrate / tocopherol alpha dl acetate / zinc oxide Entry iron in any combination including one or more of the following: multivitamins, minerals, aminoacids, herbal extracts, lecithine (except for combinations with folic acid) in the EURD list to be followed Jul-14
ammonium molybdate tetrahydrate / chromium trichloride hexahydrate / cobalt gluconate / copper gluconate / ferrous gluconate / manganese gluconate / sodium fluoride / sodium iodide / sodium selenite / zinc gluconate Entry iron in any combination including one or more of the following: multivitamins, minerals, aminoacids, herbal extracts, lecithine (except for combinations with folic acid) in the EURD list to be followed Jul-14
valpromide Entry valproic acid / sodium valproate / valproate pivoxil / valproate semisodium / valpriomide / valproate bismuth / calcium valproate / valproate magnesium in the EURD list to be followed Jul-14
divalproex sodium Entry valproic acid / sodium valproate / valproate pivoxil / valproate semisodium / valpriomide / valproate bismuth / calcium valproate / valproate magnesium in the EURD list to be followed Jul-14
valproic acid Entry valproic acid / sodium valproate / valproate pivoxil / valproate semisodium / valpriomide / valproate bismuth / calcium valproate / valproate magnesium in the EURD list to be followed Jul-14
alphatocopherol / ascorbic acid / betacarotene / cyanocobalamin / extractum ginseng / ferrous fumarate / nicotinamide / pyridoxine hydrochloride / thiamine mononitrate Entry iron in any combination including one or more of the following: multivitamins, minerals, aminoacids, herbal extracts, lecithine (except for combinations with folic acid) in the EURD list to be followed Jul-14
methotrimeprazine Entry levomepromazine in the EURD list to be followed May-14
diacethyl-midecamycin Entry midecamycin acetate in the EURD list to be followed May-14
aliskiren / amlodipine / hydrochlorothiazide Not authorised in EEA or in more than 1 Member state Feb-14
anti-human t-lymphocyte immunoglobulin from rabbits Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Feb-14
desvenlafaxine Not authorised in EEA or in more than 1 Member state Feb-14
diphtheria / tetanus / pertussis (whole cell) and hepatitis B(Rdna) (Hbv) vaccine (adsorbed) Not authorised in EEA or in more than 1 Member state Feb-14
iobitridol Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Feb-14
prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) Merged entry with pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) Feb-14
docosahexaenoic acid / eicosapentanoic acid Entry omega-3-acid-ethyl esters in the PSUR WS List to be followed Feb-14
human albumin solution Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Feb-14
laropiprant / nicotinic acid Not authorised in EEA or in more than 1 Member state Feb-14
metformin hydrochloride / rosiglitazone Not authorised in EEA or in more than 1 Member state Feb-14
rilonacept Not authorised in EEA or in more than 1 Member state Feb-14
tetrofosmin Merged entry with technetium (99mTc) tetrofosmin Feb-14
articaine hydrochloride / ephedrine Not authorised in EEA or in more than 1 Member state Jan-14
alogliptin / metformin Included in shared entry "alogliptin, alogliptin / metformin, alogliptin / pioglitazone" Jan-14
porfimer Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Jan-14
flupirtine Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Nov-13
clarithromycin Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Oct-13
doconexent / eicosapentaenoic acid / omega-3 acid ethyl esters Replaced with "omega-3-acid-ethyl esters" which is placed temporarily in the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Oct-13
testosterone enantate injection Replaced with "testosterone (all formulations apart from transdermal application and testosterone undecylate injection)" Oct-13
carbamoylphenoxyacetic acid / theophylline Not authorised in EEA or in more than 1 Member state Sep-13
cilostazol Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Sep-13
quinine combinations Entry too general, specific combinations will be specified in the EURD List if those are authorised in EEA or in more than 1 Member state. Sep-13
defibrotide Not authorised in EEA or in more than 1 Member state Jul-13
diphtheria / tetanus / pertussis (acellular, component) / hepatitis b (rdna) / poliomyelitis (inactivated) vaccines (adsorbed) Not authorised in EEA or in more than 1 Member state Jul-13
alemtuzumab Not authorised in EEA or in more than 1 Member state Jul-13
chlorhexidine gluconate / tixocortol pivalate Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Jul-13
aloe barbadensis miller / aloe ferox miller, folium Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
aloe barbadensis miller / aloe ferox miller, folium Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
arctostaphylos uva-ursi (L.) spreng., folium Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
capsicum annuum L. var. minimum (Miller) heiser, fructus Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
cassia senna L.; cassia angustifolia vahl, fructus // cassia senna L.; cassia angustifolia vahl, folium Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
cephaelis ipecacuanha (brot.) a. rich.; cephaelis acuminata karsten, radix
Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
echinacea pallida (nutt.) nutt.; echinacea purpurea (L.) moench; echinacea angustifolia dc, radix // echinacea purpurea (L.) moench, herba Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
eucalyptus globulus labill., aetheroleum Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
ginkgo biloba L., folium Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
glycyrrhiza glabra L.; glycyrrhiza inflata bat.; glycyrrhiza uralensis fisch., radix Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
melaleuca alternifolia (maiden and betche) cheel, aetheroleum Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
melaleuca viridiflora, (melaleuca quinquenervia)
Broad-leaved paperbark,
aetheroleum
Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
mentha x piperita l., aetheroleum Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
pinus sylvestris L., aetheroleum Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
plantago ovata forssk., semen Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
plantago ovata forssk., seminis tegumentum Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
rhamnus purshianus dc, cortex Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
rheum palmatum L.; rheum officinale baillon, radix Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
serenoa repens (bartram) small (sabal serrulata (michaux) nichols, fructus Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
symphytum officinale L.
radix Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
thymus vulgaris L.; thymus zygis loefl. ex L., aetheroleum Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
valeriana officinalis L., radix Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
xysmalobium undulatum L.
Aiton f. var. undulatatum, radix Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
paracetamol (IV formulation) Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” May-13
cyproterone / ethinylestradiol Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” May-13
gentamicin / zyrconium Not authorised in EEA or in more than 1 Member state Apr-13
amcinonide / neomycin Not authorised in EEA or in more than 1 Member state Apr-13
ascorbic acid / cetylpyridinium Not authorised in EEA or in more than 1 Member state Apr-13
deltamethrin Not authorised in EEA or in more than 1 Member state Apr-13
human plasma protease C1 inhibitor Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Apr-13
doxylamine Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Apr-13
almitrine dimesilate / raubasine Not authorised in EEA or in more than 1 Member state Feb-13
amylase / lipase / protease Please refer to entry: pancreatic enzymes / pancreatic extracts / pancreatin Jan-13
grepafloxacin hydrochloride Not authorised in EEA or in more than 1 Member state Dec-12
_x000D_&1#&"Verdana"&7&K737373 Classified as internal/staff & contractors by the European Medicines Agency
02.07.2026
Datei
PD
EU reference dates list
The convention used to present the active substances and combinations of active substances has changed. From the 29th October 2015 the following principles apply:
- A slash ('/') is used to separate the different active substances contained in a combination, this can be a fixed-dose combination or a combination pack.
- A comma (',') is used to indicate that a single PSUR assessment covering the different substances and/or combinations of active substances will be produced.
1 July 2026
EMA/630645/2012 Rev.161
Procedure Management Department
List of Union reference dates and frequency of submission of periodic safety update reports (PSURs)
Related Information:
Introductory cover note to the List of European Union reference dates and frequency of submission of PSURs including requirements for PSURs submission https://www.ema.europa.eu/documents/other/introductory-cover-note-list-european-union-reference-dates-frequency-submission-periodic-safety_en.pdf
Requests for amendments of the EU reference dates list https://www.ema.europa.eu/documents/template-form/template-request-amendments-addition-active-substances-combinations-active-substances-european-union_en-1.docx
The PSUR assessment procedure will start according to the Timetables published on EMA website following the Submission Dates indicated in column E and G below https://www.ema.europa.eu/documents/other/timetable-periodic-safety-update-report-psur-psur-single-assessment-psusa_en.pdf
Single Assessment Reports of PSURs are shared among all Marketing Authorisation Holders involved in the concerned procedure.
ID Active substances and combinations of active substances European Union reference date (EURD)
Not Available* = EURD not provided during the consultation phases PSUR Submission Frequency DLP Submission date
(According to the timelines defined in GVP Module VII, Section A) Next DLP
(For active substances or combination of active substances with a PSUR frequency of less than one year) Next Submission date
(According to the timelines defined in GVP Module VII, Section A - For active substances or combination of active substances with a PSUR frequency of less than one year) Are PSURs required for products referred to in Articles 10(1), 10a, 16a of Directive 2001/83/EC as amended?
Yes/No Publication Date (in accordance with Article 107c(7) of Directive 2001/83/EC as amended) Notes Procedure number of the PSUR single assessment
(DLP) Procedure number of the PSUR single assessment
procedure (Next DLP) PRAC representative of the PSUR single assessment
procedure (Lead) Member State of the PSUR single assessment procedure Centrally authorised product(s) (CAP) Nationally authorised product(s) (NAP)
2 calcium chloride / histidine / magnesium chloride / mannitol / potassium chloride / sodium chloride / tryptophan / oxogluric acid 24/11/1989 6 years 31/01/2030 01/05/2030 No 28/06/2023 Lead MS and PRAC Rapporteur name added on 18/10/2023
New entry added on 28/06/2023 PSUSA/00000002/203001 Jean-Michel Dogné Belgium NAP
4 131i-6-iodo-norcholesterol 21/06/1990 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000004/202901 NAP
5 (3s,10s,14s)-1-[4-[[(2s)-4-carboxy-2-[(2s)-4-carboxy-2-(6-[18f] fluoropyridin-3-amido) butanamido] butanamido]methyl]phenyl]-3-[(naphthalen-2-YL)methyl]-1,4,12-trioxo-2,5,11,13-tetraazahexadecane-10,14,16-tricarboxylic acid 09/12/2021 3 years 08/12/2027 07/03/2028 No 28/06/2023 New entry added on 28/06/2023 PSUSA/00000005/202712 not yet assigned none NAP
6 ¹³C-urea, ¹4C-urea 14/08/1997 5 years 15/01/2028 14/04/2028 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00000006/202801 Jan Neuhauser Austria CAP NAP
7 5 fluorouracil (IV use) 16/12/1977 3 years 16/12/2026 16/03/2027 Yes 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000007/202612 Dennis Lex Germany NAP
8 5 fluorouracil / salicylic acid 25/05/1994 5 years 25/05/2026 23/08/2026 No 17/02/2022 DLP and PSUR frequency were updated on 02/02/2022
PRAC representative was updated on 22/12/2021
PRAC representative was updated on 06/05/2020
DLP was updated on 06/02/2019
Next DLP was updated on 04/02/2016
Lead MS was added on 06/03/2015 PSUSA/00000008/202605 Jana Pecherova Slovakia NAP
9 5-aminolevulinic acid (glioma) 07/09/2007 3 years 07/03/2027 05/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00000009/202703 Carla Torre Portugal CAP
10 abacavir 29/06/1998 3 years 31/12/2025 31/03/2026 No 27/05/2026 Reference to NAP removed on 27/05/2026
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/06/2025 PSUSA/00000010/202512 Zoubida Amimour France CAP
11 abacavir / lamivudine 14/11/2003 3 years 31/12/2025 31/03/2026 No 04/02/2026 Reference to NAP removed on 04/02/2026
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/06/2025 PSUSA/00000011/202512 Zoubida Amimour France CAP
13 abatacept 22/12/2005 3 years 22/12/2025 22/03/2026 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00000013/202512 Kimmo Jaakkola Finland CAP
15 abiraterone 28/04/2011 5 years 28/04/2029 27/07/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00000015/202904 Maria del Pilar Rayon Spain CAP NAP
16 acamprosate 24/07/1987 8 years 01/07/2030 29/09/2030 No 01/03/2023 DLP was updated on 01/03/2023
Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00000016/203007 Rhea Fitzgerald Ireland NAP
17 acarbose 31/03/1990 5 years 31/03/2028 29/06/2028 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00000017/202803 Maria del Pilar Rayon Spain NAP
18 acebutolol 16/12/1974 8 years 16/12/2030 16/03/2031 No 15/01/2025 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00000018/203012 Eva Jirsova Czech Republic NAP
22 aceclofenac 19/03/1990 5 years 31/03/2028 29/06/2028 No 20/12/2023 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00000022/202803 Melinda Palfi Hungary NAP
25 sirolimus (indicated for treatment of angiofibroma associated with tuberous sclerosis complex) 15/05/2023 1 year 14/11/2026 23/01/2027 14/11/2027 23/01/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000025/202611 PSUSA/00000025/202711 Jenny-Maria Jönsson Sweden CAP NAP
26 acemetacin Not available* 6 years 01/05/2030 30/07/2030 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00000026/203005 Melinda Palfi Hungary NAP
27 acenocoumarol 06/07/1955 3 years 01/07/2027 29/09/2027 No 05/03/2025 DLP was amended on 05/03/2025 PSUSA/00000027/202707 Maria Popova-Kiradjieva Bulgaria NAP
29 acetazolamide 27/07/1953 16 years 26/10/2028 24/01/2029 Yes 28/03/2017 DLP was updated on 28/03/2017 PSUSA/00000029/202810 NAP
31 respiratory Syncytial Virus (RSV) vaccine (recombinant, adjuvanted) 03/05/2023 1 year 02/05/2026 11/07/2026 02/05/2027 11/07/2027 No 01/07/2026 Active substance name was amended on 01/07/2026
DLP was amended on 30/07/2025
PSUR frequency amended and DLP updated on 25/06/2025
DLP was amended on 18/12/2024 PSUSA/00000031/202605 PSUSA/00000031/202705 Maria del Pilar Rayon Spain CAP
33 acetylcholine 09/06/1965 16 years 01/06/2028 30/08/2028 No 01/10/2012 PSUSA/00000033/202806 NAP
34 acetylcysteine 14/09/1963 5 years 13/09/2028 12/12/2028 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00000034/202809 Adam Przybylkowski Poland NAP
39 acetylsalicylic acid 17/10/1942 8 years 01/02/2030 02/05/2030 No 28/06/2023 PSUR frequency amended and DLP updated on 28/06/2023
DLP was updated on 19/10/2022
PRAC representative was updated on 06/05/2020
DLP was updated on 23/10/2019
Next DLP was amended on 19/10/2016
Lead MS was added on 31/07/2015 PSUSA/00000039/203002 Melinda Palfi Hungary NAP
40 acetylsalicylic acid / glycine Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 Active substance name was amended on 06/03/2015 PSUSA/00000040/203001 NAP
41 acetylsalicylic acid / caffeine Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000041/203001 NAP
42 acetylsalicylic acid / caffeine / codeine phosphate Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000042/203001 NAP
43 acetylsalicylic acid / caffeine / etenzamide Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000043/203001 NAP
45 ublituximab 28/12/2022 1 year 27/12/2025 07/03/2026 27/12/2026 07/03/2027 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025
DLP was amended on 05/02/2025 PSUSA/00000045/202512 PSUSA/00000045/202612 Liana Martirosyan Netherlands CAP
46 acetylsalicylic acid / codeine phosphate Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000046/203001 NAP
48 aciclovir 10/06/1981 3 years 09/06/2027 07/09/2027 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00000048/202706 Marie Louise Schougaard Christiansen Denmark NAP
49 mirikizumab 27/03/2023 1 year 27/03/2026 05/06/2026 27/03/2027 05/06/2027 No 27/05/2026 PSUR frequency amended and DLP updated on 27/05/2026
DLP was amended on 19/11/2025 PSUSA/00000049/202603 PSUSA/00000049/202703 Sonja Radowan Austria CAP
50 acipimox 05/05/1984 5 years 05/05/2026 03/08/2026 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00000050/202605 Karin Erneholm Denmark NAP
51 acitretin 01/12/1987 2 years 30/10/2026 28/01/2027 Yes 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00000051/202610 Marie Louise Schougaard Christiansen Denmark NAP
54 acrivastine, acrivastine / pseudoephedrine 31/12/1990 7 years 02/12/2031 01/03/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00000054/203112 Terhi Lehtinen Finland NAP
58 adapalene 03/07/1992 8 years 31/07/2026 29/10/2026 No 03/04/2019 DLP was updated on 03/04/2019
PRAC Rapporteur name updated on 23/10/2018
PRAC Representative and Lead MS were added on 19/12/2017 PSUSA/00000058/202607 Eamon O'Murchu Ireland NAP
59 adapalene / benzoyl peroxide 30/09/2007 3 years 30/09/2026 29/12/2026 No 02/02/2026 DLP was amended on 05/06/2024 PSUSA/00000059/202609 Polona Golmajer Slovenia NAP
61 ademetionine 28/04/1993 8 years 03/08/2033 01/11/2033 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00000061/203308 Amelia Cupelli Italy NAP
62 adenosine 14/08/1991 5 years 14/08/2027 12/11/2027 No 03/05/2023 DLP was amended on 03/05/2023
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 07/05/2018
PRAC representative and Lead Member State were added on 30/01/2017 PSUSA/00000062/202708 Adam Przybylkowski Poland NAP
66 sodium thiosulfate 20/09/2022 1 year 19/03/2026 28/05/2026 19/03/2027 28/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00000066/202603 PSUSA/00000066/202703 Karin Erneholm Denmark CAP
67 glofitamab 24/03/2023 1 year 23/03/2026 01/06/2026 23/03/2027 01/06/2027 No 17/12/2025 DLP was amended on 17/12/2025
DLP was amended on 19/11/2025 PSUSA/00000067/202603 PSUSA/00000067/202703 Veronika Macurova Czech Republic CAP
68 futibatinib 30/09/2022 6 months 29/03/2026 07/06/2026 29/09/2026 08/12/2026 No 02/06/2026 PSUSA/00000068/202603 PSUSA/00000068/202609 Jenny-Maria Jönsson Sweden CAP
69 agalsidase alfa 03/08/2001 3 years 03/08/2027 01/11/2027 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00000069/202708 Liana Martirosyan Netherlands CAP
70 agalsidase beta 03/08/2001 3 years 31/07/2028 29/10/2028 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00000070/202807 Liana Martirosyan Netherlands CAP
71 agomelatine 19/02/2009 5 years 19/02/2029 20/05/2029 No 20/10/2021 DLP was updated on 20/10/2021
PSUR Frequency and DLP updated on 26/09/2018
PRAC Rapporteur name amended on 04/07/2018
Next DLP was amended on 25/09/2017
PRAC Rapporteur name was amended on 20/12/2016
Next DLP was updated on 22/09/2016
DLP updated on 06/10/2015 PSUSA/00000071/202902 Pernille Harg Norway CAP
72 ajmaline 09/11/1962 10 years 22/08/2026 20/11/2026 No 26/04/2017 PSUR Frequency amended and DLP updated on 26/04/2017
Entry restored to the list on 20/12/2016 PSUSA/00000072/202608 Dennis Lex Germany NAP
73 albendazole 10/07/1981 5 years 10/07/2030 08/10/2030 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00000073/203007 Adam Przybylkowski Poland NAP
74 mavacamten 28/04/2022 1 year 27/04/2026 06/07/2026 27/04/2027 06/07/2027 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025
DLP was amended on 18/12/2024 PSUSA/00000074/202604 PSUSA/00000074/202704 Kimmo Jaakkola Finland CAP
75 alclometasone 03/06/1987 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000075/203001 NAP
76 aldesleukin 03/07/1989 7 years 31/12/2029 31/03/2030 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00000076/202912 Bianca Mulder Netherlands NAP
77 miglustat (for treatment of Pompe disease) 20/03/2023 1 year 19/03/2026 28/05/2026 19/03/2027 28/05/2027 No 02/06/2026 PSUSA/00000077/202603 PSUSA/00000077/202703 Jenny-Maria Jönsson Sweden CAP
78 alendronate 10/11/2000 5 years 15/01/2026 15/04/2026 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00000078/202601 Karin Erneholm Denmark NAP
79 alendronic acid / colecalciferol, alendronic acid / calcium / colecalciferol 24/08/2005 5 years 15/01/2026 15/04/2026 No 22/09/2021 DLP was updated on 22/09/2021
LMS and PRAC representative were updated on 05/06/2019
Next DLP was updated on 22/09/2016
Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended? Yes/No" was amended on 16/07/2015
Active substance name was amended on 12/05/2015 PSUSA/00000079/202601 Jan Neuhauser Austria CAP NAP
80 alfacalcidol 31/01/1978 7 years 15/06/2032 13/09/2032 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026
DLP was amended on 04/03/2026 PSUSA/00000080/203206 Terhi Lehtinen Finland NAP
81 neomycin / triamcinolone 30/12/1991 9 years 01/08/2033 30/10/2033 No 02/04/2025 PSUR frequency amended and DLP updated on 02/04/2025 PSUSA/00000081/203308 Eva Jirsová Czech Republic NAP
82 alfentanil Not available* 3 years 14/09/2027 13/12/2027 No 25/05/2022 DLP was updated on 25/05/2022
DLP was amended on 05/06/2019
PRAC Rapporteur name was amended on 23/10/2018
Next DLP was amended on 03/06/2016
Lead MS added on 12/05/2015 PSUSA/00000082/202709 Eamon O'Murchu Ireland NAP
84 alfuzosin 12/11/1987 5 years 12/11/2027 10/02/2028 No 02/06/2026 PSUSA/00000084/202711 Jenny Jönsson Sweden NAP
85 potassium chloride / sodium chloride / magnesium chloride / sodium acetate / sodium gluconate and/or glucose 22/03/1971 20 years 02/09/2044 01/12/2044 Yes 26/07/2023 Active substance name was amended on 26/07/2023
New entry added on 26/07/2023 PSUSA/00000085/204409 not yet assigned none NAP
86 alglucosidase alfa 29/03/2006 3 years 28/09/2027 27/12/2027 No 19/09/2024 PSUSA/00000086/202709 Zoubida Amimour France CAP
88 alimemazine 05/06/1956 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000088/203001 NAP
89 aliskiren, aliskiren / hydrochlorothiazide 22/08/2007 3 years 30/09/2027 29/12/2027 No 29/06/2022 DLP was updated on 29/06/2022
PRAC representative was updated on 17/11/2021
PRAC representative was updated on 25/09/2019
DLP updated on 30/04/2019
PRAC Rapporteur name amended on 04/07/2018
Entry name and DLP were updated on 07/05/2018
DLP was updated on 23/05/2017
Next DLP was amended on 03/05/2016
"Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended? Yes/No" was amended on 16/07/2015 PSUSA/00000089/202709 Amelia Cupelli Italy CAP
91 alizapride 09/01/1979 5 years 09/01/2026 09/04/2026 No 28/04/2022 PRAC representative was updated on 19/10/2022
PRAC Representative amended on 28/04/2022
DLP was updated on 22/09/2021
PRAC Representative amended on 18/11/2016
Next DLP was updated on 22/09/2016
Lead MS was added on 06/10/2015
DLP was amended on 16/06/2015 PSUSA/00000091/202601 Jo Robays Belgium NAP
92 allantoin Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000092/203001 NAP
93 ganaxolone 18/03/2022 6 months 17/03/2026 26/05/2026 17/09/2026 26/11/2026 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00000093/202603 PSUSA/00000093/202609 Adam Przybylkowski Poland CAP
95 allopurinol 01/01/1966 3 years 31/12/2026 31/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000095/202612 Dennis Lex Germany NAP
97 piflufolastat (18F) 26/05/2021 1 year 25/05/2026 03/08/2026 25/05/2027 03/08/2027 No 04/03/2026 Correction of DLP on 04/03/2026
PSUR frequency amended and DLP updated on 04/02/2026
DLP was amended on 30/07/2025 PSUSA/00000097/202605 PSUSA/00000097/202705 Kimmo Jaakkola Finland CAP
98 alminoprofen Not available* 10 years 03/05/2035 01/08/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000098/203505 NAP
99 talquetamab 09/08/2023 6 months 08/02/2026 19/04/2026 08/08/2026 17/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00000099/202602 PSUSA/00000099/202608 Barbara Kovacic Bytyqi Croatia CAP
100 atogepant 28/09/2021 6 months 27/03/2026 05/06/2026 27/09/2026 06/12/2026 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00000100/202603 PSUSA/00000100/202609 Rugile Pilviniene Lithuania CAP
101 almotriptan 23/12/1999 5 years 30/06/2028 28/09/2028 No 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 PSUSA/00000101/202806 Maria del Pilar Rayon Spain NAP
102 respiratory syncytial virus vaccine (bivalent, recombinant) 31/05/2023 1 year 30/05/2026 08/08/2026 30/05/2027 08/08/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000102/202605 PSUSA/00000102/202705 Liana Martirosyan Netherlands CAP
104 alfa amylase 06/06/1967 10 years 01/01/2032 31/03/2032 No 19/09/2024 PSUSA/00000104/203201 Zoubida Amimour France NAP
107 epcoritamab 22/09/2023 6 months 21/03/2026 30/05/2026 21/09/2026 30/11/2026 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00000107/202603 PSUSA/00000107/202609 Maria Martinez Gonzalez Spain CAP
108 human alfa1-proteinase inhibitor (apart from the centrally authorised product) 21/03/2006 5 years 31/12/2029 31/03/2030 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00000108/202912 Marie Louise Schougaard Christiansen Denmark NAP
109 alprazolam 12/03/1980 5 years 11/03/2030 09/06/2030 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00000109/203003 Tiphaine Vaillant France NAP
110 alprostadil (erectile dysfunction) 23/07/1981 5 years 31/01/2026 01/05/2026 Yes 20/10/2021 DLP was updated on 20/10/2021
Next DLP was amended on 19/10/2016
Lead MS added on 31/07/2015. PSUSA/00000110/202601 Eva Jirsová Czech Republic NAP
111 alprostadil (indicated in peripheral arterial occlusive diseases) 28/11/1984 8 years 31/07/2030 29/10/2030 No 05/04/2023 PSUR frequency amended and DLP updated on 05/04/2023
DLP and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" were updated on 07/05/2018
PRAC representative and Lead Member State were added on 30/01/2017 PSUSA/00000111/203007 Eva Jirsová Czech Republic NAP
112 alteplase 06/06/1987 5 years 31/05/2027 29/08/2027 No 01/02/2023 DLP was updated on 01/02/2023
DLP was amended on 31/01/2018
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00000112/202705 Dennis Lex Germany NAP
115 aluminium Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000115/202903 NAP
116 cabotegravir (for pre-exposure prophylaxis of HIV-1 infection) 18/03/2020 1 year 17/03/2026 26/05/2026 17/03/2027 26/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00000116/202603 PSUSA/00000116/202703 Dennis Lex Germany CAP
118 decitabine / cedazuridine 06/07/2020 1 year 06/07/2026 14/09/2026 06/07/2027 14/09/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00000118/202607 PSUSA/00000118/202707 Marie Louise Schougaard Christiansen Denmark CAP
119 aluminium chlorhydroxide-complex Not available* 10 years 03/05/2035 01/08/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000119/203505 none NAP
120 elacestrant 28/12/2022 6 months 27/12/2025 07/03/2026 27/06/2026 05/09/2026 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000120/202512 PSUSA/00000120/202606 Sonja Radowan Austria CAP
122 aluminium oxide hydrated / magnesium hydroxide / monmectite Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000122/202903 NAP
123 Any combinations of alginate sodium, alginic acid (antacids) Not available* 7 years 03/06/2031 01/09/2031 No 27/05/2026 DLP was amended on 05/02/2025 PSUSA/00000123/203106 Terhi Lehtinen Finland NAP
124 alverine, alverine / simeticone 10/02/1950 10 years 01/02/2032 01/05/2032 No 28/05/2025 Active substance name was amended on 28/05/2025
PRAC Rapporteur updated on 15/11/2023 PSUSA/00000124/203202 Petar Mas Croatia NAP
126 amantadine 14/12/1965 6 years 01/01/2030 01/04/2030 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000126/203001 Dennis Lex Germany NAP
127 ambazone Not available* 7 years 03/06/2031 01/09/2031 Yes 18/12/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 18/12/2024
PSUR frequency and DLP amended on 28/02/2024 PSUSA/00000127/203106 Roxana Dondera Romania NAP
128 ambenonium 14/12/1956 11 years 03/10/2037 01/01/2038 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000128/203710 NAP
129 ambrisentan 21/04/2008 3 years 14/06/2026 12/09/2026 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00000129/202606 Maria del Pilar Rayon Spain CAP
130 ambroxol 23/08/1978 5 years 30/09/2027 29/12/2027 No 31/05/2023 PSUR frequency amended and DLP updated on 31/05/2023
DLP was updated on 03/06/2020
Next DLP was amended on 27/06/2017
Correction of PRAC Rapporteur name on 28/02/2017
PRAC Rapporteur name updated on 30/01/2017
PRAC Rapporteur name was amended on 20/12/2016
PRAC representative and Lead Member State were added on 03/05/2016 PSUSA/00000130/202709 Ana Sofia Diniz Martins Portugal NAP
131 ambroxol / clenbuterol 27/06/1984 5 years 30/09/2027 29/12/2027 No 31/05/2023 PSUR frequency amended and DLP updated on 31/05/2023
DLP was updated on 03/06/2020
Next DLP was amended on 27/06/2017
Correction of PRAC Rapporteur name on 28/02/2017
PRAC representative and Lead Member State were added on 03/05/2016 PSUSA/00000131/202709 Ana Sofia Diniz Martins Portugal NAP
132 gefapixant 20/01/2022 6 months 19/01/2026 30/03/2026 19/07/2026 27/09/2026 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00000132/202601 PSUSA/00000132/202607 Jan Neuhauser Austria CAP
133 ritlecitinib 23/06/2023 1 year 22/12/2025 02/03/2026 22/12/2026 02/03/2027 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00000133/202512 PSUSA/00000133/202612 Adam Przybylkowski Poland CAP
135 amcinonide Not available* 10 years 03/05/2035 01/08/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000135/203505 NAP
136 tislelizumab 26/12/2019 1 year 25/12/2025 05/03/2026 25/12/2026 05/03/2027 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025
DLP was amended on 30/07/2025 PSUSA/00000136/202512 PSUSA/00000136/202612 Bianca Mulder Netherlands CAP
138 amfepramone 01/06/1961 13 years 01/06/2033 30/08/2033 Yes 03/02/2021 DLP was updated on 03/02/2021
PRAC representative was added on 06/05/2020
LMS was added on 25/09/2019
DLP and Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/04/2019 PSUSA/00000138/203306 Marie Louise Schougaard Christiansen Denmark NAP
141 amifampridine 23/12/2009 3 years 23/12/2027 22/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00000141/202712 Karin Bolin Sweden CAP
143 amikacin (except for centrally authorised products) 06/06/1975 5 years 05/06/2027 03/09/2027 No 01/02/2023 DLP was updated on 01/02/2023
Active substance name was amended on 18/11/2020
DLP was updated on 28/02/2018
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/01/2017
PRAC representative and Lead Member State were added on 18/11/2016 PSUSA/00000143/202706 Maia Uusküla Estonia NAP
148 amiloride, amiloride / furosemide, amiloride / hydrochlorothiazide, amiloride / hydrochlorothiazide / timolol, amiloride / bumetanide, amiloride / chlortalidone 25/04/1969 8 years 03/06/2033 01/09/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000148/203306 Guðrún Stefánsdóttir Iceland NAP
152 aminaphtone 07/07/2005 13 years 06/07/2032 04/10/2032 Yes 28/02/2024 Entry re-activated on 28/02/2024 PSUSA/00000152/203207 none NAP
155 pirtobrutinib 27/01/2023 6 months 27/01/2026 07/04/2026 27/07/2026 05/10/2026 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00000155/202601 PSUSA/00000155/202607 Bianca Mulder Netherlands CAP
156 sodium hypochlorite (concentrated solution) 09/12/1991 8 years 09/12/2031 08/03/2032 No 20/12/2023 New entry added on 20/12/2023 PSUSA/00000156/203112 none NAP
157 aminoacridine / lidocaine Not available* 12 years 06/09/2036 05/12/2036 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00000157/203609 John Joseph Borg Malta NAP
159 aminocaproic acid Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000159/202903 NAP
163 aminomethylbenzoic acid 17/09/1970 10 years 02/09/2034 01/12/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000163/203409 NAP
164 aminophylline 24/02/1963 14 years 01/01/2026 01/04/2026 No 26/05/2025 PSUSA/00000164/202601 Ana Sofia Diniz Martins Portugal NAP
166 amiodarone 20/12/1966 3 years 20/12/2026 20/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000166/202612 Bianca Mulder Netherlands NAP
167 amisulpride 20/01/1986 3 years 20/01/2026 20/04/2026 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00000167/202601 Eamon O'Murchu Ireland NAP
168 magnesium gluconate 21/02/2005 9 years 21/02/2032 21/05/2032 No 20/12/2023 New entry added on 20/12/2023 PSUSA/00000168/203202 none NAP
169 zilucoplan 25/09/2023 1 year 24/09/2026 03/12/2026 24/09/2027 03/12/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00000169/202609 PSUSA/00000169/202709 Karin Erneholm Denmark CAP
170 amitriptyline / perphenazine 31/07/1961 3 years 01/01/2027 01/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000170/202701 Georgia Gkegka Greece NAP
173 palopegteriparatide 17/11/2023 1 year 16/05/2026 25/07/2026 16/05/2027 25/07/2027 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
DLP was amended on 04/02/2026 PSUSA/00000173/202605 PSUSA/00000173/202705 Lina Seibokiene Lithuania CAP
174 amlodipine 08/03/1989 5 years 07/03/2027 05/06/2027 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00000174/202703 Karin Erneholm Denmark NAP
175 lebrikizumab 16/11/2023 1 year 13/09/2026 22/11/2026 13/09/2027 22/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00000175/202609 PSUSA/00000175/202709 Liana Martirosyan Netherlands CAP
176 quizartinib 18/06/2019 1 year 17/06/2026 26/08/2026 17/06/2027 26/08/2027 No 04/03/2026 Correction of DLP on 04/03/2026
PSUR frequency amended and DLP updated on 04/02/2026
DLP was amended on 30/07/2025 PSUSA/00000176/202606 PSUSA/00000176/202706 John Joseph Borg Malta CAP
177 amlodipine / atorvastatin 30/01/2004 5 years 31/01/2030 01/05/2030 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00000177/203001 Zoubida Amimour France NAP
179 amlodipine / perindopril 23/04/2008 5 years 22/10/2026 20/01/2027 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00000179/202610 Karin Erneholm Denmark NAP
180 amlodipine / telmisartan, amlodipine / telmisartan / hydrochlorothiazide 07/10/2010 5 years 31/03/2030 29/06/2030 No 23/10/2024 Active substance name was amended on 23/10/2024
PSUR frequency and DLP were updated on 16/12/2020
PRAC Rapporteur name was amended on 31/07/2018
DLP was updated on 19/12/2017
Reference to NAP products was added on 23/05/2017
Next DLP was amended on 01/12/2014
Next DLP was amended on 02/07/2014
Correction of the DLP was done on the 01/04/2014
Next DLP was amended on 29/11/2013 PSUSA/00000180/203003 Dennis Lex Germany CAP NAP
182 ammonia solutions 19/09/1984 16 years 01/01/2028 31/03/2028 No 01/10/2012 PSUSA/00000182/202801 NAP
183 ichthammol Not available* 16 years 01/01/2028 31/03/2028 No 01/10/2012 PSUSA/00000183/202801 NAP
184 ammonium chloride, ammonium chloride combinations Not available* 16 years 01/01/2028 31/03/2028 No 01/10/2012 PSUSA/00000184/202801 NAP
185 amorolfine 10/06/1991 5 years 30/06/2027 28/09/2027 No 01/03/2023 DLP was updated on 01/03/2023
PRAC representative was updated on 06/05/2020
DLP was updated on 27/03/2018
Lead MS and PRAC Rapporteur name was added on 20/12/2016 PSUSA/00000185/202706 Melinda Palfi Hungary NAP
186 amoxapine 01/06/1973 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000186/202806 NAP
187 amoxicillin 07/03/1972 5 years 07/03/2027 05/06/2027 No 16/11/2022 DLP was updated on 16/11/2022
DLP was amended on 15/11/2017
Lead MS was added on 22/09/2016
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/06/2016 PSUSA/00000187/202703 Jan Neuhauser Austria NAP
188 amoxicillin / clavulanate 07/03/1972 5 years 07/03/2027 05/06/2027 No 16/11/2022 DLP was updated on 16/11/2022
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was amended on 15/11/2017
Lead MS was added on 22/09/2016
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/06/2016 PSUSA/00000188/202703 Dennis Lex Germany NAP
193 amphotericin b 19/03/1958 15 years 18/03/2027 16/06/2027 Yes 01/10/2012 PSUSA/00000193/202703 NAP
194 amphotericin b / tetracycline 19/03/1958 11 years 02/04/2038 01/07/2038 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000194/203804 NAP
195 ampicillin 01/03/1962 9 years 01/02/2028 01/05/2028 Yes 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000195/202802 NAP
196 ampicillin / cloxacillin 01/03/1962 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00000196/203405 NAP
197 ampicillin / sulbactam 24/02/1987 3 years 28/02/2027 29/05/2027 No 19/10/2022 PRAC representative was updated on 19/10/2022
PRAC representative was updated on 27/07/2022
DLP corrected on 02/02/2022
DLP was updated on 17/11/2021
PRAC representative was updated on 30/06/2021
DLP was updated on 21/11/2018
PRAC Rapporteur name amended on 04/07/2018
PRAC Rapporteur name amended.
PRAC Rapporteur name amended.
Next DLP was amended on 29/10/2015
Lead MS added on 04/02/2015 PSUSA/00000197/202702 Amelia Cupelli Italy NAP
199 amsacrine 23/04/1982 5 years 01/06/2029 30/08/2029 Yes 23/10/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 23/10/2024
PRAC representative updated on 31/01/2024 PSUSA/00000199/202906 Bianca Mulder Netherlands NAP
201 enalapril maleate (centrally authorised product for use in children below the age of 18) 15/11/2023 1 year 31/03/2026 09/06/2026 31/03/2027 09/06/2027 No 02/06/2026 PSUSA/00000201/202603 PSUSA/00000201/202703 Karin Bolin Sweden CAP
202 latanoprost (eye drop emulsions containing CKC) 15/11/2023 1 year 14/11/2026 23/01/2027 14/11/2027 23/01/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000202/202611 PSUSA/00000202/202711 Jean-Michel Dogné Belgium CAP
204 amylmetacresol / dichlorobenzyl alcohol, amylmetacresol / ascorbic acid / dichlorobenzyl alcohol 01/09/1958 9 years 03/03/2029 01/06/2029 No 28/05/2025 Entry updated following merge on 28/05/2025
PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000204/202903 none NAP
205 amylmetacresol / dichlorobenzyl alcohol / levomenthol 01/09/1958 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000205/203001 NAP
206 amylmetacresol / dichlorobenzyl alcohol / lidocaine 01/09/1958 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000206/203001 NAP
208 anagrelide 16/11/2004 5 years 13/09/2027 12/12/2027 No 31/05/2023 PSUR frequency amended and DLP updated on 31/05/2023
Correction: Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 21/10/2022
PSUR frequency and DLP were updated on 28/04/2021
PRAC representative was updated on 29/07/2020
PRAC representative was updated on 03/06/2020
DLP was updated on 06/05/2020
DLP was updated on 30/04/2019
DLP was updated and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was updated on 07/05/2018
PRAC Rapporteur name updated on 21/07/2017
Next DLP was amended on 26/04/2017
PRAC Rapporteur name was amended on 28/07/2016
PRAC Rapporteur name updated on 03/06/2016
Next DLP was amended on 03/05/2016
"Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended? Yes/No" was amended on 16/07/2015
Rapporteur name amended on 04/11/2014 PSUSA/00000208/202709 Tiphaine Vaillant France CAP NAP
209 anakinra 08/03/2002 5 years 01/05/2030 30/07/2030 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00000209/203005 Karin Erneholm Denmark CAP
210 anastrozole 11/08/1995 3 years 11/08/2028 09/11/2028 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00000210/202808 Zane Neikena Latvia NAP
213 anethole trithione Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000213/204001 NAP
214 adagrasib 12/12/2022 6 months 11/12/2025 19/02/2026 11/06/2026 20/08/2026 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000214/202512 PSUSA/00000214/202606 Kimmo Jaakkola Finland CAP
215 anidulafungin 20/09/2007 5 years 31/01/2027 01/05/2027 No 19/10/2022 DLP and Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" were updated on 19/10/2022
PRAC Rapporteur name was amended on 23/10/2018
PSUR Frequency amended and DLP updated on 17/10/2017
PRAC Rapporteur name was amended on 25/09/2017 PSUSA/00000215/202701 Liana Martirosyan Netherlands CAP NAP
216 rozanolixizumab 26/06/2023 1 year 25/06/2026 03/09/2026 25/06/2027 03/09/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000216/202606 PSUSA/00000216/202706 Maria del Pilar Rayon Spain CAP
217 antazoline Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000217/203501 NAP
218 antazoline / naphazoline 01/06/1961 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000218/203906 NAP
219 antazoline / tetryzoline 03/10/1972 10 years 01/12/2034 01/03/2035 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00000219/203412 John Joseph Borg Malta NAP
220 antazoline / xylometazoline 01/01/1966 11 years 02/12/2039 01/03/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000220/203912 NAP
221 rezafungin 22/03/2023 1 year 21/03/2026 30/05/2026 21/03/2027 30/05/2027 No 29/04/2026 PSUR frequency amended and DLP updated on 29/04/2026
Reference to NAP removed on 04/02/2026
DLP was amended on 19/11/2025 PSUSA/00000221/202603 PSUSA/00000221/202703 Adam Przybylkowski Poland CAP
222 pegzilarginase 14/12/2023 1 year 13/12/2025 21/02/2026 13/12/2026 21/02/2027 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00000222/202512 PSUSA/00000222/202612 Dennis Lex Germany CAP
223 vamorolone 26/10/2023 6 months 25/04/2026 04/07/2026 25/10/2026 03/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000223/202604 PSUSA/00000223/202610 Rhea Fitzgerald Ireland CAP
225 elranatamab 14/08/2023 6 months 13/02/2026 24/04/2026 13/08/2026 22/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00000225/202602 PSUSA/00000225/202608 Barbara Kovacic Bytyqi Croatia CAP
226 apixaban 18/05/2011 3 years 17/05/2027 15/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00000226/202705 Bianca Mulder Netherlands CAP
227 apomorphine 28/05/2001 3 years 19/11/2025 17/02/2026 Yes 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00000227/202511 Karin Erneholm Denmark NAP
228 apraclonidine 16/08/1967 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000228/203408 NAP
229 aprepitant 25/03/2003 5 years 25/03/2029 23/06/2029 No 02/06/2026 PSUSA/00000229/202903 Jenny-Maria Jönsson Sweden CAP NAP
230 aprotinin Not available* 2 years 28/02/2026 29/05/2026 No 16/11/2022 DLP was updated on 16/11/2022
PRAC Rapporteur name was amended on 28/04/2022
DLP was updated on 21/10/2020
PRAC Rapporteur name was amended on 03/04/2019
DLP was updated on 21/11/2018
PSUR Frequency amended and DLP updated on 18/11/2016
Lead MS and PRAC Rapporteur name was added on 07/04/2016
The DLP was amended on 27/11/2015.
The DLP was amended on 02/07/2014 PSUSA/00000230/202602 Marie Louise Schougaard Christiansen Denmark NAP
231 fezolinetant 12/05/2023 1 year 11/11/2026 20/01/2027 11/11/2027 20/01/2028 No 17/12/2025 DLP was amended on 17/12/2025
PSUR frequency amended and DLP updated on 25/06/2025
DLP was amended on 18/12/2024 PSUSA/00000231/202611 PSUSA/00000231/202711 Dennis Lex Germany CAP
232 gadopiclenol 21/09/2022 2 years 30/04/2027 29/07/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000232/202704 Dennis Lex Germany CAP NAP
233 arginine hydrochloride / cyanocobalamin / cyproheptadine hydrochloride / levocarnitine Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000233/202903 NAP
234 aripiprazole 04/06/2004 3 years 16/07/2026 14/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00000234/202607 Ana Sofia Diniz Martins Portugal CAP NAP
235 arsenic trioxide 05/03/2002 5 years 30/09/2028 29/12/2028 No 05/06/2024 PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00000235/202809 Tiphaine Vaillant France CAP
236 artemether / lumefantrin (apart from the dispersible tablet) 14/10/1998 3 years 01/10/2028 30/12/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000236/202810 Jenny Jönsson Sweden NAP
238 articaine 29/04/1975 20 years 01/01/2032 31/03/2032 No 01/10/2012 PSUSA/00000238/203201 NAP
239 articaine / epinephrine 29/04/1975 20 years 01/01/2032 31/03/2032 No 01/10/2012 PSUSA/00000239/203201 NAP
240 triamcinolone / lidocaine (rectal use) 01/03/1974 9 years 28/02/2031 29/05/2031 No 28/02/2024 New entry added on 28/02/2024 PSUSA/00000240/203102 n/a none NAP
241 acetylsalicylic acid / ascorbic acid, acetylsalicylic acid / citric acid / sodium hydrogen carbonate 28/07/1972 23 years 04/02/2035 05/05/2035 No 23/10/2024 PSUSA/00000241/203502 none NAP
242 acetylsalicylic acid / ascorbic acid / bioflavonoids Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000242/203501 NAP
243 acetylsalicylic acid / ascorbic acid / codeine phosphate hemihydrate Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000243/203501 NAP
244 exagamglogene autotemcel 15/11/2023 6 months 14/05/2026 23/07/2026 14/11/2026 23/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000244/202605 PSUSA/00000244/202611 Bianca Mulder Netherlands CAP
245 omaveloxolone 28/02/2023 1 year 27/02/2026 08/05/2026 27/02/2027 08/05/2027 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
DLP was amended on 01/04/2026 PSUSA/00000245/202602 PSUSA/00000245/202702 Amelia Cupelli Italy CAP
246 alfatocopherol / ascorbic acid / biotin / calcium pantothenate / colecalciferol / cyanocobalamin / magnesium / manganese / pyridoxine / riboflavin / thiamine / vitamin a / zinc Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000246/203501 NAP
248 ascorbic acid / dichlorobenzyl alcohol Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000248/203501 NAP
249 alfatocopherol acetate / ascorbic acid / ergocalciferol / retinol Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000249/203501 NAP
250 ascorbic acid / caffeine / glucuronamide Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000250/203501 NAP
251 ascorbic acid / paracetamol Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000251/203501 NAP
252 acetylsalicylic acid / ascorbic acid / paracetamol 13/12/1985 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000252/203501 NAP
253 ascorbic acid / caffeine / paracetamol Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000253/203501 NAP
255 ascorbic acid / paracetamol / phenylephrine hydrochloride Not available* 5 years 15/06/2030 13/09/2030 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00000255/203006 Rugile Pilviniene Lithuania NAP
256 asenapine 01/09/2010 5 years 12/08/2030 10/11/2030 No 27/05/2026 DLP was corrected on 27/05/2026
PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00000256/203008 Ana Sofia Diniz Martins Portugal CAP
257 ascorbic acid / potassium aspartate / potassium bicarbonate Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000257/204001 NAP
258 atazanavir 02/03/2004 5 years 19/06/2029 17/09/2029 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00000258/202906 Tiphaine Vaillant France CAP
259 atenolol 19/02/1976 12 years 19/02/2037 20/05/2037 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00000259/203702 Terhi Lehtinen Finland NAP
260 atenolol / chlortalidone 09/09/1997 7 years 09/09/2031 08/12/2031 No 03/06/2020 PRAC representative was updated on 22/12/2021
DLP was updated on 03/06/2020
PRAC representative was updated on 06/05/2020
PRAC representative was added on 21/11/2018
Lead MS was added on 06/03/2015 PSUSA/00000260/203109 Miroslava Gocova Slovakia NAP
262 atomoxetine 26/11/2002 5 years 26/11/2028 24/02/2029 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00000262/202811 Maria del Pilar Rayon Spain NAP
263 momelotinib 15/09/2023 1 year 14/09/2026 23/11/2026 14/09/2027 23/11/2027 No 02/06/2026 PSUSA/00000263/202609 PSUSA/00000263/202709 Jenny-Maria Jönsson Sweden CAP
264 atosiban 20/01/2000 5 years 31/01/2029 01/05/2029 No 19/10/2022 PRAC representative was updated on 19/10/2022
PRAC representative was updated on 17/11/2021
DLP was updated on 20/10/2021
PRAC representative was updated on 25/09/2019
DLP was updated on 23/10/2018
Reference to NAP added on 25/09/2017
Next DLP was amended on 29/10/2015
PRAC Rapporteur name amended on PSUSA/00000264/202901 Amelia Cupelli Italy CAP NAP
265 atovaquone 25/11/1992 13 years 30/11/2027 28/02/2028 No 19/09/2024 PSUSA/00000265/202711 Zoubida Amimour France NAP
266 atovaquone / proguanil 21/10/1996 5 years 31/10/2027 29/01/2028 No 28/06/2023 Next DLP was updated on 28/06/2023
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 04/07/2018
PRAC representative and Lead Member State were added on 28/03/2017 PSUSA/00000266/202710 Ana Sofia Diniz Martins Portugal NAP
267 atracurium 16/12/1982 10 years 16/12/2032 16/03/2033 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00000267/203212 Dennis Lex Germany NAP
268 atropine (except myopia indication) 31/08/1945 14 years 31/08/2026 29/11/2026 No 25/06/2025 Active substance name was amended on 25/06/2025 PSUSA/00000268/202608 none NAP
269 atropine / diphenoxylate 29/09/1960 14 years 01/01/2026 01/04/2026 No 17/02/2026 PSUSA/00000269/202601 Jana Pecherova Slovakia NAP
273 etrasimod 12/10/2023 1 year 11/10/2026 20/12/2026 11/10/2027 20/12/2027 No 27/05/2026 PSUR frequency amended and DLP updated on 27/05/2026
PSUR frequency corrected on 04/03/2026
DLP was amended on 19/11/2025 PSUSA/00000273/202610 PSUSA/00000273/202710 Karin Bolin Sweden CAP
274 azacitidine 17/12/2008 5 years 18/05/2029 16/08/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00000274/202905 Bianca Mulder Netherlands CAP
275 azathioprine 13/12/1965 6 years 12/12/2030 12/03/2031 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00000275/203012 Karin Erneholm Denmark CAP NAP
276 azelaic acid 27/10/1988 8 years 03/06/2033 01/09/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000276/203306 Jan Neuhauser Austria NAP
277 azelastine 20/11/1990 3 years 31/12/2026 31/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000277/202612 Jan Neuhauser Austria NAP
280 azilsartan medoxomil, azilsartan medoxomil/chlortalidone 07/12/2011 3 years 24/08/2026 22/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00000280/202608 Bianca Mulder Netherlands CAP NAP
282 hydroxyethyl salicylate / mephenesin / methyl nicotinate 19/07/2003 10 years 19/07/2035 17/10/2035 Yes 30/04/2024 New entry added on 30/04/2024 PSUSA/00000282/203507 none none NAP
283 aztreonam (inhalation use) 21/09/2009 5 years 11/09/2028 10/12/2028 No 05/06/2024 PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00000283/202809 Liana Martirosyan Netherlands CAP
284 bacillus clausii multi-antibioresistant spores 03/11/1978 5 years 30/11/2027 28/02/2028 No 26/07/2023 PSUR frequency amended and DLP updated on 26/07/2023 PSUSA/00000284/202711 Amelia Cupelli Italy NAP
285 bacitracin, bacitracin / neomycin, bacitracin / polymyxin, bacitracin / neomycin / polymyxin, bacitracin / hydrocortisone / neomyicin, bacitracin zinc / cysteine / glycine / neomycin/ threonine 02/04/1962 9 years 03/05/2029 01/08/2029 No 20/12/2023 Active substance name, PSUR frequency and DLP were amended on 20/12/2023 PSUSA/00000285/202905 none NAP
286 efbemalenograstim alfa 06/05/2023 1 year 05/05/2026 14/07/2026 05/05/2027 14/07/2027 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025
DLP was amended on 18/12/2024 PSUSA/00000286/202605 PSUSA/00000286/202705 Bianca Mulder Netherlands CAP
293 baclofen (intrathecal use) 16/01/1963 5 years 31/01/2026 01/05/2026 Yes 20/10/2021 Active substance name and DLP were updated on 20/10/2021
Next DLP was amended on 19/10/2016
DLP was amended on 06/10/2015
Lead MS was added on 13/07/2015 PSUSA/00000293/202601 Adam Przybylkowski Poland NAP
294 baclofen (oral use, for muscle spasticity indication) 17/09/1970 3 years 30/09/2026 29/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00000294/202609 Eamon O'Murchu Ireland NAP
295 bambuterol 07/12/1990 5 years 07/12/2027 06/03/2028 No 12/09/2025 Next DLP was updated on 26/07/2023 PSUSA/00000295/202712 Veronika Macurová Czech Republic NAP
296 bamifylline Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000296/202905 NAP
297 bamipine Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000297/203506 NAP
299 barium sulphate, barium sulphate combinations 03/07/1973 28 years 01/01/2040 31/03/2040 No 01/10/2012 EURD was amended on 02/07/2014 PSUSA/00000299/204001 NAP
300 barnidipine 01/07/2000 7 years 03/03/2031 01/06/2031 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00000300/203103 Bianca Mulder Netherlands NAP
301 basiliximab 09/10/1998 3 years 30/04/2027 29/07/2027 No 06/10/2025 DLP was amended on 05/02/2025 PSUSA/00000301/202704 Dirk Mentzer Germany CAP
302 bazedoxifene 17/04/2009 10 years 16/10/2034 14/01/2035 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00000302/203410 Dennis Lex Germany CAP
303 BCG (bacillus calmette-guérin) for Immunotherapy 02/03/1988 5 years 02/03/2028 31/05/2028 No 06/10/2025 DLP was amended on 15/11/2023 PSUSA/00000303/202803 Dirk Mentzer Germany NAP
304 BCG vaccine (freeze-dried) Not available* 5 years 02/03/2028 31/05/2028 No 02/06/2026 PSUSA/00000304/202803 Jenny Jönsson Sweden NAP
305 cefepime / enmetazobactam 29/06/1993 3 years 28/06/2028 26/09/2028 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00000305/202806 Liana Martirosyan Netherlands CAP
306 beclometasone 13/12/1966 5 years 31/12/2026 31/03/2027 No 20/05/2026 DLP was updated on 21/09/2022
Lead MS and PRAC Rapporteur name amended on 19/12/2018
Next DLP was amended on 25/09/2017
European Union reference date was amended on 21/07/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00000306/202612 Katarzyna Ziolkowska Poland NAP
308 beclometasone dipropionate / neomycin sulfate Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000308/204003 NAP
309 beclometasone / salbutamol Not available* 5 years 01/01/2027 01/04/2027 No 21/09/2022 DLP was updated on 21/09/2022
PSUR Frequency amended and next DLP updated on 25/09/2017
Entry name corrected on 23/05/2017
PRAC Rapporteur name corrected on 28/02/2017
PRAC Rapporteur name was amended on 20/12/2016
Lead MS and PRAC Rapporteur name was added on 28/07/2016
Active substance name was amended on 03/06/2016
Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00000309/202701 Ana Sofia Diniz Martins Portugal NAP
311 belatacept 17/06/2011 5 years 14/06/2028 12/09/2028 No 02/06/2026 PSUSA/00000311/202806 Karin Bolin Sweden CAP
312 bemiparin 16/04/1998 5 years 30/04/2027 29/07/2027 No 19/09/2025 PSUR frequency and DLP were updated on 01/02/2023
PRAC Representative updated on 16/11/2022
DLP was updated on 05/02/2020
Next DLP amended and PRAC Rapporteur name updated on 30/01/2017
PRAC Rapporteur and Lead Member State added on 27/11/2015. PSUSA/00000312/202704 Maria Martinez Gonzalez Spain NAP
313 benazepril 28/11/1989 5 years 20/11/2025 18/02/2026 No 15/01/2025 DLP was updated on 28/07/2021
PRAC Rapporteur name updated on 23/10/2018
Next DLP was amended on 28/07/2016
DLP amended on 31/07/2015
Lead MS was added on 13/07/2015 PSUSA/00000313/202511 Amelia Cupelli Italy NAP
314 benazepril / hydrochlorothiazide 19/05/1992 5 years 31/05/2026 29/08/2026 No 19/09/2024 PSUSA/00000314/202605 Zoubida Amimour France NAP
315 bendazac 09/11/1968 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000315/203408 NAP
329 benperidol 01/08/1967 6 years 31/07/2030 29/10/2030 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00000329/203007 Dennis Lex Germany NAP
330 benserazide / levodopa 27/06/1973 5 years 26/06/2027 24/09/2027 No 01/03/2023 DLP was updated on 01/03/2023
PRAC representative was updated on 06/05/2020
DLP was updated on 28/02/2018
PRAC representative and Lead Member State were added on 18/11/2016 PSUSA/00000330/202706 Melinda Palfi Hungary NAP
331 bentazepam 01/07/1980 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000331/202811 NAP
332 benzalkonium (exluding vaginal use), benzalkonium chloride / hexylresorcinol Not available* 7 years 01/11/2028 30/01/2029 No 23/10/2024 Active substance name was amended on 23/10/2024
PSUR frequency amended and DLP updated on 23/10/2024
Active substance name changed on 28/04/2022 PSUSA/00000332/202811 Amelia Cupelli Italy NAP
339 benzalkonium chloride / dequalinium chloride Not available* 9 years 03/06/2029 01/09/2029 Yes 23/10/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 23/10/2024
PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000339/202906 none NAP
342 benzalkonium / ethyl alcohol Not available* 7 years 03/07/2031 01/10/2031 No 24/09/2025 Entry name updated on 24/09/2025
Entry name updated on 30/07/2025
DLP was amended on 05/03/2025 PSUSA/00000342/203107 Guðrún Stefánsdóttir Iceland NAP
349 acetylcysteine / tuaminoheptane, acetylcysteine / benzalkonium chloride / tuaminoheptane 01/03/1971 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000349/202806 Amelia Cupelli Italy NAP
354 benzbromarone 15/10/1970 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000354/202805 NAP
357 benzocaine Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000357/203001 NAP
358 benzocaine / cetylpyridinium chloride 01/01/1996 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000358/203001 NAP
361 benzocaine / chloroxylenol Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000361/203001 NAP
362 benzocaine / dequalinium hydrochloride 09/04/1991 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000362/203001 NAP
363 benzocaine / hamamelis water / racephedrine hydrochloride Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000363/203001 NAP
364 benzocaine / menthol / phenol, racemic / thymol Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000364/203001 NAP
365 benzocaine / phenazone Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000365/203001 NAP
366 benzocaine / triclosan Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000366/203001 NAP
368 benzododecinium / boric acid Not available* 11 years 03/03/2040 01/06/2040 No 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024
Active substance name was amended on 28/02/2024 PSUSA/00000368/204003 none NAP
372 benzoxonium chloride / lidocaine hydrochloride 17/04/1989 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000372/202901 NAP
373 benzoyl peroxide 01/03/1950 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000373/203212 NAP
375 benzydamine 10/07/1964 5 years 31/10/2029 29/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00000375/202910 Amelia Cupelli Italy NAP
378 benzydamine / cetylpyridine Not available* 7 years 01/01/2026 01/04/2026 No 27/07/2022 PRAC representative was updated on 27/07/2022
PRAC representative was updated on 30/06/2021
DLP was updated on 25/09/2019
PRAC Representative and Lead Member state assigned on 04/07/2018 PSUSA/00000378/202601 Amelia Cupelli Italy NAP
379 benzylbenzoate Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000379/203001 NAP
380 benzylnicotinate Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000380/203001 NAP
383 benzylpenicillin, benzathine benzylpenicillin, benzathine benzylpenicillin / lidocaine, procaine benzylpenicillin, benzathine benzylpenicillin / procaine benzylpenicillin 27/06/1952 5 years 15/06/2030 13/09/2030 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00000383/203006 Maia Uusküla Estonia NAP
385 besilesomab 11/01/2010 5 years 10/01/2029 10/04/2029 No 19/09/2025 DLP was amended on 25/09/2024 PSUSA/00000385/202901 Maria Martinez Gonzalez Spain CAP
387 beta-carotene Not available* 9 years 03/06/2029 01/09/2029 No 15/01/2025 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000387/202906 Adam Przybylkowski Poland NAP
389 betahistine 16/05/1968 3 years 31/12/2026 31/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000389/202612 Zane Neikena Latvia NAP
390 betaine anhydrous (centrally authorised product only) 15/02/2007 3 years 28/02/2026 29/05/2026 Yes 15/11/2023 DLP was amended on 15/11/2023
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 15/11/2023
New CAP authorised on 05/05/2022
DLP was updated on 21/10/2020
PRAC Rapporteur name was amended on 31/07/2018
PSUR Frequency amended and DLP updated on 17/10/2017
Next DLP was amended on 19/10/2016
DLP amended on 06/10/2015
Active substance name was amended on 13/03/2015 PSUSA/00000390/202602 Dennis Lex Germany CAP
391 betamethasone 25/09/1961 9 years 01/01/2030 01/04/2030 No 22/09/2021 DLP was updated on 22/09/2021
PRAC representative and LMS were added on 01/07/2020 PSUSA/00000391/203001 Eamon O'Murchu Ireland NAP
393 betamethasone dipropionate / calcipotriol Not available* 9 years 01/01/2030 01/04/2030 No 22/09/2021 DLP was updated on 22/09/2021
PRAC representative and LMS were added on 01/07/2020 PSUSA/00000393/203001 Eamon O'Murchu Ireland NAP
394 betamethasone dipropionate / clotrimazole Not available* 9 years 01/01/2030 01/04/2030 No 22/09/2021 LMS was updated on 27/07/2022
DLP was updated on 22/09/2021
PRAC representative and LMS were added on 01/07/2020 PSUSA/00000394/203001 Portugal NAP
395 betamethasone dipropionate / salicylic acid Not available* 9 years 01/01/2030 01/04/2030 No 22/09/2021 DLP was updated on 22/09/2021
PRAC representative and LMS were added on 01/07/2020 PSUSA/00000395/203001 Eamon O'Murchu Ireland NAP
397 betamethasone sodium phosphate / neomycin sulfate Not available* 9 years 01/01/2030 01/04/2030 No 22/09/2021 DLP was updated on 22/09/2021
PRAC representative and LMS were updated on 01/07/2020 PSUSA/00000397/203001 Eamon O'Murchu Ireland NAP
398 betamethasone valerate / clioquinol Not available* 9 years 01/01/2030 01/04/2030 No 22/09/2021 DLP was updated on 22/09/2021
PRAC representative and LMS were updated on 01/07/2020 PSUSA/00000398/203001 Eamon O'Murchu Ireland NAP
399 betamethasone valerate / fusidic acid Not available* 9 years 01/01/2030 01/04/2030 No 22/09/2021 DLP was updated on 22/09/2021
PRAC representative and LMS were updated on 01/07/2020 PSUSA/00000399/203001 Eamon O'Murchu Ireland NAP
401 betaxolol 10/05/1982 5 years 10/05/2027 08/08/2027 No 01/02/2023 DLP was updated on 01/02/2023
PRAC representative was updated on 06/05/2020
DLP was amended on 31/01/2018
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00000401/202705 Melinda Palfi Hungary NAP
402 bethanechol Not available* 5 years 15/06/2030 13/09/2030 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00000402/203006 Jan Neuhauser Austria NAP
403 bevacizumab 12/01/2005 3 years 25/02/2028 25/05/2028 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00000403/202802 Karin Erneholm Denmark CAP
404 bexarotene 29/03/2001 3 years 15/09/2026 14/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00000404/202609 Tiphaine Vaillant France CAP
405 bezafibrate 21/07/1978 7 years 01/01/2026 01/04/2026 No 26/05/2025 PRAC representative updated on 31/01/2024 PSUSA/00000405/202601 Carla Torre Portugal NAP
406 bibrocathol Not available* 7 years 03/08/2031 01/11/2031 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00000406/203108 Karin Bolin Sweden NAP
407 bicalutamide 28/02/1995 3 years 28/02/2026 29/05/2026 No 15/11/2023 DLP was amended on 15/11/2023 PSUSA/00000407/202602 Karin Erneholm Denmark NAP
408 biclotymol 11/06/2003 7 years 03/05/2031 01/08/2031 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00000408/203105 Zoubida Amimour France NAP
409 biclotymol / enoxolone / muramidase hydrochloride Not available* 8 years 01/12/2025 01/03/2026 No 11/06/2025 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00000409/202512 Guðrún Stefánsdóttir Iceland NAP
411 bifonazole 01/12/1982 8 years 03/05/2033 01/08/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000411/203305 Dennis Lex Germany NAP
412 bifonazole / urea 02/06/1985 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000412/202812 NAP
413 bimatoprost 08/03/2002 5 years 07/03/2026 05/06/2026 No 17/11/2021 DLP and frequency were updated on 17/11/2021
PRAC Rapporteur name was corrected on 03/04/2019
DLP was updated on 21/11/2018
PRAC Rapporteur name was amended on 06/06/2018
PRAC Representative amended on 17/10/2017
Next DLP updated on 27/11/2015. PSUSA/00000413/202603 Karin Erneholm Denmark CAP NAP
414 biotin Not available* 7 years 01/01/2026 01/04/2026 No 25/09/2019 DLP was updated on 25/09/2019
PRAC Representative and Lead Member state assigned on 04/07/2018 PSUSA/00000414/202601 Jan Neuhauser Austria NAP
415 biperiden 16/08/1955 3 years 31/08/2028 29/11/2028 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00000415/202808 Jan Neuhauser Austria NAP
416 bisacodyl, bisacodyl / senna dry extract / senna pods / sennae folium, sennosides calcium salts, cassia angustifolia / cassia fistula, senna glycosides 01/06/1954 10 years 01/01/2034 01/04/2034 No 17/12/2025 Active substance name was amended on 17/12/2025
Active substance name was amended on 28/05/2025
Active substance name, PSUR frequency and DLP were amended on 20/12/2023 PSUSA/00000416/203401 none NAP
419 bisoprolol 28/01/1986 6 years 30/09/2030 29/12/2030 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
DLP was updated on 30/06/2021
Next DLP was amended on 03/06/2016
PRAC Rapporteur name updated on 06/10/2015
Lead MS added on 12/05/2015 PSUSA/00000419/203009 Kimmo Jaakkola Finland NAP
420 bisoprolol / hydrochlorothiazide 30/01/1992 7 years 30/11/2031 28/02/2032 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00000420/203111 Zoubida Amimour France NAP
421 bivalirudin 20/09/2004 5 years 20/09/2030 19/12/2030 Yes 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00000421/203009 Veronika Macurová Czech Republic NAP
422 bleomycin 18/03/1970 10 years 31/03/2032 29/06/2032 No 21/12/2022 DLP was updated on 21/12/2022
PRAC Rapporteur name was amended on 28/04/2022
LMS and PRAC representative were added on 20/10/2021 PSUSA/00000422/203203 Marie Louise Schougaard Christiansen Denmark NAP
423 borax / boric acid Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000423/203501 NAP
424 bortezomib 26/04/2004 3 years 25/04/2026 24/07/2026 Yes 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00000424/202604 Amelia Cupelli Italy CAP NAP
425 bosentan 15/05/2002 3 years 19/11/2027 17/02/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00000425/202711 Zoubida Amimour France CAP NAP
426 botulinum toxin a (except for centrally authorised products) 29/12/1989 3 years 31/12/2027 30/03/2028 Yes 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00000426/202712 Eamon O'Murchu Ireland NAP
427 botulinum toxin a - haemagglutinin complex 06/12/1990 3 years 31/12/2027 30/03/2028 Yes 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00000427/202712 Karin Bolin Sweden NAP
430 brimonidine (except for the centrally authorised product) 06/09/1996 5 years 30/09/2026 29/12/2026 No 29/06/2022 DLP was updated on 29/06/2022
Lead MS and PRAC Rapporteur name amended on 19/12/2018
Next DLP was amended on 27/06/2017
PRAC representative and Lead Member State were added on 03/05/2016
Name of active substance was amended on 02/05/2014 PSUSA/00000430/202609 Eamon O'Murchu Ireland NAP
431 brimonidine / timolol 06/09/1996 5 years 30/09/2026 29/12/2026 No 29/06/2022 DLP was updated on 29/06/2022
Lead MS and PRAC Rapporteur name amended on 19/12/2018
Next DLP was amended on 27/06/2017
PRAC representative and Lead Member State were added on 03/05/2016 PSUSA/00000431/202609 Dennis Lex Germany NAP
432 brinzolamide 09/03/2000 5 years 31/08/2026 29/11/2026 No 28/04/2022 PRAC Representative updated on 16/11/2022
DLP was updated on 28/04/2022
PSUR Frequency amended and DLP updated on 23/05/2017
Reference to NAP products added on 18/11/2016
PRAC Representative amended on 28/06/2016 PSUSA/00000432/202608 Maria del Pilar Rayon Spain CAP NAP
433 brinzolamide / timolol 25/11/2008 5 years 30/04/2029 29/07/2029 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00000433/202904 Karin Erneholm Denmark CAP NAP
434 brivudine 06/07/2000 5 years 05/07/2029 03/10/2029 No 05/03/2025 DLP was amended on 05/03/2025 PSUSA/00000434/202907 Dennis Lex Germany NAP
435 bromazepam 01/09/1973 3 years 31/08/2026 29/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00000435/202608 Tiphaine Vaillant France NAP
436 bromfenac 18/05/2011 5 years 30/05/2030 28/08/2030 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00000436/203005 Karin Erneholm Denmark CAP NAP
437 bromhexine 01/07/1963 5 years 30/09/2030 29/12/2030 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
Next DLP was updated on 31/05/2023 PSUSA/00000437/203009 Amelia Cupelli Italy NAP
438 bromocriptine 15/10/1975 7 years 15/10/2030 13/01/2031 No 03/07/2024 PSUR frequency amended and DLP updated on 03/07/2024 PSUSA/00000438/203010 Maria del Pilar Rayon Spain NAP
439 bromperidol 30/09/1980 5 years 15/11/2027 13/02/2028 No 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00000439/202711 Liana Martirosyan Netherlands NAP
443 brompheniramine / caffeine / paracetamol, brompheniramine / caffeine / calcium / paracetamol Not available* 11 years 03/03/2040 01/06/2040 No 25/09/2024 Entry name updated on 25/09/2024 PSUSA/00000443/204003 none NAP
444 brotizolam 15/05/1983 3 years 01/12/2025 01/03/2026 No 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00000444/202512 Ana Sofia Diniz Martins Portugal NAP
448 buclizine / codeine / paracetamol, acetylsalicylic acid / codeine / paracetamol, caffeine / codeine / paracetamol Not available* 5 years 03/08/2030 01/11/2030 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00000448/203008 Rhea Fitzgerald Ireland NAP
449 budesonide (nationally authorised products only) 30/04/1992 5 years 30/04/2026 29/07/2026 No 22/12/2021 PRAC Rapporteur name was amended on 28/04/2022
DLP updated on 22/12/2021
PRAC Rapporteur name was amended on 21/11/2018
Entry name was corrected on 07/05/2018
Next DLP updated on 30/01/2017
Next DLP and Submission deadline were corrected on 04/03/2016
PSUR Frequency amended and DLP updated on 04/02/2016
PRAC Rapporteur and Lead Member State added on 27/11/2015.
Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015
PRAC Rapporteur name updated on 05/11/2018 PSUSA/00000449/202604 Marie Louise Schougaard Christiansen Denmark NAP
454 bumetanide 30/09/1972 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000454/202806 NAP
459 buprenorphine (all formulations except implants) 30/03/1982 4 years 30/09/2027 29/12/2027 No 05/06/2024 New CAP authorised on 19/12/2024
PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00000459/202709 Tiphaine Vaillant France CAP NAP
461 bupropion 30/12/1985 5 years 31/12/2029 31/03/2030 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00000461/202912 Liana Martirosyan Netherlands NAP
462 buserelin 16/08/1984 5 years 16/08/2026 14/11/2026 No 02/06/2026 PSUSA/00000462/202608 Jenny Jönsson Sweden NAP
463 buspirone 29/04/1983 3 years 30/04/2027 29/07/2027 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00000463/202704 Karin Erneholm Denmark NAP
464 busulfan 09/07/2003 3 years 08/07/2027 06/10/2027 Yes 19/09/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00000464/202707 Maria Martinez Gonzalez Spain NAP
468 butamirate 18/03/1967 10 years 03/07/2034 01/10/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000468/203407 NAP
469 butamirate / guaifenesin Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000469/202906 NAP
471 butoconazole 24/10/2003 5 years 28/02/2026 29/05/2026 No 17/11/2021 DLP was updated on 17/11/2021
PRAC representative was updated on 06/05/2020
Next DLP was updated on 18/11/2016
Lead MS was added on 06/10/2015 PSUSA/00000471/202602 Melinda Palfi Hungary NAP
474 hyoscine butylbromide 01/01/1952 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000474/202712 NAP
476 cabazitaxel 17/06/2010 5 years 17/06/2029 15/09/2029 Yes 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00000476/202906 Tiphaine Vaillant France CAP NAP
477 cabergoline 13/03/1992 5 years 12/03/2027 10/06/2027 No 16/11/2022 PSUR frequency and DLP were updated on 16/11/2022
PRAC representative was updated on 19/10/2022
PRAC representative was updated on 17/11/2021
PRAC representative was updated on 30/06/2021
PSUR frequency and DLP were updated on 23/10/2019
PSUR frequency amended and DLP updated on 21/11/2018
PRAC Rapporteur name amended on 04/07/2018
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 17/10/2017
PRAC Rapporteur name updated on 04/02/2016
Next DLP updated and PRAC Rapporteur amended on 27/11/2015.
Lead MS was added on 04/02/2015 PSUSA/00000477/202703 Amelia Cupelli Italy NAP
480 cafedrine hydrochloride / theodrenaline hydrochloride Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000480/202906 NAP
481 caffeine 14/04/1969 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000481/204001 NAP
482 caffeine (apnea) 02/07/2009 3 years 02/07/2026 30/09/2026 Yes 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00000482/202607 Sonja Hrabcik Austria CAP NAP
483 caffeine / dihydroergocryptine mesilate Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000483/204001 NAP
484 caffeine / diphenhydramine Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000484/204001 NAP
485 caffeine / ergotamine Not available* 3 years 30/11/2025 28/02/2026 Yes 26/07/2023 PSUR frequency amended and DLP updated on 26/07/2023 PSUSA/00000485/202511 Tiphaine Vaillant France NAP
486 caffeine / isometheptene / metamizole Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000486/204001 NAP
487 caffeine / metamizole Not available* 28 years 01/01/2040 31/03/2040 No 07/05/2018 Entry name updated on 07/05/2018 PSUSA/00000487/204001 NAP
488 caffeine / phenazone Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000488/204001 NAP
489 caffeine citrate / glyceryl trinitrate Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000489/204001 NAP
491 calcifediol Not available* 5 years 23/06/2030 21/09/2030 No 01/04/2026 DLP was corrected on 01/04/2026
PSUR frequency amended and DLP updated on 04/03/2026 PSUSA/00000491/203006 Dennis Lex Germany NAP
492 calcipotriol 30/11/1990 8 years 03/06/2033 01/09/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000492/203306 Rhea Fitzgerald Ireland NAP
494 calcitonin salmon, synthetic analogue of eel calcitonin 13/05/1975 5 years 19/06/2026 17/09/2026 No 19/09/2025 PRAC Representative updated on 16/11/2022
PSUR frequency and DLP were updated on 02/03/2022
Next DLP was updated on 06/03/2019
PRAC Representative updated on 26/09/2018
PRAC Rapporteur name updated on 03/06/2016
Next DLP was updated on 04/03/2016
Lead MS added on 01/04/2015 PSUSA/00000494/202606 Maria Martinez Gonzalez Spain NAP
495 calcitriol 01/01/1978 5 years 01/01/2026 01/04/2026 No 19/10/2022 PRAC representative was updated on 19/10/2022
PRAC representative was updated on 27/07/2022
PSUR frequency and DLP were updated on 22/09/2021
PRAC representative was updated on 25/09/2019
DLP was updated on 26/09/2018
PRAC Rapporteur name amended on 04/07/2018
DLP updated on 06/10/2015
Lead MS was added on 22/12/2014 PSUSA/00000495/202601 Amelia Cupelli Italy NAP
496 calcium 15/06/1935 15 years 01/01/2027 01/04/2027 No 01/10/2012 PSUSA/00000496/202701 NAP
500 Any combinations or monocomponents of aluminium, calcium, magnesium, potassium, sodium salts (antacids) Not available* 15 years 01/01/2027 01/04/2027 No 27/05/2026 Active substance name was amended on 28/04/2022
Active substance name was amended on 06/03/2015 PSUSA/00000500/202701 none NAP
501 calcium bromolactobionate Not available* 15 years 01/01/2027 01/04/2027 No 01/10/2012 PSUSA/00000501/202701 NAP
502 calcium carbonate Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000502/202906 NAP
507 calcium chloride Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000507/204003 NAP
508 calcium chloride / dipotassium phosphate / magnesium chloride hexahydrate / potassium chloride / potassium phosphate monobasic / sodium chloride, disodium phosphate dihydrate/ potassium dihydrogen phosphate/ potassium hydroxide Not available* 15 years 01/01/2027 01/04/2027 No 31/07/2018 New active substances added to the entry on 31/07/2018 PSUSA/00000508/202701 NAP
509 calcium chloride / glucose anhydrous / glutathione disulphide / magnesium chloride hexahydrate Not available* 15 years 01/01/2027 01/04/2027 No 01/10/2012 PSUSA/00000509/202701 NAP
511 calcium chloride / glycine / magnesium aspartate dihydrate / sodium succinate hexahydrate Not available* 15 years 01/01/2027 01/04/2027 No 01/10/2012 PSUSA/00000511/202701 NAP
513 calcium chloride / glucose monohydrate / magnesium chloride hexahydrate Not available* 15 years 01/01/2027 01/04/2027 No 01/10/2012 PSUSA/00000513/202701 NAP
517 calcium folinate / cyanocobalamin Not available* 15 years 01/01/2027 01/04/2027 No 01/10/2012 PSUSA/00000517/202701 NAP
519 calcium folinate 5-hydrate / glutamine Not available* 15 years 01/01/2027 01/04/2027 No 01/10/2012 PSUSA/00000519/202701 NAP
520 calcium gluconate Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000520/204003 NAP
521 calcium carbonate / calcium lactate Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000521/203506 NAP
525 camphor, camphor and other terpene derivates Not available* 9 years 03/07/2029 01/10/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000525/202907 NAP
526 canakinumab 23/10/2009 5 years 30/06/2029 28/09/2029 No 06/10/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00000526/202906 Dirk Mentzer Germany CAP
527 candesartan, candesartan / hydrochlorothiazide 29/04/1997 5 years 28/04/2027 27/07/2027 No 02/06/2026 PSUSA/00000527/202704 Karin Bolin Sweden NAP
531 capecitabine 30/04/1998 5 years 29/04/2029 28/07/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00000531/202904 Dennis Lex Germany CAP NAP
532 capreomycin 19/01/1968 9 years 02/04/2028 01/07/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000532/202804 NAP
533 capsaicin 15/05/2009 5 years 15/05/2026 13/08/2026 No 02/02/2022 DLP was updated on 02/02/2022
Correction of PRAC Rapporteur name on 28/02/2017
'PSUR submission frequency and DLP were updated on 30/01/2017
'PRAC Rapporteur name was amended on 20/12/2016
'PRAC Rapporteur name updated on 04/02/2016
'Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 22/12/2014
Rapporteur name amended on 04/11/2014
The DLP was amended on 08/01/2014 PSUSA/00000533/202605 Ana Sofia Diniz Martins Portugal CAP NAP
535 captopril 15/04/1980 5 years 14/04/2030 13/07/2030 No 16/12/2020 PRAC representative was updated on 22/12/2021
DLP was updated on 16/12/2020
PRAC representative was updated on 06/05/2020
Lead MS and PRAC Rapporteur name amended on 19/12/2018
Next DLP was updated on 21/12/2015. PSUSA/00000535/203004 Miroslava Gocova Slovakia NAP
536 captopril / hydrochlorothiazide 15/04/1980 5 years 14/04/2026 13/07/2026 No 05/08/2025 PSUSA/00000536/202604 Tiphaine Vaillant France NAP
537 carbachol 10/11/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000537/203406 NAP
538 carbaethopendecinium Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000538/203506 NAP
539 carbamazepine 12/12/1961 7 years 11/12/2027 10/03/2028 No 22/09/2021 DLP and PRAC representative were updated on 22/09/2021
PRAC representative was added on 06/05/2020
LMS was added on 01/04/2020
DLP was corrected on 20/11/2019
PSUR frequency, "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?Yes/No" and DLP were updated on 25/09/2019 PSUSA/00000539/202712 Liana Martirosyan Netherlands NAP
541 carbasalate 16/07/1981 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000541/202811 NAP
543 carbazochrome 19/03/1951 11 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000543/203611 NAP
545 boric acid / carbethopendecinium bromide / sodium tetraborate Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000545/204003 NAP
546 carbetocin 24/06/1997 5 years 30/06/2027 28/09/2027 No 12/09/2025 DLP was updated on 01/03/2023
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 27/03/2018
Lead MS and PRAC Rapporteur name was added on 20/12/2016 PSUSA/00000546/202706 Veronika Macurová Czech Republic NAP
547 carbidopa / entacapone / levodopa 17/10/2003 3 years 17/10/2027 15/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00000547/202710 Terhi Lehtinen Finland CAP NAP
548 carbidopa / levodopa 13/08/1973 3 years 01/10/2028 30/12/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000548/202810 Barbara Kovacic Bytyqi Croatia NAP
550 carbimazole 31/08/1988 7 years 02/12/2030 02/03/2031 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00000550/203012 Dennis Lex Germany NAP
554 carbocisteine 14/09/1963 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000554/202803 NAP
555 carbocisteine / prenoxidiazine Not available* 9 years 03/07/2029 01/10/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000555/202907 NAP
557 carbomers Not available* 5 years 31/01/2027 01/05/2027 No 19/10/2022 DLP was updated on 19/10/2022
PRAC representative was updated on 28/07/2021
PRAC representative was updated on 28/04/2021
DLP was updated on 17/10/2017
Lead MS was amended on 22/09/2016
Lead MS and PRAC Rapporteur name was added on 28/07/2016
Active substance name was amended on 03/06/2016 PSUSA/00000557/202701 Polona Golmajer Slovenia NAP
558 carbon dioxide Not available* 8 years 01/12/2033 01/03/2034 No 30/10/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00000558/203312 Melinda Pálfi Hungary NAP
559 carboplatin 23/01/1986 5 years 23/01/2027 23/04/2027 Yes 19/10/2022 PSUR frequency and DLP were updated on 19/10/2022
PRAC representative was updated on 17/11/2021
PRAC representative was updated on 30/06/2021
DLP was udpated on 25/09/2019
Next DLP was amended on 19/10/2016
PRAC Representative was amended on 27/11/2015.
EURD and DLP amended on 06/10/2015
Lead MS added on 31/07/2015. PSUSA/00000559/202701 Amelia Cupelli Italy NAP
560 carboprost 09/01/1979 5 years 08/01/2026 08/04/2026 No 22/09/2021 DLP was updated on 22/09/2021
PRAC Rapporteur name updated on 27/06/2017
Next DLP was updated on 22/09/2016
Lead MS was added on 13/07/2015 PSUSA/00000560/202601 Eva Jirsová Czech Republic NAP
562 carmellose (eye preparation) 01/10/1990 15 years 03/06/2040 01/09/2040 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00000562/204006 Karin Bolin Sweden NAP
564 carglumic acid 24/01/2003 5 years 31/01/2030 01/05/2030 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00000564/203001 Ana Sofia Diniz Martins Portugal CAP
572 carnitine 01/09/1969 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000572/203408 NAP
574 carteolol 07/03/1984 5 years 31/03/2029 29/06/2029 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00000574/202903 Miroslava Gocova Slovakia NAP
575 carvedilol 18/04/1990 5 years 17/04/2027 16/07/2027 No 21/12/2022 DLP was updated on 21/12/2022
DLP was updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00000575/202704 Kimmo Jaakkola Finland NAP
576 caspofungin 24/10/2001 3 years 13/12/2027 12/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00000576/202712 Jo Robays Belgium CAP
582 estrogen / medroxyprogesterone 01/08/1987 5 years 31/08/2029 29/11/2029 No 12/09/2025 DLP was amended on 30/04/2025 PSUSA/00000582/202908 Veronika Macurová Czech Republic NAP
583 cefaclor 19/08/1976 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00000583/203303 Melinda Palfi Hungary NAP
584 cefadroxil 12/07/1976 5 years 11/07/2027 09/10/2027 No 05/04/2023 DLP was updated on 05/04/2023
DLP was updated on 27/03/2018
Lead MS and PRAC Rapporteur name was added on 20/12/2016 PSUSA/00000584/202707 Jan Neuhauser Austria NAP
585 cefalexin 15/03/1967 8 years 02/12/2026 02/03/2027 No 27/05/2026 PSUR frequency amended and DLP updated on 27/05/2026
PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000585/202612 none NAP
586 cefalotin Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000586/203506 NAP
587 cefamandole 29/08/1977 9 years 03/11/2028 01/02/2029 No 15/01/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000587/202811 Zane Neikena Latvia NAP
588 cefatrizine 27/08/1979 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000588/202811 NAP
589 cefazolin 29/11/1972 5 years 30/11/2026 28/02/2027 No 27/07/2022 DLP was updated on 27/07/2022
Next DLP was amended on 25/09/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00000589/202611 Jan Neuhauser Austria NAP
592 cefditoren 01/04/1994 8 years 31/03/2033 29/06/2033 No 30/10/2024 DLP was amended on 23/10/2024
PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000592/203303 Maria del Pilar Rayon Spain NAP
593 cefepime 29/06/1993 5 years 28/06/2029 26/09/2029 Yes 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 18/12/2024
DLP was updated on 02/03/2022
Next DLP was updated on 06/03/2019
Correction of PRAC Rapporteur name on 28/02/2017
PRAC Rapporteur name was amended on 20/12/2016
Next DLP was amended on 04/03/2016
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 04/03/2016
Lead MS added on 01/04/2015 PSUSA/00000593/202906 Ana Sofia Diniz Martins Portugal NAP
594 cefixime 30/06/1987 5 years 03/06/2030 01/09/2030 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00000594/203006 Eva Jirsová Czech Republic NAP
596 cefonicid Not available* 9 years 03/07/2029 01/10/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000596/202907 NAP
597 cefoperazone 12/01/1981 5 years 11/01/2026 11/04/2026 No 26/05/2025 DLP was updated on 22/09/2021
PRAC Rapporteur name was amended on 06/03/2019
Next DLP was updated on 22/09/2016
Lead MS was added on 13/07/2015 PSUSA/00000597/202601 Lina Seibokiene Lithuania NAP
598 cefoperazone / sulbactam 12/01/1981 5 years 11/01/2026 11/04/2026 No 26/05/2025 DLP was updated on 22/09/2021
PRAC Rapporteur name was amended on 06/03/2019
Next DLP was updated on 22/09/2016
Lead MS was added on 13/07/2015 PSUSA/00000598/202601 Lina Seibokiene Lithuania NAP
599 cefotaxime 18/12/1979 3 years 18/12/2027 17/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00000599/202712 Sonja Hrabcik Austria NAP
601 cefoxitin 16/03/1977 9 years 03/10/2028 01/01/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000601/202810 NAP
604 cefpodoxim 02/08/1990 7 years 02/12/2030 02/03/2031 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00000604/203012 Amelia Cupelli Italy NAP
605 cefprozil 23/12/1991 5 years 22/12/2027 21/03/2028 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00000605/202712 Polona Golmajer Slovenia NAP
606 cefradine 23/11/1971 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000606/202806 NAP
608 ceftazidime 17/10/1983 5 years 17/10/2028 15/01/2029 No 12/02/2025 DLP was amended on 03/07/2024 PSUSA/00000608/202810 Karin Bolin Sweden NAP
612 ceftizoxime 07/12/1981 9 years 03/11/2028 01/02/2029 No 15/01/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000612/202811 Ana Sofia Diniz Martins Portugal NAP
613 ceftriaxone 27/05/1982 5 years 26/05/2028 24/08/2028 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00000613/202805 Zane Neikena Latvia NAP
614 ceftriaxone sodium / lidocaine hydrochloride 27/05/1982 8 years 03/05/2033 01/08/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000614/203305 Amelia Cupelli Italy NAP
615 cefuroxime sodium (except for intracameral use) 18/08/1987 5 years 07/04/2027 06/07/2027 No 21/12/2022 DLP was updated on 21/12/2022
DLP was updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016
Name of entry was amended on 03/03/2014
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00000615/202704 Maia Uusküla Estonia NAP
616 celecoxib 31/12/1998 5 years 31/12/2028 31/03/2029 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026
DLP was amended on 25/09/2024 PSUSA/00000616/202812 Karin Bolin Sweden NAP
617 celiprolol 17/01/1983 8 years 16/01/2028 15/04/2028 No 23/09/2020 DLP was updated on 23/09/2020
PRAC representative was added on 06/05/2020
LMS was added on 31/07/2019 PSUSA/00000617/202801 Maia Uusküla Estonia NAP
624 certolizumab 01/10/2009 3 years 06/03/2026 04/06/2026 No 15/11/2023 DLP was amended on 15/11/2023 PSUSA/00000624/202603 Karin Bolin Sweden CAP
625 certoparin Not available* 5 years 01/04/2027 30/06/2027 No 21/12/2022 DLP was updated on 21/12/2022
PRAC representative added on 21/09/2022
LMS was added on 02/02/2022
PSUR frequency and DLP updated on 17/11/2021 PSUSA/00000625/202704 Dennis Lex Germany NAP
626 cetalkonium / choline salicylate 24/04/1995 8 years 03/08/2033 01/11/2033 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00000626/203308 Zoubida Amimour France NAP
628 cetirizine 06/11/1986 5 years 05/11/2027 03/02/2028 No 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00000628/202711 Terhi Lehtinen Finland NAP
629 cetirizine / pseudoephedrine 04/09/1995 5 years 31/08/2026 29/11/2026 No 28/04/2022 PRAC representative was updated on 19/10/2022
DLP and PRAC Representative were updated on 28/04/2022
DLP was updated on 23/05/2017
PRAC Representative amended on 18/11/2016
Lead MS and PRAC Rapporteur name was added on 07/04/2016 PSUSA/00000629/202608 Jo Robays Belgium NAP
630 cetrimide / chlorhexidine Not available* 9 years 03/07/2029 01/10/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000630/202907 NAP
631 cetrimide / lidocaine, cetrimide / lidocaine hydrochloride / zinc sulphate Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000631/203506 Jo Robays Belgium NAP
632 cetrimide / quinisocain chlorhydrate Not available* 8 years 01/12/2033 01/03/2034 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00000632/203312 none NAP
633 cetrorelix 13/04/1999 5 years 12/04/2030 11/07/2030 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00000633/203004 Dennis Lex Germany CAP NAP
635 cetuximab 29/06/2004 5 years 30/09/2028 29/12/2028 No 02/06/2026 PSUSA/00000635/202809 Jenny-Maria Jönsson Sweden CAP
636 cetylpyridinium 23/03/1939 11 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000636/203611 NAP
639 cetylpyridinium / lidocaine, lidocaine / chlorocresol / cetylpyridinium Not available* 10 years 03/06/2035 01/09/2035 No 18/12/2024 Active substance name was amended on 18/12/2024
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000639/203506 none NAP
640 cetylpyridinium / lysozyme, lysozyme / pyridoxine 12/01/1994 10 years 03/08/2035 01/11/2035 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00000640/203508 Zoubida Amimour France NAP
645 charcoal activated 06/04/1949 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000645/204001 NAP
646 bismuth subgallate / charcoal activated / citric acid Not available* 7 years 03/08/2031 01/11/2031 No 12/09/2025 PSUR frequency and DLP amended on 27/03/2024 PSUSA/00000646/203108 Veronika Macurová Czech Republic NAP
650 chlorambucil 14/09/1956 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000650/203401 NAP
651 chloramphenicol 25/06/1949 18 years 30/06/2030 28/09/2030 No 01/10/2012 PSUSA/00000651/203006 NAP
652 aminoacids / chloramphenicol / vitamin a Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000652/203001 NAP
654 chloramphenicol / dexamethasone 19/05/1964 18 years 31/05/2030 29/08/2030 No 01/10/2012 PSUSA/00000654/203005 NAP
655 chloramphenicol / hydrocortisone (ocular) 06/11/1958 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000655/203001 NAP
660 chlordiazepoxide 31/01/1960 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000660/203404 NAP
661 chlordiazepoxide / clidinium, amitriptyline / chlordiazepoxide Not available* 3 years 10/01/2027 10/04/2027 No 23/10/2024 PSUR frequency amended and DLP updated on 23/10/2024
Active substance name was amended on 23/10/2024
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000661/202701 none NAP
662 chlorhexidine 11/08/1976 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00000662/203303 Rugile Pilviniene Lithuania NAP
663 cetrimonium / chlorhexidine Not available* 9 years 03/07/2029 01/10/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000663/202907 NAP
664 chlorhexidine / dexpanthenol Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000664/202911 NAP
665 chlorhexidine / lidocaine 11/09/1963 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00000665/203405 NAP
669 chlorhexidine gluconate / isopropyl alcohol (covers other synonymous terms such as 2-propanol) Not available* 8 years 01/12/2025 01/03/2026 No 04/02/2026 Active substance name was amended on 04/02/2026
PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00000669/202512 Jo Robays Belgium NAP
677 chlormadinone 18/11/1974 3 years 31/01/2027 01/05/2027 Yes 21/10/2022 PSUR frequency and DLP updated on 21/10/2022
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" and DLP was amended on 29/06/2022
Next DLP was amended on 25/09/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016
The DLP was amended on 01/04/2014 PSUSA/00000677/202701 Dennis Lex Germany NAP
679 chlormadinone acetate / ethinylestradiol Not available* 3 years 31/01/2027 01/05/2027 No 21/10/2022 PSUR frequency and DLP updated on 21/10/2022
Next DLP was amended on 29/06/2022
Next DLP was amended on 25/09/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00000679/202701 Dennis Lex Germany NAP
682 chlorocresol Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000682/202911 NAP
684 chloropyramine Not available* 8 years 01/12/2028 01/03/2029 Yes 27/05/2026 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 27/05/2026
DLP was amended on 27/05/2026
PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00000684/202812 Zane Neikena Latvia NAP
685 chloroquine 20/08/1947 5 years 18/04/2026 17/07/2026 No 16/10/2025 DLP updated on 22/12/2021
DLP was updated on 03/06/2020
PSUR frequency and DLP were amended on 30/04/2019
European Union reference date, DLP and Submission date were amended on 28/02/2018
PRAC Representative amended on 19/12/2017
Next DLP was amended on 07/04/2016
Lead MS added on 01/04/2015 PSUSA/00000685/202604 Liana Martirosyan Netherlands NAP
689 chloroxylenol 01/01/1933 11 years 03/05/2040 01/08/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000689/204005 NAP
692 chlorphenamine 07/06/1954 10 years 01/01/2034 01/04/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000692/203401 NAP
693 chlorphenamine / paracetamol / pseudoephedrine, chlorphenamine / paracetamol / phenylephrine Not available* 10 years 03/05/2035 01/08/2035 No 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024
Active substance name was amended on 30/04/2024 PSUSA/00000693/203505 none NAP
694 acetylsalicylic acid / chlorphenamine / phenylephrine Not available* 8 years 03/11/2033 01/02/2034 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000694/203311 Adam Przybylkowski Poland NAP
696 ascorbic acid / chlorphenamine / paracetamol Not available* 6 years 03/11/2029 01/02/2030 No 19/09/2024 PSUSA/00000696/202911 Zoubida Amimour France NAP
697 ascorbic acid / caffeine / chlorphenamine / paracetamol Not available* 10 years 03/05/2035 01/08/2035 No 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024
Active substance name was amended on 30/04/2024 PSUSA/00000697/203505 none NAP
699 chlorphenamine / dextromethorphan hydrobromide / paracetamol Not available* 10 years 03/11/2034 01/02/2035 Yes 19/09/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00000699/203411 Maria Martinez Gonzalez Spain NAP
703 chlorphenamine / paracetamol 22/08/2001 7 years 03/03/2031 01/06/2031 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00000703/203103 Zoubida Amimour France NAP
710 chlorphenamine / pseudoephedrine, chlorphenamine / phenylephrine Not available* 10 years 03/05/2035 01/08/2035 Yes 30/04/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/04/2024
PSUR frequency amended and DLP updated on 30/04/2024
Active substance name was amended on 30/04/2024
PSUR frequency and DLP amended on 27/03/2024 PSUSA/00000710/203505 none NAP
715 chlorpromazine 29/05/1952 5 years 29/05/2028 27/08/2028 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00000715/202805 Tiphaine Vaillant France NAP
717 chlorprothixene 31/03/1959 3 years 31/03/2027 29/06/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00000717/202703 Zane Neikena Latvia NAP
718 chlortalidone 24/06/1959 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000718/203401 NAP
720 chlortalidone / oxprenolol 27/09/1976 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000720/203503 NAP
721 chlortalidone / reserpine 06/02/1962 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00000721/203405 NAP
723 chlortetracycline 01/04/1949 11 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000723/203611 NAP
726 chlorzoxazone 28/06/1960 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000726/203404 NAP
730 cholera vaccine (inactivated, oral) 28/04/2004 3 years 28/04/2026 27/07/2026 No 02/06/2026 PSUSA/00000730/202604 Karin Bolin Sweden CAP
732 choline salicylate 10/12/1963 13 years 10/12/2025 10/03/2026 No 28/03/2025 PSUSA/00000732/202512 Adam Przybylkowski Poland NAP
733 chlorobutanol hemihydrate / choline salicylate / hexetidine Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000733/202911 NAP
736 choriogonadotropin alfa, chorionic gonadotrophin 02/02/2001 3 years 19/09/2028 18/12/2028 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00000736/202809 Bianca Mulder Netherlands CAP NAP
738 chrome alum Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000738/202911 NAP
739 chromium (51 cr) edta 30/11/1975 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000739/203503 NAP
742 ciclesonide 24/02/2004 5 years 23/08/2029 21/11/2029 No 02/06/2026 PSUSA/00000742/202908 Karin Bolin Sweden NAP
745 ciclosporin (systemic use) 15/12/1982 3 years 31/12/2027 30/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00000745/202712 Maia Uusküla Estonia NAP
748 cilastatin / imipenem 28/06/1984 5 years 27/06/2027 25/09/2027 No 01/03/2023 DLP was updated on 01/03/2023
PRAC Rapporteur name amended on 04/07/2018
PSUR Frequency amended and DLP updated on 28/02/2018
PRAC Representative name was amended on 17/10/2017
PRAC representative and Lead Member State were added on 18/11/2016
Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00000748/202706 Karen Pernille Harg Norway NAP
749 cilazapril, cilazapril / hydrochlorothiazide 21/02/1990 5 years 20/02/2029 21/05/2029 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00000749/202902 Carla Torre Portugal NAP
753 cimetidine 09/11/1976 9 years 02/09/2028 01/12/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000753/202809 NAP
755 cimicifuga racemosa (L.) nutt., rhizoma Not available* 5 years 01/01/2028 31/03/2028 Yes 20/09/2023 DLP amended on 20/09/2023 PSUSA/00000755/202801 Jan Neuhauser Austria NAP
757 cinchocaine Not available* 8 years 01/12/2028 01/03/2029 Yes 27/05/2026 DLP was amended on 27/05/2026
PSUR frequency amended and DLP updated on 27/05/2026
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 27/05/2026
PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00000757/202812 Dennis Lex Germany NAP
759 1,3-butanediol / cinchocaine hydrochloride / dexamethasone 23/09/1983 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000759/202812 NAP
761 cinchocaine hydrochloride / hydrocortisone Not available* 7 years 03/08/2031 01/11/2031 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00000761/203108 John Joseph Borg Malta NAP
762 cinchocaine hydrochloride / policresulen Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000762/202911 NAP
766 cinnarizine 01/11/1961 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00000766/203405 NAP
767 cinnarizine / dimenhydrinate 19/03/1996 8 years 03/11/2033 01/02/2034 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000767/203311 Jan Neuhauser Austria NAP
768 cinnarizine / piracetam Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000768/202911 NAP
769 cinolazepam 02/12/1994 8 years 01/12/2032 01/03/2033 Yes 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00000769/203212 Miroslava Gocova Slovakia NAP
771 ciprofibrate 09/12/1983 5 years 09/12/2026 09/03/2027 No 08/04/2026 DLP was updated on 27/07/2022
Lead MS and PRAC Rapporteur name amended on 19/12/2018
Next DLP was amended on 25/09/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00000771/202612 Jo Robays Belgium NAP
772 ciprofloxacin / fluocinolone acetonide 25/03/2002 7 years 02/04/2031 01/07/2031 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00000772/203104 Maria del Pilar Rayon Spain NAP
774 ciprofloxacin hydrochloride / hydrocortisone Not available* 3 years 30/11/2026 28/02/2027 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00000774/202611 Amelia Cupelli Italy NAP
775 ciprofloxacin (systemic use) 31/01/1987 5 years 02/04/2028 01/07/2028 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00000775/202804 Karen Pernille Harg Norway NAP
776 ciprofloxacin (topical use) 31/01/1987 5 years 31/01/2028 30/04/2028 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00000776/202801 Karen Pernille Harg Norway NAP
777 cisatracurium 07/08/1995 8 years 31/07/2033 29/10/2033 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00000777/203307 Veronika Macurová Czech Republic NAP
778 cisplatin 19/12/1978 5 years 18/12/2027 17/03/2028 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00000778/202712 Marie Louise Schougaard Christiansen Denmark NAP
779 citalopram 31/12/1989 5 years 31/12/2026 31/03/2027 No 21/09/2022 DLP was updated on 21/09/2022
PRAC Rapporteur name was amended on 31/07/2018
Next DLP was amended on 25/09/2017
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/09/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00000779/202612 Karin Bolin Sweden NAP
780 citicoline 31/12/1966 10 years 03/07/2034 01/10/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000780/203407 NAP
781 citric acid Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000781/204001 NAP
782 citric acid / magnesium / sodium, citric acid anhydrous / light magnesium oxide / sodium picosulfate Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000782/202911 none NAP
783 citric acid / potassium salts, potassium citrate, potassium sodium hydrogen citrate, citric acid / potassium citrate / sodium citrate Not available* 6 years 03/11/2029 01/02/2030 No 02/04/2025 Active substance name was amended on 02/04/2025
DLP was amended on 03/07/2024 PSUSA/00000783/202911 Polona Golmajer Slovenia NAP
785 citric acid / sodium Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000785/204001 NAP
786 citric acid / urea Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000786/204001 NAP
787 cladribine (apart from products with multiple sclerosis indication) 26/02/1993 3 years 25/02/2027 26/05/2027 No 20/10/2021 DLP was updated on 20/10/2021
PRAC representative was updated on 31/03/2021
PRAC representative was updated on 25/09/2019
LMS and PRAC representative were updated on 05/06/2019
DLP was updated on 21/11/2018
Entry name amended on 19/12/2017
PRAC Representative was amended on 28/03/2017
next DLP was amended on 29/10/2015 PSUSA/00000787/202702 Marie Louise Schougaard Christiansen Denmark CAP NAP
788 clarithromycin 17/07/1989 3 years 01/04/2026 30/06/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00000788/202604 Eamon O'Murchu Ireland NAP
789 clebopride 22/02/1979 8 years 30/06/2032 28/09/2032 No 19/09/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00000789/203206 Maria Martinez Gonzalez Spain NAP
790 clebopride hydrogen maleate / simeticone Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 PSUR frequency and DLP amended on 28/08/2024. PSUSA/00000790/202912 NAP
791 clemastine 11/10/1966 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000791/202803 NAP
792 clemastine / dexamethasone Not available* 7 years 03/08/2031 01/11/2031 No 27/03/2024 PSUR frequency and DLP amended on 27/03/2024 PSUSA/00000792/203108 none NAP
794 clenbuterol 12/12/1980 5 years 30/09/2031 29/12/2031 Yes 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
Next DLP was updated on 31/05/2023 PSUSA/00000794/203109 Amelia Cupelli Italy NAP
795 clindamycin 16/10/1969 3 years 15/10/2027 13/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00000795/202710 Sonja Hrabcik Austria NAP
796 benzoyl peroxide / clindamycin phosphate 26/01/1983 8 years 03/05/2033 01/08/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000796/203305 Rugile Pilviniene Lithuania NAP
797 clioquinol Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 PSUR frequency and DLP amended on 28/08/2024. PSUSA/00000797/202912 NAP
798 clobazam 06/02/1970 8 years 06/02/2028 06/05/2028 No 21/10/2020 DLP was updated on 21/10/2020
PRAC representative was updated on 23/09/2020
PRAC representative was added on 06/05/2020
LMS was added on 01/04/2020
PSUR frequency and DLP were updated on 25/09/2019 PSUSA/00000798/202802 Kimmo Jaakkola Finland NAP
799 clobetasol 21/02/1973 5 years 28/02/2030 29/05/2030 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00000799/203002 Jo Robays Belgium NAP
800 clobetasone 17/09/1975 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000800/202808 NAP
805 clofarabine 29/05/2006 3 years 28/12/2026 28/03/2027 Yes 25/09/2024 DLP was amended on 25/09/2024
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/09/2024
PSUR frequency, DLP and PSURs required for products referred to in Articles 10(1), 10a, 16a of Directive 2001/83/EC as amended were updated on 28/07/2021
DLP and PRAC representative were updated on 29/07/2020
Reference to NAP added on 01/07/2020
New CAP authorised on 14/11/2019
DLP and Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" were updated on 31/07/2019
PRAC representative was updated on 03/06/2020
PRAC representative was updated on 03/06/2020
DLP was updated on 31/07/2018
DLP updated and PRAC Rapporteur name amended on 21/07/2017
PRAC Rapporteur name was amended on 28/07/2016
Next DLP and PRAC Rapporteur name updated was amended on 28/07/2016
PRAC Rapporteur name updated on 03/06/2016 PSUSA/00000805/202612 Tiphaine Vaillant France CAP NAP
806 clofazimine 24/04/1969 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000806/202805 none NAP
809 clomethiazole 01/11/1959 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000809/203401 NAP
810 clomifene Not available* 8 years 01/12/2025 01/03/2026 No 30/10/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00000810/202512 Eva Jirsová Czech Republic NAP
811 clomipramine 18/10/1965 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00000811/203303 Dennis Lex Germany NAP
812 clonazepam 27/06/1973 5 years 26/06/2030 24/09/2030 Yes 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00000812/203006 Maia Uusküla Estonia NAP
813 clonidine 16/08/1967 5 years 16/08/2030 14/11/2030 No 27/05/2026 DLP was corrected on 27/05/2026
PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00000813/203008 Carla Torre Portugal NAP
815 clonixin 28/02/1975 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000815/203503 NAP
816 clopamide / dihydroegocrystine / reserpine 30/04/1966 10 years 03/07/2034 01/10/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000816/203407 NAP
819 cloperastine 12/08/1981 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000819/202811 NAP
820 acetylsalicylic acid / clopidogrel, clopidogrel 15/07/1998 3 years 17/11/2025 15/02/2026 No 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00000820/202511 Carla Torre Portugal CAP NAP
821 cloprednol Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 PSUR frequency and DLP amended on 28/08/2024. PSUSA/00000821/202912 NAP
822 clorazepate 03/08/1966 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000822/202803 NAP
824 clorazepate dipotassium Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 PSUR frequency and DLP amended on 28/08/2024. PSUSA/00000824/202912 NAP
826 clotiapine Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 PSUR frequency and DLP amended on 28/08/2024. PSUSA/00000826/202912 NAP
827 clotiazepam 18/05/1978 5 years 31/05/2030 29/08/2030 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00000827/203005 Jo Robays Belgium NAP
828 clotrimazole / hexamidine diisetionate / prednisolone acetate 13/11/1991 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000828/202901 NAP
829 clotrimazole 08/10/1975 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00000829/203303 Melinda Palfi Hungary NAP
830 clotrimazole / dexamethasone Not available* 10 years 03/11/2034 01/02/2035 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00000830/203411 Carla Torre Portugal NAP
831 clotrimazole / hydrocortisone Not available* 10 years 03/11/2034 01/02/2035 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00000831/203411 Rhea Fitzgerald Ireland NAP
832 clotrimazole / metronidazole Not available* 7 years 03/11/2031 01/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00000832/203111 Roxana Dondera Romania NAP
834 clotrimazole / hexamidine diisetionate 13/11/1991 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000834/202901 NAP
835 cloxacillin 05/01/1962 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00000835/203405 NAP
836 clozapine 24/10/1969 5 years 03/03/2030 01/06/2030 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00000836/203003 Amelia Cupelli Italy NAP
838 cobamamide, hydroxocobalamin (except for products for chemical poisoning), hydroxocobalamin / cobamamide 27/11/1969 10 years 02/09/2034 01/12/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000838/203409 NAP
843 codeine 06/09/1954 5 years 31/01/2030 01/05/2030 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00000843/203001 Petar Mas Croatia NAP
850 codeine / ibuprofen 05/03/1993 5 years 02/12/2028 02/03/2029 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00000850/202812 Tiphaine Vaillant France NAP
851 codeine / paracetamol 01/09/1972 5 years 03/03/2030 01/06/2030 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00000851/203003 Veronika Macurová Czech Republic NAP
858 colchicine 30/07/1947 5 years 30/07/2028 28/10/2028 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00000858/202807 Maria del Pilar Rayon Spain NAP
863 sodium fluoride, colecalciferol / sodium fluoride, dectaflur / olaflur / sodium fluoride 22/01/1980 9 years 03/11/2028 01/02/2029 No 02/04/2025 Active substance name was amended on 02/04/2025
PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000863/202811 none NAP
864 colesevelam 10/03/2004 3 years 10/03/2027 08/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00000864/202703 Bianca Mulder Netherlands CAP NAP
865 colestipol 25/06/1976 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000865/202808 NAP
866 colestyramine 02/04/1965 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000866/202803 NAP
868 colistin sulphate 17/01/1962 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00000868/203405 NAP
873 conestat alfa 28/10/2010 6 months 28/04/2026 07/07/2026 28/10/2026 06/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000873/202604 PSUSA/00000873/202610 Jan Neuhauser Austria CAP
875 corifollitropin alfa 25/01/2010 3 years 24/07/2026 22/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00000875/202607 Bianca Mulder Netherlands CAP
876 corticorelin 01/10/1988 5 years 31/10/2029 29/01/2030 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00000876/202910 Jan Neuhauser Austria NAP
878 cortisone 18/06/1952 10 years 01/01/2034 01/04/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000878/203401 NAP
879 chloramphenicol / cortisone acetate / ethacridine lactate / zinc oxide 25/06/1949 11 years 03/05/2040 01/08/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000879/204005 NAP
883 cromoglicic acid 01/02/1969 5 years 01/02/2027 02/05/2027 No 19/10/2022 DLP was updated on 19/10/2022
PRAC Rapporteur name updated on 23/10/2018
Correction of DLP on 31/01/2018
DLP was amended on 15/11/2017
Lead MS was added on 22/09/2016 PSUSA/00000883/202702 Eamon O'Murchu Ireland NAP
884 crotamiton 14/11/1946 11 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000884/203611 NAP
885 crotamiton / hydrocortisone 17/12/1963 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000885/203406 NAP
886 cyamemazine 14/06/1971 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00000886/203303 Tiphaine Vaillant France NAP
888 cyanocobalamin 22/02/1952 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000888/203212 NAP
892 cyanocobalamin / folic acid, cyanocobalamin / folic acid / potassium iodide Not available* 7 years 03/11/2032 01/02/2033 Yes 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000892/203211 Ana Sofia Diniz Martins Portugal NAP
893 cyanocobalamin / folic acid / pyridoxine Not available* 7 years 03/11/2031 01/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00000893/203111 Dennis Lex Germany NAP
894 cyanocobalamin / l-arginine l-2 pyrrolidone-5-carboxylate Not available* 8 years 03/03/2026 01/06/2026 No 05/08/2025 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00000894/202603 Amelia Cupelli Italy NAP
896 cyclizine 02/02/1956 6 years 01/02/2032 01/05/2032 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00000896/203202 none NAP
898 cyclobenzaprine Not available* 12 years 03/06/2040 01/09/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000898/204006 NAP
899 cyclopenthiazide 11/01/1961 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000899/203906 NAP
900 cyclopentolate 19/02/1957 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000900/203401 NAP
901 cyclophosphamide 13/10/1958 12 years 31/01/2037 01/05/2037 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00000901/203701 Dennis Lex Germany NAP
902 cyproheptadine 21/12/1961 5 years 31/12/2028 31/03/2029 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00000902/202812 Melinda Palfi Hungary NAP
905 cyproterone 22/11/2009 5 years 03/07/2028 01/10/2028 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00000905/202807 Barbara Kovacic Bytyqi Croatia NAP
906 cyproterone / ethinylestradiol Not available* 3 years 31/05/2026 29/08/2026 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00000906/202605 Bianca Mulder Netherlands NAP
907 cyproterone acetate / estradiol valerate Not available* 8 years 03/03/2026 01/06/2026 No 05/08/2025 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00000907/202603 Tiphaine Vaillant France NAP
908 cystine Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000908/204003 NAP
910 cystine / pyridoxine hydrochloride Not available* 8 years 03/03/2026 01/06/2026 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00000910/202603 NAP
911 cytarabine 11/07/2001 5 years 31/03/2030 29/06/2030 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00000911/203003 Melinda Palfi Hungary NAP
913 cytisine, cytisinicline 25/02/2009 13 years 24/02/2031 25/05/2031 Yes 28/02/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/02/2024
DLP was amended on 28/02/2024
Active substance name was amended on 28/02/2024 PSUSA/00000913/203102 none NAP
914 cytomegalovirus immunoglobulin 29/12/1995 5 years 31/01/2026 01/05/2026 Yes 20/10/2021 PRAC representative was updated on 01/03/2023
DLP was updated on 20/10/2021
Next DLP was amended on 19/10/2016
The DLP was amended on 30/09/20145.
Lead MS was added on 13/07/2015 PSUSA/00000914/202601 Dirk Mentzer Germany NAP
918 dabigatran 18/03/2008 3 years 18/03/2026 16/06/2026 No 01/04/2026 Reference to NAP added on 01/04/2026
PSUR frequency amended and DLP updated on 15/11/2023 PSUSA/00000918/202603 Marie Louise Schougaard Christiansen Denmark CAP NAP
919 dacarbazine 01/02/1978 5 years 01/02/2028 01/05/2028 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00000919/202802 Jan Neuhauser Austria NAP
920 dactinomycin 01/07/1963 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000920/202803 NAP
922 dalteparin sodium 26/08/1985 2 years 31/08/2026 29/11/2026 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00000922/202608 Rugile Pilviniene Lithuania NAP
923 danaparoid 01/12/1992 5 years 01/12/2028 01/03/2029 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00000923/202812 Eamon O'Murchu Ireland NAP
924 danazol 10/06/1974 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000924/202808 NAP
925 dantrolene 31/01/1974 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000925/202808 NAP
927 dapiprazole 06/08/1985 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000927/202812 NAP
928 dapoxetine 17/12/2008 5 years 17/12/2028 17/03/2029 No 02/06/2026 PSUSA/00000928/202812 Jenny Jönsson Sweden NAP
929 dapsone Not available* 8 years 03/03/2026 01/06/2026 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00000929/202603 NAP
930 dapsone / ferrous oxalate 01/01/1974 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000930/202806 NAP
931 daptomycin 19/01/2006 5 years 11/09/2029 10/12/2029 No 25/05/2022 DLP was updated on 25/05/2022
Submission date corrected on 06/05/2020
DLP and PSUR frequency updated on 30/04/2019
PRAC Rapporteur name updated on 03/04/2018
Lead MS and PRAC Rapporteur name updated on 23/10/2018
DLP was updated on 07/05/2018
Next DLP was amended on 26/04/2017
Next DLP was amended on 03/05/2016
"Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended? Yes/No" was amended on 16/07/2015 PSUSA/00000931/202909 Pernille Harg Norway CAP
932 darbepoetin alfa 08/06/2001 3 years 31/10/2026 29/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00000932/202610 Dennis Lex Germany CAP
933 darifenacin 22/10/2004 5 years 31/10/2029 29/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00000933/202910 Maria del Pilar Rayon Spain CAP
934 darunavir 12/02/2007 5 years 23/12/2028 23/03/2029 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00000934/202812 Liana Martirosyan Netherlands CAP
935 dasatinib 20/11/2006 3 years 27/06/2028 25/09/2028 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00000935/202806 Marie Louise Schougaard Christiansen Denmark CAP NAP
936 daunorubicin 08/06/1966 3 years 07/06/2027 05/09/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00000936/202706 Sonja Hrabcik Austria NAP
939 deferasirox 28/08/2006 5 years 31/10/2030 29/01/2031 Yes 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
DLP was amended on 28/06/2023 PSUSA/00000939/203010 Tiphaine Vaillant France CAP NAP
940 deferiprone 25/08/1999 5 years 31/08/2029 29/11/2029 No 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00000940/202908 Tiphaine Vaillant France CAP
941 deferoxamine 01/12/1962 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000941/202803 NAP
943 deflazacort 26/03/1982 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000943/202811 NAP
944 degarelix 17/02/2009 5 years 17/02/2027 18/05/2027 No 19/10/2022 PSUR frequency and DLP were updated on 19/10/2022
PRAC representative was updated on 29/07/2020
PRAC representative was updated on 03/06/2020
DLP was updated on 23/10/2019
PRAC Rapporteur name updated on 21/07/2017
PSUR Frequency amended and DLP updated on 22/09/2016
PRAC Rapporteur name was amended on 28/07/2016
PRAC Rapporteur name updated on 03/06/2016
Next DLP was amended on 30/09/2015.
DLP was amended on 01/04/2015. PSUSA/00000944/202702 Tiphaine Vaillant France CAP
945 dehydrocholic acid Not available* 9 years 03/11/2026 01/02/2027 Yes 27/01/2026 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 05/03/2025
PSUR frequency amended and DLP updated on 05/03/2025
PSUR frequency and DLP amended on 27/03/2024 PSUSA/00000945/202611 Roxana Stefania Udrescu Romania NAP
949 delorazepam 24/02/1978 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000949/202811 NAP
951 demeclocycline 23/08/1967 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000951/203408 NAP
954 denosumab (indicated for osteoporosis and for bone loss associated with hormone ablation in prostate cancer) 26/05/2010 3 years 26/09/2027 25/12/2027 No 02/06/2026 PSUSA/00000954/202709 Karin Bolin Sweden CAP
957 dermatan sulfate Not available* 7 years 03/11/2031 01/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00000957/203111 Amelia Cupelli Italy NAP
958 desflurane 18/09/1992 3 years 30/09/2026 29/12/2026 Yes 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00000958/202609 Melinda Palfi Hungary NAP
962 desloratadine 15/01/2001 5 years 15/07/2026 13/10/2026 No 25/06/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/06/2025
PRAC representative was updated on 19/10/2022
PRAC Representative amended on 28/04/2022
DLP was updated on 30/03/2022
DLP was updated on 28/03/2017
PRAC Representative amended on 18/11/2016 PSUSA/00000962/202607 Jo Robays Belgium CAP NAP
963 desloratadine / pseudoephedrine 30/07/2007 5 years 15/07/2026 13/10/2026 No 28/04/2022 PRAC representative was updated on 19/10/2022
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 27/07/2022
PRAC Representative amended on 28/04/2022
DLP was updated on 30/03/2022
DLP was updated on 28/03/2017
PRAC Representative amended on 18/11/2016 PSUSA/00000963/202607 Jo Robays Belgium CAP
964 desmopressin 01/12/1972 3 years 31/12/2026 31/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000964/202612 Jan Neuhauser Austria NAP
966 desogestrel 01/07/1998 5 years 01/07/2026 29/09/2026 No 02/06/2026 PSUSA/00000966/202607 Jenny Jönsson Sweden NAP
967 desogestrel / ethinylestradiol 01/10/1994 5 years 30/09/2030 29/12/2030 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00000967/203009 Kimmo Jaakkola Finland NAP
968 desonide 31/08/1985 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00000968/202812 NAP
969 desoximetasone 23/01/1968 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000969/203408 NAP
973 dexamethasone (apart from centrally authorised products) 01/01/1952 5 years 31/01/2026 01/05/2026 No 19/10/2022 PRAC representative was updated on 19/10/2022
PRAC representative was updated on 27/07/2022
DLP was updated on 20/10/2021
PRAC representative was updated on 30/06/2021
Next DLP was amended on 19/10/2016
Entry name amended on 03/05/2016
Rapporteur's name was amended on 27/11/2015.
Lead MS added on 31/07/2015. PSUSA/00000973/202601 Amelia Cupelli Italy NAP
974 dexamethasone / framycetin / gramicidin 10/08/1954 11 years 01/12/2036 01/03/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000974/203612 NAP
977 dexamethasone / neomycin / polymyxin b, dexamethasone / neomycin 01/01/1952 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000977/203212 none NAP
978 dexamethasone / polymyxin b / trimethoprim 01/01/1952 12 years 03/06/2040 01/09/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000978/204006 NAP
979 dexamethasone / tobramycin (topical and ophtalmic use, except systemic formulations) Not available* 5 years 31/03/2026 29/06/2026 No 27/07/2022 PRAC representative was updated on 27/07/2022
DLP and active substance name updated on 22/12/2021
PRAC representative was updated on 30/06/2021
LMS and PRAC representative were added on 23/06/2020
PSUR Frequency amended and next DLP updated on 25/09/2017 PSUSA/00000979/202603 Amelia Cupelli Italy NAP
980 dexamethasone / lidocaine Not available* 8 years 11/05/2032 09/08/2032 Yes 05/06/2024 PSUR frequency amended and DLP updated on 05/06/2024
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 05/06/2024
Active substance name was amended on 05/06/2024 PSUSA/00000980/203205 none NAP
982 dexamethasone isonicotinate / tramazoline hydrochloride monohydrate 01/01/1963 11 years 03/07/2039 01/10/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00000982/203907 NAP
983 dexamethasone / framycetin sulfate / polymyxin b sulfate Not available* 10 years 01/12/2032 01/03/2033 Yes 05/06/2024 PSUR frequency amended and DLP updated on 05/06/2024
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 05/06/2024
Entry re-activated on 05/06/2024
Name of active substance was amended on 28/02/2013 PSUSA/00000983/203212 none NAP
984 dexamethasone sodium phosphate / gentamicin sulfate Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00000984/203008 NAP
985 dexamethasone (centrally authorised product indicated in uveitis and macular oedema) 27/07/2010 5 years 27/01/2030 27/04/2030 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00000985/203001 Maria del Pilar Rayon Spain CAP
986 dexamfetamine Not available* 3 years 11/09/2027 10/12/2027 Yes 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00000986/202709 Ana Sofia Diniz Martins Portugal NAP
989 dexchlorpheniramine 18/02/1962 3 years 30/06/2027 28/09/2027 No 05/03/2025 DLP was amended on 05/03/2025 PSUSA/00000989/202706 Ana Sofia Diniz Martins Portugal NAP
996 dexibuprofen 25/07/2000 3 years 31/08/2026 29/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00000996/202608 Jan Neuhauser Austria NAP
997 dexketoprofen, dexketoprofen / tramadol 07/07/2002 5 years 31/10/2029 29/01/2030 No 19/09/2025 Entry name updated on 24/09/2025
PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00000997/202910 Maria Martinez Gonzalez Spain NAP
998 dexmedetomidine 16/09/2011 3 years 15/03/2027 13/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00000998/202703 Karin Bolin Sweden CAP NAP
999 dexpanthenol 03/03/1999 10 years 02/01/2034 02/04/2034 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00000999/203401 Terhi Lehtinen Finland NAP
1000 dexpanthenol / dimethyl sulfoxide / heparin Not available* 8 years 03/03/2026 01/06/2026 No 05/08/2025 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00001000/202603 Jan Neuhauser Austria NAP
1001 dexrazoxane 17/02/1992 3 years 28/02/2028 28/05/2028 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00001001/202802 Tiphaine Vaillant France CAP NAP
1002 dextran Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001002/203506 NAP
1006 dextran 70 / sodium chloride Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001006/204003 NAP
1009 dextromethorphan, dextromethorphan / guaifenesin 01/01/1966 5 years 01/11/2026 30/01/2027 No 20/05/2026 Lead MS and PRAC Rapporteur name updated on 27/05/2026
Entry amended following merge on 28/05/2025
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 26/07/2023
PSUR frequency and DLP were updated on 28/06/2022
PRAC Representative was amended on 28/04/2022
DLP was updated on 03/07/2019
PRAC Representative was amended on 18/11/2016
Next DLP was amended on 28/07/2016
Lead MS added on 16/06/2015 PSUSA/00001009/202611 Maria del Pilar Rayon Spain NAP
1013 dextromethorphan hydrobromide / diphenhydramine hydrochloride / levomenthol Not available* 7 years 03/11/2031 01/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00001013/203111 John Joseph Borg Malta NAP
1015 dextromethorphan hydrobromide / paracetamol / phenylpropanolamine hydrochloride Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001015/203008 NAP
1021 dextromethorphan hydrobromide / pseudoephedrine hydrochloride / triprolidine hydrochloride Not available* 10 years 03/11/2034 01/02/2035 No 19/09/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00001021/203411 Maria Martinez Gonzalez Spain NAP
1026 diacerein 12/08/2007 5 years 15/12/2025 15/03/2026 Yes 22/09/2021 PSUR frequency and DLP were updated on 22/09/2021
PRAC representative was updated on 26/05/2021
PRAC Representative updated on 26/09/2018
DLP was updated on 31/07/2018
PSUR Frequency amended and next DLP updated on 25/09/2017
'PRAC Rapporteur name updated on 21/07/2017
Next DLP and PRAC Rapporteur name were amended on 28/07/2016
DLP amended on 31/07/2015
'Lead MS was added on 22/12/2014
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2014 PSUSA/00001026/202512 Tiphaine Vaillant France NAP
1028 diamorphine Not available* 7 years 03/11/2031 01/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00001028/203111 Liana Martirosyan Netherlands NAP
1029 diazepam 29/11/1963 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00001029/203303 Karin Erneholm Denmark NAP
1030 diazepam / pyridoxine 04/04/1966 11 years 02/12/2039 01/03/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001030/203912 NAP
1032 diazoxide 29/12/1972 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001032/202806 NAP
1034 dibotermin alfa 09/09/2002 5 years 08/09/2030 07/12/2030 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00001034/203009 Bianca Mulder Netherlands CAP
1040 diclofenac / misoprostol Not available* 3 years 17/07/2028 15/10/2028 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00001040/202807 Karin Erneholm Denmark NAP
1041 cyanocobalamin / diclofenac / pyridoxine / thiamine Not available* 5 years 01/01/2030 01/04/2030 Yes 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00001041/203001 Adam Przybylkowski Poland NAP
1044 diclofenac / lidocaine 11/11/2009 5 years 11/11/2029 09/02/2030 Yes 17/12/2025 Entry re-activated on 17/12/2025 PSUSA/00001044/202911 to be assigned none NAP
1045 diclofenac sodium / orphenadrine citrate Not available* 8 years 03/03/2026 01/06/2026 No 27/01/2026 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00001045/202603 Roxana Stefania Udrescu Romania NAP
1048 diclofenac (systemic formulations) 11/05/1977 5 years 30/09/2029 29/12/2029 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001048/202909 Karin Erneholm Denmark NAP
1050 dicloxacillin 24/02/1961 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001050/203404 NAP
1051 dicycloverine, dicyloverine/ paracetamol, dicycloverine/ doxylamine 11/05/1950 11 years 03/05/2040 01/08/2040 Yes 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001051/204005 NAP
1057 dienogest / ethinylestradiol 14/02/1995 5 years 15/03/2028 13/06/2028 No 15/11/2023 DLP was amended on 15/11/2023 PSUSA/00001057/202803 Dennis Lex Germany NAP
1058 diethylamine salicylate Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001058/204003 NAP
1059 diethylcarbamazine 09/01/1974 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001059/202806 NAP
1061 diflucortolone Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001061/203008 NAP
1062 diflucortolone valerate / isoconazole nitrate Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001062/203008 NAP
1063 diflunisal (for nationally authorised products) Not available* 9 years 03/11/2030 01/02/2031 No 24/09/2025 Entry name updated on 28/08/2024
PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001063/203011 none NAP
1064 digitoxin 11/09/1952 10 years 01/01/2034 01/04/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001064/203401 NAP
1065 digoxin, metildigoxin 01/11/1930 10 years 03/11/2032 01/02/2033 No 18/10/2023 PSUR frequency amended and DLP updated on 18/10/2023 PSUSA/00001065/203211 none NAP
1066 digoxin specific antibody fragments 05/10/1983 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001066/202812 NAP
1069 artenimol / piperaquine tetraphosphate 27/10/2011 5 years 27/10/2030 25/01/2031 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
DLP was amended on 28/06/2023 PSUSA/00001069/203010 Dennis Lex Germany CAP
1070 dihydrocodeine 11/11/1921 11 years 03/11/2036 01/02/2037 No 18/10/2023 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" , PSUR frequency and DLP wereamended on 18/10/2023 PSUSA/00001070/203611 none NAP
1075 dihydroergotamine 01/07/1946 3 years 01/04/2027 30/06/2027 Yes 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00001075/202704 Adam Przybylkowski Poland NAP
1080 dihydrotachysterol 01/04/1959 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001080/203401 NAP
1082 diiodohydroxyquinoline Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001082/203011 NAP
1083 diisopropylamine Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001083/203011 NAP
1084 diltiazem 02/05/1979 5 years 02/05/2027 31/07/2027 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001084/202705 Karin Erneholm Denmark NAP
1088 caffeine / dimenhydrinate, dimenhydrinate 10/02/1950 8 years 01/12/2025 01/03/2026 No 15/01/2025 Active substance name, PSUR frequency and DLP were amended on 18/10/2023 PSUSA/00001088/202512 Maria Martinez Gonzalez Spain NAP
1089 dimercaptosuccinic acid (dmsa) 31/05/1982 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001089/202812 NAP
1094 dimeticone 17/11/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001094/203406 NAP
1095 aluminium hydroxide gel / dimeticone / magnesium hydroxide Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001095/202903 NAP
1097 clebopride / dimeticone Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 PSUR frequency and DLP amended on 28/08/2024. PSUSA/00001097/202912 NAP
1098 dihydroxyaluminum sodium carbonate, dihydroxyaluminum sodium carbonate / dimeticone Not available* 10 years 03/11/2034 01/02/2035 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00001098/203411 Ana Sofia Diniz Martins Portugal NAP
1099 dimeticone / guaiazulene Not available* 8 years 03/03/2026 01/06/2026 No 05/08/2025 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00001099/202603 Tiphaine Vaillant France NAP
1100 dimeticone / metoclopramide / oxazepam hemisuccinate / polyenzymes Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001100/203506 NAP
1101 dimetindene 01/08/1961 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00001101/203405 NAP
1102 dimetindene / phenylephrine 29/09/1965 5 years 15/07/2030 13/10/2030 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00001102/203007 Jana Pecherova Slovakia NAP
1103 dinoprost trometamol 08/05/1973 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001103/202806 NAP
1104 dinoprostone 26/09/1972 3 years 30/09/2028 29/12/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00001104/202809 Jenny Jönsson Sweden NAP
1105 diosmectite 12/11/1975 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001105/202808 NAP
1106 diosmin Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001106/203011 NAP
1107 diosmin / hesperidin, ascorbic acid/ dry Ruscus extract titrated in sterolic heterosides/ Hesperidin methyl chalcone Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001107/203011 Polona Golmajer Slovenia NAP
1110 diphenhydramine / paracetamol Not available* 7 years 03/11/2031 01/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00001110/203111 Rhea Fitzgerald Ireland NAP
1112 dexamethasone / diphenhydramine hydrochloride Not available* 9 years 03/03/2030 01/06/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001112/203003 NAP
1113 allantoin / dexpanthenol / diphenhydramine hydrochloride Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001113/202903 NAP
1115 codeine phosphate / diphenhydramine hydrochloride / levomenthol Not available* 9 years 03/03/2030 01/06/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001115/203003 NAP
1116 diphenhydramine hydrochloride / lorazepam Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001116/203011 NAP
1117 anhydrous caffeine / codeine phosphate / diphenhydramine hydrochloride / paracetamol, caffeine / codeine phosphate / diphenhydramine hydrochloride / paracetamol / phenylephrine hydrochloride / ascorbic acid, caffeine / codeine phosphate / diphenhydramine hydrochloride / paracetamol / phenylephrine hydrochloride Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001117/202903 NAP
1118 diphenhydramine hydrochloride / paracetamol / pseudoephedrine hydrochloride Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001118/203011 NAP
1119 ammonium chloride / diphenhydramine hydrochloride / sodium citrate Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001119/202903 NAP
1122 diphtheria / tetanus / pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin) (acellular, component) / hepatitis b (rdna) / poliomyelitis (inactivated) / haemophilus type b conjugate vaccines (adsorbed) 23/10/2000 3 years 22/10/2026 20/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00001122/202610 Jean-Michel Dogné Belgium CAP
1124 diphtheria / tetanus / pertussis (acellular, component) / poliomyelitis (inactivated) / haemophilus type b conjugate vaccine (adsorbed) 27/06/1997 3 years 13/11/2026 11/02/2027 No 06/10/2025 DLP was amended on 31/07/2024 PSUSA/00001124/202611 Dirk Mentzer Germany NAP
1125 diphtheria / tetanus / pertussis (acellular, component) vaccine (adsorbed), diphtheria / tetanus / pertussis (acellular, component) vaccine (adsorbed) reduced antigens contents 17/03/1995 5 years 16/03/2027 14/06/2027 No 06/10/2025 PRAC representative was updated on 01/03/2023
DLP was updated on 16/11/2022
DLP was updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016
The DLP was amended on 30/09/2015
Name of active substance was amended on 28/03/2013 PSUSA/00001125/202703 Dirk Mentzer Germany NAP
1126 diphtheria / tetanus / pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed), diphtheria / tetanus / pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content) 08/07/1991 5 years 08/07/2030 06/10/2030 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00001126/203007 Marie Louise Schougaard Christiansen Denmark NAP
1127 diphtheria / tetanus / poliomyelitis (inactivated) vaccine (adsorbed, reduced antigens(s) content) 05/02/1999 5 years 04/08/2027 02/11/2027 No 06/10/2025 DLP was updated on 05/04/2023
PRAC representative was updated on 01/03/2023
DLP was updated on 07/05/2018
PRAC representative and Lead Member State were added on 30/01/2017 PSUSA/00001127/202708 Dirk Mentzer Germany NAP
1128 diphtheria / tetanus vaccines (adsorbed), diphtheria vaccines (adsorbed) 10/05/1990 5 years 09/05/2030 07/08/2030 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001128/203005 Dirk Mentzer Germany NAP
1135 diprophylline, diprophylline / turpentine oil Not available* 11 years 02/04/2040 01/07/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001135/204004 Amelia Cupelli Italy NAP
1138 dipyridamole 11/11/1959 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001138/202712 NAP
1143 disopyramide 18/04/1967 9 years 02/04/2028 01/07/2028 No 15/01/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001143/202804 Jean-Michel Dogné Belgium NAP
1144 distigmine 01/04/1979 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001144/202811 NAP
1145 disulfiram 04/03/1971 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001145/202806 NAP
1150 dobesilate calcium 13/10/1970 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001150/202805 NAP
1151 dobutamine 21/03/1977 3 years 01/03/2027 30/05/2027 No 19/09/2024 PSUSA/00001151/202703 Zoubida Amimour France NAP
1152 docetaxel 25/11/1995 5 years 30/11/2027 28/02/2028 No 26/07/2023 PSUR frequency amended and DLP updated on 26/07/2023 PSUSA/00001152/202711 Tiphaine Vaillant France CAP NAP
1158 domperidone 01/03/1978 5 years 19/11/2029 17/02/2030 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00001158/202911 Jo Robays Belgium NAP
1160 donepezil 25/11/1996 5 years 25/11/2026 23/02/2027 No 27/07/2022 DLP was updated on 27/07/2022
Lead MS and PRAC Rapporteur name amended on 19/12/2018
Next DLP was amended on 25/09/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00001160/202611 Dennis Lex Germany NAP
1161 dopamine 09/10/1975 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001161/202808 NAP
1162 dopexamine 13/11/1989 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001162/202901 NAP
1164 dornase alfa 03/09/1993 5 years 02/09/2027 01/12/2027 No 12/09/2025 DLP was amended on 03/05/2023
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 06/06/2018
Lead MS and PRAC Rapporteur name was added on 28/02/2017 PSUSA/00001164/202709 Veronika Macurová Czech Republic NAP
1166 dorzolamide / timolol 06/03/1998 5 years 18/02/2029 19/05/2029 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001166/202902 Karin Erneholm Denmark NAP
1167 dosulepin 17/04/1973 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001167/202806 NAP
1168 doxapram hydrochloride 18/12/1967 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001168/203408 NAP
1169 doxazosin 18/12/1986 7 years 17/12/2030 17/03/2031 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00001169/203012 Karin Erneholm Denmark NAP
1170 doxepin 01/08/1969 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001170/202805 NAP
1172 doxorubicin 21/06/1996 5 years 12/11/2027 10/02/2028 No 28/06/2022 PSUR frequency amended and DLP updated on 28/06/2023 PSUSA/00001172/202711 Eva Jirsová Czech Republic CAP NAP
1173 doxycycline 05/05/1967 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00001173/203303 Liana Martirosyan Netherlands NAP
1174 doxylamine 07/04/1948 5 years 06/04/2028 05/07/2028 No 20/12/2023 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00001174/202804 Ana Sofia Diniz Martins Portugal NAP
1176 doxylamine succinate / pyridoxine hydrochloride 07/04/1948 10 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001176/203211 NAP
1178 bemotrizinol / butyl methoxydibenzoylmethane / drometrizole Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001178/202905 NAP
1180 dronedarone 26/11/2009 5 years 31/07/2030 29/10/2030 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00001180/203007 Bianca Mulder Netherlands CAP
1181 droperidol 20/04/1963 9 years 03/03/2028 01/06/2028 No 26/07/2023 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 26/07/2023
Update of PSUR frequency & DLP resulting from PRAC re-allocation exercise for entries with DLPs in 2025 on 26/07/2023 PSUSA/00001181/202803 none NAP
1182 droperidol / fentanyl 14/08/1974 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001182/203503 NAP
1184 drospirenone / estradiol 07/03/2000 5 years 10/12/2029 10/03/2030 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00001184/202912 Bianca Mulder Netherlands NAP
1186 drotaverine Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001186/203011 none NAP
1187 duloxetine 11/08/2004 5 years 03/08/2028 01/11/2028 No 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00001187/202808 Maria del Pilar Rayon Spain CAP NAP
1188 ossein hydroxyapatite compound Not available* 8 years 03/11/2026 01/02/2027 No 11/06/2025 Correction of DLP on 20/11/2024
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001188/202611 Guðrún Stefánsdóttir Iceland NAP
1190 dydrogesterone 22/04/1960 9 years 01/02/2028 01/05/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001190/202802 NAP
1191 ebastine 01/01/1996 5 years 31/05/2028 29/08/2028 No 31/01/2024 Next DLP was updated on 31/01/2024 PSUSA/00001191/202805 Marie Louise Schougaard Christiansen Denmark NAP
1195 econazole, econazole nitrate / triamcinolone acetonide 04/01/1974 5 years 16/11/2027 14/02/2028 No 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00001195/202711 Melinda Palfi Hungary NAP
1198 eculizumab 20/06/2007 2 years 01/10/2027 30/12/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00001198/202710 Maria Martinez Gonzalez Spain CAP
1200 efavirenz 28/05/1999 5 years 16/04/2027 15/07/2027 Yes 22/10/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 22/10/2025
Entry re-activated on 22/10/2025
PSUR frequency and DLP were updated on 21/12/2022
PSUR frequency and DLP were updated on 18/12/2019
DLP was updated on 19/12/2018
DLP was updated on 19/12/2017
Reference to NAP added on 23/05/2017
Correction of PRAC Rapporteur name on 28/02/2017
Next DLP was updated on 18/11/2016
PSUR Frequency and Next DLP was amended on 21/12/2015.
"Are PSURs required for products referred to in Articles 10(1), 10a, 14 and 16a of Directive 2001/83/EC as amended?Yes/No" was amended on 06/03/2015 PSUSA/00001200/202704 Ana Sofia Diniz Martins Portugal NAP
1201 efavirenz / emtricitabine / tenofovir 13/12/2007 5 years 12/07/2026 10/10/2026 Yes 23/02/2026 Entry re-introduced and reference to NAP added on 27/03/2024
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" and PSUR frequency amended on 28/04/2022
Next DLP was updated on 06/03/2019
Next DLP updated on 04/03/2016 PSUSA/00001201/202607 Martin Huber Germany CAP NAP
1202 eflornithine (topical use) 20/03/2001 5 years 26/07/2028 24/10/2028 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00001202/202807 Rhea Fitzgerald Ireland CAP
1204 eletriptan 20/01/2000 5 years 19/02/2026 20/05/2026 No 20/10/2021 DLP was updated on 20/10/2021
PRAC Rapporteur name updated on 27/06/2017
Next DLP was updated on 18/11/2016
The DLP amended on 30/09/2015
Lead MS was added on 13/07/2015 PSUSA/00001204/202602 Eva Jirsová Czech Republic NAP
1205 eltrombopag 11/03/2010 3 years 30/09/2027 29/12/2027 No 19/09/2025 DLP was updated on 25/05/2022
PSUR frequency and DLP were updated on 30/04/2019
DLP was updated on 07/05/2018
DLP was updated on 23/05/2017
PRAC Representative amended on 28/06/2016
Next DLP was amended on 03/05/2016 PSUSA/00001205/202709 Maria Martinez Gonzalez Spain CAP
1207 emedastine 27/01/1999 3 years 31/05/2026 29/08/2026 No 19/09/2024 PSUSA/00001207/202605 Zoubida Amimour France CAP
1209 emtricitabine 24/10/2003 3 years 02/04/2026 01/07/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00001209/202604 Ana Sofia Diniz Martins Portugal CAP
1210 emtricitabine / tenofovir disoproxil 21/02/2005 3 years 02/04/2026 01/07/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00001210/202604 Ana Sofia Diniz Martins Portugal CAP
1211 enalapril 01/11/2004 5 years 31/03/2028 29/06/2028 No 02/06/2026 PSUSA/00001211/202803 Karin Bolin Sweden NAP
1212 enalapril / hydrochlorothiazide 24/03/2002 5 years 26/07/2027 24/10/2027 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001212/202707 Karin Erneholm Denmark NAP
1213 enalapril / nitrendipine 08/01/2002 7 years 08/01/2030 08/04/2030 No 20/09/2023 DLP and PSUR frequency amended on 20/09/2023 PSUSA/00001213/203001 Maria del Pilar Rayon Spain NAP
1214 enalapril maleate / felodipine Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001214/203011 NAP
1215 enalapril maleate / lercanidipine 26/07/2006 7 years 03/06/2031 01/09/2031 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00001215/203106 Carla Torre Portugal NAP
1217 enfuvirtide 27/05/2003 5 years 12/03/2026 10/06/2026 No 02/06/2026 PSUSA/00001217/202603 Karin Bolin Sweden CAP
1220 enoximone 27/10/1987 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001220/202901 NAP
1221 enoxolone 28/09/1988 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001221/202901 NAP
1223 entacapone 16/09/1998 3 years 16/01/2028 15/04/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00001223/202801 Terhi Lehtinen Finland CAP
1224 entecavir 26/06/2006 5 years 28/03/2027 26/06/2027 No 02/06/2026 PSUSA/00001224/202703 Karin Bolin Sweden CAP
1225 eosine Not available* 8 years 03/03/2026 01/06/2026 No 05/08/2025 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00001225/202603 Amelia Cupelli Italy NAP
1228 ephedrine 15/05/1952 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001228/203212 NAP
1229 ephedrine hydrochloride / glaucine hydrobromide Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001229/203011 NAP
1231 epinastine 18/10/2002 5 years 31/10/2027 29/01/2028 No 28/06/2023 Next DLP was updated on 28/06/2023
DLP was updated on 04/07/2018
PRAC representative and Lead Member State were added on 28/03/2017 PSUSA/00001231/202710 Karin Bolin Sweden NAP
1232 epinephrine (except for nasal use) 15/05/1952 5 years 15/07/2030 13/10/2030 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00001232/203007 Zoubida Amimour France NAP
1233 epinephrine / lidocaine 01/10/1948 8 years 30/09/2028 29/12/2028 No 30/06/2021 DLP was updated on 30/06/2021
PRAC representative was added on 06/05/2020
LMS was added on 01/04/2020
The DLP was amended on 03/03/2014 PSUSA/00001233/202809 Eamon O'Murchu Ireland NAP
1234 epirubicin 28/06/1982 5 years 30/06/2028 28/09/2028 No 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 PSUSA/00001234/202806 Marie Louise Schougaard Christiansen Denmark NAP
1235 epitizide / triamterene Not available* 8 years 03/03/2026 01/06/2026 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00001235/202603 NAP
1236 eplerenone 16/03/2004 7 years 15/03/2029 13/06/2029 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00001236/202903 Bianca Mulder Netherlands NAP
1237 epoetin alfa 04/08/1988 3 years 31/08/2027 29/11/2027 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00001237/202708 Tiphaine Vaillant France CAP NAP
1239 epoetin beta 16/07/1997 3 years 13/02/2026 14/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00001239/202602 Dennis Lex Germany CAP
1240 epoetin theta 23/10/2009 5 years 20/04/2029 19/07/2029 No 18/12/2024 PSUR frequency amended and DLP updated on 18/12/2024 PSUSA/00001240/202904 Tiphaine Vaillant France CAP
1241 epoetin zeta 18/12/2007 3 years 18/12/2026 18/03/2027 No 25/09/2024 Reference to NAP removed on 25/09/2024
Next DLP was updated on 25/09/2024
DLP was updated and reference to NAP added on 22/09/2021
PRAC Rapporteur name was amended on 31/07/2018
DLP was updated on 31/07/2018
Next DLP updated on 30/09/2015 PSUSA/00001241/202612 Dennis Lex Germany CAP
1242 epoprostenol 18/03/1981 5 years 31/03/2027 29/06/2027 No 21/12/2022 DLP was updated on 21/12/2022
PRAC Rapporteur name updated on 23/10/2018
DLP was updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00001242/202703 Eamon O'Murchu Ireland NAP
1243 eprosartan 30/04/1997 5 years 30/04/2027 29/07/2027 No 01/02/2023 DLP was updated on 01/02/2023
PRAC Rapporteur name was amended on 31/07/2018
DLP was amended on 31/01/2018
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00001243/202704 Dennis Lex Germany NAP
1244 eprosartan / hydrochlorothiazide 30/04/1997 5 years 30/04/2027 29/07/2027 No 01/02/2023 DLP was updated on 01/02/2023
PRAC Rapporteur name was amended on 31/07/2018
DLP was amended on 31/01/2018
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00001244/202704 Dennis Lex Germany NAP
1245 eptacog alfa 23/02/1996 5 years 31/12/2025 31/03/2026 No 22/09/2021 PSUR frequency, DLP and active substance name were updated on 22/09/2021
PRAC Representative updated on 26/09/2018
DLP was updated on 31/07/2018
Reference to NAP products removed on 19/12/2017
Reference to NAP products added on 17/10/2017
PSUR Frequency amended on 31/07/2015 PSUSA/00001245/202512 Bianca Mulder Netherlands CAP
1248 erdosteine Not available* 10 years 01/02/2026 02/05/2026 No 19/10/2016 PRAC Rapporteur name was amended on 28/04/2022
PRAC Rapporteur name was amended on 03/04/2019
PSUR Frequency amended and DLP updated on 19/10/2016
Lead MS added on 31/07/2015. PSUSA/00001248/202602 Marie Louise Schougaard Christiansen Denmark NAP
1251 ergometrine / oxytocin 15/06/1960 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001251/203404 NAP
1252 belladonna alkaloids / caffeine / ergotamine tartrate / paracetamol Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001252/202905 NAP
1253 belladonna alkaloids / ergotamine tartrate / phenobarbital Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001253/202905 NAP
1254 eribulin 15/11/2010 5 years 14/11/2028 12/02/2029 No 02/06/2026 PSUSA/00001254/202811 Jenny-Maria Jönsson Sweden CAP
1255 erlotinib 19/09/2005 3 years 17/11/2026 15/02/2027 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00001255/202611 Marie Louise Schougaard Christiansen Denmark CAP NAP
1256 ertapenem 18/04/2002 5 years 29/03/2030 27/06/2030 No 16/12/2020 New CAP authorised on 15/07/2022
PSUR frequency, DLP and Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" were updated on 16/12/2020
Reference to NAP added on 25/09/2019
LMS and PRAC representative updated 05/06/2019
DLP was amended on 15/11/2017
PRAC Representative was amended on 28/03/2017
PRAC Rapporteur name updated on 30/09/2015
The next DLP was amended on 01/12/2014 PSUSA/00001256/203003 Ana Sofia Diniz Martins Portugal CAP NAP
1258 benzoyl peroxide / erythromycin Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001258/202906 NAP
1259 erythromycin / tretinoin, isotretinoin, erythromycin / isotretinoin 24/10/2001 5 years 24/10/2026 22/01/2027 No 17/02/2026 Active substance name was amended on 30/07/2025
DLP was updated on 29/06/2022
PRAC representative was updated on 22/12/2021
PRAC representative was udpated on 06/05/2020
Next DLP was amended on 27/06/2017
PRAC representative and Lead Member State were added on 03/05/2016 PSUSA/00001259/202610 Jana Pecherova Slovakia NAP
1260 erythromycin / zinc acetate Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001260/203011 NAP
1263 escherichia coli lysate 11/12/1987 5 years 31/07/2030 29/10/2030 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00001263/203007 Dirk Mentzer Germany NAP
1264 escherichia coli (living cells) Not available* 15 years 31/12/2026 31/03/2027 No 19/12/2018 Entry name amended on 19/12/2018 PSUSA/00001264/202612 NAP
1265 escitalopram 31/12/2001 5 years 31/12/2026 31/03/2027 No 21/09/2022 DLP was updated on 21/09/2022
PRAC Rapporteur name was amended on 31/07/2018
Next DLP was amended on 25/09/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00001265/202612 Karin Bolin Sweden NAP
1266 esketamine (except for centrally authorised products) 01/08/1997 5 years 31/08/2026 29/11/2026 No 28/04/2022 DLP was updated on 28/04/2022
Entry name updated on 05/02/2020
DLP was updated and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 23/05/2017
Lead MS and PRAC Rapporteur name was added on 07/04/2016 PSUSA/00001266/202608 Terhi Lehtinen Finland NAP
1267 eslicarbazepine acetate 21/04/2009 3 years 21/04/2027 20/07/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00001267/202704 Dennis Lex Germany CAP NAP
1268 esmolol 13/12/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001268/202812 NAP
1269 esomeprazole 10/03/2000 5 years 10/03/2029 08/06/2029 No 20/11/2024 PSUR frequency amended and DLP updated on 20/11/2024 PSUSA/00001269/202903 Rugile Pilviniene Lithuania CAP NAP
1270 esomeprazole / naproxen Not available* 5 years 30/04/2027 29/07/2027 No 01/02/2023 DLP was updated on 01/02/2023
PRAC Rapporteur name updated on 23/10/2018
PRAC Representative updated on 26/09/2018
DLP was amended on 31/01/2018
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00001270/202704 Liana Martirosyan Netherlands NAP
1271 estazolam 30/04/1975 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001271/202808 NAP
1276 dydrogesterone / estradiol 22/02/1995 7 years 02/12/2030 02/03/2031 No 19/09/2024 PSUSA/00001276/203012 Zoubida Amimour France NAP
1277 estradiol / levonorgestrel Not available* 8 years 03/05/2026 01/08/2026 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001277/202605 NAP
1278 estradiol / norethisterone 22/06/1996 5 years 31/03/2027 29/06/2027 No 02/06/2026 PSUSA/00001278/202703 Jenny Jönsson Sweden NAP
1279 estradiol / testosterone 01/03/1976 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001279/203503 NAP
1280 estradiol valerate / norgestrel Not available* 8 years 03/05/2026 01/08/2026 No 23/09/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001280/202605 Adam Przybylkowski Poland NAP
1281 estramustine 02/09/1971 10 years 01/12/2034 01/03/2035 No 05/01/2025 Correction of DLP on 20/11/2024
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001281/203412 Tiphaine Vaillant France NAP
1282 estriol 01/01/1957 15 years 31/12/2025 31/03/2026 No 26/05/2025 PSUSA/00001282/202512 Terhi Lehtinen Finland NAP
1283 estradiol / estriol Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001283/203011 NAP
1284 estradiol / estriol / levonorgestrel Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001284/203011 NAP
1293 etacrynic acid 14/05/1965 11 years 02/12/2039 01/03/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001293/203912 NAP
1294 etamsylate 22/04/1987 15 years 03/06/2040 01/09/2040 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00001294/204006 Veronika Macurová Czech Republic NAP
1296 ethacridine Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001296/203011 NAP
1297 albumin tannate / ethacridine lactate monohydrate Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001297/202903 NAP
1298 ethambutol 17/10/1958 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001298/202712 NAP
1304 ethanol / povidone iodinated, povidone iodinated / isopropyl alcohol (covers other synonymous terms such as 2-propanol) 22/02/1974 9 years 03/08/2028 01/11/2028 No 04/02/2026 Active substance name was amended on 04/02/2026
PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001304/202808 Zoubida Amimour France NAP
1305 ethanolamine Not available* 8 years 03/06/2026 01/09/2026 No 23/09/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001305/202606 Tiphaine Vaillant France NAP
1306 ethinylestradiol 01/06/1976 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00001306/203303 Amelia Cupelli Italy NAP
1307 ethinylestradiol / etonogestrel 12/06/2001 5 years 01/07/2030 29/09/2030 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00001307/203007 Bianca Mulder Netherlands NAP
1308 ethinylestradiol / gestodene 09/07/1986 5 years 16/03/2026 14/06/2026 No 17/11/2021 PRAC Rapporteur name was amended on 28/04/2022
DLP was updated on 17/11/2021
Active substance name was amended on 05/06/2019
PRAC Rapporteur name was amended on 03/04/2019
Next DLP was updated on 18/11/2016
Lead MS was added on 30/09/2015
Name of entry was amended on 28/05/2014
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00001308/202603 Marie Louise Schougaard Christiansen Denmark NAP
1309 ethinylestradiol / levonorgestrel 22/04/1965 5 years 13/04/2030 12/07/2030 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00001309/203004 Marie Louise Schougaard Christiansen Denmark NAP
1311 ethinylestradiol / norelgestromin 20/11/2001 5 years 19/11/2029 17/02/2030 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00001311/202911 Bianca Mulder Netherlands CAP
1312 ethinylestradiol / norethisterone 07/08/1974 5 years 06/08/2027 04/11/2027 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00001312/202708 Bianca Mulder Netherlands NAP
1313 ethinylestradiol / norgestimate 29/10/1986 5 years 30/10/2026 28/01/2027 No 29/06/2022 DLP was updated on 29/06/2022
PRAC Rapporteur name was amended on 28/04/2022
PRAC representative and LMS were added on 31/03/2021
Lead MS and PRAC Rapporteur name removed on 05/02/2020
DLP was updated on 21/07/2017
Lead MS and PRAC Rapporteur name was added on 03/06/2016 PSUSA/00001313/202610 Marie Louise Schougaard Christiansen Denmark NAP
1316 ethosuximide 09/03/1961 3 years 09/03/2026 07/06/2026 No 15/11/2023 DLP was amended on 15/11/2023 PSUSA/00001316/202603 Karin Erneholm Denmark NAP
1317 ethyl loflazepate 03/11/1980 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00001317/203303 Jo Robays Belgium NAP
1318 ethyl nicotinate / hydroxyethyl salicylate / nonylic acid vanillylamide Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001318/203011 NAP
1319 ethylmorphine 19/07/1944 11 years 03/05/2040 01/08/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001319/204005 NAP
1320 etidronate 30/09/1977 5 years 30/09/2027 29/12/2027 Yes 19/12/2018 Next DLP was updated on 31/05/2023 PSUSA/00001320/202709 Rugile Pilviniene Lithuania NAP
1321 etifoxine Not available* 3 years 19/10/2026 17/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00001321/202610 Maria Popova-Kiradjieva Bulgaria NAP
1322 etilefrine (except for treatment of priapism) 17/04/1952 12 years 03/06/2040 01/09/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001322/204006 Terhi Lehtinen Finland NAP
1324 etodolac 02/08/1984 8 years 03/05/2033 01/08/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001324/203305 Karin Erneholm Denmark NAP
1325 etofenamate Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001325/203011 NAP
1326 benzyl nicotinate / etofenamate Not available* 8 years 01/12/2033 01/03/2034 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00001326/203312 none NAP
1329 etofylline, etofylline / theophylline Not available* 8 years 03/06/2027 01/09/2027 Yes 22/10/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 22/10/2025
DLP was amended on 22/10/2025
Active substance name was amended on 22/10/2025
PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001329/202706 none NAP
1330 etomidate Not available* 5 years 30/09/2027 29/12/2027 No 06/06/2018 Next DLP was updated on 31/05/2023 PSUSA/00001330/202709 Dennis Lex Germany NAP
1331 etonogestrel 25/08/1998 3 years 01/09/2027 30/11/2027 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00001331/202709 Bianca Mulder Netherlands NAP
1333 etoposide 09/07/1980 3 years 16/02/2026 17/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00001333/202602 Dennis Lex Germany NAP
1334 etoricoxib 13/02/2002 5 years 31/03/2027 29/06/2027 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00001334/202703 Carla Torre Portugal NAP
1335 etravirine 28/08/2008 3 years 27/09/2026 26/12/2026 No 19/09/2024 PSUSA/00001335/202609 Zoubida Amimour France CAP
1342 eugenol Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001342/203011 NAP
1343 everolimus (indicated for astrocytoma (SEGA), renal angiomyolipoma, refractory seizures) 02/09/2011 5 years 31/03/2029 29/06/2029 No 25/06/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/06/2025
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 18/12/2024
PSUR frequency amended and DLP updated on 18/12/2024
DLP updated on 22/12/2021
Active substance name was updated on 03/02/2021
DLP was updated on 21/11/2018
PSUR submission frequency and next DLP were amended on 29/10/2015
Correction of DLP was done on 28/05/2014
Conditional approval PSUSA/00001343/202903 Dennis Lex Germany CAP
1344 technetium (99mTc) exametazime 01/02/1986 15 years 31/01/2031 01/05/2031 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001344/203101 Karin Erneholm Denmark NAP
1345 exemestane 16/12/1998 5 years 15/12/2025 15/03/2026 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00001345/202512 Barbara Kovacic Bytyqi Croatia NAP
1346 ezetimibe 17/10/2002 5 years 31/10/2027 29/01/2028 No 28/06/2023 Next DLP was updated on 28/06/2023
PRAC Rapporteur name was amended on 31/07/2018
DLP was updated on 04/07/2018
Lead MS added on 16/06/2015 PSUSA/00001346/202710 Dennis Lex Germany NAP
1347 ezetimibe / simvastatin 02/04/2004 5 years 10/03/2029 08/06/2029 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00001347/202903 Dennis Lex Germany NAP
1349 famciclovir 10/12/1993 5 years 31/12/2025 31/03/2026 No 12/09/2025 PSUR frequency and DLP were updated on 22/09/2021
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 26/09/2018
PRAC representative and Lead Member State were added on 23/05/2017 PSUSA/00001349/202512 Veronika Macurová Czech Republic NAP
1350 famotidine 21/09/1984 5 years 30/09/2027 29/12/2027 No 27/07/2022 Next DLP was updated on 31/05/2023 PSUSA/00001350/202709 Amelia Cupelli Italy NAP
1351 calcium carbonate / famotidine / magnesium hydroxide Not available* 5 years 30/09/2028 29/12/2028 No 19/09/2024 PSUSA/00001351/202809 Zoubida Amimour France NAP
1352 fampridine 20/07/2011 5 years 21/01/2028 20/04/2028 No 23/09/2020 New CAP authorised on 24/09/2020
DLP was updated on 23/09/2020
PRAC Rapporteur name updated on 23/10/2018
PRAC Representative updated on 26/09/2018
PSUR Frequency amended and next DLP updated on 25/09/2017
Next DLP was updated on 22/09/2016
Next DLP was updated on 30/09/2105.
Next DLP was amended on 06/10/2014
Next DLP was amended on 03/03/2014
Conditional approval PSUSA/00001352/202801 Liana Martirosyan Netherlands CAP
1353 febuxostat 21/04/2008 1 year 20/04/2026 29/06/2026 20/04/2027 29/06/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00001353/202604 PSUSA/00001353/202704 Jan Neuhauser Austria CAP
1355 felbinac 25/09/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001355/202812 NAP
1356 felodipine 31/12/1987 5 years 31/12/2027 30/03/2028 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00001356/202712 Miroslava Gocova Slovakia NAP
1357 felodipine / metoprolol 31/12/1992 10 years 31/12/2027 30/03/2028 No 18/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001357/202712 Karin Erneholm Denmark NAP
1358 felodipine / ramipril 19/09/1997 5 years 19/09/2028 18/12/2028 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00001358/202809 Dennis Lex Germany NAP
1361 fenipentol Not available* 7 years 01/12/2031 29/02/2032 No 27/03/2024 PSUR frequency and DLP amended on 27/03/2024 PSUSA/00001361/203112 Miroslava Gocova Slovakia NAP
1362 fenofibrate 04/11/1974 3 years 31/07/2026 29/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00001362/202607 Jo Robays Belgium NAP
1363 fenofibrate / pravastatin 14/04/2011 3 years 14/04/2026 13/07/2026 No 19/09/2024 PSUSA/00001363/202604 Zoubida Amimour France CAP
1365 fenoprofen Not available* 8 years 03/06/2026 01/09/2026 No 23/09/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001365/202606 Tiphaine Vaillant France NAP
1366 fenoterol (respiratory indications) 27/09/1965 5 years 27/09/2027 26/12/2027 No 06/06/2018 Next DLP was updated on 31/05/2023 PSUSA/00001366/202709 Barbara Kovacic Bytyqi Croatia NAP
1367 fenoterol / ipratropium 28/05/1980 5 years 02/02/2028 02/05/2028 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00001367/202802 Bianca Mulder Netherlands NAP
1369 fentanyl (transmucosal route of administration) 04/04/2008 3 years 30/04/2026 29/07/2026 No 31/01/2024 Next DLP was updated on 31/01/2024 PSUSA/00001369/202604 Tiphaine Vaillant France CAP NAP
1370 fentanyl (transdermal patches, solution for injection - nationally authorised product only) 07/03/1995 3 years 30/04/2027 29/07/2027 No 18/12/2024 PSUR frequency amended and DLP updated on 18/12/2024 PSUSA/00001370/202704 Liana Martirosyan Netherlands NAP
1371 fenticonazole 16/04/1986 8 years 03/06/2033 01/09/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001371/203306 Marie Louise Schougaard Christiansen Denmark NAP
1382 ferucarbotran 01/07/2022 2 years 30/06/2027 28/09/2027 No 02/06/2026 PSUSA/00001382/202706 Jenny Jönsson Sweden NAP
1387 fesoterodine, desfesoterodine 20/04/2007 5 years 19/04/2030 18/07/2030 No 16/12/2020 PSUR frequency, DLP and reference to NAP were updated on 16/12/2020
PRAC Representative name was corrected on 29/07/2020
PRAC Representative updated on 26/09/2018
Entry name was amended on 06/06/2018
DLP was updated on 19/12/2017
PRAC Rapporteur name updated on 03/06/2016 PSUSA/00001387/203004 Maria del Pilar Rayon Spain CAP NAP
1388 fexofenadine 11/03/1996 5 years 11/03/2027 09/06/2027 No 16/11/2022 DLP was updated on 16/11/2022
PRAC Rapporteur name was amended on 28/04/2022
PRAC Rapporteur name was amended on 21/11/2018
DLP was amended on 15/11/2017
Lead MS was added on 22/09/2016
PRAC Rapporteur name updated on 05/11/2018 PSUSA/00001388/202703 Marie Louise Schougaard Christiansen Denmark NAP
1390 fidaxomicin 27/05/2011 3 years 26/05/2026 24/08/2026 No 02/06/2026 PSUSA/00001390/202605 Karin Bolin Sweden CAP
1391 filgrastim 15/03/1991 3 years 15/09/2027 14/12/2027 No 25/05/2022 New CAP authorised on 12/02/2025
DLP was updated on 25/05/2022
DLP was updated on 05/06/2019
Next DLP was amended on 03/06/2016
EURD was amended on 01/10/2013 PSUSA/00001391/202709 Terhi Lehtinen Finland CAP NAP
1392 finasteride, finasteride / doxazosin 17/04/1998 3 years 31/08/2028 29/11/2028 No 02/06/2026 PSUSA/00001392/202808 Jenny Jönsson Sweden NAP
1393 fingolimod 17/03/2011 3 years 28/02/2028 28/05/2028 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00001393/202802 Tiphaine Vaillant France CAP
1395 flavoxate 04/08/1967 11 years 02/12/2039 01/03/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001395/203912 NAP
1396 flecainide 25/06/1982 5 years 30/06/2027 28/09/2027 No 01/03/2023 DLP was updated on 01/03/2023
PRAC Rapporteur name amended on 04/07/2018
DLP was updated on 27/03/2018
PRAC Representative name was amended on 17/10/2017
Lead MS and PRAC Rapporteur name was added on 20/12/2016 PSUSA/00001396/202706 Karen Pernille Harg Norway NAP
1398 flopropione Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001398/203012 NAP
1399 fluanisone 01/10/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001399/202812 NAP
1400 flubendazole 10/03/1980 5 years 04/02/2029 05/05/2029 Yes 03/05/2023 Lead MS and PRAC Rapporteur name added on 26/07/2023
Entry re-activated on 03/05/2023
Entry re-activated on 21/10/2022
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 21/10/2022
DLP was updated on 17/10/2017
Correction of PRAC Rapporteur name on 28/02/2017
PRAC Rapporteur name was amended on 20/12/2016
Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00001400/202902 Ana Sofia Diniz Martins Portugal NAP
1402 flucloxacillin 14/01/1971 8 years 03/03/2028 01/06/2028 No 16/12/2020 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended" was amended on 16/12/2020
DLP was updated on 18/11/2020
PRAC representative was added on 06/05/2020
EURD updated on 25/09/2019
LMS was added on 31/07/2019 PSUSA/00001402/202803 Ana Sofia Diniz Martins Portugal NAP
1404 fluconazole 08/03/1988 3 years 02/03/2026 31/05/2026 No 15/11/2023 DLP was amended on 15/11/2023 PSUSA/00001404/202603 Marie Louise Schougaard Christiansen Denmark NAP
1405 flucytosine 01/10/1975 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00001405/203303 Zoubida Amimour France NAP
1406 fludarabine 11/08/1994 5 years 11/08/2027 09/11/2027 No 05/04/2023 DLP was updated on 05/04/2023
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 07/05/2018
PRAC Rapporteur name was amended on 27/03/2018
DLP was corrected on 28/03/2017
PRAC representative and Lead Member State were added on 30/01/2017 PSUSA/00001406/202708 Terhi Lehtinen Finland NAP
1408 fludrocortisone 28/10/1954 12 years 03/06/2040 01/09/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001408/204006 NAP
1411 fludroxycortide Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001411/203012 NAP
1412 fluindione 02/09/1969 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001412/202805 NAP
1413 flumazenil 30/12/1986 5 years 29/12/2029 29/03/2030 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00001413/202912 Liana Martirosyan Netherlands NAP
1414 flumetasone 01/01/1964 11 years 03/07/2039 01/10/2039 No 15/01/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001414/203907 Liana Martirosyan Netherlands NAP
1415 clioquinol / flumetasone 15/02/1966 10 years 03/07/2034 01/10/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001415/203407 NAP
1416 flunarizine 01/06/1977 5 years 31/05/2029 29/08/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00001416/202905 Ana Sofia Diniz Martins Portugal NAP
1417 flunisolide 25/08/1982 10 years 03/05/2035 01/08/2035 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00001417/203505 Dennis Lex Germany NAP
1418 flunitrazepam 01/01/2000 3 years 01/01/2028 31/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00001418/202801 Jan Neuhauser Austria NAP
1419 fluocinolone acetonide (all routes of administration apart from intravitreal implant in applicator) 26/02/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001419/203406 NAP
1420 fluocinolone / metronidazole / nystatin Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001420/203012 NAP
1421 clioquinol / fluocinolone acetonide Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 PSUR frequency and DLP amended on 28/08/2024. PSUSA/00001421/202912 NAP
1423 fluocinolone acetonide / lidocaine Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001423/203012 NAP
1424 bismuth subgallate / fluocinolone acetonide / lidocaine / menthol Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001424/202906 NAP
1425 fluocinonide Not available* 8 years 03/06/2026 01/09/2026 No 23/09/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001425/202606 Zane Neikena Latvia NAP
1426 fluocinonide / hexetidine / ruscogenin Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001426/203012 NAP
1427 fluocinonide / lidocaine Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001427/203012 NAP
1430 fluocortolone pivalate / lidocaine hydrochloride Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001430/203012 NAP
1431 fluorescein (topical ophthalmic use) 12/04/1961 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001431/203906 NAP
1432 fluorescein / oxybuprocaine 12/04/1961 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001432/203906 NAP
1433 fluoride (except sodium fluoride) Not available* 9 years 01/12/2030 01/03/2031 No 25/06/2025 Active substance name was amended on 25/06/2025
PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001433/203012 none NAP
1434 fluoride / malic acid Not available* 9 years 31/01/2031 01/05/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001434/203101 NAP
1435 fluoride / monofluorophosphate Not available* 9 years 31/01/2031 01/05/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001435/203101 NAP
1437 fludeoxyglucose (18F) 14/11/1994 10 years 30/11/2027 28/02/2028 No 19/12/2018 PRAC representative was updated on 29/07/2020
PRAC representative was updated on 03/06/2020
PSUR Frequency and DLP updated on 19/12/2018
DLP was updated on 31/07/2018
Active substance name was amended on 06/06/2018
Entry name was corrected and PRAC Rapporteur amended on 21/07/2017
PRAC Rapporteur name was amended on 28/07/2016
PRAC Rapporteur name updated on 07/04/2016
PRAC Rapporteur name updated on 04/02/2016
Lead MS was added on 22/12/2014 PSUSA/00001437/202711 Tiphaine Vaillant France NAP
1438 fluorometholone 14/04/1972 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001438/202806 NAP
1442 fluoxetine 07/09/1986 5 years 07/09/2027 06/12/2027 No 03/05/2023 DLP was amended on 03/05/2023
PRAC representative was updated on 29/07/2020
PRAC representative was updated on 03/06/2020
DLP was updated on 06/06/2018
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 06/06/2018
PRAC Rapporteur name updated on 21/07/2017
Lead MS and PRAC Rapporteur name was added on 28/02/2017 PSUSA/00001442/202709 Tiphaine Vaillant France NAP
1443 fluoxetine / olanzapine Not available* 9 years 31/01/2031 01/05/2031 No 24/09/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001443/203101 NAP
1444 flupentixol 30/11/1965 5 years 30/11/2028 28/02/2029 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025
DLP was amended on 31/07/2024 PSUSA/00001444/202811 Veronika Macurová Czech Republic NAP
1445 flupentixol / melitracene 31/01/1971 13 years 30/11/2036 28/02/2037 No 12/09/2025 DLP was amended on 31/07/2024 PSUSA/00001445/203611 Veronika Macurová Czech Republic NAP
1446 fluphenazine 18/12/1959 11 years 03/05/2039 01/08/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001446/203905 NAP
1448 fluprednidene / miconazole Not available* 8 years 03/06/2026 01/09/2026 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001448/202606 NAP
1449 flurazepam 02/03/1973 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001449/202806 NAP
1450 flurbiprofen 10/11/1976 5 years 30/11/2027 28/02/2028 No 26/07/2023 PSUR frequency amended and DLP updated on 26/07/2023 PSUSA/00001450/202711 Amelia Cupelli Italy NAP
1452 fluspirilene 01/09/1977 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001452/202811 NAP
1453 flutamide 24/03/1982 5 years 23/10/2028 21/01/2029 Yes 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00001453/202810 Dennis Lex Germany NAP
1454 fluticasone propionate 08/03/1990 5 years 28/02/2027 29/05/2027 No 16/11/2022 DLP was updated on 16/11/2022
PRAC representative was updated on 28/07/2021
PRAC representative was updated on 28/04/2021
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was amended on 15/11/2017
Lead MS was added on 22/09/2016 PSUSA/00001454/202702 Polona Golmajer Slovenia NAP
1455 fluticasone / salmeterol (for nationally authorised products) 25/10/1990 8 years 31/10/2032 29/01/2033 No 02/06/2026 PSUSA/00001455/203210 Karin Bolin Sweden NAP
1456 flutrimazole 01/12/1994 8 years 03/08/2033 01/11/2033 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00001456/203308 Maria Martinez Gonzalez Spain NAP
1457 fluvastatin 23/08/1993 5 years 31/08/2027 29/11/2027 No 03/05/2023 DLP was amended on 03/05/2023
DLP was updated on 06/06/2018
Lead MS and PRAC Rapporteur name was added on 28/02/2017 PSUSA/00001457/202708 Eva Jirsová Czech Republic NAP
1458 fluvoxamine 13/07/1983 5 years 31/07/2027 29/10/2027 No 05/04/2023 DLP was updated on 05/04/2023
PRAC Rapporteur name was amended on 06/03/2019
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 07/05/2018
PRAC representative and Lead Member State were added on 30/01/2017 PSUSA/00001458/202707 Rugile Pilviniene Lithuania NAP
1459 folic acid 13/12/1947 10 years 13/12/2027 12/03/2028 No 31/01/2018 PRAC Rapporteur name was amended on 28/04/2022
PRAC Rapporteur name was amended on 03/04/2019
PSUR frequency amended and DLP updated on 31/01/2018
Lead MS and PRAC Rapporteur name was added on 19/10/2016
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00001459/202712 Marie Louise Schougaard Christiansen Denmark NAP
1461 folic acid / nicotinamide Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00001461/204001 NAP
1463 follitropin alfa 20/10/1995 5 years 19/10/2029 17/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00001463/202910 Bianca Mulder Netherlands CAP
1464 follitropin alfa / lutropin alfa 25/06/2007 5 years 19/10/2029 17/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00001464/202910 Marie Louise Schougaard Christiansen Denmark CAP
1465 follitropin beta 03/05/1996 3 years 01/05/2026 30/07/2026 No 31/01/2024 Next DLP was updated on 31/01/2024 PSUSA/00001465/202605 Rhea Fitzgerald Ireland CAP
1466 fomepizole 21/09/2000 7 years 03/03/2032 01/06/2032 Yes 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00001466/203203 Zoubida Amimour France NAP
1467 fondaparinux 21/03/2002 3 years 06/12/2027 05/03/2028 No 02/06/2026 PSUSA/00001467/202712 Karin Bolin Sweden CAP NAP
1469 formoterol 29/06/1990 5 years 31/05/2030 29/08/2030 No 02/06/2026 PSUSA/00001469/203005 Karin Bolin Sweden NAP
1470 fosamprenavir 12/07/2004 5 years 20/10/2028 18/01/2029 No 19/09/2024 PSUSA/00001470/202810 Zoubida Amimour France CAP
1471 fosaprepitant 11/01/2008 5 years 25/03/2029 23/06/2029 No 02/06/2026 PSUSA/00001471/202903 Jenny-Maria Jönsson Sweden CAP
1472 foscarnet 31/03/1989 8 years 31/03/2031 29/06/2031 No 20/12/2023 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00001472/203103 Liana Martirosyan Netherlands NAP
1476 fosphenytoin 05/08/1996 5 years 05/08/2030 03/11/2030 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00001476/203008 Eamon O'Murchu Ireland NAP
1477 fotemustine 14/04/1989 8 years 03/06/2033 01/09/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001477/203306 Amelia Cupelli Italy NAP
1478 framycetin Not available* 11 years 02/04/2040 01/07/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001478/204004 NAP
1479 framycetin sulfate / lidocaine hydrochloride Not available* 9 years 31/01/2031 01/05/2031 No 24/09/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001479/203101 NAP
1482 framycetin sulfate / triamcinolone acetonide Not available* 9 years 31/01/2031 01/05/2031 No 24/09/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001482/203101 NAP
1484 frovatriptan 31/10/2001 5 years 01/03/2027 30/05/2027 No 16/11/2022 DLP was updated on 16/11/2022
DLP was amended on 15/11/2017
PRAC Rapporteur name updated on 27/06/2017
Lead MS was added on 22/09/2016 PSUSA/00001484/202703 Eva Jirsová Czech Republic NAP
1486 fructose / glucose / xylitol Not available* 9 years 31/01/2031 01/05/2031 No 24/09/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001486/203101 NAP
1489 fulvestrant 10/03/2004 5 years 25/04/2028 24/07/2028 No 02/06/2026 PSUSA/00001489/202804 Jenny-Maria Jönsson Sweden CAP
1491 furosemide 01/01/1955 5 years 01/01/2028 31/03/2028 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00001491/202801 Carla Torre Portugal NAP
1493 furosemide / spironolactone 11/01/1961 5 years 17/03/2028 15/06/2028 No 15/11/2023 DLP was amended on 15/11/2023 PSUSA/00001493/202803 Karin Erneholm Denmark NAP
1494 furosemide / triamterene Not available* 9 years 31/01/2031 01/05/2031 No 24/09/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001494/203101 NAP
1498 fusidic acid / hydrocortisone acetate Not available* 9 years 31/01/2031 01/05/2031 No 24/09/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001498/203101 NAP
1499 gabapentin 05/02/1993 3 years 01/02/2028 01/05/2028 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00001499/202802 Dennis Lex Germany NAP
1500 gadobenic acid 22/07/1997 2 years 30/04/2027 29/07/2027 Yes 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001500/202704 Dennis Lex Germany NAP
1502 gadobutrol 20/08/1998 2 years 30/04/2027 29/07/2027 Yes 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001502/202704 Dennis Lex Germany NAP
1503 gadodiamide 01/02/1993 2 years 30/04/2027 29/07/2027 No 02/06/2026 PSUSA/00001503/202704 Karin Bolin Sweden NAP
1504 gadopentetic acid Not available* 2 years 30/04/2027 29/07/2027 Yes 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001504/202704 Dennis Lex Germany NAP
1505 gadoteric acid (intra articular formulation) 31/01/2002 2 years 30/04/2027 29/07/2027 Yes 30/04/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00001505/202704 Bianca Mulder Netherlands NAP
1506 gadoteric acid (IV and intravascular formulations) 08/03/1989 2 years 30/04/2027 29/07/2027 Yes 30/04/2026 DLP was amended on 04/02/2026 PSUSA/00001506/202704 Bianca Mulder Netherlands NAP
1507 gadoteridol 29/10/1992 2 years 30/04/2027 29/07/2027 Yes 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001507/202704 Karin Erneholm Denmark NAP
1509 gadoxetic acid disodium 20/08/1998 2 years 30/04/2027 29/07/2027 No 03/06/2026 Correction of Lead Member State and PRAC rapporteur name on 29/04/2026
DLP was amended on 04/02/2026 PSUSA/00001509/202704 Karin Bolin Sweden NAP
1511 galactose / palmitic acid 21/06/1995 8 years 03/08/2033 01/11/2033 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00001511/203308 NAP
1512 galantamine 01/03/2000 5 years 01/03/2029 30/05/2029 No 18/11/2020 DLP was updated on 18/11/2020
PRAC Rapporteur name was amended on 31/07/2018
Next DLP was updated and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 18/11/2016
PRAC Rapporteur name amended on 29/10/2015
Lead MS was added on 30/09/2015 PSUSA/00001512/202903 Karin Bolin Sweden NAP
1513 gallium (67ga) citrate 31/03/1972 10 years 01/12/2034 01/03/2035 Yes 02/04/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 02/04/2025
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001513/203412 Eva Jirsova Czech Republic NAP
1514 gallopamil 30/12/1986 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001514/202901 NAP
1515 galsulfase 31/05/2005 3 years 31/05/2027 29/08/2027 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00001515/202705 Ana Sofia Diniz Martins Portugal CAP
1516 ganciclovir 15/06/1988 6 years 14/06/2031 12/09/2031 No 04/03/2026 PSUR frequency amended and DLP updated on 04/03/2026 PSUSA/00001516/203106 Liana Martirosyan Netherlands NAP
1517 ganirelix 17/05/2000 5 years 28/02/2027 29/05/2027 No 16/11/2022 DLP was updated on 16/11/2022
New CAP authorised on 15/07/2022
DLP was updated on 17/10/2017
PRAC Rapporteur name amended on 29/10/2015. PSUSA/00001517/202702 Kimmo Jaakkola Finland CAP
1518 gefitinib 24/06/2009 5 years 05/07/2026 03/10/2026 No 02/06/2026 PSUSA/00001518/202607 Jenny-Maria Jönsson Sweden CAP
1519 gemcitabine 12/01/1995 5 years 12/01/2028 11/04/2028 No 02/06/2026 PSUSA/00001519/202801 Jenny Jönsson Sweden NAP
1521 gemfibrozil 01/06/1981 8 years 03/05/2033 01/08/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001521/203305 Karin Erneholm Denmark NAP
1522 gentamicin (topical use) 28/02/1973 11 years 03/03/2036 01/06/2036 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00001522/203603 Amelia Cupelli Italy NAP
1523 betamethasone / gentamicin Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001523/202906 NAP
1524 dexamethasone / gentamicin / tetryzoline Not available* 9 years 03/03/2030 01/06/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001524/203003 NAP
1525 gestrinone 21/01/1983 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001525/202812 NAP
1529 glatiramer 23/12/1996 3 years 30/11/2026 28/02/2027 Yes 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00001529/202611 Karin Erneholm Denmark NAP
1530 glibenclamide (for nationally authorised products only) 01/01/1969 9 years 03/05/2028 01/08/2028 No 18/10/2023 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?", PSUR frequency and DLP were amended on 18/10/2023
Active substance name updated on 04/07/2018 PSUSA/00001530/202805 none NAP
1532 gliclazide 26/04/1971 5 years 28/02/2026 29/05/2026 No 05/08/2025 DLP updated on 17/11/2021
Correction to the PRAC representative name on 05/02/2020
Lead MS and PRAC Rapporteur name amended on 19/12/2018
Next DLP was updated and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 18/11/2016
European Union reference date (EURD) was amended on 28/06/2016
Lead MS was added on 30/09/2015 PSUSA/00001532/202602 Guðrún Stefánsdóttir Iceland NAP
1533 glicofosfopeptical 07/12/1987 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001533/202901 NAP
1534 glimepiride 20/06/1995 5 years 20/06/2027 18/09/2027 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00001534/202706 Bianca Mulder Netherlands NAP
1535 glipizide 20/11/1971 5 years 31/01/2030 01/05/2030 Yes 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00001535/203001 Petar Mas Croatia NAP
1536 glipizide / metformin Not available* 9 years 03/03/2031 01/06/2031 Yes 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001536/203103 NAP
1537 gliquidone 16/09/1969 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001537/204003 none NAP
1538 glucagon (except for centrally authorised products) Not available* 8 years 30/06/2026 28/09/2026 No 31/07/2024 DLP amended on 20/11/2024
PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001538/202606 Terhi Lehtinen Finland NAP
1539 glucosamine 31/07/1996 5 years 31/03/2027 29/06/2027 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001539/202703 Karin Erneholm Denmark NAP
1541 calcium / glucose / glutathione disulphide / magnesium / potassium / sodium / sodium bicarbonate Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001541/202906 NAP
1544 benfotiamine / glutamate sodium / inositol Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001544/202905 NAP
1545 glutathione Not available* 8 years 03/06/2026 01/09/2026 No 23/09/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001545/202606 Amelia Cupelli Italy NAP
1546 glutethimide 15/04/1974 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001546/203503 NAP
1548 glycerol Not available* 8 years 03/06/2026 01/09/2026 No 23/09/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001548/202606 Jan Neuhauser Austria NAP
1549 glycerol / paraffin liquid / vaselin Not available* 8 years 03/06/2026 01/09/2026 No 23/09/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001549/202606 Tiphaine Vaillant France NAP
1550 glycerol / sucrose Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001550/203103 NAP
1551 glycerol / lecithin / soybean oil / triglycerides medium-chain Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001551/203103 NAP
1552 glyceryl trinitrate 19/10/1981 5 years 15/07/2030 13/10/2030 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00001552/203007 Polona Golmajer Slovenia NAP
1553 glycine Not available* 8 years 03/08/2026 01/11/2026 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001553/202608 NAP
1556 glycopyrronium (all indications except for the treatment of severe sialorhoea or for the treatment of chronic obstructive pulmonary disease) Not available* 15 years 30/09/2030 29/12/2030 No 22/09/2021 Active substance name amended on 22/09/2021
PRAC Rapporteur name was amended on 23/10/2018
The name of the active substance was amended on 22/09/2016
PSUR Frequency amended and DLP updated on 03/06/2016
Lead MS added on 12/05/2015
Name of active substance was amended on 30/11/2012 PSUSA/00001556/203009 Eamon O'Murchu Ireland NAP
1557 neostigmine, glycopyrronium / neostigmine 06/03/1992 15 years 30/09/2030 29/12/2030 No 20/12/2023 Active substance name was amended on 20/12/2023
PRAC Rapporteur name was amended on 23/10/2018
PSUR Frequency amended and DLP updated on 03/06/2016
Lead MS added on 12/05/2015 PSUSA/00001557/203009 Eamon O'Murchu Ireland NAP
1558 glycosaminoglycan polysulphate / salicylic acid / suprarenal gland extract Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001558/203103 NAP
1560 golimumab 01/10/2009 3 years 06/04/2026 05/07/2026 No 04/03/2026 New CAP authorised on 10/02/2026
New CAP authorised on 17/11/2025
DLP was amended on 20/12/2023 PSUSA/00001560/202604 Karin Bolin Sweden CAP
1561 gonadorelin 29/08/1973 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001561/203503 NAP
1562 goserelin 12/05/1987 5 years 12/05/2026 10/08/2026 No 02/02/2022 DLP was updated on 02/02/2022
Next DLP was amended on 30/01/2017
PRAC Rapporteur and Lead Member State added on 27/11/2015. PSUSA/00001562/202605 Dennis Lex Germany NAP
1563 gramicidin Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001563/203103 NAP
1564 benzocaine / cetylpyridinium chloride / dichlorobenzyl alcohol / gramicidin Not available* 8 years 01/12/2033 01/03/2034 No 30/10/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00001564/203312 Terhi Lehtinen Finland NAP
1567 gramicidin / neomycin sulfate / polymyxin b sulphate Not available* 8 years 03/08/2026 01/11/2026 No 18/11/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001567/202608 Petar Mas Croatia NAP
1568 granisetron (all formulations except transdermal patch) 19/02/1991 5 years 18/02/2026 19/05/2026 No 17/02/2026 Name of active substance was amended on 25/05/2022
PRAC representative was updated on 22/12/2021
DLP was updated on 20/10/2021
PRAC representative was updated on 06/05/2020
Next DLP was updated on 18/11/2016
PRAC Rapporteur name and country updated on 29/10/2015.
Name of active substance was amended on 31/05/2013 PSUSA/00001568/202602 Jana Pecherova Slovakia NAP
1572 griseofulvin 16/07/1959 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001572/203401 NAP
1573 guaiazulene Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001573/203103 NAP
1574 guaifenesin 31/05/1949 10 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001574/203211 NAP
1576 codeine / guaifenesin, ammonium chloride / codeine phosphate hemihydrate / guaifenesin / thyme oil Not available* 7 years 03/11/2026 01/02/2027 Yes 01/04/2026 Active substance name was amended on 01/04/2026
DLP was amended on 28/05/2025
Active substance name was amended on 28/05/2025
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025
PSUR frequency and DLP amended on 27/03/2024 PSUSA/00001576/202611 Jan Neuhauser Austria NAP
1580 guaifenesin / pseudoephedrine / triprolidine, guaifenesin / pseudoephedrine Not available* 8 years 03/08/2026 01/11/2026 No 18/11/2025 Active substance name was amended on 23/10/2024
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001580/202608 Miroslava Gocova Slovakia NAP
1582 haemophilus influenzae / klebsiella ozaenae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus / streptococcus pneumoniae / streptococcus pyogenes / streptococcus viridans vaccine 26/09/1983 5 years 31/12/2027 30/03/2028 No 06/10/2025 DLP amended on 20/09/2023 PSUSA/00001582/202712 Dirk Mentzer Germany NAP
1583 haemophilus type b and meningococcal group C conjugate vaccine 19/12/2005 3 years 01/02/2026 02/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00001583/202602 Jean-Michel Dogné Belgium NAP
1584 haemophilus type b conjugate vaccines 06/02/1992 3 years 06/02/2026 07/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00001584/202602 Jean-Michel Dogné Belgium NAP
1587 haloperidol 25/04/1960 5 years 24/01/2030 24/04/2030 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00001587/203001 Maia Uusküla Estonia NAP
1588 halothane Not available* 8 years 03/08/2026 01/11/2026 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001588/202608 NAP
1589 heparin 31/03/1939 9 years 08/11/2027 06/02/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001589/202711 none NAP
1591 heparinoid 01/05/1964 10 years 03/06/2034 01/09/2034 No 15/01/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001591/203406 Miroslava Gocova Slovakia NAP
1592 heparinoid / ibuprofen Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001592/202611 Miroslava Gocova Slovakia NAP
1593 hepatitis a (inactivated) / hepatitis b (rdna) vaccines (adsorbed) 20/09/1996 3 years 20/09/2027 19/12/2027 No 25/05/2022 DLP was updated on 25/05/2022
DLP was updated on 05/06/2019
Lead MS and PRAC Rapporteur name added on 21/11/2018
PRAC Representative amended on 28/03/2017
PSUR Frequency amended and DLP updated on 03/05/2016 PSUSA/00001593/202709 Jean-Michel Dogné Belgium CAP
1594 hepatitis a (inactivated) / typhoid polysaccharide vaccine (adsorbed) 22/06/1999 3 years 22/06/2026 20/09/2026 No 06/10/2025 DLP was amended on 28/02/2024 PSUSA/00001594/202606 Dirk Mentzer Germany NAP
1596 hepatitis A vaccines (inactivated, adsorbed) 01/01/1992 5 years 01/01/2029 01/04/2029 No 06/10/2025 DLP was amended on 25/09/2024 PSUSA/00001596/202901 Dirk Mentzer Germany NAP
1597 hepatitis B vaccine (rDNA) 14/11/1986 5 years 28/02/2030 29/05/2030 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00001597/203002 Dirk Mentzer Germany CAP NAP
1598 hepatitis B (rDNA) vaccine (adjuvanted, adsorbed) 02/02/2005 3 years 01/02/2027 02/05/2027 No 19/10/2022 DLP was updated on 19/10/2022
DLP was updated on 21/10/2020
PRAC representative was updated on 23/09/2020
Reference to NAP removed on 01/07/2020
Reference to NAP added on 25/09/2019
DLP was updated on 26/09/2018
PRAC Representative amended on 18/11/2016
Next DLP was updated on 22/09/2016
DLP was corrected on 13/03/2015
PSUR submission frequency was corrected on 06/03/2015
Name of active substance was amended on 31/05/2013 PSUSA/00001598/202702 Jean-Michel Dogné Belgium CAP
1601 deanol and all combinations with deanol except for diclofenac deanol Not available* 9 years 03/03/2030 01/06/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001601/203003 Ana Sofia Diniz Martins Portugal NAP
1602 hexamidine 29/03/1951 11 years 01/12/2036 01/03/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001602/203612 NAP
1603 chlorocresol / chlorhexidine / hexamidine Not available* 7 years 03/08/2031 01/11/2031 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00001603/203108 Zoubida Amimour France NAP
1604 hexamidine / lidocaine 29/03/1951 11 years 01/12/2036 01/03/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001604/203612 Zoubida Amimour France NAP
1606 hexaminolevulinate hydrochloride 17/09/2004 5 years 16/09/2029 15/12/2029 No 02/06/2026 PSUSA/00001606/202909 Karin Bolin Sweden NAP
1607 hexetidine Not available* 10 years 12/02/2035 13/05/2035 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001607/203502 NAP
1608 hexylresorcinol Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001608/203106 NAP
1609 hidrosmin Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001609/203106 NAP
1610 histamine (indicated for acute myeloid leukemia) 07/10/2008 1 year 06/10/2026 15/12/2026 06/10/2027 15/12/2027 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00001610/202610 PSUSA/00001610/202710 Eamon O Murchu Ireland CAP
1614 human anti-d immunoglobulin 28/03/1969 3 years 28/03/2027 26/06/2027 No 06/10/2025 DLP was amended on 20/11/2024 PSUSA/00001614/202703 Dirk Mentzer Germany NAP
1617 human coagulation factor IX 12/07/1985 5 years 12/07/2027 10/10/2027 No 06/10/2025 PRAC representative was updated on 01/03/2023
Lead MS and PRAC Representative name added on 19/10/2022
DLP was updated on 01/04/2020
Reference to centrally authorised products removed on 23/10/2019
PRAC Representative updated on 26/09/2018
DLP was updated on 28/03/2017
The DLP was amended on 01/04/2014 PSUSA/00001617/202707 Dirk Mentzer Germany NAP
1619 human coagulation factor VII 01/11/1975 3 years 31/10/2028 29/01/2029 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00001619/202810 Sonja Hrabcik Austria NAP
1620 human coagulation factor VIII (antihemophilic factor A) 30/11/1989 5 years 30/11/2029 28/02/2030 No 06/10/2025 DLP was amended on 30/07/2025 PSUSA/00001620/202911 Dirk Mentzer Germany NAP
1621 human coagulation factor viii / human von willebrand factor 07/06/1982 5 years 07/10/2026 05/01/2027 No 06/10/2025 PRAC representative was updated on 01/03/2023
PSUR frequency and DLP were updated on 28/06/2022
DLP was updated on 03/07/2019
Next DLP was updated on 28/06/2016
Lead MS added on 16/06/2015 PSUSA/00001621/202610 Dirk Mentzer Germany NAP
1622 human coagulation factor XIII Not available* 5 years 30/06/2027 28/09/2027 No 06/10/2025 DLP was amended on 03/05/2023
PRAC representative was updated on 01/03/2023
DLP was updated on 27/03/2018
Lead MS and PRAC Rapporteur name was added on 20/12/2016 PSUSA/00001622/202706 Dirk Mentzer Germany NAP
1624 human fibrinogen 04/01/1966 5 years 30/06/2029 28/09/2029 No 06/10/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00001624/202906 Dirk Mentzer Germany NAP
1629 human hemin 05/05/1995 3 years 31/05/2027 29/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00001629/202705 Tiphaine Vaillant France NAP
1631 human hepatitis B immunoglobulin 02/06/1979 5 years 30/11/2028 28/02/2029 Yes 06/10/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 23/10/2024
PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00001631/202811 Dirk Mentzer Germany CAP NAP
1633 human normal immunoglobulin (IgG) 25/01/1985 5 years 31/05/2030 29/08/2030 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001633/203005 Dirk Mentzer Germany CAP NAP
1634 human papillomavirus vaccine (rDNA) - 4-valent 20/09/2006 5 years 31/05/2030 29/08/2030 No 02/06/2026 PSUSA/00001634/203005 Jenny Jönsson Sweden CAP
1635 human plasma (pooled and treated for virus inactivation) 31/05/2006 3 years 28/02/2026 29/05/2026 No 06/10/2025 DLP was amended on 15/11/2023 PSUSA/00001635/202602 Dirk Mentzer Germany NAP
1638 human prothrombin complex Not available* 5 years 30/04/2026 29/07/2026 Yes 06/10/2025 PRAC representative was updated on 01/03/2023
DLP and Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" were amended on 22/12/2021
Next DLP was amended on 30/01/2017
Lead MS was amended on 22/09/2016
PRAC Rapporteur and Lead Member State added on 27/11/2015. PSUSA/00001638/202604 Dirk Mentzer Germany NAP
1639 human rabies immunoglobulin 27/04/1984 5 years 26/04/2027 25/07/2027 No 06/10/2025 PRAC representative was updated on 01/03/2023
DLP was updated on 21/12/2022
PSUR frequency amended and DLP updated on 31/01/2018
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00001639/202704 Dirk Mentzer Germany NAP
1642 human von willebrand factor 30/09/2003 5 years 30/09/2028 29/12/2028 No 06/10/2025 PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00001642/202809 Dirk Mentzer Germany NAP
1644 hyaluronic acid Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001644/203106 NAP
1645 hyaluronidase 31/05/1960 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001645/203404 NAP
1646 hydralazine, dihydralazine 13/03/1952 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001646/202712 none NAP
1650 hydrochlorothiazide 22/12/1958 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001650/202712 NAP
1655 hydrochlorothiazide / losartan 15/02/1995 5 years 15/02/2028 15/05/2028 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00001655/202802 Bianca Mulder Netherlands NAP
1657 hydrochlorothiazide / metoprolol 11/05/1978 8 years 11/05/2026 09/08/2026 Yes 22/10/2025 DLP was amended on 22/10/2025
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 22/10/2025 PSUSA/00001657/202605 Dennis Lex Germany NAP
1658 hydrochlorothiazide / nebivolol 20/09/2009 6 years 03/11/2029 01/02/2030 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00001658/202911 Amelia Cupelli Italy NAP
1662 hydrochlorothiazide / spironolactone Not available* 5 years 01/01/2029 01/04/2029 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00001662/202901 Barbara Kovacic Bytyqi Croatia NAP
1664 hydrochlorothiazide / triamterene, hydrochlorothiazide / propranolol / triamterene Not available* 9 years 03/06/2031 01/09/2031 No 19/10/2023 Active substance name, PSUR frequency and DLP were amended on 19/10/2023 PSUSA/00001664/203106 none NAP
1672 hydrocortisone / natamycin / neomycine sulphate 20/06/1995 8 years 03/08/2033 01/11/2033 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00001672/203308 Terhi Lehtinen Finland NAP
1675 hydrocortisone / urea 31/12/1986 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001675/202901 NAP
1676 benzocaine / hydrocortisone acetate Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001676/202906 NAP
1678 gentamicin sulphate / hydrocortisone acetate Not available* 10 years 12/02/2035 13/05/2035 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001678/203502 NAP
1679 lidocaine / hydrocortisone Not available* 10 years 12/02/2035 13/05/2035 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001679/203502 NAP
1680 hydrocortisone acetate / lidocaine hydrochloride / mefenidramium metilsulfate Not available* 10 years 12/02/2035 13/05/2035 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001680/203502 NAP
1684 hydrocortisone acetate / zinc sulfate Not available* 8 years 03/11/2026 01/02/2027 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001684/202611 NAP
1686 hydromorphone 25/11/1998 3 years 30/11/2027 28/02/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00001686/202711 Polona Golmajer Slovenia NAP
1688 quinidine, hydroquinidine 02/07/1973 5 years 02/07/2027 30/09/2027 No 23/10/2024 Active substance name was amended on 23/10/2024
DLP was updated on 01/03/2023
PRAC Representative updated on 16/11/2022
PRAC representative was updated on 20/10/2021
European Union reference date, DLP and submission dates updated on 07/05/2018
PSUR frequency amended and DLP updated on 15/11/2017
Lead MS was added on 22/09/2016
Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00001688/202707 Maria del Pilar Rayon Spain NAP
1689 hydroquinone Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001689/202611 María Martínez González Spain NAP
1692 hydroxycarbamide (for centrally authorised product only) 29/06/2007 1 year 28/06/2026 06/09/2026 28/06/2027 06/09/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001692/202606 PSUSA/00001692/202706 Jo Robays Belgium CAP
1693 hydroxychloroquine 18/04/1955 5 years 18/04/2026 17/07/2026 No 22/12/2021 PSUR frequency and DLP were updated on 22/12/2021
LMS and PRAC representative were added on 23/09/2020
DLP was updated on 03/06/2020 PSUSA/00001693/202604 Marie Louise Schougaard Christiansen Denmark NAP
1694 hydroxyethyl starch, hydroxyethyl starch combinations Not available* 1 year 01/03/2026 10/05/2026 01/03/2027 10/05/2027 No 04/03/2026 Active substance name was amended on 04/03/2026
DLP was amended on 22/10/2025 PSUSA/00001694/202603 PSUSA/00001694/202703 Dennis Lex Germany NAP
1696 hydroxyzine, hydroxyzine combination 14/12/1955 5 years 01/11/2028 30/01/2029 No 03/07/2024 PSUR frequency amended and DLP updated on 03/07/2024 PSUSA/00001696/202811 Tiphaine Vaillant France NAP
1697 hymecromone 27/07/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001697/203406 NAP
1698 hyoscine 01/01/1952 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001698/203212 NAP
1699 hyoscyamine 01/02/1966 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001699/203406 NAP
1701 hypericum perforatum L., herba 07/04/1998 5 years 01/01/2028 31/03/2028 Yes 20/09/2023 DLP amended on 20/09/2023 PSUSA/00001701/202801 Melinda Palfi Hungary NAP
1702 ibandronic acid 25/06/1996 5 years 24/06/2029 22/09/2029 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00001702/202906 Karin Erneholm Denmark CAP NAP
1708 ibuprofen / levomenthol Not available* 8 years 15/07/2028 13/10/2028 No 13/08/2025 DLP was updated on 31/03/2021
LMS and PRAC representative were added on 18/12/2019
DLP was updated on 05/06/2019 PSUSA/00001708/202807 Veronika Macurová Czech Republic NAP
1711 ibuprofen / pseudoephedrine Not available* 3 years 18/07/2026 16/10/2026 Yes 18/11/2025 PSUSA/00001711/202607 Tiphaine Vaillant France NAP
1712 ibuprofen (indicated in ductus arteriosus) 29/07/2004 3 years 29/07/2026 27/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00001712/202607 Rhea Fitzgerald Ireland CAP
1713 ibutilide 28/12/1995 5 years 31/12/2027 30/03/2028 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00001713/202712 Georgia Gkegka Greece NAP
1714 icatibant 11/07/2008 3 years 11/07/2027 09/10/2027 No 02/06/2026 PSUSA/00001714/202707 Karin Bolin Sweden CAP
1718 calcium oxide / ichthammol / potassium aluminium sulfate / sodium perborate Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001718/202906 NAP
1720 idarubicin 29/11/1989 3 years 30/11/2025 28/02/2026 No 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00001720/202511 Jan Neuhauser Austria NAP
1722 idursulfase 08/01/2007 3 years 23/07/2027 21/10/2027 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00001722/202707 Liana Martirosyan Netherlands CAP
1723 ifosfamide 13/07/1976 8 years 31/07/2028 29/10/2028 No 02/06/2026 PSUSA/00001723/202807 Jenny Jönsson Sweden NAP
1724 iloprost (nebuliser solution only) 27/04/1994 5 years 15/09/2028 14/12/2028 No 19/09/2024 PSUSA/00001724/202809 Zoubida Amimour France CAP NAP
1725 imatinib 07/11/2001 3 years 10/05/2027 08/08/2027 No 19/09/2025 DLP was amended on 05/02/2025 PSUSA/00001725/202705 Maria Martinez Gonzalez Spain CAP NAP
1726 imidapril 10/10/1993 7 years 02/12/2030 02/03/2031 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00001726/203012 John Joseph Borg Malta NAP
1727 imiglucerase 23/05/1994 3 years 23/05/2026 21/08/2026 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00001727/202605 Liana Martirosyan Netherlands CAP
1728 imipramine 13/03/1958 8 years 15/07/2028 13/10/2028 No 31/03/2021 PSUR frequency and DLP were updated on 31/03/2021
LMS and PRAC representative were added on 04/03/2020
PSUR frequency and DLP were updated on 05/06/2019 PSUSA/00001728/202807 Dennis Lex Germany NAP
1729 imiquimod 18/09/1998 3 years 26/01/2026 26/04/2026 No 25/06/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/06/2025
Next DLP was updated on 18/10/2023 PSUSA/00001729/202601 Adam Przybylkowski Poland CAP NAP
1730 indacaterol 30/11/2009 5 years 30/11/2027 28/02/2028 No 26/07/2023 PSUR frequency amended and DLP updated on 26/07/2023 PSUSA/00001730/202711 Marie Louise Schougaard Christiansen Denmark CAP
1731 indapamide 25/02/2002 5 years 25/11/2025 23/02/2026 No 28/07/2021 DLP was updated on 28/07/2021
PRAC Rapporteur name was amended on 31/07/2018
Next DLP was amended on 28/07/2016
Lead MS was added on 16/06/2015 PSUSA/00001731/202511 Dennis Lex Germany NAP
1734 indium (111In) chloride, indium (111In) oxine Not available* 8 years 15/07/2029 13/10/2029 Yes 28/04/2022 PRAC representative was updated on 19/10/2022
PRAC Representative was amended on 28/04/2022
DLP was updated on 30/03/2022
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" and DLP were updated on 03/02/2021
LMS and PRAC representative were added on 18/12/2019
DLP was updated on 05/06/2019 PSUSA/00001734/202907 Jo Robays Belgium NAP
1736 indobufen 05/05/1984 8 years 04/05/2033 02/08/2033 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00001736/203305 Amelia Cupelli Italy NAP
1737 indocyanine green 16/04/2003 7 years 03/05/2031 01/08/2031 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00001737/203105 Jean-Michel Dogné Belgium NAP
1738 indometacin Not available* 3 years 15/07/2026 13/10/2026 No 19/09/2025 DLP was amended on 27/03/2024 PSUSA/00001738/202607 Maria Martinez Gonzalez Spain NAP
1742 influenza vaccine (live, nasal) 27/01/2011 1 year 31/08/2026 09/11/2026 31/08/2027 09/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00001742/202608 PSUSA/00001742/202708 Jean-Michel Dogné Belgium CAP
1744 influenza vaccine (surface antigen, inactivated) 16/02/1998 1 year 15/03/2026 24/05/2026 15/03/2027 24/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00001744/202603 PSUSA/00001744/202703 Amelia Cupelli Italy NAP
1749 insulin aspart 07/09/1999 3 years 30/09/2026 29/12/2026 No 02/06/2026 PSUSA/00001749/202609 Karin Bolin Sweden CAP
1750 insulin detemir 01/06/2004 5 years 31/10/2029 29/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00001750/202910 Marie Louise Schougaard Christiansen Denmark CAP
1751 insulin glargine 21/04/2000 3 years 21/04/2028 20/07/2028 No 31/01/2024 New CAP authorised on 09/01/2026
PRAC representative updated on 31/01/2024 PSUSA/00001751/202804 Bianca Mulder Netherlands CAP
1752 insulin glulisine 16/04/2004 3 years 16/04/2026 15/07/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00001752/202604 Marie Louise Schougaard Christiansen Denmark CAP
1753 insulin human, insulin human / insulin isophane (subcutaneous and intravenous routes of administration) 26/10/1980 5 years 26/10/2028 24/01/2029 No 03/07/2024 PSUR frequency amended and DLP updated on 03/07/2024 PSUSA/00001753/202810 Marie Louise Schougaard Christiansen Denmark CAP NAP
1755 insulin lispro 30/04/1995 3 years 30/04/2027 29/07/2027 No 02/06/2026 PSUSA/00001755/202704 Karin Bolin Sweden CAP
1759 interferon beta-1b 30/11/1995 5 years 23/07/2029 21/10/2029 No 02/04/2025 PSUR frequency amended and DLP updated on 02/04/2025 PSUSA/00001759/202907 Dennis Lex Germany CAP
1760 interferon gamma 28/09/1992 8 years 31/01/2033 01/05/2033 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00001760/203301 Liana Martirosyan Netherlands NAP
1761 iobitridol 24/08/1994 5 years 30/04/2029 29/07/2029 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00001761/202904 Eamon O'Murchu Ireland NAP
1763 iodine (123i) iobenguane 31/01/1995 8 years 03/08/2033 01/11/2033 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00001763/203308 Adam Przybylkowski Poland NAP
1764 iodine (131i) iobenguane 01/06/1991 5 years 01/05/2029 30/07/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00001764/202905 Karin Erneholm Denmark NAP
1766 iodixanol 01/05/1993 8 years 30/04/2028 29/07/2028 No 03/02/2021 DLP was updated on 03/02/2021
PRAC representative was added on 06/05/2020
LMS was added on 25/09/2019 PSUSA/00001766/202804 Karen Pernille Harg Norway NAP
1767 ioflupane (123i) 27/07/2000 5 years 27/07/2027 25/10/2027 No 05/04/2023 DLP was updated on 05/04/2023
New CAP authorised on 17/06/2021
PRAC representative was updated on 29/07/2020
PRAC representative was updated on 03/06/2020
New CAP authorised on 25/06/2019
LMS and PRAC representative updated 05/06/2019
DLP was updated on 27/03/2018 PSUSA/00001767/202707 Tiphaine Vaillant France CAP
1768 iohexol 04/06/1982 8 years 30/06/2028 28/09/2028 No 03/03/2021 DLP was updated on 03/03/2021
PRAC representative was added on 06/05/2020
LMS was added on 01/04/2020 PSUSA/00001768/202806 Karen Pernille Harg Norway NAP
1769 iomeprol 11/12/1992 8 years 30/04/2028 29/07/2028 No 03/02/2021 DLP was updated on 03/02/2021
PRAC representative was added on 06/05/2020
LMS was added on 25/09/2019 PSUSA/00001769/202804 Karen Pernille Harg Norway NAP
1771 iopamidol 18/05/1981 8 years 31/12/2027 30/03/2028 No 23/09/2020 DLP was updated on 23/09/2020
LMS and PRAC representatives were added on 31/07/2019 PSUSA/00001771/202712 Eamon O'Murchu Ireland NAP
1773 iopromide 28/02/1985 8 years 30/06/2028 28/09/2028 No 03/03/2021 DLP was updated on 03/03/2021
PRAC representative was added on 06/05/2020
LMS was added on 01/04/2020 PSUSA/00001773/202806 Karen Pernille Harg Norway NAP
1775 ioversol 01/06/1989 8 years 03/06/2033 01/09/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001775/203306 Rhea Fitzgerald Ireland NAP
1779 ioxitalamate 11/03/2003 8 years 10/03/2036 08/06/2036 No 30/04/2024 EURD, PSUR frequency and DLP updated on 30/04/2024
Active substance name was amended on 30/04/2024 PSUSA/00001779/203603 none NAP
1780 ipratropium 14/08/1974 3 years 31/01/2026 01/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00001780/202601 Melinda Palfi Hungary NAP
1781 ipratropium / salbutamol 22/03/1994 3 years 31/01/2026 01/05/2026 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00001781/202601 Petar Mas Croatia NAP
1783 irinotecan (except for liposomal formulations) 05/05/1995 5 years 04/05/2028 02/08/2028 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00001783/202805 Tiphaine Vaillant France NAP
1784 isocarboxazid Not available* 11 years 03/05/2040 01/08/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001784/204005 NAP
1785 isoconazole Not available* 9 years 03/07/2031 01/10/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001785/203107 NAP
1786 isoflurane 07/10/1981 3 years 31/10/2028 29/01/2029 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00001786/202810 Melinda Palfi Hungary NAP
1788 dichloralphenazone / isometheptene mucate / paracetamol Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001788/203008 NAP
1789 isoniazid, isoniazid / pyridoxine hydrochloride, isoniazid / rifampicin, isoniazid / pyrazinamide / rifampicin, ethambutol / isoniazid / pyrazinamide / rifampicin 28/02/1973 5 years 01/11/2029 30/01/2030 No 02/06/2026 PSUSA/00001789/202911 Jenny Jönsson Sweden NAP
1793 isoprenaline 04/04/1977 13 years 03/04/2034 02/07/2034 No 05/01/2025 DLP was amended on 18/12/2024 PSUSA/00001793/203404 Pernille Harg Norway NAP
1794 isosorbide 01/05/1980 13 years 30/04/2034 29/07/2034 No 05/01/2025 DLP was amended on 18/12/2024 PSUSA/00001794/203404 Dennis Lex Germany NAP
1797 isradipine 03/01/1989 15 years 03/06/2040 01/09/2040 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026
DLP was amended on 04/02/2026 PSUSA/00001797/204006 Veronika Macurová Czech Republic NAP
1798 itraconazole 31/08/1974 5 years 31/03/2027 29/06/2027 No 21/12/2022 DLP was updated on 21/12/2022
PRAC Rapporteur name was amended on 28/04/2022
PRAC Rapporteur name was amended on 03/04/2019
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00001798/202703 Marie Louise Schougaard Christiansen Denmark NAP
1799 ivabradine 25/04/2005 3 years 25/04/2026 24/07/2026 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00001799/202604 Bianca Mulder Netherlands CAP NAP
1801 japanese encephalitis virus (inactivated) 31/03/2009 3 years 31/03/2027 29/06/2027 No 06/10/2025 DLP was amended on 18/12/2024 PSUSA/00001801/202703 Dirk Mentzer Germany CAP
1803 kanamycin Not available* 10 years 12/02/2035 13/05/2035 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001803/203502 NAP
1804 ketamine 10/12/1968 3 years 09/12/2027 08/03/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00001804/202712 Jean-Michel Dogné Belgium NAP
1806 ketazolam Not available* 9 years 03/07/2031 01/10/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001806/203107 NAP
1807 ketobemidone, ketobemidone/dimethylaminodiphenylbutene hydrochloride 07/05/1993 9 years 31/05/2029 29/08/2029 No 03/02/2021 DLP and Name of active substance were updated on 03/02/2021
PSUR Frequency was amended on 03/06/2020
PRAC representative was added on 06/05/2020
LMS was added on 25/09/2019 PSUSA/00001807/202905 Karen Pernille Harg Norway NAP
1808 ketoconazole 01/06/1980 7 years 31/05/2031 29/08/2031 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00001808/203105 Guðrún Stefánsdóttir Iceland NAP
1809 ketoprofen (all formulations except topical) 27/07/1972 5 years 23/01/2027 23/04/2027 No 19/10/2022 DLP was updated on 19/10/2022
DLP was updated on 07/05/2018
PRAC representative and Lead Member State were added on 30/01/2017 PSUSA/00001809/202701 Karin Bolin Sweden NAP
1810 ketorolac (ophtalmic formulations) 20/07/1989 5 years 31/07/2027 29/10/2027 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001810/202707 Karin Erneholm Denmark NAP
1811 ketorolac (systemic formulations) 20/07/1989 5 years 19/07/2027 17/10/2027 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001811/202707 Karin Erneholm Denmark NAP
1812 ketotifen (ophtalmic formulations) 15/10/1977 10 years 30/06/2032 28/09/2032 No 01/03/2023 PSUR frequency and DLP were updated on 01/03/2023
DLP was updated on 27/03/2018
Lead MS and PRAC Rapporteur name was added on 20/12/2016 PSUSA/00001812/203206 Karin Bolin Sweden NAP
1813 ketotifen (oral formulations) 15/10/1977 5 years 31/10/2028 29/01/2029 No 03/07/2024 PSUR frequency amended and DLP updated on 03/07/2024 PSUSA/00001813/202810 Amelia Cupelli Italy NAP
1814 labetalol 04/03/1977 8 years 28/02/2028 28/05/2028 No 21/10/2020 DLP was updated on 21/10/2020
PRAC representative was added on 06/05/2020
LMS was added on 31/07/2019 PSUSA/00001814/202802 Karen Pernille Harg Norway NAP
1815 lacidipine 07/11/1990 5 years 31/10/2026 29/01/2027 No 29/06/2022 DLP was updated on 29/06/2022
DLP was updated on 21/07/2017
Lead MS and PRAC Rapporteur name was added on 03/06/2016 PSUSA/00001815/202610 Maia Uusküla Estonia NAP
1816 lacosamide 29/08/2008 3 years 31/08/2027 29/11/2027 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00001816/202708 Karin Bolin Sweden CAP
1817 lactic acid Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00001817/203001 NAP
1818 lactic acid / salicylic acid 25/04/1977 9 years 03/11/2028 01/02/2029 No 24/09/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001818/202811 Adam Przybylkowski Poland NAP
1819 lactitol 03/09/1985 5 years 23/09/2030 22/12/2030 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00001819/203009 Jan Neuhauser Austria NAP
1821 lactulose 21/05/1964 5 years 31/05/2026 29/08/2026 No 27/07/2022 PRAC representative was updated on 27/07/2022
DLP was updated on 02/02/2022
PRAC representative was updated on 30/06/2021
Next DLP was updated on 30/01/2017
PRAC Rapporteur name updated on 04/02/2016
PRAC Rapporteur and Lead Member State added on 27/11/2015 PSUSA/00001821/202605 Amelia Cupelli Italy NAP
1822 lactose monohydrate / lactulose Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00001822/203001 NAP
1823 lactulose / paraffin liquid / vaseline Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00001823/203001 NAP
1824 lamivudine (chronic hepatitis B) 29/07/1999 5 years 31/07/2030 29/10/2030 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00001824/203007 Zoubida Amimour France CAP NAP
1825 lamotrigine 05/11/1990 5 years 30/11/2027 28/02/2028 No 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00001825/202711 Liana Martirosyan Netherlands NAP
1826 lanreotide 16/05/1994 3 years 31/05/2026 29/08/2026 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00001826/202605 Zane Neikena Latvia NAP
1827 dexlansoprazole, lansoprazole 31/12/1990 5 years 31/12/2026 31/03/2027 No 21/09/2022 DLP was updated on 21/09/2022
Next DLP was amended on 25/09/2017
Correction of PRAC Rapporteur name on 28/02/2017
PRAC Rapporteur name was amended on 20/12/2016
Lead MS and PRAC Rapporteur name was added on 28/07/2016
Name of active substance was amended on 08/01/2014
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00001827/202612 Ana Sofia Diniz Martins Portugal NAP
1829 lapatinib 10/06/2008 5 years 12/03/2030 10/06/2030 No 02/06/2026 PSUSA/00001829/203003 Jenny-Maria Jönsson Sweden CAP
1830 laronidase 10/06/2003 3 years 30/04/2027 29/07/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00001830/202704 Zoubida Amimour France CAP
1832 latanoprost 05/06/1996 5 years 30/04/2028 29/07/2028 No 19/11/2025 Correction of DLP on 19/11/2025
Active substance name was amended on 05/03/2025
PRAC Representative amended on 28/04/2022
DLP was updated on 22/12/2021
Next DLP and typo in the name amended on 30/01/2017
PRAC Representative amended on 18/11/2016
Lead Member State was added on 21/12/2015.
Name of entry amended on 03/03/2014 PSUSA/00001832/202804 Jean-Michel Dogné Belgium NAP
1833 latanoprost / timolol 05/06/1996 5 years 04/06/2027 02/09/2027 No 01/02/2023 DLP was updated on 01/02/2023
PSUR Frequency amended and DLP updated on 28/02/2018
PRAC representative and Lead Member State were added on 18/11/2016
Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00001833/202706 Karin Bolin Sweden NAP
1835 lauromacrogol 400 25/05/1966 18 years 25/05/2030 23/08/2030 No 01/10/2012 PSUSA/00001835/203005 NAP
1836 lauromacrogols combinations Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00001836/203001 NAP
1837 leflunomide 10/09/1998 3 years 10/09/2026 09/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00001837/202609 Liana Martirosyan Netherlands CAP NAP
1838 lenalidomide 14/06/2007 3 years 26/12/2025 26/03/2026 Yes 20/09/2023 DLP and PSUR frequency amended on 20/09/2023 PSUSA/00001838/202512 Tiphaine Vaillant France CAP NAP
1839 lenograstim 11/10/1991 5 years 31/10/2027 29/01/2028 No 28/06/2023 PSUR frequency amended and DLP updated on 28/06/2023
PRAC representative was updated on 29/07/2020
DLP was updated on 01/07/2020
PRAC representative was updated on 03/06/2020
DLP updated and PRAC Rapporteur name amended on 21/07/2017
PRAC Rapporteur name was amended on 28/07/2016
Lead MS and PRAC Rapporteur name was added on 03/06/2016
Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00001839/202710 Tiphaine Vaillant France NAP
1841 lercanidipine 22/03/1996 5 years 31/08/2029 29/11/2029 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00001841/202908 Kimmo Jaakkola Finland NAP
1842 letrozole 24/07/1996 3 years 31/10/2027 29/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00001842/202710 Tiphaine Vaillant France NAP
1846 levetiracetam 29/09/2000 3 years 30/11/2027 28/02/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00001846/202711 Jo Robays Belgium CAP NAP
1848 levobupivacaine 01/01/1999 5 years 31/12/2027 30/03/2028 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00001848/202712 Karin Bolin Sweden NAP
1849 levocabastine 22/02/1993 5 years 14/11/2027 12/02/2028 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001849/202711 Karin Erneholm Denmark NAP
1850 levocetirizine 03/01/2001 6 years 02/07/2029 30/09/2029 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00001850/202907 Dennis Lex Germany NAP
1853 levodropropizine 08/05/1997 7 years 02/01/2031 02/04/2031 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00001853/203101 Melinda Palfi Hungary NAP
1855 levomethadone 22/03/1969 5 years 01/05/2030 30/07/2030 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00001855/203005 Jan Neuhauser Austria NAP
1858 levosimendan 22/09/2000 5 years 22/09/2029 21/12/2029 No 03/06/2020 PRAC Rapporteur name was amended on 01/02/2023
PRAC Rapporteur name was amended on 22/09/2022
PSUR frequency and DLP were updated on 03/06/2020
PRAC Rapporteur name updated on 23/10/2018
PRAC Rapporteur name was amended on 31/07/2018
Next DLP was amended on 27/06/2017
PRAC representative and Lead Member State were added on 03/05/2016
PSUSA number was amended on 06/10/2014 PSUSA/00001858/202909 Karin Bolin Sweden NAP
1859 levosulpiride, sulpiride 01/04/1986 8 years 03/06/2033 01/09/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001859/203306 Amelia Cupelli Italy NAP
1860 levothyroxine 01/01/1952 5 years 31/01/2027 01/05/2027 No 19/09/2024 PSUSA/00001860/202701 Zoubida Amimour France NAP
1867 lidocaine / prilocaine (not centrally authorised product) 01/04/1985 5 years 31/03/2027 29/06/2027 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00001867/202703 Karin Erneholm Denmark NAP
1868 lidocaine / tetracaine 29/06/2006 8 years 30/06/2028 28/09/2028 No 03/03/2021 DLP was updated on 03/03/2021
PRAC representative was added on 06/05/2020
LMS was added on 01/04/2020 PSUSA/00001868/202806 Jean-Michel Dogné Belgium NAP
1869 carrageenin / titanium dioxide / zinc oxide, carrageenin / lidocaine / titanium dioxide / zinc oxide, titanium dioxide / zinc oxide / tetracaine hydrochloride, carrageenin / lidocaine / titanium dioxide Not available* 8 years 15/06/2028 13/09/2028 No 02/04/2025 Active substance name was amended on 02/04/2025
DLP was updated on 03/03/2021
PRAC representative was added on 06/05/2020
LMS was added on 01/04/2020
DLP was updated on 05/06/2019
The active substance name was amended on 01/04/2015
The active substance name was amended on 01/12/2014 PSUSA/00001869/202806 none NAP
1879 lidocaine hydrochloride / methylprednisolone acetate Not available* 8 years 01/08/2028 30/10/2028 No 31/03/2021 DLP was updated on 31/03/2021
PRAC representative and LMS were added on 04/03/2020
DLP was updated on 05/06/2019 PSUSA/00001879/202808 Zane Neikena Latvia NAP
1887 lincomycin 01/01/1960 10 years 03/03/2034 01/06/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001887/203403 NAP
1888 linezolid 18/04/2000 3 years 17/04/2028 16/07/2028 No 17/02/2026 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 17/12/2025
DLP was amended on 17/12/2025
PSUR frequency and DLP were updated on 21/12/2022
PRAC representative was updated on 27/07/2022
PRAC representative was updated on 06/05/2020
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00001888/202804 Jana Pecherova Slovakia NAP
1890 liothyronine 16/12/1997 7 years 02/01/2031 02/04/2031 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00001890/203101 Dennis Lex Germany NAP
1891 levothyroxine sodium / liothyronine sodium Not available* 9 years 02/09/2031 01/12/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001891/203109 NAP
1892 liraglutide, insulin degludec / liraglutide 30/06/2009 3 years 31/12/2026 31/03/2027 No 01/07/2026 Active substance name was amended on 01/07/2026
DLP was amended on 25/09/2024 PSUSA/00001892/202612 Bianca Mulder Netherlands CAP
1897 lithium 20/02/1967 6 years 03/08/2029 01/11/2029 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00001897/202908 Dennis Lex Germany NAP
1898 lodoxamide 02/07/1990 8 years 03/06/2033 01/09/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001898/203306 Terhi Lehtinen Finland NAP
1899 lofepramine 27/02/1976 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001899/202808 NAP
1902 lomustine 26/01/1976 5 years 26/01/2028 25/04/2028 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00001902/202801 Miroslava Gocova Slovakia NAP
1905 lopinavir / ritonavir 20/03/2001 5 years 30/09/2029 29/12/2029 No 19/09/2024 PSUSA/00001905/202909 Zoubida Amimour France CAP
1906 loprazolam 10/07/1981 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001906/202811 NAP
1907 loratadine 01/10/1991 5 years 02/02/2027 03/05/2027 No 19/10/2022 DLP was updated on 19/10/2022
PRAC Representative amended on 28/04/2022
DLP was updated on 17/10/2017
PRAC Representative amended on 18/11/2016
Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00001907/202702 Jean-Michel Dogné Belgium NAP
1908 loratadine / pseudoephedrine 01/10/1991 5 years 02/02/2027 03/05/2027 No 19/10/2022 DLP was updated on 19/10/2022
PRAC Representative amended on 28/04/2022
DLP was updated on 17/10/2017
PRAC Representative amended on 18/11/2016
Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00001908/202702 Jean-Michel Dogné Belgium NAP
1909 lorazepam 31/12/1963 3 years 31/01/2028 30/04/2028 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00001909/202801 Karin Erneholm Denmark NAP
1910 lormetazepam 07/12/1980 3 years 31/12/2026 31/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00001910/202612 Sonja Hrabcik Austria NAP
1911 lornoxicam Not available* 7 years 01/12/2031 29/02/2032 No 19/09/2025 DLP was amended on 30/07/2025 PSUSA/00001911/203112 Maria Martinez Gonzalez Spain NAP
1912 losartan 02/09/1994 8 years 01/09/2033 30/11/2033 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00001912/203309 Bianca Mulder Netherlands NAP
1913 loteprednol 31/03/2003 7 years 03/05/2031 01/08/2031 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00001913/203105 Amelia Cupelli Italy NAP
1916 loxapine 20/12/1961 9 years 01/02/2028 01/05/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001916/202802 NAP
1918 lutropin alfa 29/11/2000 5 years 28/11/2027 26/02/2028 No 26/07/2023 PSUR frequency amended and DLP updated on 26/07/2023 PSUSA/00001918/202711 Marie Louise Schougaard Christiansen Denmark CAP
1919 lymecycline 31/01/1961 9 years 01/02/2028 01/05/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001919/202802 NAP
1920 lynestrenol 20/03/1973 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001920/202806 NAP
1924 macrogol 3350, macrogol 3350 combinations (oral use) 15/04/1991 5 years 31/05/2027 29/08/2027 No 25/06/2025 Active substance name was amended on 25/06/2025
PSUR frequency and DLP were updated on 01/02/2023
PRAC representative was updated on 27/07/2022
DLP was updated on 05/02/2020
PRAC representative was updated on 25/09/2019
Lead MS and PRAC Rapporteur name amended on 19/12/2018
Next DLP amended on 30/01/2017
PRAC Rappoerteur and Lead Member State added on 27/11/2015.
PSUSA number was amended on 06/10/2014 PSUSA/00001924/202705 Amelia Cupelli Italy NAP
1926 magnesium hydroxide 09/11/1970 5 years 31/10/2026 29/01/2027 No 27/02/2026 DLP was updated on 29/06/2022
DLP was updated on 21/07/2017
Lead MS and PRAC Rapporteur name was added on 03/06/2016 PSUSA/00001926/202610 Polona Golmajer Slovenia NAP
1928 magnesium orotate, magnesium lactate Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001928/202611 Melinda Palfi Hungary NAP
1929 ascorbic acid / magnesium oxide, magnesium oxide Not available* 7 years 03/06/2031 01/09/2031 Yes 18/12/2024 Active substance name was amended on 18/12/2024
PSUR frequency and DLP amended on 28/02/2024 PSUSA/00001929/203106 Adam Przybylkowski Poland NAP
1930 malathion 04/03/1992 18 years 04/03/2030 02/06/2030 No 01/10/2012 PSUSA/00001930/203003 NAP
1932 manidipine 29/06/1990 5 years 29/06/2029 27/09/2029 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00001932/202906 Amelia Cupelli Italy NAP
1933 maprotiline 23/09/1970 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001933/202805 NAP
1934 maraviroc 18/09/2007 5 years 05/08/2026 03/11/2026 No 02/06/2026 PSUSA/00001934/202608 Karin Bolin Sweden CAP
1936 measles / mumps / rubella / varicella vaccines (live) 26/07/2006 3 years 05/09/2027 04/12/2027 No 06/10/2025 DLP was amended on 30/04/2025 PSUSA/00001936/202709 Dirk Mentzer Germany CAP NAP
1937 measles / mumps / rubella vaccines (live, attenuated) 28/11/1997 3 years 04/05/2027 02/08/2027 No 06/10/2025 DLP was amended on 05/02/2025 PSUSA/00001937/202705 Dirk Mentzer Germany CAP NAP
1939 mebendazole 03/05/1971 15 years 03/05/2040 01/08/2040 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00001939/204005 Amelia Cupelli Italy NAP
1940 mebeverine 10/11/1964 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001940/202803 NAP
1942 mecasermin 03/08/2007 1 year 31/08/2026 09/11/2026 31/08/2027 09/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00001942/202608 PSUSA/00001942/202708 Terhi Lehtinen Finland CAP
1943 mecillinam 31/05/1977 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001943/202811 NAP
1945 meclozine 08/05/1953 15 years 31/08/2040 29/11/2040 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00001945/204008 Jo Robays Belgium NAP
1946 meclozine hydrochloride / pyridoxine hydrochloride Not available* 10 years 12/02/2035 13/05/2035 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001946/203502 NAP
1947 mecobalamin 22/02/1952 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001947/203212 NAP
1948 medazepam Not available* 9 years 02/09/2031 01/12/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001948/203109 NAP
1949 medrogestone Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001949/202611 Tiphaine Vaillant France NAP
1950 conjugated estrogens / medrogestone Not available* 9 years 03/03/2030 01/06/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001950/203003 NAP
1951 medroxyprogesterone 20/08/1959 5 years 19/08/2026 17/11/2026 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00001951/202608 none NAP
1954 mefenamic acid 28/03/1962 9 years 01/02/2028 01/05/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001954/202802 NAP
1955 mefloquine 20/02/1984 3 years 19/02/2026 20/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00001955/202602 Karen Pernille Harg Norway NAP
1956 mefruside / nifedipine 10/07/1984 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001956/202812 NAP
1957 megestrol 18/08/1971 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00001957/202806 NAP
1959 meglumine antimonate 22/01/1947 11 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001959/203611 NAP
1963 melatonin 29/06/2007 3 years 28/09/2026 27/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00001963/202609 Ana Sofia Diniz Martins Portugal CAP NAP
1965 melperone 17/01/1968 9 years 02/04/2028 01/07/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00001965/202804 NAP
1967 memantine 15/05/2002 5 years 15/09/2028 14/12/2028 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00001967/202809 Maria del Pilar Rayon Spain CAP NAP
1969 meningococcal group a, c, w135, y conjugate vaccine (conjugated to Corynebacterium diphtheriae CRM197 protein) 15/03/2010 5 years 14/03/2030 12/06/2030 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00001969/203003 Liana Martirosyan Netherlands CAP
1971 meningococcal group c polysaccharide conjugate vaccine 15/10/1999 3 years 15/10/2027 13/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00001971/202710 Jean-Michel Dogné Belgium NAP
1972 menotrophin Not available* 7 years 31/12/2031 30/03/2032 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00001972/203112 Veronika Macurová Czech Republic NAP
1974 mepartricin 28/02/1974 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001974/203503 NAP
1978 mephenoxalone Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001978/202611 Eva Jirsová Czech Republic NAP
1979 epinephrine / mepivacaine hydrochloride, mepivacaine / norepinephrine, mepivacaine 01/04/1956 7 years 31/03/2030 29/06/2030 No 20/12/2023 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00001979/203003 Karin Erneholm Denmark NAP
1982 mepivacaine hydrochloride / polyestradiol phosphate Not available* 11 years 03/05/2040 01/08/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001982/204005 NAP
1984 meptazinol Not available* 9 years 02/09/2031 01/12/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001984/203109 NAP
1985 mepyramine 31/12/1969 9 years 31/12/2031 30/03/2032 No 18/12/2024 PSUSA/00001985/203112 none NAP
1988 mercaptopurine 11/09/1953 3 years 01/09/2026 30/11/2026 No 02/06/2026 PSUSA/00001988/202609 Jenny-Maria Jönsson Sweden CAP NAP
1989 meropenem 31/08/1994 3 years 31/08/2027 29/11/2027 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00001989/202708 Jan Neuhauser Austria NAP
1990 mesalazine 20/02/1984 2 years 19/02/2026 20/05/2026 Yes 19/10/2022 DLP was updated on 19/10/2022
PRAC Rapporteur name was amended on 28/04/2022
LMS and PRAC representative and 'Are PSURs required for products referred to in Articles 10(1), 10a, 16a of Directive 2001/83/EC as amended' were updated on 28/07/2021
PSUR frequency and DLP were updated on 21/10/2020
Lead MS and PRAC Rapporteur name amended on 19/12/2018
The Next DLP was amended on 29/10/2015
Lead MS was added on 04/02/2015 PSUSA/00001990/202602 Marie Louise Schougaard Christiansen Denmark NAP
1991 mesna Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001991/202611 Adam Przybylkowski Poland NAP
1994 metacycline Not available* 10 years 03/08/2036 01/11/2036 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001994/203608 NAP
1995 metadoxine Not available* 9 years 02/12/2031 01/03/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001995/203112 NAP
1996 caffeine / drotaverine hydrochloride / metamizole sodium 24/11/1992 4 years 07/01/2028 06/04/2028 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00001996/202801 Miroslava Gocova Slovakia NAP
1997 metamizole 24/03/1923 3 years 24/03/2027 22/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00001997/202703 Melinda Palfi Hungary NAP
1998 hyoscine butylbromide / metamizole 03/11/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00001998/203406 NAP
1999 metamizole sodium / triacetonamine tosilate Not available* 5 years 01/01/2030 01/04/2030 Yes 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00001999/203001 Maria Popova-Kiradjieva Bulgaria NAP
2001 metformin 19/03/1959 3 years 01/04/2027 30/06/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00002001/202704 Amimour Zoubida France NAP
2002 glibenclamide / metformin hydrochloride 18/06/1993 4 years 18/06/2028 16/09/2028 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00002002/202806 Zoubida Amimour France NAP
2004 methadone 01/01/1930 5 years 01/05/2030 30/07/2030 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00002004/203005 Eamon O'Murchu Ireland NAP
2005 methenamine 02/08/1956 11 years 03/10/2037 01/01/2038 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002005/203710 NAP
2006 boric acid / calcium thiocyanate / camphor / menthol / methenamine Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002006/202906 NAP
2007 calcium thiocyanate / methenamine Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002007/202906 NAP
2011 methocarbamol, methocarbamol / paracetamol Not available* 10 years 01/12/2034 01/03/2035 No 30/07/2025 Active substance name was amended on 30/07/2025
PSUR frequency amended and DLP updated on 30/07/2025
PSUR frequency and DLP amended on 27/03/2024 PSUSA/00002011/203412 Dennis Lex Germany NAP
2014 methotrexate 01/01/1962 5 years 31/10/2030 29/01/2031 Yes 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
DLP was amended on 03/07/2024 PSUSA/00002014/203010 Dennis Lex Germany CAP NAP
2016 methoxsalen 31/03/1958 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002016/203401 NAP
2017 methoxy polyethylene glycol-epoetin beta 20/07/2007 3 years 19/07/2026 17/10/2026 No 19/09/2025 DLP was amended on 27/03/2024 PSUSA/00002017/202607 Maria Martinez Gonzalez Spain CAP
2019 methylaminolevulinate 15/06/2001 5 years 30/06/2027 28/09/2027 No 02/06/2026 PSUSA/00002019/202706 Jenny Jönsson Sweden NAP
2021 methyldopa 01/01/1960 9 years 01/02/2028 01/05/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002021/202802 NAP
2022 methylergometrine Not available* 9 years 02/12/2031 01/03/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002022/203112 NAP
2023 methylnaltrexone bromide 02/07/2008 3 years 27/03/2028 25/06/2028 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00002023/202803 Dennis Lex Germany CAP
2024 methylphenidate 06/10/1954 5 years 31/10/2029 29/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00002024/202910 Dennis Lex Germany CAP NAP
2025 methylphenobarbital Not available* 5 years 31/03/2028 29/06/2028 Yes 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00002025/202803 Benjamin Micallef Malta NAP
2026 methylprednisolone (systemic use) 18/12/1957 3 years 30/11/2026 28/02/2027 No 30/04/2025 DLP was corrected on 30/04/2025
PSUR frequency amended and DLP updated on 25/09/2024
Entry name updated on 25/09/2024
DLP was amended on 31/07/2024 PSUSA/00002026/202611 Jan Neuhauser Austria NAP
2029 methylthioninium chloride 03/11/1987 3 years 05/05/2026 03/08/2026 No 02/06/2026 PSUSA/00002029/202605 Karin Bolin Sweden CAP
2036 metoclopramide 17/11/1964 5 years 17/11/2029 15/02/2030 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00002036/202911 Karen Pernille Harg Norway NAP
2037 metolazone 01/01/1991 8 years 03/06/2033 01/09/2033 No 02/06/2026 PSUSA/00002037/203306 Karin Bolin Sweden NAP
2039 metoprolol 28/02/1975 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00002039/203303 Dennis Lex Germany NAP
2041 metronidazole 29/07/1959 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002041/202712 NAP
2042 metronidazole / miconazole, chlorquinaldol / metronidazole 18/12/1992 8 years 03/07/2033 01/10/2033 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00002042/203307 Eva Jirsová Czech Republic NAP
2045 metronidazole / spiramycin 29/07/1959 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002045/203401 NAP
2046 metyrapone 14/06/1961 6 years 14/06/2030 12/09/2030 Yes 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00002046/203006 Kimmo Jaakkola Finland NAP
2047 mexazolam Not available* 7 years 01/12/2031 29/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00002047/203112 John Joseph Borg Malta NAP
2048 mexiletine (nationally authorised products only) 06/10/1975 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002048/202808 NAP
2050 mianserin 01/01/1974 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002050/202806 NAP
2051 micafungin 25/04/2008 5 years 08/10/2029 06/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00002051/202910 Dennis Lex Germany CAP
2052 miconazole, hydrocortisone / miconazole nitrate, miconazole nitrate / zinc oxide, benzoyl peroxide / miconazole 31/07/1971 10 years 09/10/2034 07/01/2035 No 02/06/2026 PSUSA/00002052/203410 Jenny Jönsson Sweden NAP
2057 midazolam (all pharmaceutical forms and indications apart from oromucosal and nasal routes of administration) 10/09/1982 5 years 09/09/2027 08/12/2027 No 01/04/2026 Active substance name was amended on 01/04/2026
DLP was amended on 03/05/2023
DLP correction on 19/12/2018
DLP was updated on 06/06/2018
Name of entry was amended, and Lead MS added on 12/05/2015.
Name of entry was amended on 06/10/2014
Name of active substance was amended on 30/04/2013 PSUSA/00002057/202709 Dennis Lex Germany NAP
2058 midecamycin 24/05/1984 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002058/202812 NAP
2059 mifamurtide 06/03/2009 5 years 05/03/2027 03/06/2027 No 16/11/2022 PSUR frequency and DLP were updated on 16/11/2022
DLP was updated on 23/10/2019
PRAC Representative updated on 26/09/2018
PSUR Frequency amended and DLP updated on 19/10/2016
Next DLP was updated on 30/09/2015 PSUSA/00002059/202703 Bianca Mulder Netherlands CAP
2060 mifepristone 31/05/1988 3 years 31/05/2026 29/08/2026 No 02/06/2026 PSUSA/00002060/202605 Jenny Jönsson Sweden NAP
2062 miglustat (all other indications) 20/11/2002 5 years 19/10/2029 17/01/2030 No 02/06/2026 PSUSA/00002062/202910 Karin Bolin Sweden CAP
2063 milnacipran 06/12/1966 3 years 30/04/2028 29/07/2028 Yes 25/09/2024 DLP was amended on 25/09/2024
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/09/2024
DLP was updated on 02/02/2022
PRAC representative was updated on 29/07/2020
PRAC representative was updated on 03/06/2020
DLP was updated on 06/02/2019
PRAC representative was updated on 03/06/2020
PRAC Rapporteur name updated on 21/07/2017
PRAC Rapporteur name was amended on 28/07/2016
Next DLP was amended on 04/02/2016
Lead MS was added on 06/03/2015 PSUSA/00002063/202804 Tiphaine Vaillant France NAP
2064 milrinone 16/10/1987 3 years 16/10/2027 14/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00002064/202710 Jan Neuhauser Austria NAP
2065 minocycline 07/08/1961 5 years 31/08/2027 29/11/2027 No 03/05/2023 DLP was amended on 03/05/2023
PRAC Representative name was corrected on 29/07/2020
PRAC Representative updated on 26/09/2018
DLP was updated on 06/06/2018
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/03/2017
Lead MS and PRAC Rapporteur name was added on 28/02/2017 PSUSA/00002065/202708 Maria del Pilar Rayon Spain NAP
2066 minoxidil (non topical formulations) 18/10/1979 3 years 31/10/2028 29/01/2029 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
DLP was updated on 30/06/2021
PRAC Rapporteur name updated on 23/10/2018
Next DLP was amended on 28/07/2016
"Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended? Yes/No" was amended on 16/07/2015
Lead MS added on 16/06/2015 PSUSA/00002066/202810 Eamon O'Murchu Ireland NAP
2067 minoxidil (topical formulation) 18/10/1979 3 years 31/10/2026 29/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00002067/202610 Eamon O'Murchu Ireland NAP
2068 mirtazapine 01/09/1994 5 years 31/08/2028 29/11/2028 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00002068/202808 Liana Martirosyan Netherlands NAP
2074 mitomycin 05/10/1962 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002074/202803 NAP
2075 mitotane 28/04/2004 5 years 28/04/2028 27/07/2028 No 25/06/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/06/2025
PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00002075/202804 Maria del Pilar Rayon Spain CAP
2076 mitoxantrone 15/06/1981 3 years 30/06/2028 28/09/2028 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00002076/202806 Karin Erneholm Denmark NAP
2077 mivacurium 22/01/1992 10 years 31/01/2028 30/04/2028 No 23/10/2018 PRAC Rapporteur name updated on 23/10/2018
PSUR frequency amended and DLP updated on 23/10/2018
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 21/07/2017
Lead MS and PRAC Rapporteur name was added on 27/06/2017 PSUSA/00002077/202801 Eamon O'Murchu Ireland NAP
2078 mizolastine 21/11/1995 5 years 21/11/2027 19/02/2028 No 12/09/2025 Next DLP was updated on 26/07/2023 PSUSA/00002078/202711 Veronika Macurová Czech Republic NAP
2079 moclobemide 26/10/1989 5 years 01/04/2027 30/06/2027 No 21/12/2022 DLP was updated on 21/12/2022
PRAC Rapporteur name updated on 23/10/2018
PRAC Representative updated on 26/09/2018
DLP was updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00002079/202704 Liana Martirosyan Netherlands NAP
2084 molsidomine Not available* 9 years 02/12/2031 01/03/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002084/203112 NAP
2085 mometasone 22/01/1997 5 years 22/05/2028 20/08/2028 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00002085/202805 Karin Bolin Sweden NAP
2087 montelukast 25/08/1997 3 years 30/07/2027 28/10/2027 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00002087/202707 Kimmo Jaakkola Finland NAP
2088 morniflumate Not available* 8 years 03/11/2026 01/02/2027 No 05/01/2025 Correction of DLP on 20/11/2024
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002088/202611 Amelia Cupelli Italy NAP
2089 moroctocog alfa 13/04/1999 5 years 26/08/2029 24/11/2029 No 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00002089/202908 Marie Louise Schougaard Christiansen Denmark CAP
2093 caffeine / moxastine teoclate Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002093/204003 NAP
2094 moxifloxacin (topical ophthalmic use) 31/05/1999 5 years 31/05/2026 29/08/2026 No 02/02/2022 DLP was updated on 02/02/2022
Next DLP was amended on 30/01/2017
'Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?
Yes/No' was amended on 27/11/2015.
PRAC Rapporteur and Lead Member state was added on 27/11/2015
Name of active substance was amended on 21/12/2012 PSUSA/00002094/202605 Dennis Lex Germany NAP
2095 moxonidine 23/01/1991 5 years 23/01/2027 23/04/2027 No 19/10/2022 DLP was updated on 19/10/2022
PRAC representative was updated on 06/05/2020
DLP was updated on 17/10/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00002095/202701 Melinda Palfi Hungary NAP
2096 mupirocin 26/03/1985 5 years 31/03/2027 29/06/2027 No 21/12/2022 DLP was updated on 21/12/2022
PRAC representative was updated on 28/07/2021
PRAC representative was updated on 28/04/2021
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00002096/202703 Polona Golmajer Slovenia NAP
2100 nabilone Not available* 6 years 02/12/2029 02/03/2030 Yes 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00002100/202912 Jan Neuhauser Austria NAP
2101 nabumetone 15/03/1984 10 years 01/03/2027 30/05/2027 No 15/11/2017 PRAC Rapporteur name updated on 23/10/2018
PRAC Representative updated on 26/09/2018
PSUR frequency amended and DLP updated on 15/11/2017
Lead MS was added on 22/09/2016 PSUSA/00002101/202703 Liana Martirosyan Netherlands NAP
2102 nadifloxacin 06/07/2000 5 years 31/05/2026 29/08/2026 No 02/02/2022 DLP was updated on 02/02/2022
Next DLP updated on 30/01/2017
PRAC Rapporteur and Lead Member State added on 27/11/2015. PSUSA/00002102/202605 Dennis Lex Germany NAP
2103 nadolol 22/07/1976 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002103/202808 NAP
2104 nadroparin 04/03/1985 5 years 31/03/2026 29/06/2026 No 19/09/2025 PRAC Representative updated on 16/11/2022
PSUR frequency and DLP were updated on 22/12/2021
DLP was updated on 19/12/2018
PRAC Rapporteur name was amended on 25/09/2017
Next DLP was updated on 21/12/2015.
Lead MS was added on 06/03/2015 PSUSA/00002104/202603 Maria Martinez Gonzalez Spain NAP
2105 nafarelin 15/02/1990 5 years 14/02/2029 15/05/2029 No 20/10/2021 DLP was updated on 20/10/2021
DLP was updated on 23/10/2018
PRAC Rapporteur name was updated on 04/07/2018
PRAC Rapporteur name was amended on 27/06/2017
The DLP was amended on
29/10/2015
Lead MS was added on 04/02/2015 PSUSA/00002105/202902 Karen Pernille Harg Norway NAP
2107 naftazone 18/12/1987 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002107/202901 NAP
2108 naftidrofuryl 30/10/1970 9 years 06/03/2028 04/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002108/202803 NAP
2109 naftifine Not available* 8 years 01/08/2028 30/10/2028 No 31/03/2021 DLP was updated on 31/03/2021
PRAC representative was added on 06/05/2020
LMS was added on 01/04/2020
DLP was updated on 05/06/2019 PSUSA/00002109/202808 Maia Uusküla Estonia NAP
2110 nalbuphine 15/05/1979 5 years 01/05/2028 30/07/2028 Yes 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00002110/202805 Eva Jirsová Czech Republic NAP
2112 naloxone (for use in medical settings only) 14/04/1975 9 years 03/08/2028 01/11/2028 No 24/09/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002112/202808 Adam Przybylkowski Poland NAP
2113 buprenorphine / naloxone 26/09/2006 4 years 26/09/2027 25/12/2027 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00002113/202709 Dennis Lex Germany CAP NAP
2114 naloxone / oxycodone 31/05/2006 3 years 03/08/2026 01/11/2026 No 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00002114/202608 Dennis Lex Germany NAP
2117 naltrexone 20/11/1984 3 years 19/11/2025 17/02/2026 Yes 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00002117/202511 Eamon O'Murchu Ireland NAP
2118 nandrolone 01/01/1960 10 years 03/03/2034 01/06/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002118/203403 NAP
2120 methylthioninium / naphazoline Not available* 10 years 03/08/2036 01/11/2036 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002120/203608 NAP
2125 naproxen 04/08/1961 3 years 03/08/2026 01/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00002125/202608 Amelia Cupelli Italy NAP
2126 naratriptan 10/03/1997 5 years 28/02/2027 29/05/2027 No 16/11/2022 DLP was updated on 16/11/2022
PRAC Rapporteur name was amended on 31/07/2018
DLP was amended on 15/11/2017
Lead MS was added on 22/09/2016 PSUSA/00002126/202702 Karin Bolin Sweden NAP
2127 natalizumab 27/06/2006 3 years 07/08/2027 05/11/2027 No 06/10/2025 DLP was amended on 02/04/2025 PSUSA/00002127/202708 Dirk Mentzer Germany CAP
2129 nebivolol 18/10/1995 6 years 31/03/2030 29/06/2030 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00002129/203003 Bianca Mulder Netherlands NAP
2130 nedocromil 24/04/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002130/202812 NAP
2131 nefopam Not available* 5 years 30/03/2030 28/06/2030 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00002131/203003 Barbara Kovacic Bytyqi Croatia NAP
2132 nelarabine 22/08/2007 3 years 27/10/2026 25/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00002132/202610 Marie Louise Schougaard Christiansen Denmark CAP
2134 neomycin 24/06/1954 10 years 31/01/2034 01/05/2034 No 15/01/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002134/203401 Ana Sofia Diniz Martins Portugal NAP
2135 hydrocortisone / neomycin Not available* 11 years 02/04/2040 01/07/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002135/204004 NAP
2139 neomycin sulfate / nystatin / polymyxin b sulfate Not available* 8 years 03/11/2032 01/02/2033 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00002139/203211 Zoubida Amimour France NAP
2140 neomycin sulfate / nystatin / triamcinolone acetonide Not available* 6 years 02/12/2029 02/03/2030 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00002140/202912 Adam Przybylkowski Poland NAP
2143 nepafenac 11/12/2007 5 years 30/05/2027 28/08/2027 No 01/02/2023 PSUR frequency and DLP were updatde on 01/02/2023
PRAC Representative updated on 16/11/2022
Reference to NAP added on 29/06/2022
DLP was updated on 05/02/2020
Next DLP updated on 30/01/2017
PRAC Representative amended on 28/06/2016
PSUR Frequency amended and DLP updated on 04/02/2016
DLP was amended on 04/02/2015
Next DLP was amended on 31/01/2014
Next DLP was amended on 31/01/2014 PSUSA/00002143/202705 Maria del Pilar Rayon Spain CAP NAP
2146 netilmicin 01/01/1982 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002146/202811 NAP
2147 nevirapine 05/02/1998 5 years 06/05/2026 04/08/2026 No 02/02/2022 DLP and PSUR frequency were updated on 02/02/2022
DLP was updated on 06/02/2019
Reference to NAP removed on 15/11/2017
Correction of PRAC Rapporteur name on 28/02/2017
PRAC Rapporteur name was amended on 20/12/2016
Next DLP was amended on 04/02/2016
"Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?Yes/No" was amended on 06/03/2015 PSUSA/00002147/202605 Ana Sofia Diniz Martins Portugal CAP
2149 nicardipine 31/05/1981 3 years 31/05/2028 29/08/2028 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00002149/202805 Amelia Cupelli Italy NAP
2150 nicergoline 26/05/1972 5 years 25/05/2030 23/08/2030 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00002150/203005 Zane Neikena Latvia NAP
2151 niclosamide 23/03/1964 5 years 01/08/2028 30/10/2028 No 27/03/2024 PSUR frequency amended and DLP updated on 27/03/2024 PSUSA/00002151/202808 Amelia Cupelli Italy NAP
2152 nicorandil 09/02/1990 3 years 28/02/2026 29/05/2026 Yes 30/07/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/07/2025
DLP was amended on 25/06/2025
DLP was updated on 16/11/2022
DLP was updated on 20/11/2019
Next DLP was updated on 18/11/2016
Lead Member State was added on 30/09/2015 PSUSA/00002152/202602 Jan Neuhauser Austria NAP
2153 nicotine Not available* 10 years 01/12/2034 01/03/2035 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00002153/203412 Karin Erneholm Denmark NAP
2156 nifedipine 31/08/1993 8 years 31/08/2033 29/11/2033 No 27/05/2026 DLP was corrected on 27/05/2026
PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00002156/203308 Bianca Mulder Netherlands NAP
2157 niflumic acid Not available* 5 years 31/12/2029 31/03/2030 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00002157/202912 Melinda Palfi Hungary NAP
2158 nifuratel 04/05/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002158/203406 NAP
2159 nifuratel / nystatin 12/10/1976 9 years 02/09/2028 01/12/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002159/202809 NAP
2160 nifuroxazide 18/08/1992 5 years 18/08/2026 16/11/2026 No 13/08/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/09/2024
PSUR frequency and DLP were updated on 28/04/2022
PSUR frequency, DLP and Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended" were updated on 06/05/2020
LMS and PRAC representatives were added on 31/07/2019
PSUR Frequency and Next DLP amended on 16/07/2015 PSUSA/00002160/202608 Veronika Macurová Czech Republic NAP
2162 nilotinib 19/11/2007 3 years 31/01/2027 01/05/2027 No 22/09/2021 PRAC Rapporteur name was amended on 28/04/2022
DLP and PSUR frequency were updated on 22/09/2021
PRAC representative was updated on 31/03/2021
DLP was updated on 23/09/2020
PRAC representative and DLP were updated on 25/09/2019
PRAC Rapporteur name was amended on 03/04/2019
DLP was updated on 26/09/2018
Next DLP was amended on 25/09/2017
Next DLP was updated on 22/09/2016
Next DLP was updated on 30/09/2015 PSUSA/00002162/202701 Marie Louise Schougaard Christiansen Denmark CAP
2163 nilutamide 02/07/1986 6 years 02/07/2030 30/09/2030 No 05/03/2025 DLP was amended on 05/03/2025 PSUSA/00002163/203007 Bianca Mulder Netherlands NAP
2165 nimesulide (topical formulations) 10/12/1999 5 years 30/06/2028 28/09/2028 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00002165/202806 Amelia Cupelli Italy NAP
2166 nimodipine 01/11/1987 5 years 01/11/2028 30/01/2029 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00002166/202811 Karen Pernille Harg Norway NAP
2169 nitisinone 21/02/2005 3 years 20/02/2028 20/05/2028 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00002169/202802 Amelia Cupelli Italy CAP
2170 nitrazepam 02/03/1965 3 years 02/03/2027 31/05/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00002170/202703 Karin Erneholm Denmark NAP
2171 nitrendipine 31/03/1985 3 years 31/03/2027 29/06/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00002171/202703 Jan Neuhauser Austria NAP
2172 nitric oxide 23/12/1999 3 years 23/12/2027 22/03/2028 Yes 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00002172/202712 Jo Robays Belgium CAP NAP
2173 nitrofural Not available* 11 years 03/05/2040 01/08/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002173/204005 none NAP
2174 nitrofurantoin, nitrofurantoin / pyridoxine hydrochloride 28/02/1953 5 years 28/02/2026 29/05/2026 No 05/08/2025 Active substance name was amended on 18/10/2023
PSUR frequency and DLP were updated on 17/11/2021
Active substance name was amended on 22/09/2021
PRAC Rapporteur name was amended on 06/03/2019
DLP was updated on 21/11/2018
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 17/10/2017
The next DLP was amended on 29/10/2015.
Lead MS was added on 04/02/2015
Name of active substance was amended on 03/07/2013 PSUSA/00002174/202602 Lina Seibokiene Lithuania NAP
2181 nomegestrol Not available* 3 years 31/01/2027 01/05/2027 No 20/10/2021 DLP was updated on 20/10/2021
DLP was updated on 23/10/2018
The next DLP was amended on 29/10/2015
Lead MS was added on 04/02/2015 PSUSA/00002181/202701 Adam Przybylkowski Poland NAP
2182 estradiol / nomegestrol acetate 27/07/2011 5 years 26/01/2029 26/04/2029 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00002182/202901 Zoubida Amimour France CAP NAP
2183 nonacog alfa 27/08/1997 5 years 10/08/2028 08/11/2028 No 06/10/2025 PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00002183/202808 Dirk Mentzer Germany CAP
2186 nordazepam Not available* 9 years 02/12/2031 01/03/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002186/203112 NAP
2187 norepinephrine 30/10/1962 9 years 03/03/2028 01/06/2028 No 26/07/2023 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 26/07/2023
Update of PSUR frequency & DLP resulting from PRAC re-allocation exercise for entries with DLPs in 2025 on 26/07/2023 PSUSA/00002187/202803 none NAP
2188 norethisterone 29/04/1971 5 years 06/08/2027 04/11/2027 No 05/04/2023 DLP was updated on 05/04/2023
DLP was updated on 07/05/2018
PRAC representative and Lead Member State were added on 30/01/2017 PSUSA/00002188/202708 Kimmo Jaakkola Finland NAP
2190 norfloxacin 04/11/1982 13 years 04/06/2036 02/09/2036 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00002190/203606 Maria del Pilar Rayon Spain NAP
2192 nortriptyline 31/03/1963 5 years 31/03/2028 29/06/2028 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00002192/202803 Maia Uusküla Estonia NAP
2193 diazepam / nortriptyline hydrochloride 17/03/1969 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002193/203408 NAP
2194 noscapine Not available* 10 years 03/08/2036 01/11/2036 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002194/203608 NAP
2195 nystatin 13/08/1954 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002195/203401 NAP
2197 obidoxime 29/01/1964 11 years 03/07/2039 01/10/2039 No 15/01/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002197/203907 Dennis Lex Germany NAP
2199 octenidine dihydrochloride / phenoxyethanol Not available* 10 years 01/01/2032 31/03/2032 Yes 21/09/2022 PSUR frequency and DLP were updated on 21/09/2022
PRAC Rapporteur name was amended on 06/03/2019
Next DLP was amended on 25/09/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016
PSUR Frequency and DLP was amended on 27/11/2015 PSUSA/00002199/203201 Rugile Pilviniene Lithuania NAP
2200 octocog alfa 04/08/2000 5 years 26/08/2030 24/11/2030 No 27/05/2026 DLP was corrected on 27/05/2026
PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00002200/203008 Dirk Mentzer Germany CAP NAP
2201 octreotide (for nationally authorised products) 23/06/1995 3 years 30/06/2026 28/09/2026 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00002201/202606 Eamon O'Murchu Ireland NAP
2203 ofloxacin (systemic use) 16/04/1985 5 years 16/04/2030 15/07/2030 No 17/12/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 17/12/2025
PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00002203/203004 Petar Mas Croatia NAP
2204 ofloxacin (topical use) 02/05/1989 5 years 16/04/2029 15/07/2029 No 18/12/2024 PSUR frequency amended and DLP updated on 18/12/2024 PSUSA/00002204/202904 Petar Mas Croatia NAP
2207 olmesartan 25/04/2002 5 years 24/10/2026 22/01/2027 No 29/06/2022 DLP was updated on 29/06/2022
PRAC Rapporteur name was amended on 31/07/2018
Next DLP was amended on 27/06/2017
PRAC representative and Lead Member State were added on 03/05/2016
The DLP was amended on 08/01/2014
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00002207/202610 Dennis Lex Germany NAP
2208 amlodipine / olmesartan 25/04/2012 5 years 24/04/2027 23/07/2027 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00002208/202704 Bianca Mulder Netherlands NAP
2209 hydrochlorothiazide / olmesartan 25/04/2002 5 years 24/10/2026 22/01/2027 No 29/06/2022 DLP was updated on 29/06/2022
PRAC Rapporteur name was amended on 31/07/2018
Next DLP was amended on 27/06/2017
PRAC representative and Lead Member State were added on 03/05/2016
EURD and DLP were amended on 08/01/2014 PSUSA/00002209/202610 Dennis Lex Germany NAP
2210 amlodipine besilate / hydrochlorothiazide / olmesartan medoxomil 02/12/2010 5 years 24/04/2027 23/07/2027 No 12/09/2025 DLP was updated on 21/12/2022
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was amended on 31/01/2018
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00002210/202704 Veronika Macurová Czech Republic NAP
2211 olopatadine 17/05/2002 5 years 30/04/2029 29/07/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00002211/202904 Eamon O Murchu Ireland CAP NAP
2213 olsalazine 01/06/1986 5 years 31/05/2027 29/08/2027 No 01/02/2023 DLP was updated on 01/02/2023
DLP was amended on 31/01/2018
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00002213/202705 Terhi Lehtinen Finland NAP
2214 omalizumab 25/10/2005 3 years 31/12/2025 31/03/2026 No 02/06/2026 PSUSA/00002214/202512 Karin Bolin Sweden CAP
2215 omeprazole 15/04/1987 5 years 15/04/2027 14/07/2027 No 21/12/2022 DLP was updated on 21/12/2022
PRAC representative was updated was updated on 04/03/2020
DLP was updated and PRAC Representative amended on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00002215/202704 Liana Martirosyan Netherlands NAP
2216 omoconazole 23/09/1987 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002216/202901 NAP
2217 ondansetron 23/02/1990 3 years 28/02/2027 29/05/2027 No 17/11/2021 DLP was updated on 17/11/2021
PRAC representative was updated on 28/07/2021
PRAC representative was updated on 28/04/2021
DLP was updated on 21/11/2018
Lead MS was amended on 22/09/2016
The next DLP was amended on 29/10/2015
Lead MS was added on 04/02/2015
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00002217/202702 Polona Golmajer Slovenia NAP
2218 opipramol 12/10/1961 9 years 01/02/2028 01/05/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002218/202802 NAP
2220 orlistat 08/08/1997 3 years 07/02/2028 07/05/2028 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00002220/202802 Zoubida Amimour France CAP NAP
2221 ornidazole 19/06/1979 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002221/202811 NAP
2224 orphenadrine / paracetamol, orphenadrine Not available* 10 years 03/08/2036 01/11/2036 No 23/10/2024 Active substance name was amended on 23/10/2024
PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00002224/203608 none NAP
2225 oseltamivir 20/06/2002 5 years 20/09/2029 19/12/2029 No 23/10/2024 Reference to NAP removed on 23/10/2024
DLP was updated on 25/05/2022
DLP was updated on 05/06/2019
Reference to NAP added on 31/01/2018
Next DLP was amended on 03/06/2016 PSUSA/00002225/202909 Terhi Lehtinen Finland CAP
2226 otilonium bromide 08/09/1976 9 years 02/09/2028 01/12/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002226/202809 NAP
2227 oxaceprol 15/10/1977 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002227/202811 NAP
2228 oxacillin 01/01/1962 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00002228/203405 NAP
2229 oxaliplatin 12/04/1996 5 years 12/04/2029 11/07/2029 Yes 18/12/2024 PSUR frequency amended and DLP updated on 18/12/2024 PSUSA/00002229/202904 Tiphaine Vaillant France NAP
2234 oxazepam 11/12/1963 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002234/202803 NAP
2235 oxcarbazepine 10/08/1999 3 years 31/08/2027 29/11/2027 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00002235/202708 Karin Erneholm Denmark NAP
2237 oxeladin 06/06/1967 10 years 03/07/2034 01/10/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002237/203407 NAP
2240 oxetorone 20/08/1973 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002240/202806 NAP
2241 oxiconazole Not available* 10 years 03/08/2036 01/11/2036 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002241/203608 NAP
2244 oxitriptan Not available* 9 years 03/03/2032 01/06/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002244/203203 NAP
2246 oxolamine 18/06/1960 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002246/203906 NAP
2247 oxolamine / propyphenazone 05/03/1963 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00002247/203405 NAP
2249 oxomemazine 11/03/1964 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002249/203406 NAP
2250 oxprenolol 26/02/1968 11 years 01/02/2040 01/05/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002250/204002 none NAP
2251 oxybuprocaine 20/03/1957 11 years 03/10/2037 01/01/2038 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002251/203710 NAP
2253 oxybutynin 17/07/1984 5 years 17/07/2027 15/10/2027 No 05/04/2023 DLP was updated on 05/04/2023
PRAC representative was updated on 19/10/2022
PRAC Representative amended on 28/04/2022
DLP was updated on 27/03/2018
PRAC Representative amended on 18/11/2016 PSUSA/00002253/202707 Jo Robays Belgium CAP NAP
2254 oxycodone 12/12/1995 3 years 12/04/2027 11/07/2027 No 20/11/2024 PSUR frequency amended and DLP updated on 20/11/2024 PSUSA/00002254/202704 Liana Martirosyan Netherlands NAP
2255 acetylsalicylic acid / oxycodone hydrochloride Not available* 9 years 03/03/2029 01/06/2029 Yes 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002255/202903 NAP
2256 oxycodone hydrochloride / paracetamol Not available* 3 years 03/07/2027 01/10/2027 Yes 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00002256/202707 Amelia Cupelli Italy NAP
2257 oxygen Not available* 7 years 01/12/2031 29/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00002257/203112 Amelia Cupelli Italy NAP
2258 oxymetazoline 31/05/1962 6 years 01/08/2026 30/10/2026 No 31/03/2021 DLP was updated on 31/03/2021
PSUR frequency, DLP and PRAC rapporteur were updated on 05/06/2019 PSUSA/00002258/202608 Maia Uusküla Estonia NAP
2261 oxymorphone Not available* 9 years 03/03/2032 01/06/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002261/203203 NAP
2262 oxytetracycline, hydrocortisone / oxytetracycline, hydrocortisone / oxytetracycline / polymyxin b, oxytetracycline / polymyxin b 31/05/1950 11 years 03/06/2040 01/09/2040 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024
Entry name updated on 25/09/2024 PSUSA/00002262/204006 none NAP
2264 paclitaxel 29/12/1992 5 years 28/12/2026 28/03/2027 No 20/05/2026 Reference to CAP removed on 28/02/2024
PSUR frequency and DLP were updated on 21/09/2022
DLP was updated on 31/07/2019
New CAP authorised on 20/11/2018
PRAC Representative updated on 26/09/2018
Next DLP was updated on 22/09/2016
Lead MS was added on 13/07/2015 PSUSA/00002264/202612 Ana Sofia Diniz Martins Portugal NAP
2266 paliperidone 25/06/2007 3 years 30/06/2027 28/09/2027 No 05/03/2025 DLP was amended on 05/03/2025 PSUSA/00002266/202706 Karin Bolin Sweden CAP
2267 palivizumab 13/08/1999 5 years 18/06/2029 16/09/2029 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00002267/202906 Marie Louise Schougaard Christiansen Denmark CAP
2268 palonosetron 22/03/2005 5 years 24/07/2030 22/10/2030 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00002268/203007 Rhea Fitzgerald Ireland CAP NAP
2269 pamidronate 02/05/1989 5 years 31/05/2026 29/08/2026 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00002269/202605 Bianca Mulder Netherlands NAP
2273 amylase / bromelain / chymotrypsin / lipase / pancreatin / papain / rutoside / trypsin, trypsin/ bromelain/ rutoside trihydrate Not available* 9 years 03/03/2029 01/06/2029 No 12/09/2025 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002273/202903 Veronika Macurová Czech Republic NAP
2275 pancuronium 01/01/1991 6 years 01/12/2025 01/03/2026 Yes 15/01/2025 DLP was updated on 29/07/2020
PRAC Rapporteur name updated on 23/10/2018
PRAC Representative and Lead Member state assigned on 04/07/2018
Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00002275/202512 Dennis Lex Germany NAP
2281 pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) 19/10/2009 3 years 19/05/2027 17/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00002281/202705 Liana Martirosyan Netherlands CAP
2283 panitumumab 03/12/2007 5 years 30/09/2030 29/12/2030 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
PSUR frequency amended and DLP updated on 03/05/2023
DLP was updated on 25/05/2022
DLP was updated on 26/05/2021
DLP was updated on 06/05/2020
DLP was updated on 30/04/2019
Lead MS and PRAC Rapporteur name updated on 23/10/2018
DLP was updated on 07/05/2018
DLP was updated on 23/05/2017
PRAC Representative amended on 28/03/2017
Next DLP was amended on 03/05/2016
Conditional approval
Next DLP was amended on 28/05/2014 PSUSA/00002283/203009 David Olsen Norway CAP
2285 pantoprazole 23/08/1994 5 years 23/08/2027 21/11/2027 No 03/05/2023 DLP was amended on 03/05/2023
LMS and PRAC representative updated 05/06/2019
DLP was updated on 07/05/2018
PRAC Representative amended on 28/03/2017 PSUSA/00002285/202708 Rugile Pilviniene Lithuania CAP NAP
2286 amoxicillin / clarithromycin / pantoprazole 23/08/1994 3 years 03/08/2028 01/11/2028 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00002286/202808 Dennis Lex Germany NAP
2287 papaverine 21/02/1950 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002287/203212 NAP
2289 paracetamol (non IV formulations) 21/12/1959 11 years 03/05/2039 01/08/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002289/203905 NAP
2290 acetylsalicylic acid / paracetamol Not available* 8 years 03/11/2033 01/02/2034 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00002290/203311 none NAP
2291 acetylsalicylic acid / caffeine / paracetamol 24/10/1972 15 years 01/12/2038 01/03/2039 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00002291/203812 Dennis Lex Germany NAP
2294 caffeine / paracetamol 24/06/1969 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002294/204003 NAP
2297 caffeine / paracetamol / phenylephrine hydrochloride Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002297/202906 NAP
2298 caffeine / paracetamol / propyphenazone, paracetamol / propyphenazone Not available* 8 years 01/12/2025 01/03/2026 No 27/01/2026 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00002298/202512 Roxana Stefania Udrescu Romania NAP
2300 dextromethorphan hydrobromide / paracetamol / promethazine hydrochloride Not available* 7 years 03/11/2031 01/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00002300/203111 John Joseph Borg Malta NAP
2302 caffeine / guaifenesin / paracetamol Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002302/202906 NAP
2303 hyoscine butylbromide / paracetamol 10/08/1983 8 years 03/05/2033 01/08/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00002303/203305 Dennis Lex Germany NAP
2305 ascorbic acid / caffeine / paracetamol / phenylephrine hydrochloride / terpine Not available* 8 years 03/11/2033 01/02/2034 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00002305/203311 Melinda Pálfi Hungary NAP
2306 guaifenesin / paracetamol / phenylephrine hydrochloride Not available* 8 years 03/08/2026 01/11/2026 No 18/11/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002306/202608 Maia Uusküla Estonia NAP
2307 paracetamol / pseudoephedrine, dextromethorphan / paracetamol / pseudoephedrine, ascorbic acid / dextromethorphan / paracetamol / pseudoephedrine Not available* 5 years 28/06/2028 26/09/2028 Yes 01/07/2026 Lead MS and PRAC Rapporteur name removed on 01/07/2026
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 23/10/2024
Active substance name was amended on 23/10/2024
DLP was amended on 28/02/2024 PSUSA/00002307/202806 none NAP
2308 ascorbic acid / paracetamol / pseudoephedrine Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002308/202905 NAP
2310 paracetamol / tramadol Not available* 5 years 01/08/2028 30/10/2028 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00002310/202808 Tiphaine Vaillant France NAP
2311 paracetamol (IV formulation) Not available* 5 years 07/05/2026 05/08/2026 Yes 02/02/2022 DLP and PSUR frequency were updated on 02/02/2022
PRAC representative was updated on 29/07/2020
PRAC representative was updated on 03/06/2020
PSUR frequency amended and DLP updated on 19/12/2018
DLP was updated on 19/12/2017
PRAC Rapporteur name updated on 21/07/2017
Next DLP was amended on 20/12/2016
PRAC Rapporteur name was amended on 28/07/2016
Next DLP was updated on 21/12/2015.
Lead MS was added on 06/03/2015 PSUSA/00002311/202605 Tiphaine Vaillant France NAP
2312 caffeine / codeine / paracetamol / propyphenazone, acetylsalicylic acid / caffeine / codeine / paracetamol 01/06/1957 5 years 01/06/2030 30/08/2030 Yes 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00002312/203006 Petar Mas Croatia NAP
2314 parecoxib 22/03/2002 3 years 31/03/2026 29/06/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00002314/202603 Rhea Fitzgerald Ireland CAP
2316 paricalcitol 17/04/1998 5 years 17/08/2027 15/11/2027 No 19/09/2025 PSUR frequency amended and DLP updated on 03/05/2023
PRAC Representative updated on 16/11/2022
DLP was updated on 06/05/2020
PRAC Representative updated on 26/09/2018
Next DLP was amended on 26/04/2017
PRAC representative and Lead Member State were added on 04/03/2016 PSUSA/00002316/202708 Maria Martinez Gonzalez Spain NAP
2318 paromomycin 29/11/1960 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002318/203404 NAP
2319 paroxetine 11/12/1990 5 years 10/12/2027 09/03/2028 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00002319/202712 Liana Martirosyan Netherlands NAP
2320 patent blue V sodium 31/03/1974 5 years 30/04/2028 29/07/2028 Yes 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00002320/202804 Melinda Palfi Hungary NAP
2321 pazopanib 14/06/2010 5 years 18/10/2029 16/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00002321/202910 Marie Louise Schougaard Christiansen Denmark CAP
2322 pefloxacin 07/08/1984 3 years 31/08/2026 29/11/2026 Yes 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00002322/202608 Polona Golmajer Slovenia NAP
2326 pegfilgrastim 31/01/2002 5 years 31/01/2030 01/05/2030 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00002326/203001 Bianca Mulder Netherlands CAP
2328 pegvisomant 13/11/2002 3 years 30/11/2025 28/02/2026 No 19/09/2024 PSUSA/00002328/202511 Zoubida Amimour France CAP
2329 pelargonium sidoides dc and/or pelargonium reniforme curt. / radix Not available* 5 years 01/06/2028 30/08/2028 Yes 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00002329/202806 Melinda Palfi Hungary NAP
2330 pemetrexed 20/09/2004 5 years 04/02/2029 05/05/2029 No 05/06/2024 New CAP authorised on 09/12/2022
DLP was updated on 20/10/2021
PRAC representative was updated on 29/07/2020
PRAC representative was updated on 03/06/2020
DLP was updated on 23/10/2018
Reference to NAP added on 25/09/2017
PRAC Rapporteur name updated on 21/07/2017
PRAC Rapporteur name was amended on 28/07/2016
PRAC Rapporteur name updated on 03/06/2016
Next DLP was updated on 30/09/2015 PSUSA/00002330/202902 Tiphaine Vaillant France CAP NAP
2333 penciclovir 28/02/1996 5 years 28/08/2026 26/11/2026 No 28/04/2022 DLP was updated on 28/04/2022
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 23/05/2017
Lead MS and PRAC Rapporteur name was added on 07/04/2016 PSUSA/00002333/202608 Jan Neuhauser Austria NAP
2335 penicillamine 04/04/1963 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002335/202803 NAP
2336 pentaerithrityl tetranitrate Not available* 9 years 03/03/2032 01/06/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002336/203203 NAP
2337 pentagastrin 09/11/1981 10 years 03/05/2035 01/08/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002337/203505 NAP
2338 pentamidine 15/06/1988 5 years 15/06/2027 13/09/2027 No 01/03/2023 DLP was updated on 01/03/2023
PRAC representative was updated on 19/10/2022
PRAC Representative amended on 28/04/2022
DLP was updated on 28/02/2018
PRAC representative and Lead Member State were added on 18/11/2016 PSUSA/00002338/202706 Jo Robays Belgium NAP
2339 pentazocine 15/09/1966 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002339/202803 NAP
2341 pentosan polysulfate sodium (apart from centrally authorised product) 13/06/1961 10 years 02/04/2034 01/07/2034 No 05/01/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002341/203404 Melinda Palfi Hungary NAP
2343 pentostatin Not available* 8 years 03/11/2026 01/02/2027 No 05/01/2025 Correction of DLP on 20/11/2024
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002343/202611 Marie Louise Schougaard Christiansen Denmark NAP
2344 pentoxifylline 14/05/1967 9 years 02/04/2028 01/07/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002344/202804 NAP
2345 pentoxyverine 15/12/1954 5 years 31/12/2028 31/03/2029 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00002345/202812 Dennis Lex Germany NAP
2347 peptidic preparation from porcine brain (cerebrolysin) Not available* 10 years 03/08/2036 01/11/2036 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002347/203608 NAP
2350 perflutren 18/05/1998 5 years 27/12/2029 27/03/2030 No 02/06/2026 PSUSA/00002350/202912 Karin Bolin Sweden CAP
2352 periciazine 09/05/1963 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00002352/203405 NAP
2354 perindopril 22/06/1988 5 years 22/10/2030 20/01/2031 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00002354/203010 Karin Erneholm Denmark NAP
2355 permethrin Not available* 3 years 31/08/2026 29/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00002355/202608 Dennis Lex Germany NAP
2356 perphenazine 15/10/1952 10 years 01/01/2034 01/04/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002356/203401 NAP
2357 pethidine 28/03/1941 5 years 01/08/2030 30/10/2030 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00002357/203008 Melinda Palfi Hungary NAP
2358 phenazone Not available* 9 years 03/03/2032 01/06/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002358/203203 NAP
2359 lidocaine / phenazone Not available* 5 years 01/01/2030 01/04/2030 Yes 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00002359/203001 Rugile Pilviniene Lithuania NAP
2363 phenelzine 01/03/1962 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00002363/203405 NAP
2368 paracetamol / pheniramine hydrogenomaleate / phenylephrine hydrochloride, ascorbic acid / paracetamol / pheniramine maleate, ascorbic acid / paracetamol / pheniramine hydrogenomaleate / phenylephrine hydrochloride 06/06/1980 8 years 07/03/2028 05/06/2028 No 22/10/2025 Active substance name was amended on 22/10/2025
DLP was updated on 18/11/2020
PRAC representative was added on 06/05/2020
LMS was added on 31/07/2019 PSUSA/00002368/202803 Maia Uusküla Estonia NAP
2370 phenobarbital 27/01/1943 8 years 27/01/2028 26/04/2028 No 21/10/2020 DLP was updated on 21/10/2020
PRAC representative was added on 06/05/2020
LMS was added on 01/04/2020
PSUR frequency, "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?Yes/No" and DLP were updated on 25/09/2019 PSUSA/00002370/202801 Maia Uusküla Estonia NAP
2373 phenoxymethylpenicillin 01/06/1956 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002373/202712 NAP
2374 phenprocoumon 16/02/1955 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002374/202712 NAP
2376 phentolamine 02/04/1951 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002376/203212 NAP
2377 phenylbutazone 19/02/1952 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002377/203212 NAP
2382 ascorbic acid / guaifenesin / paracetamol / phenylephrine hydrochloride Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002382/202905 NAP
2386 mepyramine / phenylephrine Not available* 9 years 02/09/2031 01/12/2031 No 18/12/2024 Active substance name was amended on 18/12/2024
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002386/203109 none NAP
2387 paracetamol / phenylephrine hydrochloride Not available* 9 years 03/03/2032 01/06/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002387/203203 NAP
2392 phenytoin 12/08/1960 3 years 12/08/2026 10/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00002392/202608 Eamon O'Murchu Ireland NAP
2393 metylphenobarbital / phenytoin sodium 20/04/1950 10 years 01/12/2032 01/03/2033 No 18/10/2023 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?", PSUR frequency and DLP were amended on 18/10/2023 PSUSA/00002393/203212 none NAP
2398 phosphocreatine Not available* 8 years 03/11/2032 01/02/2033 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00002398/203211 Amelia Cupelli Italy NAP
2400 phytomenadione, menadiol 01/01/1954 10 years 01/01/2034 01/04/2034 No 23/10/2024 Active substance name was amended on 23/10/2024
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002400/203401 none NAP
2402 phytosterol Not available* 10 years 03/08/2036 01/11/2036 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002402/203608 NAP
2403 picloxydine 13/04/1962 11 years 03/07/2039 01/10/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002403/203907 NAP
2408 pilocarpine / timolol 13/02/1989 5 years 15/07/2026 13/10/2026 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00002408/202607 Karin Erneholm Denmark NAP
2409 pilocarpine (non ophthalmic formulations) 01/04/1994 5 years 31/07/2027 29/10/2027 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00002409/202707 Petar Mas Croatia NAP
2410 pilocarpine (ophthalmic formulation) 01/04/1994 7 years 31/08/2028 29/11/2028 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00002410/202808 Petar Mas Croatia NAP
2411 pimecrolimus 14/12/2001 3 years 31/03/2026 29/06/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00002411/202603 Marie Louise Schougaard Christiansen Denmark NAP
2413 pimozide 15/02/1971 12 years 15/02/2037 16/05/2037 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00002413/203702 Jo Robays Belgium NAP
2414 pinaverium 01/12/1975 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002414/202808 NAP
2415 pindolol 10/11/1969 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002415/202805 NAP
2417 glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone 13/10/2000 3 years 31/07/2027 29/10/2027 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00002417/202707 Rhea Fitzgerald Ireland CAP
2420 pipamperone 14/10/1965 15 years 14/10/2040 12/01/2041 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00002420/204010 Dennis Lex Germany NAP
2422 pipecuronium Not available* 9 years 03/05/2032 01/08/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002422/203205 NAP
2424 piperacillin 07/05/1980 8 years 03/03/2026 01/06/2026 Yes 30/07/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/07/2025
PSUR frequency amended and DLP updated on 03/07/2024 PSUSA/00002424/202603 Amelia Cupelli Italy NAP
2425 piperacillin / tazobactam 02/07/1992 5 years 01/09/2027 30/11/2027 No 17/02/2026 DLP was amended on 03/05/2023
PRAC representative was updated on 27/07/2022
PRAC representative was updated on 06/05/2020
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 06/06/2018
Lead MS and PRAC Rapporteur name was added on 28/02/2017 PSUSA/00002425/202709 Jana Pecherova Slovakia NAP
2426 piperazine Not available* 10 years 03/11/2036 01/02/2037 No 15/01/2025 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00002426/203611 Ana Sofia Diniz Martins Portugal NAP
2429 piracetam 19/04/1971 5 years 30/04/2027 29/07/2027 No 01/02/2023 DLP was updated on 01/02/2023
DLP was amended on 31/01/2018
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00002429/202704 Terhi Lehtinen Finland NAP
2430 dihydroergocristine / piracetam Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002430/203011 NAP
2431 pirenoxine Not available* 7 years 01/01/2032 31/03/2032 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00002431/203201 Amelia Cupelli Italy NAP
2434 piretanide / ramipril, piretanide 17/10/1980 8 years 03/08/2033 01/11/2033 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00002434/203308 Zoubida Amimour France NAP
2435 pirfenidone 28/02/2011 3 years 27/02/2027 28/05/2027 No 20/10/2021 New CAP authorised on 10/01/2023
New CAP authorised on 20/06/2022
DLP and PSUR frequency were updated on 20/10/2021
DLP was updated on 21/10/2020
DLP was updated on 25/09/2019
Lead MS and PRAC Rapporteur name updated on 30/04/2019
DLP was updated on 26/09/2018
DLP was updated on 17/10/2017
Next DLP was amended on 19/10/2016
Next DLP was updated on 30/09/2015
Next DLP was amended on 02/05/2014 PSUSA/00002435/202702 Rhea Fitzgerald Ireland CAP
2436 piribedil 10/10/1990 3 years 31/03/2026 29/06/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00002436/202603 Zane Neikena Latvia NAP
2437 piritramide 01/04/1969 5 years 31/03/2030 29/06/2030 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00002437/203003 Jo Robays Belgium NAP
2438 piroxicam 03/04/1979 3 years 01/04/2026 30/06/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00002438/202604 Melinda Palfi Hungary NAP
2441 fenpiverinium bromide / metamizole sodium / pitofenone hydrochloride Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002441/203011 NAP
2443 metamizole sodium / pitofenone hydrochloride Not available* 7 years 01/12/2031 29/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00002443/203112 Miroslava Gocova Slovakia NAP
2444 pivampicillin 31/10/1974 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002444/202808 NAP
2445 pivmecillinam 31/05/1977 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002445/202811 NAP
2446 pizotifen 14/07/1969 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002446/202805 NAP
2451 plerixafor 31/07/2009 3 years 15/12/2025 15/03/2026 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00002451/202512 Bianca Mulder Netherlands CAP
2453 pneumococcal polysaccharide vaccine 06/02/1981 3 years 03/05/2028 01/08/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00002453/202805 Pernille Harg Norway NAP
2454 podophyllotoxin Not available* 6 years 15/09/2026 14/12/2026 No 02/02/2026 DLP was updated on 26/05/2021
PRAC representative and LMS were added on 04/03/2020
PSUR frequency and DLP were updated on 05/06/2019 PSUSA/00002454/202609 Rhea Fitzgerald Ireland NAP
2455 policresulen Not available* 8 years 01/12/2026 01/03/2027 No 23/10/2024 DLP amended on 23/10/2024 PSUSA/00002455/202612 NAP
2456 lauromacrogol 400 / urea Not available* 8 years 01/12/2026 01/03/2027 No 01/07/2026 Active substance name was amended on 01/07/2026
DLP amended on 23/10/2024 PSUSA/00002456/202612 Dennis Lex Germany NAP
2459 poliovirus type 1 / poliovirus type 2 / poliovirus type 3 vaccine (inactivated) 02/07/1982 5 years 01/07/2030 29/09/2030 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024
Entry re-introduced and entry name changed on 04/03/2020 PSUSA/00002459/203007 none NAP
2468 polygeline Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002468/203611 NAP
2469 polymyxin b 01/01/1956 11 years 01/12/2036 01/03/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002469/203612 NAP
2470 polymyxin b / trimethoprim Not available* 9 years 03/05/2032 01/08/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002470/203205 NAP
2472 polystyrene sulfonate 26/10/1955 8 years 26/10/2030 24/01/2031 No 12/09/2025 PSUR frequency amended and DLP updated on 31/05/2023
DLP and Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was updated on 29/06/2022
PSUR frequency, DLP and
PRAC representative and PSURs required for products referred to in Articles 10(1), 10a, 16a of Directive 2001/83/EC as amended? were updated on 30/06/2021
LMS were added on 01/04/2020
The DLP was amended on 30/09/2015 PSUSA/00002472/203010 Veronika Macurová Czech Republic NAP
2475 povidone, polyvinyl alcohol / povidone 01/01/1981 8 years 02/09/2033 01/12/2033 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00002475/203309 Adam Przybylkowski Poland NAP
2476 polyvinyl alcohol 27/08/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002476/203406 NAP
2478 poractant alfa 06/08/1992 5 years 31/08/2030 29/11/2030 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00002478/203008 Terhi Lehtinen Finland NAP
2480 posaconazole 25/10/2005 3 years 25/10/2026 23/01/2027 No 19/09/2024 PSUSA/00002480/202610 Zoubida Amimour France CAP NAP
2481 potassium / sodium Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00002481/202612 Amelia Cupelli Italy NAP
2483 potassium chloride Not available* 9 years 03/05/2032 01/08/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002483/203205 NAP
2485 potassium iodate 06/03/1978 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002485/203503 NAP
2486 perchlorates Not available* 7 years 20/03/2026 18/06/2026 Yes 05/08/2025 DLP was amended on 28/05/2025
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025
PSUR frequency and DLP amended on 27/03/2024 PSUSA/00002486/202603 Jan Neuhauser Austria NAP
2487 povidone iodinated 24/04/1996 5 years 02/01/2029 02/04/2029 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00002487/202901 Zoubida Amimour France NAP
2488 allantoine / povidone iodinated Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002488/202903 NAP
2489 prajmalium 22/12/1972 10 years 31/01/2035 01/05/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002489/203501 NAP
2490 pralidoxime 02/07/1968 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002490/203408 NAP
2491 pramipexole 14/10/1997 3 years 06/04/2026 05/07/2026 No 15/11/2023 PSUR frequency amended and DLP updated on 15/11/2023 PSUSA/00002491/202604 Karin Erneholm Denmark CAP NAP
2492 pramiracetam Not available* 5 years 30/09/2029 29/12/2029 No 03/06/2020 DLP was updated on 03/06/2020
Next DLP amended on 13/07/2015
'PRAC Rapporteur name amended on 16/06/2015
PRAC Rapporteur name and country updated on 01/12/2014 PSUSA/00002492/202909 Zane Neikena Latvia NAP
2498 estradiol / prasterone enantate Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002498/203506 NAP
2499 prasugrel 23/02/2009 5 years 25/02/2029 26/05/2029 No 20/10/2021 DLP was updated on 20/10/2021
PRAC Rapporteur name was corrected on 03/04/2019
PSUR Frequency and DLP updated on 26/09/2018
PRAC Rapporteur name was amended on 06/06/2018
DLP was updated and PRAC representative amended on 17/10/2017
Next DLP was updated on 22/09/2016
Next DLP was updated on 30/09/2015
The next DLP was amended on 01/04/2014 PSUSA/00002499/202902 Marie Louise Schougaard Christiansen Denmark CAP
2500 pravastatin 31/03/1989 5 years 30/03/2028 28/06/2028 No 19/09/2024 PSUSA/00002500/202803 Zoubida Amimour France NAP
2502 prazepam 18/12/1974 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00002502/203303 Jo Robays Belgium NAP
2503 praziquantel 30/04/1980 3 years 30/04/2027 29/07/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00002503/202704 Zoubida Amimour France NAP
2504 prazosin 24/05/1974 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002504/202808 NAP
2505 prednicarbate 02/10/1985 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002505/202812 NAP
2506 prednisolone 13/07/1956 6 years 03/08/2029 01/11/2029 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00002506/202908 Polona Golmajer Slovenia NAP
2507 prednisolone / salicylic acid Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00002507/202612 Petar Mas Croatia NAP
2508 estradiol benzoate / prednisolone / salicylic acid Not available* 8 years 03/05/2026 01/08/2026 No 23/09/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002508/202605 Dennis Lex Germany NAP
2510 prednisone 18/05/1955 8 years 31/01/2033 01/05/2033 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00002510/203301 Karin Erneholm Denmark NAP
2511 pregabalin 06/07/2004 3 years 31/01/2026 01/05/2026 No 18/10/2023 PSUR frequency amended and DLP updated on 18/10/2023 PSUSA/00002511/202601 Liana Martirosyan Netherlands CAP NAP
2512 prenoxdiazin hydrochloride 26/05/1965 13 years 26/05/2026 24/08/2026 No 18/11/2025 Entry reintroduced and renamed 24/09/2025 PSUSA/00002512/202605 Melinda Palfi Hungary NAP
2522 prilocaine 01/01/1963 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002522/202803 NAP
2524 felypressin / prilocaine hydrochloride Not available* 10 years 12/02/2035 13/05/2035 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002524/203502 NAP
2525 primidone 30/06/1953 8 years 30/06/2028 28/09/2028 No 03/03/2021 DLP was updated on 03/03/2021
LMS and PRAC representative were added on 04/03/2020
PSUR frequency, "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?Yes/No" and DLP were updated on 25/09/2019 PSUSA/00002525/202806 Dennis Lex Germany NAP
2527 probenecid 01/05/1960 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002527/203404 NAP
2528 procainamide Not available* 11 years 03/05/2040 01/08/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002528/204005 NAP
2529 procaine Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002529/203611 NAP
2533 phenazone / procaine hydrochloride Not available* 11 years 03/05/2040 01/08/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002533/204005 none NAP
2534 procarbazine 07/10/1966 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002534/202803 NAP
2536 perazine 06/12/1957 9 years 02/12/2027 01/03/2028 No 31/01/2024 Active substance name, PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00002536/202712 none NAP
2537 procyanidolic oligomers 11/05/1977 10 years 11/05/2032 09/08/2032 No 01/02/2023 DLP was updated on 01/02/2023
LMS and PRAC representative were added on 20/10/2021 PSUSA/00002537/203205 Melinda Palfi Hungary NAP
2538 procyclidine 07/03/1953 10 years 01/01/2034 01/04/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002538/203401 NAP
2540 progesterone 09/09/1971 10 years 09/09/2035 08/12/2035 No 02/06/2026 PSUSA/00002540/203509 Jenny Jönsson Sweden NAP
2541 proglumetacin 01/02/1980 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002541/202811 Carla Torre Portugal NAP
2543 promazine 13/04/1956 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002543/203401 NAP
2544 promegestone 31/07/1981 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002544/202811 NAP
2545 promethazine 26/10/1948 9 years 26/04/2033 25/07/2033 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00002545/203304 Eva Jirsová Czech Republic NAP
2547 carbocisteine / promethazine hydrochloride Not available* 13 years 03/11/2026 01/02/2027 Yes 28/05/2025 DLP was amended on 28/05/2025
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025
DLP was amended on 19/10/2023 PSUSA/00002547/202611 Amelia Cupelli Italy NAP
2550 propafenone 10/12/1978 5 years 31/01/2026 01/05/2026 No 20/10/2021 DLP was updated on 20/10/2021
PRAC representative was updated on 28/07/2021
PRAC representative was updated on 28/04/2021
Lead MS and PRAC Rapporteur name amended on 19/12/2018
Next DLP was amended on 19/10/2016
The DLP was amended on 30/09/2015
Lead MS was added on 13/07/2015 PSUSA/00002550/202601 Polona Golmajer Slovenia NAP
2554 propiverine 22/10/1981 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002554/202811 NAP
2555 propofol 08/11/1995 5 years 07/11/2027 05/02/2028 No 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00002555/202711 Karen Pernille Harg Norway NAP
2558 propylthiouracil Not available* 7 years 31/01/2032 30/04/2032 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00002558/203201 Maia Uusküla Estonia NAP
2562 protamine 31/12/1951 11 years 31/12/2034 31/03/2035 No 18/12/2024 PSUR frequency amended and DLP updated on 18/12/2024 PSUSA/00002562/203412 none NAP
2563 human protein C 16/07/2001 5 years 31/07/2030 29/10/2030 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00002563/203007 Dirk Mentzer Germany CAP NAP
2564 prothipendyl 07/10/2005 3 years 07/10/2028 05/01/2029 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00002564/202810 Jan Neuhauser Austria NAP
2565 protionamide Not available* 7 years 31/01/2027 01/05/2027 Yes 30/07/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/07/2025
DLP was amended on 30/07/2025
PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00002565/202701 Dennis Lex Germany NAP
2567 proxymetacaine 01/03/1971 10 years 02/09/2034 01/12/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002567/203409 NAP
2568 prucalopride 15/10/2009 3 years 14/10/2028 12/01/2029 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026 PSUSA/00002568/202810 Karin Bolin Sweden CAP
2569 prulifloxacin 21/06/2004 3 years 30/09/2026 29/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00002569/202609 Amelia Cupelli Italy NAP
2578 pyrantel 30/12/1970 10 years 02/09/2034 01/12/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002578/203409 NAP
2579 pyrazinamide 25/01/1956 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002579/202712 NAP
2580 pyridostigmine 01/12/1953 10 years 01/01/2034 01/04/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002580/203401 NAP
2582 pyrimethamine 01/01/1952 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002582/203212 NAP
2583 pyrimethamine / sulfadoxine 14/07/1970 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002583/202805 NAP
2584 pyrithione zinc Not available* 9 years 03/06/2032 01/09/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002584/203206 NAP
2585 pyritinol 17/01/1960 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002585/203404 NAP
2587 pyrvinium Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002587/203611 NAP
2589 quetiapine 31/07/1997 3 years 31/07/2026 29/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00002589/202607 Liana Martirosyan Netherlands NAP
2590 quinagolide 29/06/1993 10 years 31/07/2027 29/10/2027 No 02/06/2026 PSUSA/00002590/202707 Jenny Jönsson Sweden NAP
2591 quinapril 14/04/1989 5 years 13/04/2026 12/07/2026 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00002591/202604 Karin Erneholm Denmark NAP
2592 hydrochlorothiazide / quinapril 14/04/1989 5 years 13/04/2026 12/07/2026 No 27/01/2026 DLP was updated on 22/12/2021
Next DLP was amended on 20/12/2016
Lead Member State and PRAC Rapporteur added on 27/11/2015. PSUSA/00002592/202604 Roxana Stefania Udrescu Romania NAP
2598 quinine 15/01/1951 5 years 30/11/2026 28/02/2027 No 27/07/2022 DLP was updated on 27/07/2022
PRAC Rapporteur name updated on 23/10/2018
Next DLP was amended on 25/09/2017
PRAC representative and Lead Member State were added on 30/01/2017
Next DLP was amended on 03/06/2016
The 8 digit unique identification
number was corrected. PSUSA/00002598/202611 Eamon O'Murchu Ireland NAP
2600 quinisocaine Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00002600/202612 Dennis Lex Germany NAP
2601 rabeprazole 14/10/1997 5 years 13/10/2026 11/01/2027 No 29/06/2022 DLP was updated on 29/06/2022
EURD corrected on 05/06/2019
Next DLP was amended on 27/06/2017
PSUR Frequency amended and DLP updated on 28/06/2016
Lead MS added on 16/06/2015
The DLP was amended on 01/04/2014 PSUSA/00002601/202610 Jan Neuhauser Austria NAP
2602 racecadotril Not available* 5 years 31/03/2028 29/06/2028 No 19/09/2025 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00002602/202803 Maria Martinez Gonzalez Spain NAP
2603 raloxifene 05/08/1998 5 years 09/12/2028 09/03/2029 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00002603/202812 Terhi Lehtinen Finland CAP
2605 raltitrexed 11/08/1995 8 years 02/09/2033 01/12/2033 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00002605/203309 Veronika Macurová Czech Republic NAP
2607 ramipril 10/01/1989 6 years 03/08/2029 01/11/2029 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00002607/202908 Dennis Lex Germany NAP
2609 ranibizumab 22/01/2007 3 years 05/10/2028 03/01/2029 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00002609/202810 Karin Bolin Sweden CAP
2610 ranitidine 15/06/1981 5 years 31/05/2029 29/08/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00002610/202905 Amelia Cupelli Italy NAP
2611 ranolazine 09/07/2008 3 years 26/01/2027 26/04/2027 No 02/06/2026 PSUSA/00002611/202701 Karin Bolin Sweden CAP
2612 rasagiline 21/02/2005 5 years 02/01/2029 02/04/2029 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00002612/202901 Ana Sofia Diniz Martins Portugal CAP NAP
2613 rasburicase 23/02/2001 5 years 23/02/2028 23/05/2028 No 18/10/2023 PSUR frequency amended and DLP updated on 18/10/2023 PSUSA/00002613/202802 Bianca Mulder Netherlands CAP
2615 reboxetine 10/04/1997 5 years 09/04/2030 08/07/2030 No 24/09/2024 DLP was updated on 16/12/2020
Lead MS and PRAC Rapporteur name amended on 19/12/2018
Next DLP amended on 21/12/2015
Lead MS was added on 06/03/2015 PSUSA/00002615/203004 Karin Bolin Sweden NAP
2616 regadenoson 10/04/2008 3 years 09/04/2027 08/07/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00002616/202704 Maria del Pilar Rayon Spain CAP
2617 remifentanil 17/05/1996 5 years 16/05/2026 14/08/2026 No 02/02/2022 DLP and PSUR frequency were updated on 02/02/2022
PRAC representative and LMS were added on 23/09/2020
"Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?Yes/No" was amended on 12/05/2015 PSUSA/00002617/202605 Dennis Lex Germany NAP
2618 repaglinide 17/08/1998 5 years 31/12/2025 31/03/2026 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00002618/202512 Bianca Mulder Netherlands CAP NAP
2620 resorcinol Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002620/203611 NAP
2625 retinol 13/10/1966 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002625/202803 NAP
2633 a-tocopherol / ergocalciferol / phytomenadion / retinol palmitate Not available* 10 years 03/11/2035 01/02/2036 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002633/203511 Miroslava Gocova Slovakia NAP
2638 haemophilus influenzae / membrane fraction of klebsiella pneumoniae / ribosomal fractions of klebsiella pneumoniae / streptococcus pneumoniae / streptococcus pyogenes vaccine 30/03/1989 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002638/202901 NAP
2639 rifabutin 19/10/1992 11 years 03/07/2036 01/10/2036 No 04/03/2026 PSUR frequency amended and DLP updated on 04/03/2026 PSUSA/00002639/203607 Marie Louise Schougaard Christiansen Denmark NAP
2640 rifampicin 01/05/1968 5 years 03/03/2030 01/06/2030 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00002640/203003 Maria Popova-Kiradjieva Bulgaria NAP
2641 rifamycin 01/04/1962 11 years 01/04/2034 30/06/2034 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00002641/203404 Marie Louise Schougaard Christiansen Denmark NAP
2642 rifaximin 14/09/1985 8 years 03/05/2033 01/08/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00002642/203305 Melinda Pálfi Hungary NAP
2643 rilmenidine 23/04/1987 5 years 23/08/2029 21/11/2029 No 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00002643/202908 Melinda Palfi Hungary NAP
2645 riluzole 10/12/1995 5 years 12/12/2028 12/03/2029 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00002645/202812 Karin Erneholm Denmark CAP NAP
2648 risedronate, risedronate / calcium / colecalciferol 31/03/1998 5 years 31/03/2026 29/06/2026 No 02/06/2026 PSUSA/00002648/202603 Karin Bolin Sweden NAP
2649 risperidone 01/06/1993 5 years 31/05/2027 29/08/2027 No 26/07/2023 Reference to CAP added and active substance name was amended on 26/07/2023
DLP was updated on 01/02/2023
Active substance name updated on 02/03/2022
DLP was amended on 31/01/2018
Lead MS and PRAC Rapporteur name was added on 19/10/2016
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 19/10/2016 PSUSA/00002649/202705 Dennis Lex Germany CAP NAP
2650 ritodrine hydrochloride Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00002650/202612 Pilar Rayón Iglesias Spain NAP
2651 ritonavir 26/08/1996 5 years 31/08/2028 29/11/2028 No 29/04/2026 PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00002651/202808 Liana Martirosyan Netherlands CAP
2652 rituximab 02/06/1998 3 years 17/11/2026 15/02/2027 No 28/08/2024 New CAP authorised on 19/09/2024
PSUR frequency amended and DLP updated on 28/08/2024
DLP was amended on 03/07/2024 PSUSA/00002652/202611 Karin Erneholm Denmark CAP
2653 rivaroxaban, acetylsalicylic acid / rivaroxaban 30/09/2008 3 years 15/09/2027 14/12/2027 No 02/06/2026 PSUSA/00002653/202709 Karin Bolin Sweden CAP NAP
2654 rivastigmine 12/05/1998 5 years 31/01/2029 01/05/2029 No 25/09/2019 Reference to NAP added on 23/10/2024
PRAC representative was updated on 29/07/2020
PRAC representative was updated on 03/06/2020
PSUR frequency and DLP were updated on 25/09/2019
Reference to NAP products removed on 04/07/2018
PRAC Rapporteur name updated on 21/07/2017
PSUR Frequency amended and DLP updated on 22/09/2016
PRAC Rapporteur name was amended on 28/07/2016
Next DLP was updated on 30/09/2015
Rapporteur amended on 04/11/2014 PSUSA/00002654/202901 Tiphaine Vaillant France CAP NAP
2655 rizatriptan 11/02/1998 5 years 11/06/2028 09/09/2028 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00002655/202806 Liana Martirosyan Netherlands NAP
2656 rocuronium 17/03/1994 5 years 28/02/2030 29/05/2030 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00002656/203002 Eva Jirsová Czech Republic NAP
2658 roflumilast 05/07/2010 5 years 05/01/2029 05/04/2029 No 19/09/2025 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00002658/202901 Maria Martinez Gonzalez Spain CAP
2660 romiplostim 04/02/2009 5 years 31/07/2027 29/10/2027 No 19/09/2025 PSUR frequency amended and DLP updated on 05/04/2023
DLP was updated on 01/04/2020
PSUR Frequency amended and DLP updated on 28/02/2017
PRAC Representative amended on 28/06/2016
Next DLP was updated on 04/03/2016
The DLP was amended on 06/03/2015
The DLP was amended on 01/04/2014 PSUSA/00002660/202707 Maria Martinez Gonzalez Spain CAP
2661 ropinirole 08/07/1996 3 years 08/07/2028 06/10/2028 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00002661/202807 Tiphaine Vaillant France NAP
2662 ropivacaine 15/09/1995 5 years 14/09/2027 13/12/2027 No 06/06/2018 Next DLP was updated on 31/05/2023 PSUSA/00002662/202709 Liana Martirosyan Netherlands NAP
2664 rosuvastatin 06/11/2002 5 years 06/11/2027 04/02/2028 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00002664/202711 Bianca Mulder Netherlands NAP
2665 rotavirus vaccine monovalent (live, oral) 21/02/2006 3 years 11/07/2028 09/10/2028 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00002665/202807 Jean-Michel Dogné Belgium CAP
2666 rotavirus vaccine pentavalent (live, oral) 27/06/2006 3 years 27/11/2026 25/02/2027 No 02/06/2026 PSUSA/00002666/202611 Karin Bolin Sweden CAP
2667 rotigotine 15/02/2006 3 years 15/02/2026 16/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00002667/202602 Ana Sofia Diniz Martins Portugal CAP
2669 roxithromycin 04/08/1986 3 years 31/12/2027 30/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00002669/202712 Amelia Cupelli Italy NAP
2671 rufinamide 16/01/2007 5 years 15/01/2028 14/04/2028 No 25/06/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/06/2025
DLP and PSUR frequency amended on 20/09/2023 PSUSA/00002671/202801 Tiphaine Vaillant France CAP
2673 rupatadine 12/12/2005 5 years 30/12/2028 30/03/2029 No 19/09/2025 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00002673/202812 Maria Martinez Gonzalez Spain NAP
2674 rutoside 31/10/1962 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00002674/203405 NAP
2679 salicylamide Not available* 8 years 01/12/2026 01/03/2027 No 23/10/2024 DLP amended on 23/10/2024 PSUSA/00002679/202612 NAP
2680 salicylic acid (topical use) Not available* 6 years 02/12/2029 02/03/2030 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00002680/202912 Dennis Lex Germany NAP
2681 salmeterol 25/10/1990 5 years 31/10/2030 29/01/2031 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00002681/203010 Karin Bolin Sweden NAP
2682 samarium (153sm) lexidronam 05/02/1998 5 years 04/02/2029 05/05/2029 No 25/09/2019 PSUR frequency, DLP and PRAC representative were updated on 25/09/2019
Lead MS and PRAC Rapporteur name updated on 30/04/2019
PRAC Representative amended on 28/03/2017
Next DLP was updated on 22/09/2016 PSUSA/00002682/202902 Karin Erneholm Denmark CAP
2683 sapropterin 02/12/2008 3 years 01/12/2027 29/02/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00002683/202712 Eamon O Murchu Ireland CAP
2685 saxagliptin, metformin / saxagliptin 01/10/2009 3 years 30/07/2026 28/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00002685/202607 Bianca Mulder Netherlands CAP
2687 secnidazole Not available* 9 years 03/06/2032 01/09/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002687/203206 NAP
2688 selegiline 14/03/1980 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00002688/203303 Veronika Macurová Czech Republic NAP
2690 selenium Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00002690/202612 Dennis Lex Germany NAP
2693 serrapeptase 30/09/1968 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002693/203408 NAP
2694 sertaconazole 10/03/1992 10 years 03/06/2035 01/09/2035 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00002694/203506 Ana Sofia Martins Portugal NAP
2695 sertindole 11/07/2002 3 years 11/01/2026 11/04/2026 Yes 20/09/2023 DLP amended on 20/09/2023 PSUSA/00002695/202601 Melinda Palfi Hungary NAP
2696 sertraline 01/03/1990 5 years 31/03/2027 29/06/2027 No 21/12/2022 DLP was updated on 21/12/2022
PRAC Rapporteur name updated on 23/10/2018
PRAC Representative updated on 26/09/2018
DLP was updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016
Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00002696/202703 Liana Martirosyan Netherlands NAP
2697 sevelamer 30/10/1998 3 years 30/10/2027 28/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00002697/202710 Jo Robays Belgium CAP NAP
2698 sevoflurane 23/01/1990 5 years 31/01/2030 01/05/2030 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00002698/203001 Eamon O'Murchu Ireland NAP
2699 sildenafil (indicated for erectile dysfunction) 14/09/1998 5 years 31/12/2026 31/03/2027 No 21/09/2022 DLP was updated on 21/09/2022
Reference to NAP added on 25/05/2022
PSUR Frequency amended and next DLP updated on 25/09/2017
PSUSA procedure published on 01/04/2014. Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00002699/202612 Liana Martirosyan Netherlands CAP NAP
2700 sildenafil (indicated for pulmonary hypertension) 28/10/2005 3 years 31/05/2027 29/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00002700/202705 Bianca Mulder Netherlands CAP NAP
2701 silodosin 29/01/2010 3 years 30/01/2026 30/04/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00002701/202601 Amelia Cupelli Italy CAP
2702 silver sulfadiazine 25/01/1973 8 years 15/09/2033 14/12/2033 No 27/05/2026 PSUR frequency amended and DLP updated on 27/05/2026
DLP was updated on 26/05/2021
PRAC representative was added on 06/05/2020
LMS was added on 01/04/2020
PSUR frequency and DLP were updated on 05/06/2019 PSUSA/00002702/203309 Maia Uusküla Estonia NAP
2703 cerium nitrate / silver sulfadiazine 25/01/1973 10 years 31/01/2035 01/05/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002703/203501 NAP
2705 simeticone, pancreatin / simeticone, dimethicone / pancreatin, pancreatic enzymes, pancreatic extracts, pancreatin 28/04/1967 9 years 02/04/2028 01/07/2028 No 18/10/2023 Active substance name, PSUR frequency and DLP were amended on 18/10/2023
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00002705/202804 none NAP
2706 aluminium oxide / magnesium hydroxide / simeticone Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002706/202903 NAP
2709 simvastatin 06/04/1988 5 years 05/04/2030 04/07/2030 No 16/12/2020 PSUR frequency and DLP were updated on 16/12/2020
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016
Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00002709/203004 Terhi Lehtinen Finland NAP
2710 sirolimus (for prophylaxis of organ rejection indication) 13/03/2001 3 years 14/09/2026 13/12/2026 No 02/06/2026 PSUSA/00002710/202609 Karin Bolin Sweden CAP
2713 sobrerol Not available* 9 years 03/06/2032 01/09/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002713/203206 NAP
2719 sodium benzoate / sodium phenylacetate Not available* 9 years 03/06/2032 01/09/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002719/203206 NAP
2723 sodium bicarbonate / sodium hydrogen phoshate / sodium sulphate 11/01/1966 11 years 02/12/2039 01/03/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002723/203912 NAP
2724 solutions for haemofiltration and haemodiafiltration, solutions for haemodialysis Not available* 9 years 03/08/2032 01/11/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002724/203208 none NAP
2731 succinylated gelatin, sodium chloride / sodium hydroxide / succinylated gelatin, calcium chloride / magnesium chloride / potassium chloride / sodium acetate /sodium chloride / succinylated gelatin, gelatin / sodium chloride / potassium chloride / magnesium chloride hexahydrate / sodium lactate 27/09/2006 15 years 26/09/2033 25/12/2033 No 23/10/2024 PSUR frequency amended and DLP updated on 23/10/2024
EURD added on 23/10/2024
Active substance name was amended on 01/04/2020
Active substance name was amended on 05/02/2020 PSUSA/00002731/203309 Liana Martirosyan Netherlands NAP
2732 sodium chloride / urea Not available* 8 years 01/12/2026 01/03/2027 No 23/10/2024 DLP amended on 23/10/2024 PSUSA/00002732/202612 NAP
2735 sodium citrate / sodium lauryl sulfoacetate, sodium citrate / sodium lauryl sulfoacetate / sorbitol Not available* 7 years 31/01/2032 30/04/2032 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00002735/203201 Zoubida Amimour France NAP
2737 disodium hydrogen phosphate / sodium dihydrogen phosphate, phosphate sodium 06/01/2005 13 years 06/01/2038 06/04/2038 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00002737/203801 Guðrún Stefánsdóttir Iceland NAP
2738 disodium edetate dihydrate / sodium dihydrogen phosphate dihydrate / sodium hydrogen phosphate dodecahydrate / water for injection Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002738/203011 none NAP
2739 glucose monohydrate / sodium dihydrogen phosphate dihydrate / zinc acetate dihydrate Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002739/203103 NAP
2745 sodium glycerophosphate pentahydrate Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00002745/202612 Jo Robays Belgium NAP
2748 sodium hydrogen carbonate Not available* 9 years 03/08/2032 01/11/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002748/203208 NAP
2752 sodium iodide (123i) 31/01/1995 7 years 31/03/2027 29/06/2027 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00002752/202703 Karin Erneholm Denmark NAP
2753 sodium iodide (131i) 01/10/1973 5 years 01/03/2027 30/05/2027 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00002753/202703 Carla Torre Portugal NAP
2756 sodium nitroprusside 30/11/1976 9 years 02/09/2028 01/12/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002756/202809 NAP
2758 sodium phenylbutyrate 08/12/1999 3 years 31/12/2027 30/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00002758/202712 Rhea Fitzgerald Ireland CAP
2759 sodium picosulfate 01/10/1967 9 years 02/04/2028 01/07/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002759/202804 NAP
2760 liquid paraffin / sodium picosulfate Not available* 13 years 03/06/2040 01/09/2040 No 23/10/2024 DLP amended on 23/10/2024 PSUSA/00002760/204006 NAP
2767 sodium tetradecyl sulphate Not available* 3 years 30/04/2026 29/07/2026 Yes 12/09/2025 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00002767/202604 Veronika Macurová Czech Republic NAP
2769 solifenacin 08/06/2004 5 years 08/06/2030 06/09/2030 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00002769/203006 Liana Martirosyan Netherlands NAP
2770 somatorelin 01/01/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002770/202812 NAP
2771 somatostatin 03/12/1989 8 years 03/06/2033 01/09/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00002771/203306 Maria Martinez Gonzalez Spain NAP
2772 somatropin 28/04/1988 3 years 31/03/2026 29/06/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00002772/202603 Karin Erneholm Denmark CAP NAP
2773 sorafenib 19/07/2006 5 years 31/12/2029 31/03/2030 No 02/06/2026 PSUSA/00002773/202912 Jenny-Maria Jönsson Sweden CAP NAP
2774 sotalol 22/08/1973 7 years 21/08/2031 19/11/2031 No 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00002774/203108 Karin Erneholm Denmark NAP
2775 spaglumic acid Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002775/203211 NAP
2777 spectinomycin 21/08/1970 10 years 02/09/2034 01/12/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002777/203409 NAP
2778 spiramycin 08/02/1955 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002778/202712 NAP
2780 spironolactone 01/03/1962 3 years 08/03/2027 06/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00002780/202703 Terhi Lehtinen Finland CAP NAP
2781 altizide / spironolactone 21/01/1964 3 years 21/01/2027 21/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00002781/202701 Barbara Kovacic Bytyqi Croatia NAP
2786 bacterial lysate of haemophilus influenzae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus / streptococcus mitis / streptococcus pneumoniae / streptococcus pyogenes, bacterial lysate of haemophilus influenzae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus / streptococcus pneumoniae / streptococcus pyogenes, streptococcus pneumoniae / streptococcus agalactiae / staphylococcus aureus / haemophilus influenzae 11/01/1974 5 years 31/03/2026 29/06/2026 No 06/10/2025 PRAC representative was updated on 01/03/2023
DLP was updated on 22/12/2021
Entry name and EURD were amended on 31/01/2018
Next DLP was amended on 20/12/2016
DLP was corrected on 04/02/2016.
Active Substance and DLP was amended on 21/12/2015.
PRAC representative name was amended on 31/07/2015
Active Substance name amended on 16/07/2015
Lead MS was added on 04/02/2015 PSUSA/00002786/202603 Dirk Mentzer Germany NAP
2788 stibogluconate 30/03/1966 10 years 03/07/2034 01/10/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002788/203407 NAP
2789 stiripentol 04/01/2007 1 year 04/11/2026 13/01/2027 04/11/2027 13/01/2028 Yes 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00002789/202611 PSUSA/00002789/202711 Maia Uusküla Estonia CAP NAP
2791 streptodornase / streptokinase 01/03/1933 11 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002791/203611 NAP
2792 streptokinase Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002792/203611 NAP
2793 streptomycin 15/04/1956 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002793/203401 NAP
2794 streptozocin 07/05/1982 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002794/202812 NAP
2796 sucralfate 23/02/1968 9 years 02/04/2028 01/07/2028 No 15/01/2025 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002796/202804 Amelia Cupelli Italy NAP
2798 sufentanil 30/11/1978 3 years 30/11/2027 28/02/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00002798/202711 Adam Przybylkowski Poland CAP NAP
2799 sugammadex 25/07/2008 5 years 31/01/2029 01/05/2029 No 23/10/2019 Reference to NAP added on 03/07/2024
New CAP authorised on 23/06/2023
New CAP authorised on 26/05/2023
New CAP authorised on 10/01/2023
New CAP authorised on 15/07/2022
New CAP authorised on 15/11/2021
DLP and frequency were updated on 23/10/2019
DLP was updated on 25/09/2019
Next DLP was updated on 22/09/2016
The DLP was amended on 08/01/2014 PSUSA/00002799/202901 Terhi Lehtinen Finland CAP NAP
2801 sulbutiamine 28/05/1973 10 years 03/11/2035 01/02/2036 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
EURD updated on 01/07/2026
PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002801/203511 Tiphaine Vaillant France NAP
2802 sulconazole 30/09/1987 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002802/202901 NAP
2805 sulfacetamide Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002805/203611 NAP
2806 sulfadiazine Not available* 8 years 03/08/2027 01/11/2027 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002806/202708 NAP
2807 sodium hyaluronate / sulfadiazine silver Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00002807/202612 Amelia Cupelli Italy NAP
2809 sulfaguanidine 07/01/1974 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002809/203503 NAP
2816 sulfasalazine 25/04/1942 10 years 02/12/2033 02/03/2034 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00002816/203312 Marie Louise Schougaard Christiansen Denmark NAP
2818 sulfinpyrazone 25/09/1958 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002818/203401 NAP
2822 sulfur hexafluoride 26/03/2001 3 years 30/09/2026 29/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00002822/202609 Tiphaine Vaillant France CAP
2823 sulindac 30/06/1975 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002823/202808 NAP
2824 sulodexide 09/10/1972 10 years 01/12/2034 01/03/2035 No 05/01/2025 Correction of DLP on 20/11/2024
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002824/203412 Amelia Cupelli Italy NAP
2828 sulprostone 17/12/1980 3 years 21/04/2028 20/07/2028 No 19/09/2024 PSUSA/00002828/202804 Zoubida Amimour France NAP
2829 sultamicillin 01/11/1983 5 years 20/11/2025 18/02/2026 No 28/07/2021 DLP was updated on 28/07/2021
Next DLP was amended on 28/07/2016
DLP amended on 13/07/2015
Lead MS was added on 13/07/2015 PSUSA/00002829/202511 Maia Uusküla Estonia NAP
2830 sultiame Not available* 10 years 03/11/2036 01/02/2037 No 18/10/2023 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" , PSUR frequency and DLP were amended on 18/10/2023 PSUSA/00002830/203611 none NAP
2831 sultopride 01/10/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002831/202812 NAP
2832 sumatriptan, naproxen / sumatriptan 11/04/1991 5 years 30/09/2029 29/12/2029 No 21/12/2022 Active substance name changed on 21/12/2022
DLP was updated on 03/06/2020
PRAC Rapporteur name updated on 23/10/2018
PRAC Representative updated on 26/09/2018
Next DLP amended on 13/07/2015
PRAC Rapporteur name and country updated on 01/12/2014
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00002832/202909 Liana Martirosyan Netherlands NAP
2833 sunitinib 19/07/2006 3 years 30/04/2026 29/07/2026 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00002833/202604 Amelia Cupelli Italy CAP
2834 suxamethonium 14/08/1952 3 years 13/08/2026 11/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00002834/202608 Barbara Kovacic Bytyqi Croatia NAP
2835 suxibuzone Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002835/203611 NAP
2838 tacalcitol Not available* 8 years 03/08/2027 01/11/2027 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002838/202708 NAP
2839 tacrolimus (systemic formulations) 02/04/1993 3 years 31/03/2027 29/06/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00002839/202703 Eamon O'Murchu Ireland CAP NAP
2840 tacrolimus (topical formulations) 28/02/2002 3 years 31/03/2028 29/06/2028 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00002840/202803 Rhea Fitzgerald Ireland CAP NAP
2841 tadalafil 12/11/2002 3 years 15/10/2028 13/01/2029 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00002841/202810 Maria del Pilar Rayon Spain CAP NAP
2842 tafamidis 16/11/2011 2 years 15/05/2026 13/08/2026 No 18/12/2024 PSUR frequency amended and DLP updated on 18/12/2024 PSUSA/00002842/202605 Zoubida Amimour France CAP
2843 tafluprost 30/04/2008 3 years 29/04/2027 28/07/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00002843/202704 Dennis Lex Germany NAP
2846 tamoxifen 29/04/1974 5 years 29/04/2030 28/07/2030 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00002846/203004 Eamon O'Murchu Ireland NAP
2847 tamsulosin 02/07/1993 5 years 01/07/2026 29/09/2026 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00002847/202607 Liana Martirosyan Netherlands NAP
2849 tapentadol 20/11/2008 5 years 20/11/2029 18/02/2030 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00002849/202911 Dennis Lex Germany NAP
2850 tasonermin 13/04/1999 7 years 14/08/2030 12/11/2030 No 29/04/2026 PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00002850/203008 Karin Erneholm Denmark CAP
2855 technetium (99mtc) albumin nanocolloid 29/11/1993 15 years 29/11/2027 27/02/2028 No 25/09/2019 PSUR frequency and DLP were updated on 25/09/2019 PSUSA/00002855/202711 NAP
2856 technetium (99mTc) bicisate 08/10/1993 15 years 07/10/2034 05/01/2035 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00002856/203410 Karin Erneholm Denmark NAP
2857 technetium (99mtc) depreotide 29/11/2000 15 years 15/09/2027 14/12/2027 No 25/09/2019 PSUR frequency and DLP were updated on 25/09/2019
DLP was updated on 05/06/2019 PSUSA/00002857/202709 NAP
2859 technetium (99mtc) human albumin Not available* 15 years 01/01/2027 01/04/2027 No 25/09/2019 PSUR frequency and DLP were updated on 25/09/2019 PSUSA/00002859/202701 NAP
2860 technetium (99mtc) macrosalb 02/03/1990 15 years 28/02/2028 28/05/2028 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00002860/202802 Karin Erneholm Denmark NAP
2861 technetium (99mtc) mebrofenin 29/11/1993 15 years 01/11/2030 30/01/2031 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00002861/203011 Karin Erneholm Denmark NAP
2862 technetium (99mtc) medronic acid Not available* 15 years 01/01/2027 01/04/2027 No 20/05/2026 PSUR frequency and DLP were updated on 25/09/2019 PSUSA/00002862/202701 Katarzyna Ziolkowska Poland NAP
2863 technetium (99mTc) mertiatide, technetium (99mTc) betiatide Not available* 15 years 01/01/2027 01/04/2027 Yes 20/05/2026 Active substance name was amended and 'Are PSURs required for products referred to in Articles 10(1), 10a, 16a of Directive 2001/83/EC as amended?' was updated on 29/07/2020
PSUR frequency and DLP were updated on 25/09/2019 PSUSA/00002863/202701 Katarzyna Ziolkowska Poland NAP
2864 technetium (99mtc) oxidronate 21/03/1983 15 years 21/03/2027 19/06/2027 No 25/09/2019 PSUR frequency and DLP were updated on 25/09/2019 PSUSA/00002864/202703 NAP
2865 technetium (99mtc) pentetate 21/06/1990 15 years 21/06/2027 19/09/2027 No 25/09/2019 PSUR frequency and DLP were updated on 25/09/2019 PSUSA/00002865/202706 NAP
2866 technetium (99mTc) pertechnetate 01/06/1983 15 years 01/06/2032 30/08/2032 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00002866/203206 Karin Erneholm Denmark NAP
2867 sodium pyrophosphate, technetium (99mtc) pyrophosphate (for diagnosistic purpose) 04/02/1991 15 years 04/02/2027 05/05/2027 Yes 25/09/2019 PSUR frequency and DLP were updated on 25/09/2019
Entry name amended and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 21/07/2017 PSUSA/00002867/202702 NAP
2868 technetium (99mtc) sestamibi 09/12/1987 15 years 08/06/2032 06/09/2032 Yes 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00002868/203206 Karin Erneholm Denmark NAP
2869 technetium (99mTc) succimer Not available* 15 years 01/01/2027 01/04/2027 No 25/09/2019 PSUR frequency and DLP were updated on 25/09/2019 PSUSA/00002869/202701 NAP
2870 technetium (99mTc) tetrofosmin, tetrofosmin 31/05/1993 15 years 31/05/2032 29/08/2032 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00002870/203205 Karin Erneholm Denmark NAP
2872 technetium (99mTc) tin colloid Not available* 15 years 01/01/2027 01/04/2027 No 25/09/2019 PSUR frequency and DLP were updated on 25/09/2019 PSUSA/00002872/202701 NAP
2873 technetium (99mTc) trimethylphenylcarbamoylmethyliminodiacetic acid Not available* 15 years 01/01/2027 01/04/2027 No 25/09/2019 PSUR frequency and DLP were updated on 25/09/2019 PSUSA/00002873/202701 NAP
2874 tegafur Not available* 8 years 03/08/2027 01/11/2027 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002874/202708 NAP
2875 gimeracil / oteracil monopotassium / tegafur 14/03/2011 5 years 24/01/2026 24/04/2026 No 04/03/2026 Reference to NAP added on 04/03/2026
PSUR frequency and DLP were updated on 20/10/2021
PSUR Frequency, DLP and PRAC Representative were updated on 26/09/2018
Next DLP was amended on 25/09/2017
Next DLP was updated on 22/09/2016
Next DLP was updated on 30/09/2015
Next DLP was amended on 28/05/2014 PSUSA/00002875/202601 Bianca Mulder Netherlands CAP NAP
2878 teicoplanin 01/11/1986 5 years 01/11/2026 30/01/2027 No 29/06/2022 DLP was updated on 29/06/2022
Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?
Yes/No was corrected on 07/05/2018
DLP was updated and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 21/07/2017
Lead MS and PRAC Rapporteur name was added on 03/06/2016 PSUSA/00002878/202611 Eva Jirsová Czech Republic NAP
2882 hydrochlorothiazide / telmisartan, telmisartan 11/12/1998 5 years 31/03/2030 29/06/2030 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00002882/203003 Amelia Cupelli Italy CAP NAP
2883 temazepam 26/11/1969 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002883/202805 NAP
2884 temocillin 25/10/1984 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002884/202812 NAP
2885 temoporfin 24/10/2001 13 years 30/04/2037 29/07/2037 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00002885/203704 Bianca Mulder Netherlands CAP
2886 temozolomide 26/01/1999 3 years 12/07/2026 10/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00002886/202607 Dennis Lex Germany CAP
2887 temsirolimus 19/11/2007 5 years 31/03/2029 29/06/2029 No 25/06/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/06/2025
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 18/12/2024
PSUR frequency amended and DLP updated on 18/12/2024
DLP was updated on 22/12/2021
DLP was updated on 21/11/2018
Next DLP and PRAC Rapporteur amended on 27/11/2015.
PRAC Representative amended on 31/07/2015 PSUSA/00002887/202903 Dennis Lex Germany CAP
2888 tenecteplase 23/02/2001 3 years 31/08/2028 29/11/2028 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00002888/202808 Dennis Lex Germany CAP
2889 teniposide 05/04/1976 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002889/202808 NAP
2891 eucalyptus / paracetamol / tenoate sodium 15/05/1964 11 years 02/12/2039 01/03/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002891/203912 NAP
2892 tenofovir disoproxil 05/02/2002 3 years 31/03/2026 29/06/2026 No 19/09/2024 PSUSA/00002892/202603 Zoubida Amimour France CAP
2893 tenoxicam 20/02/1986 5 years 28/02/2026 29/05/2026 No 19/10/2022 PRAC representative was updated on 19/10/2022
PRAC representative was updated on 27/07/2022
DLP and PSUR frequency were updated on 17/11/2021
PRAC representative was updated on 30/06/2021
DLP was updated on 21/11/2018
PRAC Rapporteur name was updated on 04/07/2018
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 17/10/2017
PRAC Rapporteur name updated on 04/02/2016
PRAC Representative amended on 27/11/2015.
The Next DLP was amended on 29/10/2015
Lead MS was added on 04/02/2015 PSUSA/00002893/202602 Amelia Cupelli Italy NAP
2895 terazosin 30/11/1984 8 years 20/11/2031 18/02/2032 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00002895/203111 Liana Martirosyan Netherlands NAP
2896 terbinafine 03/10/1990 3 years 30/09/2028 29/12/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00002896/202809 Jana Pecherova Slovakia NAP
2897 terbutaline 31/12/1970 5 years 31/12/2026 31/03/2027 No 21/09/2022 PLP was updated on 21/09/2022
PRAC representative was updated on 23/09/2020
Next DLP was amended on 25/09/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00002897/202612 Melinda Palfi Hungary NAP
2898 guaifenesin / terbutaline sulfate Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002898/203103 NAP
2903 teriparatide 10/06/2003 3 years 12/09/2027 11/12/2027 No 28/05/2025 New CAP authorised on 27/04/2026
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025
DLP was amended on 28/05/2025
New CAP authorised on 12/01/2023
New CAPs authorised on 18/11/2022
DLP and Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" were amended on 25/05/2022
New CAP authorised on 24/03/2022
PRAC representative was updated on 26/05/2021
New CAPs authorised on 27/08/2020
DLP updated on 05/06/2019
Lead MS and PRAC Rapporteur name amended on 06/02/2019
Lead MS and PRAC Rapporteur name amended on 21/11/2018
Reference to NAP added on 31/01/2018
PSUR Frequency amended and DLP updated on 03/05/2016 PSUSA/00002903/202709 Tiphaine Vaillant France CAP NAP
2904 terizidone 25/01/1973 5 years 15/09/2030 14/12/2030 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00002904/203009 Rugile Pilviniene Lithuania NAP
2905 terlipressin 01/05/1980 3 years 30/04/2027 29/07/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00002905/202704 Karin Erneholm Denmark NAP
2906 tertatolol 25/04/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002906/202812 NAP
2908 testosterone (topical use) 28/07/2006 3 years 31/12/2027 30/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00002908/202712 Maia Uusküla Estonia NAP
2909 human tetanus immunoglobulin 30/08/1999 5 years 29/08/2027 27/11/2027 No 06/10/2025 DLP was amended on 03/05/2023
PRAC representative was updated on 01/03/2023
DLP was updated on 07/05/2018
PRAC representative and Lead Member State were added on 30/01/2017 PSUSA/00002909/202708 Dirk Mentzer Germany NAP
2910 tetanus vaccines 01/01/1978 5 years 01/01/2028 31/03/2028 No 06/10/2025 DLP amended on 20/09/2023 PSUSA/00002910/202801 Dirk Mentzer Germany NAP
2911 tetrabenazine 23/10/1995 5 years 31/10/2028 29/01/2029 No 03/07/2024 PSUR frequency amended and DLP updated on 03/07/2024 PSUSA/00002911/202810 Eamon O'Murchu Ireland NAP
2912 tetracaine 01/06/1973 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002912/202806 NAP
2914 tetracosactide 07/05/1965 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002914/202803 NAP
2915 tetracycline 19/11/1953 10 years 01/01/2034 01/04/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002915/203401 NAP
2918 tetryzoline Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002918/203611 NAP
2919 thalidomide 16/04/2008 3 years 09/10/2027 07/01/2028 Yes 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00002919/202710 Tiphaine Vaillant France CAP NAP
2920 thallium [201TL] 31/08/1980 10 years 31/08/2034 29/11/2034 Yes 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00002920/203408 Jean-Michel Dogné Belgium NAP
2921 theophylline 14/06/1947 5 years 14/06/2027 12/09/2027 No 01/03/2023 DLP was updated on 01/03/2023
European Union reference date and DLP amended on 0405/2018
DLP was updated on 27/03/2018
Lead MS and PRAC Rapporteur name was added on 20/12/2016 PSUSA/00002921/202706 Maria Popova-Kiradjieva Bulgaria NAP
2922 thiamazole 30/06/1978 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00002922/203303 Dennis Lex Germany NAP
2924 cyanocobalamin / pyridoxine / thiamine Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002924/203506 NAP
2925 thiamphenicol 14/07/1960 5 years 31/05/2028 29/08/2028 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00002925/202805 Amelia Cupelli Italy NAP
2928 thioctic acid Not available* 8 years 03/08/2027 01/11/2027 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002928/202708 NAP
2929 thiopental 15/10/1945 15 years 31/03/2031 29/06/2031 No 20/12/2016 PRAC Rapporteur name updated on 23/10/2018
PSUR Frequency amended and DLP updated on 20/12/2016
Lead Member State and PRAC Representative added on 27/11/2015. PSUSA/00002929/203103 Eamon O'Murchu Ireland NAP
2931 thioridazine 01/02/1959 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002931/202712 NAP
2932 thiotepa 09/03/1959 3 years 31/03/2027 29/06/2027 Yes 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00002932/202703 Tiphaine Vaillant France CAP NAP
2936 thiamphenicol glycinate acetylcysteinate Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002936/203611 Amelia Cupelli Italy NAP
2940 thyrotropin alfa 30/11/1998 5 years 30/11/2029 28/02/2030 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00002940/202911 Rhea Fitzgerald Ireland CAP
2942 tiagabine 14/06/1996 5 years 30/06/2029 28/09/2029 Yes 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00002942/202906 Tiphaine Vaillant France NAP
2943 tianeptine 06/02/1987 5 years 30/06/2029 28/09/2029 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00002943/202906 Tiphaine Vaillant France NAP
2944 tiapride 27/07/1988 3 years 27/07/2027 25/10/2027 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00002944/202707 Tiphaine Vaillant France NAP
2945 tiaprofenic acid 26/08/1974 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002945/202808 NAP
2946 tibezonium iodide 23/11/1976 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002946/203503 NAP
2947 tibolone 01/12/1987 5 years 01/12/2029 01/03/2030 No 02/06/2026 PSUSA/00002947/202912 Jenny Jönsson Sweden NAP
2948 ticagrelor, acetylsalicylic acid / ticagrelor 03/12/2010 3 years 31/12/2026 31/03/2027 No 01/04/2026 Reference to NAP added on 01/04/2026
Active substance name was amended on 01/04/2026
DLP was amended on 25/09/2024 PSUSA/00002948/202612 Bianca Mulder Netherlands CAP NAP
2950 clavulanate / ticarcillin 12/09/1973 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002950/203503 NAP
2951 tick-borne encephalitis vaccine (inactivated) 29/01/2001 3 years 31/01/2026 01/05/2026 No 06/10/2025 Next DLP was updated on 18/10/2023 PSUSA/00002951/202601 Dirk Mentzer Germany NAP
2952 ticlopidine 08/05/1978 8 years 08/05/2033 06/08/2033 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00002952/203305 Amelia Cupelli Italy NAP
2954 tigecycline 24/04/2006 5 years 14/06/2028 12/09/2028 No 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 PSUSA/00002954/202806 Maria del Pilar Rayon Spain CAP
2955 tilactase Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002955/203211 NAP
2957 tilidine 08/07/1970 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002957/202805 NAP
2958 tilbroquinol / tiliquinol 15/11/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002958/203406 NAP
2961 bimatoprost / timolol 19/06/2006 5 years 19/11/2026 17/02/2027 No 27/07/2022 PSUR frequency and DLP were updated on 27/07/2022
DLP was updated on 31/07/2019
PRAC Rapporteur name was corrected on 03/04/2019
Reference to NAP added on 19/12/2018
PRAC Rapporteur name was amended on 06/06/2018
PRAC Representative amended on 17/10/2017
Next DLP was amended on 28/07/2016 PSUSA/00002961/202611 Karin Erneholm Denmark CAP NAP
2962 timolol / travoprost 24/04/2006 5 years 28/02/2028 28/05/2028 No 15/11/2023 PSUR frequency amended and DLP updated on 15/11/2023 PSUSA/00002962/202802 Maria del Pilar Rayon Spain CAP NAP
2967 tinzaparin 28/02/1991 7 years 02/12/2030 02/03/2031 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00002967/203012 Jo Robays Belgium NAP
2969 tioguanine 18/01/1966 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00002969/202803 NAP
2972 tiotropium 09/10/2001 5 years 09/10/2026 07/01/2027 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00002972/202610 Bianca Mulder Netherlands NAP
2973 tipranavir 25/10/2005 5 years 31/12/2027 30/03/2028 No 19/09/2024 PSUSA/00002973/202712 Zoubida Amimour France CAP
2974 tirofiban 14/05/2003 5 years 31/05/2027 29/08/2027 No 01/02/2023 PSUR frequency and DLP were updated on 01/02/2023
DLP was updated on 05/02/2020
Next DLP updated on 30/01/2017
PRAC Rapporteur and Lead Member State was added on 27/11/2015.
PSUSA number was amended on 06/10/2014 PSUSA/00002974/202705 Dennis Lex Germany NAP
2975 tiropramide 30/03/1982 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002975/202811 NAP
2977 tizanidine 15/12/1983 5 years 31/12/2029 31/03/2030 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00002977/202912 Terhi Lehtinen Finland NAP
2980 tocilizumab 11/04/2005 3 years 10/04/2028 09/07/2028 No 06/10/2025 New CAP authorised on 27/04/2026
New CAP authorised on 14/02/2025
New CAP authorised on 20/06/2024
New CAP authorised on 15/09/2023
PRAC representative was updated on 01/03/2023
DLP was updated on 21/12/2022
PSUR frequency and DLP were updated on 20/11/2019
DLP was updated on 21/11/2018
DLP was amended on 15/11/2017
PSUR Frequency amended and DLP updated on 23/05/2017
Next DLP was updated on 18/11/2016
Next DLP was amended on 03/06/2016
Next DLp was updated on 27/11/2015.
Next DLP was amended on 01/12/2014
Next DLP was amended on 28/05/2014
Next DLP was amended 30/11/2013 PSUSA/00002980/202804 Dirk Mentzer Germany CAP
2981 tocofersolan 24/07/2009 1 year 31/07/2026 09/10/2026 31/07/2027 09/10/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00002981/202607 PSUSA/00002981/202707 Melinda Palfi Hungary CAP
2982 tofisopam Not available* 7 years 31/01/2032 30/04/2032 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00002982/203201 Melinda Palfi Hungary NAP
2984 tolbutamide Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002984/203611 NAP
2985 tolcapone 27/08/1997 3 years 01/03/2027 30/05/2027 No 17/11/2021 DLP was updated on 17/11/2021
PRAC Rapporteur name updated on 19/12/2018
DLP and PRAC Rapporteur name updated on 23/10/2018
The Next DLP was amended on 29/10/2015 PSUSA/00002985/202703 Eamon O Murchu Ireland CAP
2986 tolfenamic acid Not available* 8 years 03/08/2027 01/11/2027 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002986/202708 NAP
2988 tolnaftate 16/10/1977 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00002988/202811 NAP
2989 nystatine / tolnaftate Not available* 9 years 03/03/2032 01/06/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002989/203203 NAP
2990 tolnaftate / triclosan Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00002990/203211 NAP
2991 tolperisone Not available* 3 years 01/06/2027 30/08/2027 Yes 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00002991/202706 Melinda Palfi Hungary NAP
2993 tolterodine 05/09/1997 5 years 05/09/2026 04/12/2026 No 02/06/2026 PSUSA/00002993/202609 Jenny Jönsson Sweden NAP
2994 tolvaptan (indicated for adults with hyponatraemia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH)) 03/08/2009 3 years 18/05/2027 16/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00002994/202705 Amelia Cupelli Italy CAP
2996 topiramate 18/07/1995 5 years 18/01/2027 18/04/2027 No 21/09/2022 DLP was updated on 21/09/2022
PRAC Rapporteur name was amended on 31/07/2018
Next DLP was amended on 25/09/2017
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/09/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00002996/202701 Karin Bolin Sweden NAP
2997 topotecan 12/11/1996 5 years 28/05/2030 26/08/2030 No 02/06/2026 PSUSA/00002997/203005 Jenny Jönsson Sweden CAP NAP
2998 torasemide 14/04/1987 8 years 03/06/2033 01/09/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00002998/203306 Dennis Lex Germany NAP
2999 toremifene 14/02/1996 5 years 30/09/2028 29/12/2028 No 05/06/2024 PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00002999/202809 Tiphaine Vaillant France CAP
3000 tosylchloramide Not available* 8 years 03/11/2026 01/02/2027 Yes 28/05/2025 DLP was amended on 28/05/2025
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025
PSUR frequency and DLP amended on 28/08/2024 PSUSA/00003000/202611 Amelia Cupelli Italy NAP
3001 trabectedin 17/09/2007 3 years 17/09/2028 16/12/2028 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00003001/202809 Marie Louise Schougaard Christiansen Denmark CAP NAP
3002 tramadol 18/04/1973 3 years 22/06/2026 20/09/2026 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00003002/202606 Tiphaine Vaillant France NAP
3003 tramazoline 01/02/1964 11 years 02/12/2039 01/03/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003003/203912 NAP
3004 trandolapril, verapamil / trandolapril 19/02/1992 8 years 18/02/2027 19/05/2027 No 19/11/2025 Active substance name was amended on 19/11/2025
DLP was amended on 19/11/2025
PRAC representative updated on 31/01/2024 PSUSA/00003004/202702 Bianca Mulder Netherlands NAP
3006 tranexamic acid 21/01/1966 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00003006/203303 Rhea Fitzgerald Ireland NAP
3007 transfer factor porcine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003007/203211 NAP
3008 tranylcypromine Not available* 8 years 03/11/2027 01/02/2028 No 05/01/2025 Correction of DLP on 20/11/2024
PSUR frequency and DLP amended on 28/08/2024 PSUSA/00003008/202711 Dennis Lex Germany NAP
3010 trastuzumab 25/09/1998 3 years 24/09/2027 23/12/2027 No 06/10/2025 New CAP authorised on 30/06/2025
New CAP authorised on 19/09/2024
New CAP authorised on 15/11/2023
PRAC representative was updated on 01/03/2023
DLP was updated on 29/06/2022
PSUR frequency and DLP were updated on 05/06/2019
New CAP authorised on 12/12/2018
PSUR Frequency amended and DLP updated on 26/04/2017
Next DLP was amended on 03/05/2016
The Next DLP was amended on 29/10/2015
Next DLP was amended on 16/07/2015, and the 1-yearly cycle PSUR should be submitted after the current Next DLP (24/09/2015).
Next DLP was amended on 04/11/2014
Next DLP was amended on 02/05/2014 PSUSA/00003010/202709 Dirk Mentzer Germany CAP
3011 travoprost 27/11/2001 5 years 28/02/2027 29/05/2027 No 16/11/2022 PSUR frequency and DLP were updated on 16/11/2022
DLP was updated on 20/11/2019
PSUR Frequency amended and DLP updated on 19/10/2016
PRAC Representative amended on 28/06/2016
The Next DLP was amended on 29/10/2015 PSUSA/00003011/202702 Maria del Pilar Rayon Spain CAP NAP
3012 trazodone 15/10/1971 6 years 03/08/2029 01/11/2029 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00003012/202908 Rugile Pilviniene Lithuania NAP
3013 treprostinil 21/05/2002 3 years 21/05/2028 19/08/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00003013/202805 Zane Neikena Latvia CAP NAP
3015 tretinoin (oral formulations) 31/03/1994 5 years 30/03/2027 28/06/2027 No 11/06/2025 DLP was updated on 21/12/2022
PRAC representative was updated on 19/10/2022
PRAC representative was updated on 17/11/2021
PRAC representative was updated on 28/07/2021
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00003015/202703 Zoubida Amimour France NAP
3016 tretinoin (topical formulations) 25/01/1973 5 years 31/08/2027 29/11/2027 Yes 03/05/2023 DLP was amended on 03/05/2023
Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 06/06/2018
Lead MS and PRAC Rapporteur name was added on 28/02/2017 PSUSA/00003016/202708 Adam Przybylkowski Poland NAP
3017 triamcinolone (topical and nasal formulations) 14/12/1953 5 years 13/07/2027 11/10/2027 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00003017/202707 Carla Torre Portugal NAP
3019 carbethopendecinium bromide / salicylic acid / triamcinolone Not available* 9 years 03/07/2029 01/10/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00003019/202907 NAP
3020 chloroxine / triamcinolone Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00003020/202911 NAP
3021 salicylic acid / triamcinolone acetonide Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00003021/202612 Polona Golmajer Slovenia NAP
3022 triamterene 19/06/1963 10 years 03/05/2034 01/08/2034 No 03/10/2024 Updated & published on 23/10/2024 PSUSA/00003022/203405 NAP
3023 triazolam 08/03/1997 5 years 31/07/2027 29/10/2027 No 05/04/2023 DLP was updated on 05/04/2023
DLP was updated on 07/05/2018
PRAC representative and Lead Member State were added on 30/01/2017 PSUSA/00003023/202707 Kimmo Jaakkola Finland NAP
3024 tribenoside 06/04/1967 10 years 03/07/2034 01/10/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003024/203407 NAP
3025 lidocaine / tribenoside 01/06/1971 10 years 02/09/2034 01/12/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003025/203409 NAP
3027 triclocarban Not available* 9 years 03/11/2032 01/02/2033 No 11/06/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003027/203211 Zoubida Amimour France NAP
3028 triclosan 01/01/1985 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00003028/202812 NAP
3029 benzalkonium / chloride solution / light liquid paraffin / triclosan Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00003029/202906 NAP
3033 trifluperidol 31/01/1964 11 years 03/07/2039 01/10/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003033/203907 NAP
3035 triflusal 19/01/1981 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00003035/202811 NAP
3036 trihexyphenidyl 05/06/1956 11 years 03/10/2037 01/01/2038 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003036/203710 NAP
3038 trimebutine 15/03/1988 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00003038/202901 NAP
3039 ruscogenin / trimebutine 10/12/1973 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003039/203503 NAP
3040 trimecaine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003040/203211 NAP
3041 carbaethopendecinium bromide / trimecaine hydrochloride Not available* 8 years 01/12/2025 01/03/2026 No 30/10/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00003041/202512 Eva Jirsová Czech Republic NAP
3043 trimetazidine 06/08/2001 3 years 06/08/2026 04/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00003043/202608 Amelia Cupelli Italy NAP
3045 trimethoprim Not available* 7 years 31/01/2032 30/04/2032 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00003045/203201 Maia Uusküla Estonia NAP
3046 trimipramine 05/10/1960 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003046/203906 NAP
3047 pseudoephedrine / triprolidine Not available* 3 years 31/12/2026 31/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00003047/202612 Dennis Lex Germany NAP
3048 triptorelin 05/03/1986 5 years 31/03/2027 29/06/2027 No 21/12/2022 DLP was updated on 21/12/2022
DLP was updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00003048/202703 Dennis Lex Germany NAP
3049 trolamine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003049/203211 NAP
3050 tromantadine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003050/203211 NAP
3051 disodium phosphate anhydrous / sodium hydrogen carbonate / trometamol Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00003051/203011 NAP
3053 tropicamide 01/03/1951 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003053/203212 NAP
3055 trospium 17/10/1984 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00003055/202812 none NAP
3056 troxerutin, troxerutin / heptaminol / ginkgo leaf 09/10/1970 8 years 03/11/2027 01/02/2028 No 05/01/2025 DLP correction on 20/11/2024
Active substance name, PSUR frequency and DLP were amended on 20/12/2023 PSUSA/00003056/202711 Dennis Lex Germany NAP
3059 amylase / cortex granati / gentiana lutea / lipase / quercus cortex / radix ratanhiae / rhizoma tormentillae / salicylic acid / tannic acid / trypsin Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00003059/202903 NAP
3062 tryptophan Not available* 8 years 03/11/2027 01/02/2028 Yes 28/05/2025 DLP was amended on 28/05/2025
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025
PSUR frequency and DLP amended on 28/08/2024 PSUSA/00003062/202711 Dennis Lex Germany NAP
3063 tuberculin purified protein derivative 16/11/1979 7 years 01/09/2028 30/11/2028 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00003063/202809 Karin Erneholm Denmark NAP
3065 typhoid polysaccharide vaccine 05/08/1998 3 years 05/08/2026 03/11/2026 No 06/10/2025 DLP was amended on 30/04/2024 PSUSA/00003065/202608 Dirk Mentzer Germany NAP
3067 typhoid vaccine (live, attenuated) 12/12/1984 3 years 31/12/2027 30/03/2028 Yes 06/10/2025 DLP was amended on 24/09/2025 PSUSA/00003067/202712 Dirk Mentzer Germany NAP
3068 tyrothricin 20/10/1950 11 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003068/203611 NAP
3070 benzalkonium / benzocaine / tyrothricin Not available* 8 years 01/12/2025 01/03/2026 No 30/10/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00003070/202512 Dennis Lex Germany NAP
3071 benzocaine / dequalinium chloride / dexamethasone / tyrothricin Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00003071/202906 NAP
3072 chlorhexidine digluconate / lidocaine hydrochloride / tyrothricin Not available* 13 years 01/01/2028 31/03/2028 Yes 21/07/2017 PSUR Frequency, DLP and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended updated on 21/07/2017 PSUSA/00003072/202801 NAP
3073 ubidecarenone Not available* 8 years 03/11/2026 01/02/2027 Yes 28/05/2025 DLP was amended on 28/05/2025
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025
PSUR frequency and DLP amended on 28/08/2024 PSUSA/00003073/202611 Amelia Cupelli Italy NAP
3074 ulipristal (female emergency contraceptive) 15/05/2009 3 years 14/05/2027 12/08/2027 Yes 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00003074/202705 Bianca Mulder Netherlands CAP NAP
3075 ulobetasol Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003075/203211 NAP
3076 undecylenic acid Not available* 8 years 03/11/2032 01/02/2033 Yes 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00003076/203211 Polona Golmajer Slovenia NAP
3078 urapidil 31/07/1980 5 years 01/07/2026 29/09/2026 No 02/03/2022 DLP and PSUR frequency were updated on 02/03/2022
Next DLP was updated on 06/03/2019
Correction of Lead MS and PRAC Rapporteur on 28/02/2017
PRAC Representative amended on 18/11/2016
Lead MS and PRAC Rapporteur name were amended on 28/07/2016
Next DLP was updated on 04/03/2016
Lead MS added on 01/04/2015. PSUSA/00003078/202607 Eva Jirsová Czech Republic NAP
3080 uridine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003080/203211 NAP
3082 urofollitropin 24/03/2004 5 years 23/03/2027 21/06/2027 No 19/12/2018 Lead MS and PRAC Rapporteur name amended on 19/12/2018
DLP was updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00003082/202703 Eamon O'Murchu Ireland NAP
3083 urokinase 24/05/1972 8 years 03/03/2033 01/06/2033 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00003083/203303 Dennis Lex Germany NAP
3085 ustekinumab 16/01/2009 2 years 31/12/2025 31/03/2026 No 31/07/2024 New CAP authorised on 18/11/2025
New CAP authorised on 17/09/2025
New CAP authorised on 02/06/2025
New CAP authorised on 14/02/2025
New CAP authorised on 12/12/2024
New CAP authorised on 25/09/2024
New CAP authorised on 12/09/2024
New CAP authorised on 22/08/2024
PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00003085/202512 Rhea Fitzgerald Ireland CAP
3086 valaciclovir 20/12/1994 5 years 19/12/2029 19/03/2030 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00003086/202912 Veronika Macurová Czech Republic NAP
3089 valganciclovir 29/03/2001 5 years 28/03/2026 26/06/2026 No 22/12/2021 DLP was updated on 22/12/2021
PRAC representative was updated on 04/03/2020
PRAC Representative updated on 26/09/2018
Next DLP was amended on 20/12/2016
Lead Member State added on 27/11/2015. PSUSA/00003089/202603 Liana Martirosyan Netherlands NAP
3090 valproic acid, sodium valproate, valproate pivoxil, valproate semisodium, valpriomide, valproate bismuth, calcium valproate, valproate magnesium 23/01/1967 3 years 23/01/2027 23/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00003090/202701 Liana Martirosyan Netherlands NAP
3097 vancomycin 01/01/1955 5 years 31/01/2030 01/05/2030 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00003097/203001 Marie Louise Schougaard Christiansen Denmark NAP
3098 vardenafil 04/03/2003 5 years 04/03/2029 02/06/2029 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00003098/202903 Maria del Pilar Rayon Spain CAP
3099 varenicline 26/09/2006 3 years 09/05/2026 07/08/2026 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00003099/202605 Karin Erneholm Denmark CAP
3102 vecuronium bromide 01/11/1990 5 years 30/11/2025 28/02/2026 Yes 28/07/2021 PSUR frequency and DLP were updated on 28/07/2021
DLP was updated and Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 20/11/2019
Next DLP was amended on 25/09/2017
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/09/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016
Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00003102/202511 Eva Jirsová Czech Republic NAP
3103 velaglucerase alfa 26/02/2010 2 years 25/02/2026 26/05/2026 No 16/11/2022 DLP was updated on 16/11/2022
DLP was updated on 21/10/2020
DLP was updated on 23/10/2018
PRAC Rapporteur name was amended on 31/07/2018
PSUR Frequency amended and DLP updated on 22/09/2016
Next DLP was updated on 06/10/2015
EURD was amended on 21/12/2012 PSUSA/00003103/202602 Dennis Lex Germany CAP
3104 venlafaxine, desvenlafaxine 23/09/1993 5 years 05/05/2028 03/08/2028 No 28/02/2024 Active substance name was amended on 28/02/2024
PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00003104/202805 Karin Bolin Sweden NAP
3105 verapamil 25/01/1963 7 years 25/01/2027 25/04/2027 No 21/10/2020 DLP was updated on 21/10/2020
PRAC representative was added on 06/05/2020
LMS was added on 31/07/2019 PSUSA/00003105/202701 Terhi Lehtinen Finland NAP
3107 hydrochlorothiazide / verapamil hydrochloride, hydrochlorothiazide / triamterene / verapamil hydrochloride Not available* 9 years 03/06/2031 01/09/2031 No 19/10/2023 Active substance name, PSUR frequency and DLP were amended on 19/10/2023 PSUSA/00003107/203106 none NAP
3109 vernakalant hydrochloride 01/09/2010 5 years 31/08/2028 29/11/2028 No 29/04/2026 PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00003109/202808 Bianca Mulder Netherlands CAP
3110 verteporfin 27/07/2000 3 years 31/12/2027 30/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00003110/202712 Zoubida Amimour France CAP
3112 vigabatrin 22/09/1989 3 years 22/09/2026 21/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00003112/202609 Terhi Lehtinen Finland CAP NAP
3113 vildagliptin, metformin / vildagliptin 26/09/2007 3 years 28/02/2027 29/05/2027 No 02/06/2026 PSUSA/00003113/202702 Karin Bolin Sweden CAP NAP
3117 vinblastine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003117/203211 NAP
3118 vinburnine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003118/203211 NAP
3119 vincamine 26/06/1982 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00003119/202812 NAP
3120 piracetam / vincamine Not available* 9 years 03/05/2032 01/08/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003120/203205 NAP
3121 vincristine 12/04/1995 6 years 03/08/2029 01/11/2029 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00003121/202908 Dennis Lex Germany NAP
3122 vindesine 11/04/1979 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00003122/202811 NAP
3123 vinflunine 21/09/2009 5 years 21/09/2026 20/12/2026 No 25/05/2022 PSUR frequency and DLP were updated on 25/05/2022
PSUR frequency and DLP were updated on 05/06/2019
Lead MS and PRAC Rapporteur name amended on 21/11/2018
PSUR Frequency amended and DLP updated on 26/04/2017
PRAC Representative amended on 28/03/2017
Next DLP was amended on 03/05/2016 PSUSA/00003123/202609 Maria del Pilar Rayon Spain CAP
3124 vinorelbine 11/04/1989 5 years 01/04/2027 30/06/2027 No 21/12/2022 DLP was updated on 21/12/2022
DLP was updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 30/11/2012 PSUSA/00003124/202704 Eva Jirsová Czech Republic NAP
3125 vinpocetine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003125/203211 NAP
3127 voriconazole 19/03/2002 3 years 28/02/2027 29/05/2027 No 17/11/2021 DLP corrected on 02/02/2022
DLP was updated on 17/11/2021
PSUR frequency, DLP and PRAC Rapporteur amended on 23/10/2018
DLP was updated on 17/10/2017
PRAC Rapporteur name was amended on 25/09/2017
Next DLP was amended on 19/10/2016
NAP products added on 22/09/2016
NAP products removed on 03/06/2016
The Next DLP was amended on 29/10/2015
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 04/11/2014 PSUSA/00003127/202702 Liana Martirosyan Netherlands CAP NAP
3129 warfarin 31/05/1962 8 years 31/01/2033 01/05/2033 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00003129/203301 Marie Louise Schougaard Christiansen Denmark NAP
3133 xipamide, triamterene / xipamide 30/07/1969 7 years 31/01/2032 30/04/2032 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00003133/203201 Dennis Lex Germany NAP
3134 xylometazoline 29/08/1959 5 years 31/05/2028 29/08/2028 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00003134/202805 Zane Neikena Latvia NAP
3135 yellow fever vaccine (live) 27/01/1986 3 years 02/12/2025 02/03/2026 No 06/10/2025 Next DLP was updated on 26/07/2023 PSUSA/00003135/202512 Dirk Mentzer Germany NAP
3136 yohimbine 01/06/1944 5 years 31/05/2029 29/08/2029 Yes 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00003136/202905 Jan Neuhauser Austria NAP
3137 yttrium (90y) chloride 24/03/2003 7 years 23/03/2032 21/06/2032 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00003137/203203 Karin Erneholm Denmark CAP
3141 zanamivir (except for centrally authorised products) 09/02/1999 5 years 31/01/2027 01/05/2027 No 02/06/2026 PSUSA/00003141/202701 Jenny Jönsson Sweden NAP
3142 ziconotide 21/02/2005 5 years 28/12/2029 28/03/2030 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00003142/202912 Jo Robays Belgium CAP
3143 zidovudine 03/03/1987 5 years 30/09/2029 29/12/2029 No 13/08/2025 DLP was updated on 29/06/2022
PSUR frequency and DLP updated on 05/06/2019
Lead MS and PRAC Rapporteur name amended on 21/11/2018
PSUR Frequency amended and DLP updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00003143/202909 Veronika Macurová Czech Republic NAP
3144 abacavir / lamivudine / zidovudine 28/12/2000 3 years 31/12/2025 31/03/2026 Yes 19/09/2024 PSUSA/00003144/202512 Zoubida Amimour France CAP NAP
3145 zinc acetate dihydrate 13/10/2004 5 years 30/10/2026 28/01/2027 No 29/06/2022 DLP was updated on 29/06/2022
PRAC Rapporteur name updated on 19/12/2018
PRAC Rapporteur name was amended on 23/10/2018
Next DLP was amended on 27/06/2017 PSUSA/00003145/202610 Eamon O Murchu Ireland CAP
3146 ziprasidone 05/02/1998 5 years 31/07/2030 29/10/2030 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00003146/203007 Karin Bolin Sweden NAP
3147 zofenopril 30/07/1998 7 years 02/01/2031 02/04/2031 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00003147/203101 Amelia Cupelli Italy NAP
3148 hydrochlorothiazide / zofenopril 03/03/2004 7 years 03/05/2031 01/08/2031 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00003148/203105 Amelia Cupelli Italy NAP
3149 zoledronic acid (indicated for cancer and fractures) 20/03/2001 3 years 31/08/2026 29/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00003149/202608 Karin Erneholm Denmark CAP NAP
3150 zolmitriptan 07/03/1997 5 years 06/03/2027 04/06/2027 No 16/11/2022 DLP was updated on 16/11/2022
PRAC Rapporteur name was amended on 31/07/2018
DLP was amended on 15/11/2017
Lead MS was added on 22/09/2016 PSUSA/00003150/202703 Karin Bolin Sweden NAP
3151 zolpidem 09/06/1987 3 years 03/08/2026 01/11/2026 No 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00003151/202608 Amelia Cupelli Italy NAP
3152 zonisamide 10/03/2005 3 years 31/03/2028 29/06/2028 No 21/12/2022 PSUR frequency and DLP were updated on 21/12/2022
DLP was corrected on 03/03/2021
PSUR frequency and DLP were updated on 18/11/2020
DLP was updated on 20/11/2019
DLP was updated on 21/11/2018
PRAC Rapporteur name was amended on 23/10/2018
Reference to NAP added on 31/07/2018
DLP was amended on 15/11/2017
DLP was updated on 18/11/2016
DLP was amended on 29/10/2015
Requirement to submit generics changed on 31/01/2014 PSUSA/00003152/202803 Rhea Fitzgerald Ireland CAP NAP
3153 zopiclone, eszopiclone 10/12/1984 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00003153/202812 NAP
3154 zotepine 07/12/1981 8 years 03/05/2033 01/08/2033 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00003154/203305 Veronika Macurová Czech Republic NAP
3155 zuclopenthixol 31/05/1976 5 years 31/05/2028 29/08/2028 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00003155/202805 Jean-Michel Dogné Belgium NAP
3157 ascorbic acid 25/02/1960 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003157/203906 Roxana Dondera Romania NAP
3158 N(2)-L-alanyl-L-glutamine 29/03/1995 5 years 29/03/2026 27/06/2026 No 27/01/2026 PRAC representative was updated on 31/05/2023
DLP was updated on 22/12/2021
PRAC representative was updated on 31/03/2021
Next DLP was amended on 20/12/2016
Lead Member State added on 27/11/2015. PSUSA/00003158/202603 Roxana Stefania Udrescu Romania NAP
3159 antithrombin III 01/01/1983 5 years 31/12/2025 31/03/2026 No 22/09/2021 PRAC representative was updated on 17/11/2021
PSUR frequency, DLP and active substance name were updated on 22/09/2021
PRAC representative was updated on 30/06/2021
PSUR frequency amended and DLP updated on 31/07/2018
Next DLP was amended on 25/09/2017
PSUR Frequency amended and DLP updated on 09/09/2016
PRAC Representative amended on 27/11/2015.
Lead MS was added on 13/07/2015 PSUSA/00003159/202512 Amelia Cupelli Italy NAP
3160 arginine aspartate 07/10/1964 10 years 03/06/2034 01/09/2034 No 11/06/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003160/203406 Zoubida Amimour France NAP
3161 asparaginase, crisantaspase (L-asparaginase from Erwinia chrysanthemi) 03/04/1988 3 years 31/08/2027 29/11/2027 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00003161/202708 Jan Neuhauser Austria CAP
3162 bendamustine hydrochloride 07/07/2010 5 years 06/01/2030 06/04/2030 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00003162/203001 Dennis Lex Germany NAP
3163 bilastine 08/09/2010 5 years 07/03/2029 05/06/2029 No 20/11/2024 PSUR frequency amended and DLP updated on 20/11/2024 PSUSA/00003163/202903 Roxana Dondera Romania NAP
3164 chlorquinaldol Not available* 8 years 01/12/2028 01/03/2029 Yes 27/05/2026 DLP was amended on 27/05/2026
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 27/05/2026
PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00003164/202812 Roxana Stefania Udrescu Romania NAP
3165 ciclopirox and ciclopirox olamine 02/04/1975 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003165/203503 Melinda Palfi Hungary NAP
3166 cycloserine Not available* 8 years 03/03/2026 01/06/2026 No 27/01/2026 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00003166/202603 Roxana Stefania Udrescu Romania NAP
3167 dienogest 02/12/2009 3 years 02/12/2025 02/03/2026 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00003167/202512 Bianca Mulder Netherlands NAP
3168 dorzolamide 11/11/1994 5 years 18/02/2030 19/05/2030 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00003168/203002 Zoubida Amimour France NAP
3170 hexoprenaline sulfate 13/08/1970 5 years 13/08/2030 11/11/2030 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00003170/203008 Roxana Dondera Romania NAP
3171 hypromellose 30/11/1955 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003171/203401 NAP
3175 lanthanum Not available* 3 years 18/03/2027 16/06/2027 No 02/06/2026 PSUSA/00003175/202703 Karin Bolin Sweden NAP
3177 methandienone Not available* 8 years 03/11/2026 01/02/2027 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003177/202611 NAP
3178 midodrine 06/02/1974 10 years 06/06/2026 04/09/2026 No 27/01/2026 PRAC representative was updated on 31/05/2023
PRAC representative was updated on 31/03/2021
PSUR Frequency amended and DLP updated on 28/02/2017
Lead MS and PRAC Rapporteur name updated on 04/02/2016
PSUSA number was amended on 06/10/2014 PSUSA/00003178/202606 Roxana Stefania Udrescu Romania NAP
3179 natamycin Not available* 8 years 03/11/2032 01/02/2033 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00003179/203211 Adam Przybylkowski Poland NAP
3180 sodium chloride 24/11/1972 10 years 31/01/2035 01/05/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003180/203501 NAP
3181 riboflavin Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003181/203611 NAP
3183 silibinin, dry extract from Milk Thistle fruit (silymarin)) Not available* 9 years 03/06/2032 01/09/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00003183/203206 Roxana Dondera Romania NAP
3184 sorbitol Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00003184/202612 Roxana Dondera Romania NAP
3185 tenonitrozole 11/02/1997 13 years 11/02/2028 11/05/2028 No 27/01/2026 PRAC representative was updated on 31/05/2023
PRAC representative was updated on 31/03/2021
PRAC Rapporteur amended on 06/02/2019
PRAC Representative updated on 26/09/2018
PRAC Rapporteur amended on 28/02/2018
The PSUR Frequency and Next DLP was amended on 29/10/2015
Lead MS was added on 04/02/2015 PSUSA/00003185/202802 Roxana Stefania Udrescu Romania NAP
3186 a-tocopheril, a-tocopherol, vitamin E Not available* 8 years 03/11/2033 01/02/2034 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00003186/203311 Roxana Stefania Udrescu Romania NAP
9004 aciclovir / hydrocortisone 31/07/2009 5 years 30/07/2028 28/10/2028 No 27/03/2024 PSUR frequency amended and DLP updated on 27/03/2024 PSUSA/00009004/202807 Jan Neuhauser Austria NAP
9005 aclidinium bromide 20/07/2012 1 year 20/07/2026 28/09/2026 20/07/2027 28/09/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00009005/202607 PSUSA/00009005/202707 Adam Przybylkowski Poland CAP
9050 aluminium chloride hexahydrate Not available* 10 years 03/11/2035 01/02/2036 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009050/203511 Dennis Lex Germany NAP
9052 amlodipine / bisoprolol, amlodipine / nebivolol Not available* 9 years 03/03/2027 01/06/2027 No 22/10/2025 DLP was amended on 22/10/2025
Active substance name was amended on 22/10/2025
PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009052/202703 none NAP
9054 amoxicillin / lansoprazole / metronidazole Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009054/202903 NAP
9057 argatroban 31/01/1990 2 years 31/01/2026 01/05/2026 No 02/06/2026 PSUSA/00009057/202601 Karin Bolin Sweden NAP
9062 ascorbic acid / biotin / calcium pantotenate Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009062/202905 NAP
9068 atropine sulfate / phenylephrine acetate / prednisolone acetate 13/12/1960 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009068/203906 NAP
9071 bacampicillin Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009071/202905 NAP
9074 balsalazide 18/12/1997 7 years 02/01/2031 02/04/2031 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00009074/203101 Amelia Cupelli Italy NAP
9075 belimumab 13/07/2011 3 years 08/03/2027 06/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00009075/202703 Karin Bolin Sweden CAP
9080 bisulepin Not available* 7 years 03/08/2031 01/11/2031 Yes 23/10/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 23/10/2024
PSUR frequency and DLP amended on 27/03/2024 PSUSA/00009080/203108 Miroslava Gocova Slovakia NAP
9083 bornaprin 13/12/1974 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009083/203503 NAP
9084 botulinum neurotoxin type a (150 kd) free from complexing proteins 31/05/2005 3 years 31/12/2027 30/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00009084/202712 Rhea Fitzgerald Ireland NAP
9088 caffeine / dextropropoxyphene / paracetamol Not available* 8 years 01/12/2033 01/03/2034 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00009088/203312 none NAP
9091 calcium lactate Not available* 8 years 01/12/2033 01/03/2034 No 30/10/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00009091/203312 John Joseph Borg Malta NAP
9092 calcium pantothenate Not available* 8 years 01/12/2033 01/03/2034 No 30/10/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00009092/203312 Polona Golmajer Slovenia NAP
9099 cefuroxime axetil 18/08/1987 5 years 07/04/2027 06/07/2027 No 21/12/2022 DLP was updated on 21/12/2022
DLP was updated on 19/12/2017
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00009099/202704 Maia Uusküla Estonia NAP
9100 chloral hydrate 08/02/1967 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009100/202803 NAP
9107 cloricromen hydrochloride 18/06/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009107/202812 NAP
9112 colistimethate sodium (dry inhalation powder) 13/02/2012 3 years 12/02/2026 13/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00009112/202602 Adam Przybylkowski Poland CAP
9113 conjugated estrogens 09/03/1950 10 years 01/12/2032 01/03/2033 No 11/06/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009113/203212 Guðrún Stefánsdóttir Iceland NAP
9114 conjugated estrogens / norgestrel Not available* 9 years 03/03/2030 01/06/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009114/203003 NAP
9118 decitabine 02/05/2006 5 years 01/05/2028 30/07/2028 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00009118/202805 Tiphaine Vaillant France CAP
9119 denosumab (indicated for skeletal related events associated with bone metastases and for giant cell tumour of bone) 13/07/2011 3 years 26/09/2026 25/12/2026 No 02/06/2026 PSUSA/00009119/202609 Karin Bolin Sweden CAP
9120 dexamethasone / heparin sodium 16/08/1961 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009120/203906 NAP
9121 dexpanthenol / polyvinyl alcohol Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009121/203008 NAP
9128 diclofenac / pyridoxine / thiamine Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009128/203008 NAP
9129 didecyldimethylammonium chloride Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009129/203008 NAP
9131 diethylamine salicylate / myrtecaine 20/11/1967 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009131/203408 NAP
9136 diphenhydramine / racemic camphor / zinc oxide Not available* 8 years 03/03/2026 01/06/2026 No 05/08/2025 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00009136/202603 Carla Torre Portugal NAP
9139 dithranol Not available* 8 years 03/03/2026 01/06/2026 No 05/08/2025 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00009139/202603 Rhea Fitzgerald Ireland NAP
9142 emtricitabine / rilpivirine / tenofovir disoproxil 28/11/2011 3 years 10/08/2026 08/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00009142/202608 Liana Martirosyan Netherlands CAP
9143 escin 06/04/1983 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009143/202812 NAP
9144 diethylamine-salicylate / escin Not available* 8 years 03/03/2026 01/06/2026 No 05/08/2025 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00009144/202603 Eva Jirsová Czech Republic NAP
9145 estradiol (17-beta) / progesterone Not available* 7 years 01/12/2031 29/02/2032 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00009145/203112 Amelia Cupelli Italy NAP
9146 estriol / lactobacillus acidophilus Not available* 8 years 03/06/2026 01/09/2026 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009146/202606 NAP
9147 exenatide 20/11/2006 3 years 31/03/2027 29/06/2027 No 02/06/2026 PSUSA/00009147/202703 Karin Bolin Sweden CAP
9150 clonazoline hydrochloride / fluocinolone acetonide Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 PSUR frequency and DLP amended on 28/08/2024. PSUSA/00009150/202912 NAP
9152 fluocinolone / neomycin, fluocinolone / neomycin / polymyxin b 01/05/1965 10 years 01/05/2033 30/07/2033 No 23/10/2024 PSUR frequency amended and DLP updated on 23/10/2024
Active substance name was amended on 23/10/2024
EURD added on 23/10/2024
Active substance name was amended on 22/12/2021 PSUSA/00009152/203305 Dennis Lex Germany NAP
9153 fluorescein (systemic use) 30/11/1971 3 years 30/04/2026 29/07/2026 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00009153/202604 Dennis Lex Germany NAP
9154 fluticasone furoate 11/01/2008 3 years 26/04/2027 25/07/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00009154/202704 Adam Przybylkowski Poland CAP NAP
9159 gentamicin (systemic use) 28/02/1973 3 years 31/03/2026 29/06/2026 Yes 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00009159/202603 Amelia Cupelli Italy NAP
9162 calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide 25/03/2004 5 years 25/03/2029 23/06/2029 No 20/11/2024 PSUR frequency amended and DLP updated on 20/11/2024 PSUSA/00009162/202903 Maria Popova-Kiradjieva Bulgaria NAP
9163 guaiazulene / matricaria oil Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009163/203103 NAP
9164 guaifenesin / herbal extracts Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009164/203103 NAP
9165 guaifenesin / levomenthol Not available* 8 years 03/08/2026 01/11/2026 No 18/11/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009165/202608 Rhea Fitzgerald Ireland NAP
9166 diphenhydramine / guaifenesin / levomenthol Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009166/203011 NAP
9167 glucose / guaiphenesin / treacle Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009167/203103 NAP
9168 halometasone Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009168/203103 NAP
9169 halometasone / triclosan Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009169/203106 NAP
9170 dexpanthenol / heparin Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009170/203008 NAP
9171 hydroxyethyl salicylate / heparin / menthol Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009171/203106 Jan Neuhauser Austria NAP
9172 benzyl nicotinate / heparin sodium Not available* 8 years 01/12/2033 01/03/2034 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00009172/203312 none NAP
9174 human coagulation factor VIII (inhibitor bypassing fraction) 04/02/1977 3 years 28/02/2027 29/05/2027 No 20/10/2021 PSUR frequency and DLP were updated on 20/10/2021
DLP was updated on 21/10/2020
DLP was updated on 23/10/2019
PRAC Rapporteur name was updated on 05/06/2019
DLP was updated on 23/10/2018
DLP was updated and PRAC Representative name amended on 17/10/2017
Next DLP was amended on 19/10/2016
DLP was amended on 30/09/2015.
Lead MS was added on 13/07/2015
Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015 PSUSA/00009174/202702 Sonja Hrabcik Austria NAP
9175 human papillomavirus vaccine (rDNA) - 2-valent 20/09/2007 3 years 17/11/2025 15/02/2026 No 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00009175/202511 Jean-Michel Dogné Belgium CAP
9176 hydrocortisone (for centrally authorised products for adrenal insufficiency, congenital adrenal hyperplasia, modified-release formulations) 03/11/2011 3 years 03/11/2028 01/02/2029 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00009176/202811 Karin Bolin Sweden CAP
9177 dexpanthenol / hydrocortisone Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009177/203008 NAP
9178 hydrogen peroxide Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009178/203106 NAP
9179 hydrotalcite Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009179/202611 Dennis Lex Germany NAP
9180 hydrotalcite / simeticone Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009180/203106 NAP
9182 hydroxycarbamide (except for centrally authorised product) 07/12/1967 3 years 06/12/2026 06/03/2027 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00009182/202612 Petar Mas Croatia NAP
9183 hyetellose / sodium chloride 11/01/1990 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009183/202901 NAP
9187 ibuprofen / phenylephrine Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009187/202611 Adam Przybylkowski Poland NAP
9188 ichthammol / titanium dioxide / zinc oxide and other substances, zinc oxide/dimethicone 18/01/1934 13 years 03/06/2040 01/09/2040 No 23/10/2024 DLP amended on 23/10/2024 PSUSA/00009188/204006 NAP
9190 iloprost (intravenous (IV)use only) 27/04/1994 5 years 31/01/2029 01/05/2029 No 19/09/2024 PSUSA/00009190/202901 Zoubida Amimour France NAP
9191 indium (111In) pentetate 06/03/1992 8 years 15/07/2028 13/10/2028 Yes 28/04/2022 PRAC representative was updated on 19/10/2022
PRAC Representative was amended on 28/04/2022
DLP was updated on 31/03/2021
LMS and PRAC representative were added on 18/12/2019
DLP was updated on 05/06/2019
Active substance name was amended on 19/10/2016 PSUSA/00009191/202807 Jo Robays Belgium NAP
9192 indium (111In) pentetreotide 16/02/1994 8 years 15/07/2028 13/10/2028 No 31/03/2021 PRAC representative was updated on 19/10/2022
DLP was updated on 31/03/2021
PRAC representative was added on 06/05/2020
LMS was added on 01/04/2020
DLP was updated on 05/06/2019 PSUSA/00009192/202807 Jo Robays Belgium NAP
9200 ipilimumab 13/07/2011 3 years 24/03/2027 22/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00009200/202703 Bianca Mulder Netherlands CAP
9201 ipratropium / xylometazoline 07/04/2006 6 years 03/08/2029 01/11/2029 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00009201/202908 Petar Mas Croatia NAP
9204 ivacaftor 23/07/2012 3 years 23/01/2026 23/04/2026 No 19/09/2025 Next DLP was updated on 18/10/2023 PSUSA/00009204/202601 Maria Martinez Gonzalez Spain CAP
9205 ketoprofen (topical use only) 23/01/1975 5 years 23/01/2027 23/04/2027 No 19/10/2022 PSUR frequency and DLP were updated on 19/10/2022
DLP was updated on 25/09/2019
DLP was corrected on 28/02/2018
PSUR Frequency amended and DLP updated and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" amended on 23/05/201
Next DLP was amended on 03/06/2016
EURD and DLP amended on 16/07/2015
Lead MS added on 12/05/2015
For advice on submission for DLPs falling before 10/09/2015 please consult the List of substance under Work sharing scheme and other substance contained in Nationally Authorised Products with DLPs synchronised. PSUSA/00009205/202701 Karin Bolin Sweden NAP
9206 lactic acid / propylene glycol, propylene glycol Not available* 9 years 03/07/2031 01/10/2031 Yes 01/04/2026 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 01/04/2026
Active substance name was amended on 01/04/2026
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009206/203107 none NAP
9207 lamivudine (HIV infections), lamivudine / zidovudine 18/03/1998 5 years 30/11/2029 28/02/2030 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00009207/202911 Zoubida Amimour France CAP
9208 white soft paraffin, white soft paraffin combinations (except ocular indications) 30/06/1982 13 years 30/06/2040 28/09/2040 No 01/04/2026 Active substance name was amended on 01/04/2026
DLP was amended on 18/12/2024
Name of active substance was amended on 21/12/2012 PSUSA/00009208/204006 Jo Robays Belgium NAP
9210 levomenthol Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009210/202611 Maria Popova-Kiradjieva Bulgaria NAP
9212 levothyroxine / potassium iodide Not available* 9 years 02/09/2031 01/12/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009212/203109 NAP
9213 fluorescein sodium / lidocain hydrochloride Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009213/203012 NAP
9215 isopropyl myristate / liquid paraffin Not available* 9 years 03/07/2031 01/10/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009215/203107 NAP
9216 acetylated wool alcohols / liquid paraffin Not available* 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009216/202901 NAP
9219 magaldrate Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009219/202611 Jo Robays Belgium NAP
9225 magnesium sulfate Not available* 5 years 30/06/2030 28/09/2030 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00009225/203006 Marie Louise Schougaard Christiansen Denmark NAP
9226 mannitol (indicated in cystic fibrosis) 13/04/2012 3 years 12/04/2028 11/07/2028 No 19/09/2024 PSUSA/00009226/202804 Zoubida Amimour France CAP
9231 moxifloxacin (systemic use) 31/05/1999 4 years 31/05/2027 29/08/2027 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00009231/202705 Dennis Lex Germany NAP
9234 nicotinamide Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 Correction of DLP on 20/11/2024
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009234/202611 Tiphaine Vaillant France NAP
9236 nimesulide (systemic formulations) 06/08/1985 5 years 30/06/2029 28/09/2029 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00009236/202906 Amelia Cupelli Italy NAP
9237 nitroxoline Not available* 8 years 03/11/2026 01/02/2027 Yes 28/05/2025 DLP was amended on 28/05/2025
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009237/202611 Dennis Lex Germany NAP
9239 amoxicillin / clarithromycin / omeprazole Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009239/202903 NAP
9241 aspergillus orizae / pancreatin Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009241/202905 NAP
9242 belladonna extract / hyosciamine / papaverine hydrochloride Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009242/202905 NAP
9243 dextromethorphan / doxylamine / paracetamol Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009243/203008 NAP
9244 dextromethorphan / doxylamine / ephedrine / paracetamol Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009244/203008 NAP
9245 dextromethorphan / doxylamine / paracetamol / pseudoephedrine Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009245/203008 NAP
9247 dextromethorphan / paracetamol / phenylephrine Not available* 10 years 03/11/2034 01/02/2035 Yes 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00009247/203411 Miroslava Gocova Slovakia NAP
9248 ascorbic acid / paracetamol / propyphenazone 21/12/1959 11 years 03/05/2039 01/08/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009248/203905 NAP
9251 paraffin liquid Not available* 12 years 03/06/2040 01/09/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009251/204006 Jo Robays Belgium NAP
9253 pasireotide 24/04/2012 3 years 24/10/2026 22/01/2027 No 02/06/2026 PSUSA/00009253/202610 Karin Bolin Sweden CAP
9254 peginterferon alfa-2a 05/07/2001 3 years 04/07/2026 02/10/2026 No 02/06/2026 PSUSA/00009254/202607 Karin Bolin Sweden CAP
9255 perampanel 23/07/2012 3 years 22/07/2028 20/10/2028 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00009255/202807 Tiphaine Vaillant France CAP NAP
9256 phenol Not available* 10 years 16/04/2030 15/07/2030 Yes 16/12/2020 Correction of PSUR frequency and DLP on 29/06/2022
DLP was updated on 16/12/2020
PRAC Representative amended on 07/05/2018
DLP was updated and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/03/2017
Lead MS was added on 06/03/2015 PSUSA/00009256/203004 John Joseph Borg Malta NAP
9257 esculoside / phenylephrine Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009257/203011 NAP
9258 piketoprofen 08/08/1983 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009258/202812 NAP
9260 pinazepam 24/03/1975 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009260/203503 NAP
9262 pneumococcal polysaccharide conjugate vaccine (adsorbed) - 10 valent 30/03/2009 5 years 10/12/2027 09/03/2028 No 02/06/2026 PSUSA/00009262/202712 Karin Bolin Sweden CAP
9263 pneumococcal polysaccharide conjugate vaccine (adsorbed) - 13 valent 09/12/2009 5 years 09/01/2028 08/04/2028 No 02/06/2026 PSUSA/00009263/202801 Karin Bolin Sweden CAP
9264 magnesium aspartate / potassium aspartate Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009264/202611 Melinda Palfi Hungary NAP
9266 potassium canrenoate Not available* 7 years 31/01/2026 01/05/2026 Yes 28/05/2025 DLP was amended on 28/05/2025
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025
PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00009266/202601 Amelia Cupelli Italy NAP
9268 potassium iodide, potassium iodide / iodine Not available* 9 years 03/05/2032 01/08/2032 Yes 27/05/2026 Active substance name was amended on 27/05/2026
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009268/203205 none NAP
9269 chloramphenicol hemisuccinate / prednisolone sodium succinate Not available* 9 years 03/08/2029 01/11/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009269/202908 none NAP
9271 promestriene (cream and vaginal capsules) 31/01/1974 5 years 31/03/2029 29/06/2029 No 27/01/2026 PSUR frequency amended and DLP updated on 18/12/2024 PSUSA/00009271/202903 Roxana Dondera Romania NAP
9272 chlorquinaldol (vaginal tablet) / promestriene 13/06/1977 13 years 30/09/2032 29/12/2032 No 03/06/2020 PRAC representative was updated on 31/03/2021
PSUR frequency and CLP were updated on 03/06/2020
PSUR Frequency amended and DLP updated on 23/05/2017
EURD date amended on 22/09/2016
PSUR Frequency amended and DLP updated on 03/06/2016
Lead MS added on 12/05/2015 PSUSA/00009272/203209 Roxana Dondera Romania NAP
9273 protirelin 01/01/1974 8 years 01/01/2032 31/03/2032 No 12/09/2025 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00009273/203201 Veronika Macurová Czech Republic NAP
9275 pyridoxine Not available* 9 years 03/05/2032 01/08/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009275/203205 NAP
9276 l(+)biaspartate / glutamic acid / glycin / magnesium / potassium / pyridoxine 01/12/1975 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009276/203503 NAP
9277 rabies vaccine 16/05/1975 5 years 11/03/2026 09/06/2026 No 17/11/2021 DLP was updated on 17/11/2021
PRAC representative was updated on 17/11/2021
PRAC representative was updated on 25/09/2019
Next DLP was updated on 18/11/2016
PRAC Representative was amended on 27/11/2015.
Lead Member State was added on 30/09/2015 PSUSA/00009277/202603 Amelia Cupelli Italy NAP
9279 ascorbic acid / colecalciferol / retinol Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009279/202905 NAP
9280 a-tocopherol nicotinate / retinol palmitate 31/12/1968 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009280/204003 NAP
9282 rilpivirine (for oral use) 28/11/2011 3 years 19/05/2027 17/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00009282/202705 Liana Martirosyan Netherlands CAP
9284 saccharomyces boulardii Not available* 5 years 07/02/2028 07/05/2028 No 18/10/2023 PSUR frequency amended and DLP updated on 18/10/2023 PSUSA/00009284/202802 Eva Jirsová Czech Republic NAP
9286 flumetasone / salicylic acid Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009286/203012 NAP
9288 scopolamine aminoxide hydrobromide Not available* 9 years 03/06/2032 01/09/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009288/203206 NAP
9292 silver nitrate Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00009292/202612 Benjamin Micallef Malta NAP
9295 sodium chloride (eye drops) Not available* 9 years 03/06/2032 01/09/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009295/203206 NAP
9296 sodium chloride (nasal drops) Not available* 9 years 03/08/2032 01/11/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009296/203208 NAP
9298 chamomile extract / glucose / potassium chloride / sodium chloride / sodium hydrogen carbonate Not available* 9 years 03/07/2029 01/10/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00009298/202907 NAP
9300 strontium chloride hexahydrate Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009300/203211 NAP
9302 sucrose Not available* 8 years 03/08/2027 01/11/2027 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009302/202708 NAP
9303 hamamelis virginiana l. extract / phenazone / tannic acid Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009303/203106 NAP
9305 teduglutide 30/08/2012 2 years 30/08/2026 28/11/2026 No 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00009305/202608 Marie Louise Schougaard Christiansen Denmark CAP
9310 tetracycline (topical use) 23/08/1984 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00009310/202812 NAP
9312 thiamine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009312/203211 NAP
9315 tobramycin (inhalation powder, capsules) 20/07/2011 6 years 30/06/2030 28/09/2030 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00009315/203006 Liana Martirosyan Netherlands CAP
9316 tobramycin (nebuliser solution) (apart from centrally authorised product) 10/12/1999 3 years 31/12/2026 31/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00009316/202612 Amelia Cupelli Italy NAP
9317 tobramycin (ophthalmic and otic use) 01/06/1977 5 years 31/03/2026 29/06/2026 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00009317/202603 Carla Torre Portugal NAP
9318 tobramycin (systemic use) 29/10/1973 8 years 15/09/2028 14/12/2028 No 19/10/2022 PRAC representative was updated on 19/10/2022
PRAC representative was updated on 27/07/2022
DLP was updated on 26/05/2021
PRAC representative and LMS were added on 04/03/2020
DLP was updated on 05/06/2019 PSUSA/00009318/202809 Amelia Cupelli Italy NAP
9319 treosulfan (except for centrally authorised product) Not available* 5 years 31/08/2027 29/11/2027 No 03/05/2023 DLP was amended on 03/05/2023
PRAC Rapporteur name was amended on 28/04/2022
Active substance name amended on 31/07/2019
PRAC Rapporteur name was amended on 03/04/2019
DLP was updated on 06/06/2018
Lead MS and PRAC Rapporteur name was added on 28/02/2017 PSUSA/00009319/202708 Marie Louise Schougaard Christiansen Denmark NAP
9321 triamterene / trichlormethiazide Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009321/203211 NAP
9323 cetrimonium bromide / lidocaine / tyrothricin 28/09/1966 10 years 03/07/2034 01/10/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009323/203407 NAP
9326 urea hydrogen peroxide Not available* 8 years 03/11/2032 01/02/2033 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00009326/203211 Melinda Palfi Hungary NAP
9327 vandetanib 06/04/2011 3 years 06/04/2028 05/07/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00009327/202804 Tiphaine Vaillant France CAP
9329 vemurafenib 17/02/2012 3 years 16/08/2028 14/11/2028 No 02/06/2026 PSUSA/00009329/202808 Jenny-Maria Jönsson Sweden CAP
9330 xylene 14/05/1957 11 years 02/04/2038 01/07/2038 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009330/203804 NAP
9331 zinc orotate Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009331/203211 NAP
9333 zinc sulfate, zinc histidine 30/03/1973 10 years 31/01/2035 01/05/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009333/203501 Dennis Lex Germany NAP
9334 zoledronic acid (indicated for Osteoporosis) 15/04/2005 5 years 31/08/2028 29/11/2028 No 02/06/2026 PSUSA/00009334/202808 Karin Bolin Sweden CAP
9999 levomepromazine Not available* 9 years 03/07/2031 01/10/2031 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00009999/203107 NAP
10000 5 fluorouracil (topical application) Not available* 3 years 16/01/2026 16/04/2026 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00010000/202601 Dennis Lex Germany NAP
10002 fluorodopa (18F) Not available* 3 years 10/03/2027 08/06/2027 Yes 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010002/202703 John Joseph Borg Malta NAP
10005 mannitol (all indications apart from cystic fibrosis) Not available* 5 years 28/02/2030 29/05/2030 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010005/203002 Petar Mas Croatia NAP
10006 5-aminolevulinic acid (keratosis) 07/09/2007 5 years 14/06/2029 12/09/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010006/202906 Dennis Lex Germany CAP NAP
10007 ribavirin (oral formulations) 07/05/1999 3 years 24/07/2026 22/10/2026 Yes 18/11/2025 PSUSA/00010007/202607 Tiphaine Vaillant France NAP
10008 pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted), prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted), prepandemic influenza vaccine (H5N8) (surface antigen, inactivated, adjuvanted) 19/10/2009 3 years 19/10/2027 17/01/2028 No 28/05/2025 Active substance name was amended on 28/05/2025
DLP was amended on 05/06/2024 PSUSA/00010008/202710 Amelia Cupelli Italy CAP
10012 ciprofloxacin / dexamethasone (ear drops, suspension) 31/05/2012 5 years 30/04/2030 29/07/2030 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010012/203004 Dennis Lex Germany NAP
10013 ceftaroline fosamil 29/10/2010 3 years 28/10/2027 26/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00010013/202710 Maia Uusküla Estonia CAP
10015 ruxolitinib 23/08/2012 1 year 22/02/2026 03/05/2026 22/02/2027 03/05/2027 No 02/06/2026 PSUSA/00010015/202602 PSUSA/00010015/202702 Jenny-Maria Jönsson Sweden CAP
10019 aflibercept (oncological indication(s)) 03/08/2012 5 years 03/08/2029 01/11/2029 No 02/06/2026 PSUSA/00010019/202908 Jenny-Maria Jönsson Sweden CAP
10020 aflibercept (ophthalmological indication(s)) 22/11/2012 3 years 30/11/2025 28/02/2026 No 19/09/2024 New CAP authorised on 15/09/2025
New CAP authorised on 14/08/2025
New CAP authorised on 04/04/2025
New CAP authorised on 12/02/2025
New CAP authorised on 13/01/2025
New CAP authorised on 13/11/2024 PSUSA/00010020/202511 Zoubida Amimour France CAP
10021 alprostadil (patency of the ductus arteriosus) 23/07/1981 3 years 22/07/2027 20/10/2027 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00010021/202707 Sonja Hrabcik Austria NAP
10022 axitinib 27/01/2012 3 years 26/01/2028 25/04/2028 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010022/202801 David Olsen Norway CAP
10025 linaclotide 30/08/2012 3 years 26/08/2028 24/11/2028 No 27/05/2026 DLP was corrected on 27/05/2026
PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00010025/202808 Dennis Lex Germany CAP
10026 dectaflur / olaflur Not available* 8 years 03/03/2026 01/06/2026 No 05/08/2025 PSUR frequency and DLP amended on 31/07/2024. PSUSA/00010026/202603 Dennis Lex Germany NAP
10028 concentrate of proteolytic enzymes enriched in bromelain 18/12/2012 1 year 17/12/2025 25/02/2026 17/12/2026 25/02/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010028/202512 PSUSA/00010028/202612 Dennis Lex Germany CAP
10029 dapagliflozin, dapagliflozin / metformin, saxagliptin / dapagliflozin, dapagliflozin / sitagliptin 05/10/2012 3 years 04/10/2027 02/01/2028 No 02/06/2026 PSUSA/00010029/202710 Karin Bolin Sweden CAP
10030 dexpanthenol / xylometazoline Not available* 8 years 31/05/2028 29/08/2028 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00010030/202805 Barbara Kovacic Bytyqi Croatia NAP
10031 mirabegron 01/07/2011 3 years 30/06/2028 28/09/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010031/202806 Maria del Pilar Rayon Spain CAP
10032 florbetapir (18f) 06/04/2012 5 years 06/04/2030 05/07/2030 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00010032/203004 Dennis Lex Germany CAP
10034 catridecacog 19/07/2012 3 years 31/07/2026 29/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00010034/202607 Tiphaine Vaillant France CAP
10036 insulin degludec, insulin degludec / insulin aspart 28/09/2012 3 years 30/09/2026 29/12/2026 No 02/06/2026 PSUSA/00010036/202609 Karin Bolin Sweden CAP
10039 brentuximab vedotin 19/08/2011 3 years 18/08/2028 16/11/2028 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010039/202808 Bianca Mulder Netherlands CAP
10041 magnesium pidolate 01/04/1992 15 years 03/06/2040 01/09/2040 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010041/204006 Veronika Macurová Czech Republic NAP
10042 crizotinib 26/08/2011 3 years 25/08/2027 23/11/2027 No 29/04/2026 PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00010042/202708 Tiphaine Vaillant France CAP
10043 meningococcal group-B vaccine (rDNA, component, adsorbed) 14/01/2013 3 years 13/01/2027 13/04/2027 No 02/06/2026 PSUSA/00010043/202701 Karin Bolin Sweden CAP
10044 meningococcal group a, c, w135, y conjugate vaccine (conjugated to tetanus toxoid carrier protein) 20/04/2012 3 years 19/04/2026 18/07/2026 No 20/12/2023 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00010044/202604 David Olsen Norway CAP
10047 glycopyrronium bromide (for centrally authorised product indicated for chronic obstructive pulmonary disease) 28/09/2012 5 years 28/09/2027 27/12/2027 No 31/05/2023 PSUR frequency amended and DLP updated on 31/05/2023
PRAC Rapporteur name was amended on 28/04/2022
PRAC representative was updated on 31/03/2021
DLP was updated on 03/06/2020
PRAC representative was updated on 25/09/2019
PRAC Rapporteur name was corrected on 03/04/2019
PRAC Rapporteur name was amended on 06/06/2018
PRAC Representative amended on 17/10/2017
PSUR Frequency amended and DLP updated on 26/04/2017
The name of the active substance was amended on 22/09/2016
Next DLP was amended on 03/05/2016
Next DLP amended on 04/11/2014
Next DLP amended on 02/05/2014 PSUSA/00010047/202709 Marie Louise Schougaard Christiansen Denmark CAP
10049 zinc gluconate Not available* 8 years 03/11/2026 01/02/2027 Yes 11/06/2025 DLP was amended on 28/05/2025
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025
PSUR frequency and DLP amended on 28/08/2024 PSUSA/00010049/202611 Guðrún Stefánsdóttir Iceland NAP
10050 caffeine / dexpanthenol / nicotinamide / pyridoxine / riboflavine / thiamin 23/06/1966 11 years 02/12/2039 01/03/2040 No 02/06/2026 PSUSA/00010050/203912 Karin Bolin Sweden NAP
10051 lovastatin 21/07/1987 5 years 20/07/2026 18/10/2026 No 30/03/2022 PRAC Representative updated on 16/11/2022
DLP was updated on 30/03/2022
PRAC Representative updated on 26/09/2018
PSUR Frequency amended and DLP updated on 28/03/2017
Lead MS and PRAC Rapporteur name updated on 04/02/2016 PSUSA/00010051/202607 Maria del Pilar Rayon Spain NAP
10052 vortioxetine 18/12/2013 2 years 29/09/2026 28/12/2026 No 28/04/2022 Next DLP was updated on 31/05/2023 PSUSA/00010052/202609 Jo Robays Belgium CAP
10054 afatinib 25/09/2013 5 years 25/09/2028 24/12/2028 No 02/06/2026 PSUSA/00010054/202809 Jenny-Maria Jönsson Sweden CAP
10055 alemtuzumab 12/09/2013 3 years 12/09/2028 11/12/2028 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00010055/202809 Karin Erneholm Denmark CAP
10061 alogliptin, alogliptin / metformin, alogliptin / pioglitazone 16/04/2013 3 years 15/04/2028 14/07/2028 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00010061/202804 Bianca Mulder Netherlands CAP
10066 avanafil 21/06/2013 5 years 21/06/2028 19/09/2028 No 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 PSUSA/00010066/202806 Maria del Pilar Rayon Spain CAP
10067 azelastine / fluticasone 24/01/2013 5 years 26/10/2029 24/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010067/202910 Jan Neuhauser Austria NAP
10068 beclometasone / formoterol (inhalative application) 14/07/2006 5 years 14/07/2030 12/10/2030 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00010068/203007 Dennis Lex Germany NAP
10070 benzalkonium chloride / chlorhexidine digluconate 19/11/1998 7 years 01/11/2028 30/01/2029 No 29/06/2022 PSUR frequency and DLP were updated on 29/06/2022
PRAC Rapporteur name was amended on 06/03/2019
DLP was updated on 21/07/2017
Lead MS and PRAC Rapporteur name was added on 03/06/2016 PSUSA/00010070/202811 Rugile Pilviniene Lithuania NAP
10071 betamethasone / chloramphenicol 24/03/1964 18 years 31/08/2030 29/11/2030 No 29/11/2013 PSUSA/00010071/203008 NAP
10072 betamethasone / tetryzoline 17/05/1966 9 years 30/09/2033 29/12/2033 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00010072/203309 Petar Mas Croatia NAP
10073 bosutinib 04/09/2012 3 years 03/03/2027 01/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010073/202703 Dennis Lex Germany CAP
10074 bedaquiline 05/03/2014 3 years 05/09/2028 04/12/2028 No 02/06/2026 PSUSA/00010074/202809 Karin Bolin Sweden CAP
10075 dolutegravir, dolutegravir / abacavir / lamivudine, dolutegravir / lamivudine 16/01/2014 3 years 16/01/2028 15/04/2028 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00010075/202801 Dennis Lex Germany CAP
10077 canagliflozin, canagliflozin / metformin 29/03/2013 3 years 28/03/2026 26/06/2026 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00010077/202603 Dennis Lex Germany CAP
10078 chloroprocaine hydrochloride 19/03/2012 5 years 19/03/2027 17/06/2027 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00010078/202703 Petar Mas Croatia NAP
10080 clindamycin phosphate / tretinoin 22/03/2013 5 years 31/07/2027 29/10/2027 No 17/02/2026 DLP was updated on 05/04/2023
PRAC representative was updated on 22/12/2021
PRAC representative was updated on 06/05/2020
DLP was updated on 07/05/2018
PRAC representative and Lead Member State were added on 30/01/2017 PSUSA/00010080/202707 Jana Pecherova Slovakia NAP
10081 cobicistat 27/08/2013 3 years 26/08/2026 24/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010081/202608 Ana Sofia Diniz Martins Portugal CAP
10082 cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil 27/08/2012 3 years 26/08/2026 24/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010082/202608 Ana Sofia Diniz Martins Portugal CAP
10084 dabrafenib 26/08/2013 3 years 29/05/2028 27/08/2028 No 02/06/2026 PSUSA/00010084/202805 Jenny Jönsson Sweden CAP
10086 defibrotide 18/10/2013 3 years 18/10/2026 16/01/2027 No 02/06/2026 PSUSA/00010086/202610 Karin Bolin Sweden CAP
10087 dexpanthenol / retinol palmitate 16/07/1975 20 years 31/08/2032 29/11/2032 No 29/11/2013 PSUSA/00010087/203208 NAP
10088 dextran 40 / sodium chloride / potassium chloride / magnesium sulphate heptahydrate / disodium phosphate dodecahydrate / monopotassium phosphate / dextrose monohydrate 22/05/1970 10 years 02/09/2034 01/12/2034 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010088/203409 NAP
10091 diphtheria / tetanus / pertussis antigens (pertussis toxoid, filamentous haemagglutinin) (acellular, component) / hepatitis b (rdna) / poliomyelitis (inactivated) / haemophilus type b conjugate vaccines (adsorbed) 17/04/2013 3 years 17/04/2028 16/07/2028 No 06/10/2025 PRAC representative was updated on 01/03/2023
DLP was updated on 21/12/2022
PSUR frequency and DLP were updated on 20/11/2019
DLP was updated on 21/11/2018
DLP was amended on 15/11/2017
DLP was updated on 18/11/2016
DLP was updated on 27/11/2015
DLP was amended on 01/12/2014
DLP was amended on 28/05/2014 PSUSA/00010091/202804 Dirk Mentzer Germany CAP
10092 docosanol 14/11/2003 5 years 30/04/2026 29/07/2026 No 22/12/2021 DLP was updated on 22/12/2021
Next DLP was updated on 30/01/2017
PRAC Representative amended on 18/11/2016
Lead Member State and PRAC Representative was added on 27/11/2015. PSUSA/00010092/202604 Petar Mas Croatia NAP
10093 brimonidine (centrally authorised product only) 21/02/2014 3 years 21/02/2027 22/05/2027 No 20/10/2021 DLP and PSUR frequency were updated on 20/10/2021
DLP was updated on 21/10/2020
DLP was updated on 25/09/2019
Lead MS and PRAC Rapporteur name updated on 30/04/2019
DLP was updated on 26/09/2018
PSUR frequency amended and DLP updated on 27/03/2018
Next DLP was amended on 25/09/2017
DLP was updated and PRAC Representative amended on 28/03/2017
Next DLP was updated on 22/09/2016
Next DLP was amended on 07/04/2016
DLP and Next DLP was updated on 06/10/2015
Next DLP was amended on 01/04/2015 PSUSA/00010093/202702 Rhea Fitzgerald Ireland CAP
10094 florbetaben (18f) 20/02/2014 3 years 20/02/2026 21/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00010094/202602 Dennis Lex Germany CAP
10095 enzalutamide 31/08/2012 3 years 30/08/2026 28/11/2026 No 30/04/2024 New CAP authorised on 09/01/2026
DLP was amended on 30/04/2024 PSUSA/00010095/202608 Maria del Pilar Rayon Spain CAP
10096 fenofibrate / simvastatin 26/08/2013 3 years 25/02/2028 25/05/2028 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010096/202802 Maia Uusküla Estonia CAP
10097 fluprednidene Not available* 10 years 11/03/2034 09/06/2034 No 12/09/2025 DLP was amended on 20/11/2024 PSUSA/00010097/203403 Veronika Macurová Czech Republic NAP
10098 fluprednidene / gentamicin Not available* 10 years 11/03/2034 09/06/2034 No 12/09/2025 DLP was amended on 20/11/2024 PSUSA/00010098/203403 Veronika Macurová Czech Republic NAP
10099 fluticasone furoate / vilanterol 10/05/2013 5 years 09/05/2029 07/08/2029 No 19/09/2025 PSUR frequency amended and DLP updated on 30/04/2025
DLP was amended on 05/02/2025 PSUSA/00010099/202905 Maria Martinez Gonzalez Spain CAP
10100 framycetin sulphate / hydrocortisone acetate Not available* 9 years 31/01/2031 01/05/2031 No 12/09/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010100/203101 Veronika Macurová Czech Republic NAP
10101 granisetron (transdermal patch) 20/04/2012 3 years 19/10/2026 17/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010101/202610 Rugile Pilviniene Lithuania CAP
10102 human coagulation factor viii / human von willebrand factor (centrally authorised product only) 12/08/2013 5 years 12/08/2026 10/11/2026 No 28/04/2022 PSUR frequency amended and DLP updated on 28/04/2022
PSUR frequency amended and DLP updated on 03/04/2019
PRAC Representative updated on 26/09/2018
DLP was updated on 27/03/2018
DLP was updated on 28/03/2017
Next DLP was updated on 22/09/2016
PSUR Frequency amended and DLP updated on 07/04/2016
Next DLP was updated on 30/09/2015
Next DLP was amended on 01/04/2015
Correction of PSUSA number (Next DLP) on 06/10/2014
Correction of submission date on 31/01/2014
Name of active substance was amended on 30/11/2013 PSUSA/00010102/202608 Bianca Mulder Netherlands CAP
10104 C1-inhibitor, human plasma derived (centrally authorised products) 16/07/2001 2 years 15/06/2027 13/09/2027 No 01/04/2026 Reference to CAP removed on 01/04/2026
Active substance name was amended on 01/04/2026
DLP was amended on 04/03/2026 PSUSA/00010104/202706 Dirk Mentzer Germany NAP
10105 indacaterol / glycopyrronium bromide 19/09/2013 5 years 28/09/2028 27/12/2028 No 05/06/2024 PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00010105/202809 Marie Louise Schougaard Christiansen Denmark CAP
10107 insulin human (Intraperitoneal use only) 19/09/2013 3 years 19/09/2026 18/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00010107/202609 Jean-Michel Dogné Belgium CAP
10108 isopropyl alcohol (covers other synonymous terms such as 2-propanol) / propyl alcohol / mecetronium ethyl sulfate 20/01/1984 5 years 30/09/2026 29/12/2026 No 04/02/2026 Active substance name was amended on 04/02/2026
PSUR frequency and DLP were updated on 29/06/2022
PRAC representative added on 25/05/2022
LMS was added on 03/03/2021 PSUSA/00010108/202609 Dennis Lex Germany NAP
10109 levobunolol (ophthalmic indication) 02/01/1985 5 years 02/01/2027 02/04/2027 No 21/09/2022 DLP was updated on 21/09/2022
Next DLP was amended on 25/09/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00010109/202701 Eva Jirsová Czech Republic NAP
10110 lidocaine / prilocaine (centrally authorised product only) 15/11/2013 5 years 15/05/2030 13/08/2030 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010110/203005 Maria del Pilar Rayon Spain CAP
10111 lipegfilgrastim 25/07/2013 3 years 25/07/2027 23/10/2027 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00010111/202707 Terhi Lehtinen Finland CAP
10112 lomitapide 31/07/2013 1 year 31/07/2026 09/10/2026 31/07/2027 09/10/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010112/202607 PSUSA/00010112/202707 Bianca Mulder Netherlands CAP
10113 loxapine (pre-dispensed inhalation powder) 20/02/2013 3 years 20/08/2027 18/11/2027 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00010113/202708 Liana Martirosyan Netherlands CAP
10114 lurasidone 28/10/2010 3 years 27/10/2026 25/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010114/202610 Karin Bolin Sweden CAP
10115 macitentan 20/12/2013 3 years 17/10/2026 15/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010115/202610 Maria del Pilar Rayon Spain CAP
10118 midazolam (oromucosal solution or nasal routes of administration) 05/09/2011 3 years 09/09/2028 08/12/2028 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00010118/202809 Liana Martirosyan Netherlands CAP NAP
10119 smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara) 31/07/2013 1 year 31/07/2026 09/10/2026 31/07/2027 09/10/2027 No 04/03/2026 PSUR frequency amended and DLP updated on 04/03/2026
DLP was amended on 24/09/2025 PSUSA/00010119/202607 PSUSA/00010119/202707 Dirk Mentzer Germany CAP
10120 nalmefene 25/02/2013 3 years 24/02/2027 25/05/2027 No 20/10/2021 DLP was updated on 20/10/2021
PSUR Frequency and DLP updated on 26/09/2018
DLP was updated on 17/10/2017
Next DLP was updated on 22/09/2016
Next DLP was updated on 30/09/2015
Next DLP was amended on 06/10/2014
Next DLP was amended on 01/04/2014 PSUSA/00010120/202702 Dennis Lex Germany CAP
10123 paclitaxel albumin 11/01/2008 5 years 06/01/2027 06/04/2027 No 21/09/2022 PSUR frequency and DLP were updated on 21/09/2022
DLP was updated on 25/09/2019
New CAP authorised on 06/05/2019
PRAC Representative updated on 26/09/2018
PSUR Frequency amended and DLP updated on 22/09/2016 PSUSA/00010123/202701 Bianca Mulder Netherlands CAP
10124 papaverine / phentolamine Not available* 8 years 03/11/2026 01/02/2027 No 20/11/2024 DLP corrected on 20/11/2024
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010124/202611 Liana Martirosyan Netherlands NAP
10125 pertuzumab 08/06/2012 3 years 07/06/2027 05/09/2027 No 05/02/2025 New CAP authorised on 23/04/2026
DLP was amended on 05/02/2025 PSUSA/00010125/202706 Marie Louise Schougaard Christiansen Denmark CAP
10126 phenol-methanal-urea polycondensate / sulphonated / sodium salt Not available* 20 years 22/12/2034 22/03/2035 No 31/01/2014 PSUSA/00010126/203412 NAP
10127 pomalidomide 08/02/2013 5 years 07/02/2029 08/05/2029 Yes 19/09/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 20/11/2024
PSUR frequency and DLP were updated on 20/10/2021
Correction to PSUR frequency, DLP and submission date on 05/02/2020
DLP was updated on 25/09/2019
Lead MS and PRAC Rapporteur name updated on 30/04/2019
DLP was updated on 26/09/2018
Next DLP was amended on 25/09/2017
Correction of the next DLP and PSUR frequency on 11/04/2017
DLP was updated and PRAC representative amended on 28/03/2017
Next DLP was updated on 22/09/2016
Next DLP was amended on 07/04/2016
Next DLP was updated on 30/09/2015
Next DLP was amended on 01/04/2015
Next DLP was amended on 06/10/2014 PSUSA/00010127/202902 Maria Martinez Gonzalez Spain CAP
10128 ponatinib 14/12/2012 3 years 13/12/2026 13/03/2027 No 02/06/2026 PSUSA/00010128/202612 Jenny-Maria Jönsson Sweden CAP
10130 potassium para-aminobenzoate Not available* 5 years 04/02/2030 05/05/2030 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010130/203002 Dennis Lex Germany NAP
10132 radium-223 dichloride 13/11/2013 3 years 14/05/2027 12/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010132/202705 Rugile Pilviniene Lithuania CAP
10133 regorafenib 26/09/2012 3 years 26/09/2026 25/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00010133/202609 Bianca Mulder Netherlands CAP
10134 sofosbuvir 06/12/2013 5 years 05/12/2029 05/03/2030 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00010134/202912 Ana Sofia Diniz Martins Portugal CAP
10135 teriflunomide 12/09/2013 3 years 12/09/2026 11/12/2026 Yes 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00010135/202609 Dennis Lex Germany CAP NAP
10136 trastuzumab emtansine 15/11/2013 2 years 21/02/2026 22/05/2026 No 19/10/2022 PSUR frequency and DLP were updated on 19/10/2022
DLP was updated on 20/10/2021
PRAC representative was updated on 31/03/2021
DLP was updated on 21/10/2020
PRAC representative and DLP were updated on 25/09/2019
PRAC Rapporteur name was amended on 03/04/2019
DLP was updated on 26/09/2018
DLP was updated on 17/10/2017
Next DLP was updated on 22/09/2016
Next DLP was updated on 30/09/2015
The DLP was amended on 01/04/2014 PSUSA/00010136/202602 Karin Erneholm Denmark CAP
10137 triamcinolone (tablets and injectables) 28/09/1966 8 years 28/09/2028 27/12/2028 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00010137/202809 Carla Torre Portugal NAP
10138 turoctocog alfa 15/10/2013 3 years 31/10/2026 29/01/2027 No 06/10/2025 DLP was amended on 03/07/2024 PSUSA/00010138/202610 Dirk Mentzer Germany CAP
10139 unsaturated fatty acids (C18:2)(topical use) 28/06/1968 28 years 28/06/2040 26/09/2040 No 29/11/2013 PSUSA/00010139/204006 NAP
10140 vismodegib 30/01/2012 3 years 29/01/2027 29/04/2027 No 02/06/2026 PSUSA/00010140/202701 Jenny-Maria Jönsson Sweden CAP
10143 dimethyl fumarate, diroximel fumarate (multiple sclerosis) 30/01/2014 3 years 26/03/2028 24/06/2028 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00010143/202803 Dennis Lex Germany CAP
10155 felbamate 15/05/1994 5 years 30/09/2030 29/12/2030 Yes 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
Next DLP was updated on 31/05/2023 PSUSA/00010155/203009 Tiphaine Vaillant France NAP
10156 lidocaine / norepinephrine 01/10/1948 8 years 30/09/2021 29/12/2021 No 06/10/2014 PRAC representative and LMS were added on 03/03/2021 PSUSA/00010156/202109 Adam Przybylkowski Poland NAP
10163 C1-inhibitor, human plasma derived (nationally authorised products) 23/07/1979 2 years 04/08/2027 02/11/2027 No 01/04/2026 DLP was amended on 01/04/2026
Active substance name was amended on 01/04/2026
DLP was amended on 30/04/2024 PSUSA/00010163/202708 Dirk Mentzer Germany NAP
10171 para-aminosalicylic acid (centrally authorised product) 07/04/2014 5 years 07/10/2029 05/01/2030 Yes 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010171/202910 Karin Bolin Sweden CAP
10174 riociguat 19/03/2013 3 years 19/09/2027 18/12/2027 No 25/05/2022 DLP was updated on 25/05/2022
PSUR frequency was amended on 01/10/2019
PRAC Rapporteur name was updated on 03/07/2019
DLP was updated on 30/04/2019
Lead MS and PRAC Rapporteur name updated on 23/10/2018
DLP was updated on 07/05/2018
Next DLP was amended on 26/04/2017
PSUR frequency and following DLP updated on 18/11/2016
Next DLP was amended on 19/10/2016
DLP and next DLP were amended on 03/05/2016
The Next DLP was amended on 29/10/2015.
Next DLP was amended on 12/05/2015
EURD was amended on 04/11/2014 PSUSA/00010174/202709 Kimmo Jaakkola Finland CAP
10178 aztreonam (parenteral use) 04/08/1984 7 years 03/08/2030 01/11/2030 No 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00010178/203008 Marie Louise Schougaard Christiansen Denmark NAP
10180 cabozantinib 29/11/2012 3 years 28/11/2027 26/02/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010180/202711 Bianca Mulder Netherlands CAP
10186 vedolizumab 20/05/2014 3 years 19/05/2027 17/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010186/202705 Adam Przybylkowski Poland CAP
10187 amino acid combinations (only combinations of pure amino acids or combination of amino acids with mineral compounds/electrolytes, i.v. application) Not available* 7 years 01/01/2026 01/04/2026 No 25/09/2019 DLP was updated on 25/09/2019
PRAC Representative and Lead Member state assigned on 04/07/2018 PSUSA/00010187/202601 Dennis Lex Germany NAP
10190 amino acid combinations / glucose / triglyceride combinations (e.g. olive oil, soya bean oil, fish oil)/ with or without electrolytes/ mineral compounds (i.v. application) - only for the drug Numeta 20/01/2011 3 years 31/12/2027 30/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010190/202712 Karin Bolin Sweden NAP
10191 amlodipine / candesartan, amlodipine / candesartan / hydrochlorothiazide, candesartan / amlodipine / atorvastatin 20/03/2014 5 years 28/04/2027 27/07/2027 No 23/10/2024 Active substance name was amended on 23/10/2024
Active substance name was amended on 20/12/2023
DLP was updated on 21/12/2022
DLP was updated on 21/11/2018
DLP was amended on 31/01/2018
Lead MS and PRAC Rapporteur name was added on 19/10/2016 PSUSA/00010191/202704 Eva Jirsová Czech Republic NAP
10192 amlodipine / lisinopril 30/04/2004 5 years 31/12/2026 31/03/2027 No 21/09/2022 DLP was updated on 21/09/2022
Next DLP was amended on 25/09/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016 PSUSA/00010192/202612 Zane Neikena Latvia NAP
10196 benfotiamine 21/08/2013 5 years 03/07/2028 01/10/2028 Yes 15/11/2023 DLP was amended on 15/11/2023
Lead MS and PRAC Rapporteur name added on 26/07/2023
Update of PSUR frequency & DLP resulting from PRAC re-allocation exercise for entries with DLPs in 2025 on 05/04/2023 PSUSA/00010196/202807 Maia Uusküla Estonia NAP
10198 bismuth salts and combinations (except for fixed dose combination bismuth subcitrate potassium / metronidazole / tetracycline) Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 Name of entry was amended on 02/07/2014 PSUSA/00010198/203501 NAP
10199 bismuth subcitrate potassium / metronidazole / tetracycline 24/11/2011 3 years 24/05/2027 22/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010199/202705 Barbara Kovacic Bytyqi Croatia NAP
10203 calcium gluconate / colecalciferol / nicotinic acid Not available* 13 years 20/01/2027 20/04/2027 No 17/10/2017 Entry name amended on 17/10/2017
Correction of DLP was done on 08/08/2014 PSUSA/00010203/202701 NAP
10204 calcium levofolinate, calcium folinate 03/04/1982 15 years 03/04/2029 02/07/2029 No 01/12/2014 PSUSA/00010204/202904 NAP
10206 cefuroxime sodium (for intracameral use) 18/08/1987 3 years 15/05/2027 13/08/2027 Yes 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010206/202705 Maia Uusküla Estonia NAP
10208 cholic acid (oxosteroid-reductase or hydroxy-steroid dehydrogenase deficiency indication) 12/09/2013 3 years 12/09/2027 11/12/2027 Yes 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00010208/202709 Maria Poulianiti Greece CAP
10209 cilostazol 20/01/1988 3 years 19/01/2026 19/04/2026 Yes 20/09/2023 DLP amended on 20/09/2023 PSUSA/00010209/202601 Adam Przybylkowski Poland NAP
10210 colistimethate sodium (all applications except for dry inhalation powder) 08/10/1962 13 years 31/12/2026 31/03/2027 No 06/10/2014 PSUSA/00010210/202612 NAP
10213 delamanid 28/04/2014 6 months 27/04/2026 06/07/2026 27/10/2026 05/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010213/202604 PSUSA/00010213/202610 Jo Robays Belgium CAP
10217 drospirenone / ethinylestradiol 07/03/2000 5 years 06/09/2030 05/12/2030 No 27/05/2026 DLP was corrected on 27/05/2026
PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00010217/203009 Bianca Mulder Netherlands NAP
10218 elosulfase alfa 14/02/2014 3 years 13/02/2027 14/05/2027 No 20/10/2021 PSUR frequency updated on 17/11/2021
DLP was updated on 20/10/2021
DLP was updated on 23/09/2020
DLP was updated on 25/09/2019
Lead MS and PRAC Rapporteur name updated on 30/04/2019
DLP was updated on 26/09/2018
Next DLP was amended on 25/09/2017
PSUR Frequency and DLP updated and PRAC Representative amended on 28/03/2017
PSUR Frequency and following DLP updated and EURD date amended on 18/11/2016
PSUR Frequency amended and DLP updated on 22/09/2016
Next DLP was amended on 07/04/2016
Next DLP updated on 30/09/2015
The next DLP was amended on 01/04/2015
The DLP was corrected on 08/08/2014 PSUSA/00010218/202702 Rhea Fitzgerald Ireland CAP
10220 ethanol (cutaneous route of administration) Not available* 16 years 15/06/2030 13/09/2030 No 06/10/2015 PSUSA/00010220/203006 NAP
10221 ethyl esters of iodised fatty acids from poppyseed oil 31/03/1978 15 years 31/01/2028 30/04/2028 No 02/07/2014 PSUSA/00010221/202801 NAP
10224 fluocinolone acetonide (intravitreal implant in applicator) 04/05/2012 3 years 26/08/2028 24/11/2028 No 27/05/2026 DLP was corrected on 27/05/2026
PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00010224/202808 Carla Torre Portugal NAP
10226 fusidic acid (systemic use) 31/05/1962 3 years 30/05/2028 28/08/2028 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010226/202805 Zoubida Amimour France NAP
10227 fusidic acid (topical use) 31/05/1962 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00010227/202803 Zoubida Amimour France NAP
10228 hydroxocobalamin (only for products for chemical poisoning) 23/11/2007 3 years 23/11/2025 21/02/2026 No 19/09/2024 PSUSA/00010228/202511 Zoubida Amimour France CAP
10230 indapamide / perindopril, indapamide / ramipril 30/08/2001 5 years 25/11/2026 23/02/2027 No 22/10/2025 Active substance name was amended on 22/10/2025
PRAC representative updated on 31/01/2024 PSUSA/00010230/202611 Carla Torre Portugal NAP
10233 iron in any combination with multivitamins and/or minerals and/or aminoacids (except for combinations with folic acid) 09/05/1969 13 years 03/11/2032 01/02/2033 No 11/06/2025 DLP was amended on 23/10/2024
Active substance name was amended on 23/10/2024 PSUSA/00010233/203211 Guðrún Stefánsdóttir Iceland NAP
10234 iron in combination with folic acid and/or multivitamins and/or minerals and/or aminoacids 10/07/1962 13 years 03/11/2032 01/02/2033 No 16/01/2025 DLP was amended on 23/10/2024
Active substance name was amended on 23/10/2024 PSUSA/00010234/203211 Georgia Gkegka Greece NAP
10235 iron / oral preparations 01/01/1949 10 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010235/203211 Zane Neikena Latvia NAP
10239 magnesium sulfate / sodium sulfate / potassium sulfate 05/08/2010 3 years 05/08/2027 03/11/2027 No 12/09/2025 DLP was amended on 02/04/2025 PSUSA/00010239/202708 Veronika Macurová Czech Republic NAP
10242 modafinil 01/09/1994 3 years 31/08/2026 29/11/2026 No 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00010242/202608 Dennis Lex Germany NAP
10245 olodaterol 18/09/2013 5 years 03/03/2029 01/06/2029 No 20/11/2024 PSUR frequency amended and DLP updated on 20/11/2024 PSUSA/00010245/202903 Bianca Mulder Netherlands NAP
10250 propranolol (centrally authorised product) 23/04/2014 5 years 23/04/2029 22/07/2029 No 19/09/2025 PSUR frequency amended and DLP updated on 18/12/2024
DLP and PSUR frequency were updated on 02/02/2022
PSUR frequency and DLP were updated on 20/11/2019
DLP was updated on 21/11/2018
DLP was updated on 19/12/2017
Next DLP was amended on 20/12/2016
PRAC Representative amended on 28/06/2016
PSUR Frequency amended and DLP updated on 03/06/2016
Next DLP was updated on 27/11/2015.
Next DLP was amended on 16/06/2015 PSUSA/00010250/202904 Maria Martinez Gonzalez Spain CAP
10251 propranolol (except for centrally authorised product) 30/06/1965 8 years 30/06/2032 28/09/2032 Yes 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00010251/203206 Guðrún Stefánsdóttir Iceland NAP
10252 anti-t lymphocyte immunoglobulin for human use, rabbit 16/04/1984 3 years 30/06/2027 28/09/2027 No 04/03/2026 Active substance name was amended on 04/03/2026
DLP was amended on 05/03/2025 PSUSA/00010252/202706 Maia Uusküla Estonia NAP
10254 siltuximab 23/04/2014 3 years 22/04/2028 21/07/2028 No 06/10/2025 PRAC representative was updated on 01/03/2023
DLP was updated on 21/12/2022
PSUR frequency and DLP were updated on 18/12/2019
DLP was updated on 20/11/2019
DLP was updated on 21/11/2018
DLP was updated on 06/06/2018
PSUR Frequency amended and DLP updated on 19/12/2017
DLP was updated on 23/05/2017
Next DLP was amended on 20/12/2016
Next DLP was amended on 03/06/2016
Next DLP was updated on 27/11/2015.
Next DLP was amended on 16/06/2015
The DLP was corrected on 27/07/2014 PSUSA/00010254/202804 Dirk Mentzer Germany CAP
10256 sodium feredetate Not available* 8 years 01/12/2026 01/03/2027 No 08/04/2026 DLP amended on 23/10/2024 PSUSA/00010256/202612 Tiphaine Vaillant France NAP
10262 trametinib 29/05/2014 3 years 29/05/2028 27/08/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010262/202805 David Olsen Norway CAP
10263 umeclidinium 16/04/2014 3 years 17/12/2027 16/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010263/202712 Amelia Cupelli Italy CAP
10264 umeclidinium bromide / vilanterol 18/12/2013 3 years 17/12/2027 16/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010264/202712 Amelia Cupelli Italy CAP
10266 varicella-zoster immunoglobuline 29/12/1995 5 years 31/12/2029 31/03/2030 No 06/10/2025 DLP was amended on 24/09/2025 PSUSA/00010266/202912 Dirk Mentzer Germany NAP
10268 everolimus (indicated for advanced renal cell carcinoma, advanced breast cancer, advanced neuroendocrine tumors (gastrointestinal, lung, pancreatic cancers) (NET) 03/08/2009 5 years 31/03/2029 29/06/2029 No 25/06/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/06/2025
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 18/12/2024
PSUR frequency amended and DLP updated on 18/12/2024
Reference to NAP added on 30/03/2022
PSUR frequency and DLP were updated on 22/12/2021
Active substance name was updated on 03/02/2021
PSUR frequency and DLP were amended on 15/11/2017
DLP was updated on 18/11/2016
The Next DLP was amended on 29/10/2015. PSUSA/00010268/202903 Dennis Lex Germany CAP NAP
10269 everolimus (indicated for rejection of transplanted organs) 08/07/2003 3 years 31/07/2027 29/10/2027 No 02/06/2026 PSUSA/00010269/202707 Karin Bolin Sweden NAP
10270 paracetamol / pseudoephedrine hydrochloride / triprolidine hydrochloride Not available* 8 years 03/11/2036 01/02/2037 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010270/203611 Amelia Cupelli Italy NAP
10271 ezetimibe / rosuvastatin 24/07/2014 3 years 24/07/2026 22/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00010271/202607 Barbara Kovacic Bytyqi Croatia NAP
10273 brinzolamide / brimonidine tartrate 18/07/2014 5 years 30/06/2027 28/09/2027 No 01/03/2023 PSUR frequency and DLP were updated on 01/03/2023
DLP was updated on 03/03/2021
PSUR frequency amended and DLP updated on 06/02/2019
PRAC Rapporteur name updated on 19/12/2018
DLP was amended on 31/01/2018
Next DLP updated on 30/01/2017
PSUR Frequency amended and DLP updated on 04/02/2016
PSUR Frequency and Next DLP amended on 31/07/2015
The Next DLP was amended on 01/12/2014
New CAP authorised on 18/07/2014 PSUSA/00010273/202706 Eamon O Murchu Ireland CAP
10275 peginterferon beta-1A 18/07/2014 3 years 18/07/2027 16/10/2027 No 05/02/2025 PSUR frequency and DLP corrected on 02/04/2025
PSUR frequency amended and DLP updated on 05/02/2025
PSUR Frequency and next DLP were updated on 02/03/2022
DLP was updated on 03/03/2021
DLP was updated on 04/03/2020
Next DLP, Lead MS and PRAC Rapporteur name were amended on 06/03/2019
DLP was updated on 28/02/2018
PSUR Frequency amended and next DLP updated on 25/09/2017
Next DLP was amended on 28/02/2017
Next DLP was updated on 22/09/2016
DLP and Next DLP were updated on 04/03/2016
Next DLP was updated on 30/09/2015 PSUSA/00010275/202707 Karin Bolin Sweden CAP
10276 simoctocog alfa 22/07/2014 2 years 22/01/2027 22/04/2027 No 02/06/2026 DLP was amended on 24/09/2025 PSUSA/00010276/202701 Karin Bolin Sweden CAP
10279 obinutuzumab 01/11/2013 3 years 31/10/2026 29/01/2027 No 02/06/2026 PSUSA/00010279/202610 Jenny-Maria Jönsson Sweden CAP
10280 acetylsalicylic acid / atorvastatin / ramipril 20/02/2014 3 years 20/02/2026 21/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00010280/202602 Jan Neuhauser Austria NAP
10283 gaxilose 10/11/2011 9 years 09/11/2032 07/02/2033 No 05/06/2024 Entry re-activated and DLP updated on 05/06/2024
PRAC Representative name was corrected on 29/07/2020
PRAC Representative updated on 26/09/2018
PSUR Frequency amended and next DLP updated on 25/09/2017
Next DLP was updated on 22/09/2016
PRAC Rapporteur name updated on 03/06/2016
PSUR Frequency amended and DLP updated on 07/04/2016
Active Substance corrected on 21/12/2015.
Next DLP was updated on 30/09/2015
Lead MS was added on 22/12/2014 PSUSA/00010283/203211 Maria del Pilar Rayon Spain NAP
10285 solifenacin / tamsulosin 06/05/2013 5 years 01/07/2026 29/09/2026 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00010285/202607 Bianca Mulder Netherlands NAP
10287 acetylsalicylic acid / bisoprolol 05/11/2010 7 years 05/11/2031 03/02/2032 No 17/02/2026 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00010287/203111 Jana Pecherova Slovakia NAP
10288 clevidipine 23/11/2011 3 years 23/11/2026 21/02/2027 No 03/07/2024 PSUR frequency amended and DLP updated on 03/07/2024 PSUSA/00010288/202611 Jan Neuhauser Austria NAP
10289 lisdexamfetamine 23/02/2007 3 years 22/02/2028 22/05/2028 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00010289/202802 Karin Bolin Sweden NAP
10291 misoprostol (gastrointestinal indication) 28/06/1984 3 years 30/06/2028 28/09/2028 Yes 01/04/2026 Correction of DLP on 01/04/2026
PSUR frequency amended and DLP updated on 04/03/2026 PSUSA/00010291/202806 Marie Louise Schougaard Christiansen Denmark NAP
10292 triamcinolone (intraocular formulations) 31/03/2011 3 years 31/03/2028 29/06/2028 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00010292/202803 Carla Torre Portugal NAP
10293 flutemetamol (18f) 22/08/2014 3 years 31/10/2027 29/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00010293/202710 Dennis Lex Germany CAP
10296 sucroferric oxyhydroxide 27/11/2013 3 years 26/11/2027 24/02/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010296/202711 Kimmo Jaakkola Finland CAP
10297 human fibrinogen / human thrombin 08/06/2004 3 years 08/06/2026 06/09/2026 No 06/10/2025 DLP was amended on 31/01/2024 PSUSA/00010297/202606 Dirk Mentzer Germany CAP
10298 influenza vaccine (split virion, inactivated) (non centrally authorised products) 08/08/1996 1 year 15/03/2026 24/05/2026 15/03/2027 24/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010298/202603 PSUSA/00010298/202703 Dirk Mentzer Germany NAP
10300 influenza vaccine (surface antigen, inactivated, adjuvanted) 20/09/2010 1 year 15/03/2026 24/05/2026 15/03/2027 24/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010300/202603 PSUSA/00010300/202703 Jean-Michel Dogné Belgium CAP
10301 ibrutinib 13/11/2013 2 years 12/11/2025 10/02/2026 No 03/07/2024 PSUR frequency amended and DLP updated on 03/07/2024 PSUSA/00010301/202511 Barbara Kovacic Bytyqi Croatia CAP
10302 ibuprofen / paracetamol Not available* 8 years 03/11/2026 01/02/2027 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010302/202611 Lina Šeibokienė Lithuania NAP
10303 idelalisib 23/07/2014 5 years 22/07/2029 20/10/2029 No 02/04/2025 PSUR frequency amended and DLP updated on 02/04/2025 PSUSA/00010303/202907 Dennis Lex Germany CAP
10304 folinic acid, (di)sodium folinate, levomefolic acid 03/04/1982 15 years 03/04/2029 02/07/2029 No 28/02/2018 Entry name amended on 28/02/2018 PSUSA/00010304/202904 NAP
10305 Phenol / halogenated phenols / sodium salicylate / chloroxylenol / triclosan 07/07/1988 13 years 30/06/2027 28/09/2027 No 22/12/2014 PSUSA/00010305/202706 NAP
10306 sofosbuvir / ledipasvir 10/10/2014 5 years 09/10/2029 07/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010306/202910 Ana Sofia Diniz Martins Portugal CAP
10307 aclidinium bromide / formoterol fumarate dihydrate 19/11/2014 3 years 19/11/2025 17/02/2026 No 28/06/2023 PSUR frequency amended and DLP updated on 28/06/2023
DLP was updated on 29/06/2022
DLP was updated on 30/06/2021
DLP was updated on 01/07/2020
DLP was updated on 03/07/2019
PRAC Representative and LMS updated on 19/12/2018
DLP was updated on 04/07/2018
PSUR Frequency amended and DLP updated on 19/12/2017
Next DLP was amended on 27/06/2017
Next DLP was amended on 20/12/2016
Next DLP was amended on 28/06/2016
Next DLP was updated on 21/12/2015.
New CAP authorised on 19/11/2014 PSUSA/00010307/202511 Adam Przybylkowski Poland CAP
10311 dulaglutide 18/09/2014 3 years 18/09/2027 17/12/2027 No 27/07/2022 PRAC representative was updated on 27/07/2022
PSUR frequency and DLP were updated on 28/04/2022
PSUR frequency and DLP were corrected on 26/05/2021
PSUR frequency and DLP were updated on 28/04/2021
DLP was updated on 06/05/2020
PRAC representative was updated on 25/09/2019
DLP was updated on 30/04/2019
PRAC Rapporteur name amended on 04/07/2018
DLP was updated on 07/05/2018
PSUR Frequency amended and DLP updated on 17/10/2017
Next DLP was amended on 26/04/2017
Next DLP was amended on 19/10/2016
Next DLP was amended on 03/05/2016
The Next DLP was amended on 29/10/2015.
New CAP authorised on 21/11/2014 PSUSA/00010311/202709 Amelia Cupelli Italy CAP
10312 omega-3-acid ethyl esters 12/07/2000 3 years 22/01/2028 21/04/2028 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00010312/202801 Amelia Cupelli Italy NAP
10314 afamelanotide 22/12/2014 2 years 22/06/2027 20/09/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010314/202706 Dennis Lex Germany CAP
10315 darunavir / cobicistat 19/11/2014 3 years 18/05/2026 16/08/2026 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00010315/202605 Amelia Cupelli Italy CAP
10316 ketoconazole (centrally authorised product only) 19/11/2014 3 years 19/11/2027 17/02/2028 Yes 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010316/202711 Petar Mas Croatia CAP
10317 naloxegol 16/09/2014 3 years 15/09/2027 14/12/2027 No 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00010317/202709 Eamon O Murchu Ireland CAP
10318 nintedanib (oncology indications) 15/10/2014 3 years 15/10/2028 13/01/2029 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010318/202810 Georgia Gkegka Greece CAP
10319 nintedanib (respiratory indication) 15/10/2014 6 months 15/04/2026 24/06/2026 15/10/2026 24/12/2026 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010319/202604 PSUSA/00010319/202610 Barbara Kovacic Bytyqi Croatia CAP
10320 nonacog gamma 19/12/2014 3 years 30/06/2026 28/09/2026 No 06/10/2025 DLP was amended on 28/02/2024 PSUSA/00010320/202606 Dirk Mentzer Germany CAP
10321 oestrogens conjugated / bazedoxifene 16/12/2014 5 years 02/04/2030 01/07/2030 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00010321/203004 Dennis Lex Germany CAP
10322 olaparib 16/12/2014 3 years 15/12/2027 14/03/2028 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00010322/202712 Amelia Cupelli Italy CAP
10323 ramucirumab 21/04/2014 3 years 21/04/2028 20/07/2028 No 06/10/2025 PRAC representative was updated on 01/03/2023
DLP was updated on 21/12/2022
PSUR frequency and DLP were updated on 20/11/2019
DLP was updated on 21/11/2018
DLP was updated on 19/12/2017
PSUR Frequency amended and DLP updated on 23/05/2017
Next DLP was amended on 20/12/2016
Next DLP was amended on 03/06/2016
Next DLP was updated on 27/11/2015.
New CAP authorised on 19/12/2014. PSUSA/00010323/202804 Dirk Mentzer Germany CAP
10324 tafluprost / timolol 02/12/2014 3 years 02/12/2026 02/03/2027 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00010324/202612 Dennis Lex Germany NAP
10325 yttrium (90Y) citrate 28/10/1985 10 years 27/10/2035 25/01/2036 Yes 23/10/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 23/10/2024
DLP was amended on 23/10/2024
DLP was amended on 03/07/2024 PSUSA/00010325/203510 Amelia Cupelli Italy NAP
10326 fosfomycin (oral formulation) 27/08/1986 5 years 31/07/2027 29/10/2027 No 19/09/2024 PSUSA/00010326/202707 Zoubida Amimour France NAP
10330 salbutamol 31/01/1969 3 years 31/01/2026 01/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00010330/202601 Melinda Palfi Hungary NAP
10332 porfimer 19/04/1993 3 years 19/04/2026 18/07/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00010332/202604 Petar Mas Croatia NAP
10333 tixocortol, chlorhexidine gluconate / tixocortol pivalate 18/11/1976 5 years 01/11/2027 30/01/2028 No 19/09/2024 PSUSA/00010333/202711 Zoubida Amimour France NAP
10335 bupivacaine, bupivacaine / epinephrine 27/04/1966 5 years 26/04/2029 25/07/2029 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010335/202904 Zane Neikena Latvia NAP
10336 fosfomycin (IV formulation) 13/07/1983 5 years 31/07/2027 29/10/2027 No 19/09/2024 PSUSA/00010336/202707 Zoubida Amimour France NAP
10338 apremilast 21/03/2014 3 years 20/03/2028 18/06/2028 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010338/202803 Maria Martinez Gonzalez Spain CAP
10339 fluticasone propionate / formoterol fumarate dihydrate 23/08/2012 5 years 31/07/2026 29/10/2026 No 02/06/2026 PSUSA/00010339/202607 Karin Bolin Sweden NAP
10340 ospemifene 26/02/2013 3 years 26/02/2027 27/05/2027 No 20/10/2021 PSUR frequency and DLP were updated on 20/10/2021
DLP was updated on 21/10/2020
DLP was updated on 25/09/2019
Lead MS and PRAC Rapporteur name updated on 30/04/2019
DLP was updated on 26/09/2018
PSUR frequency amended and DLP updated on 27/03/2018
DLP was updated on 17/10/2017
DLP was updated on 28/03/2017
Next DLP was amended on 19/10/2016
Next DLP was amended on 07/04/2016
New CAP authorised on 15/01/2015. PSUSA/00010340/202702 Terhi Lehtinen Finland CAP
10341 secukinumab 26/12/2014 3 years 25/12/2026 25/03/2027 No 19/09/2025 DLP was amended on 25/09/2024 PSUSA/00010341/202612 Maria Martinez Gonzalez Spain CAP
10342 diclofenac (topical formulations), diclofenac / heparin 11/05/1977 6 years 30/09/2029 29/12/2029 No 03/07/2024 Active substance name was amended on 03/07/2024
PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00010342/202909 Karin Erneholm Denmark NAP
10344 amlodipine / valsartan, amlodipine / hydrochlorothiazide / valsartan 16/01/2007 5 years 30/06/2026 28/09/2026 No 02/03/2022 DLP was updated on 02/03/2022
Correction of Reference to NAP added on 20/10/2021
PRAC Rapporteur name was corrected on 03/04/2019
PRAC Rapporteur name was amended on 06/06/2018
PRAC Representative amended on 17/10/2017
DLP was updated on 28/03/2017 PSUSA/00010344/202606 Karin Erneholm Denmark CAP NAP
10346 aprotinin / calcium chloride / human factor xiii / human fibrinogen / human thrombin, aprotinin / fibrinogen / fibronectin / human coagulation factor XIII / plasma protein fraction / plasminogen / thrombin, aprotinin / human fibrinogen / thrombin / calcium chloride, aprotinin / calcium chloride / factor xiii / human thrombin / human clottable protein containing mainly fibrinogen and fibronectin, calcium chloride / human fibrinogen / factor xiii / fibronectin / plasminogen / human thrombin / bovine aprotinin, calcium chloride / human fibrinogen / factor xiii / fibronectin / human thrombin / bovine aprotinin, human fibrinogen / calcium chloride dihydrate / plasma fibronectin / thrombin / bovine aprotinin / human coagulation factor xiii, human fibrinogen / calcium chloride dihydrate / plasma protein fraction / fibronectin / thrombin / bovine aprotinin / human coagulation factor xiii, human fibrinogen / plasminogen / human thrombin / bovine aprotinin / human coagulation factor xiii / human fibronectin Not available* 5 years 30/11/2026 28/02/2027 No 06/10/2025 PRAC representative was updated on 01/03/2023
DLP was updated on 27/07/2022
Next DLP was amended on 25/09/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016
The name of the active substance was amended on 06/10/2015 PSUSA/00010346/202611 Dirk Mentzer Germany NAP
10347 atorvastatin 07/11/1996 6 years 31/10/2029 29/01/2030 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010347/202910 Dennis Lex Germany NAP
10348 carmustine (implant) 23/09/1996 5 years 23/09/2029 22/12/2029 No 25/05/2022 DLP was updated on 25/05/2022
PRAC representative was updated on 29/07/2020
PRAC representative was updated on 03/06/2020
DLP was updated 05/06/2019
PRAC Rapporteur name updated on 21/07/2017
PRAC Rapporteur name was amended on 28/07/2016
Next DLP was amended on 03/06/2016
PRAC Rapporteur name updated on 07/04/2016
PRAC Rapporteur name updated on 04/02/2016
DLP was amended on 16/06/2015 PSUSA/00010348/202909 Tiphaine Vaillant France NAP
10349 carmustine (powder and solvent for solution for infusion) 23/04/1974 5 years 22/04/2029 21/07/2029 No 18/12/2024 PSUR frequency amended and DLP updated on 18/12/2024 PSUSA/00010349/202904 Tiphaine Vaillant France NAP
10350 dalbavancin 23/05/2014 3 years 22/11/2026 20/02/2027 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00010350/202611 Rugile Pilviniene Lithuania CAP
10351 eliglustat 19/01/2015 3 years 19/08/2027 17/11/2027 No 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00010351/202708 Maria del Pilar Rayon Spain CAP
10352 ex vivo expanded autologous human corneal epithelial cells containing stem cells 17/02/2015 1 year 17/02/2026 28/04/2026 17/02/2027 28/04/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010352/202602 PSUSA/00010352/202702 Eamon O Murchu Ireland CAP
10353 misoprostol (gynaecological indication - labour induction) Not available* 3 years 31/05/2028 29/08/2028 Yes 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010353/202805 Marie Louise Schougaard Christiansen Denmark NAP
10354 misoprostol (gynaecological indication - termination of pregnancy) Not available* 3 years 31/05/2026 29/08/2026 Yes 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00010354/202605 Marie Louise Schougaard Christiansen Denmark NAP
10355 phloroglucinol, phloroglucinol / trimethylphloroglucinol, phloroglucinol / simeticone 18/02/1992 3 years 30/09/2027 29/12/2027 No 02/04/2025 Active substance name was amended on 02/04/2025 PSUSA/00010355/202709 Zoubida Amimour France NAP
10356 safinamide 24/02/2015 5 years 24/02/2028 24/05/2028 No 18/10/2023 PSUR frequency amended and DLP updated on 18/10/2023 PSUSA/00010356/202802 Eamon O Murchu Ireland CAP
10358 amlodipine / indapamide, amlodipine / indapamide / perindopril 23/09/2013 5 years 25/11/2027 23/02/2028 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00010358/202711 Bianca Mulder Netherlands NAP
10359 benzoyl peroxide hydrous / potassium hydroxyquinoline sulphate 03/02/1987 13 years 30/03/2033 28/06/2033 No 19/10/2022 Entry re-activated on 19/10/2022
LMS and PRAC representative were added on 06/05/2020 PSUSA/00010359/203303 Eamon O'Murchu Ireland NAP
10360 cangrelor 23/03/2015 3 years 23/03/2028 21/06/2028 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010360/202803 Amelia Cupelli Italy CAP
10361 chlorphenoxamine Not available* 9 years 17/05/2027 15/08/2027 Yes 26/07/2023 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 26/07/2023
Active substance name, PSUR frequency and DLP were amended on 26/07/2023
DLP was updated on 06/02/2019
PRAC representative added on 17/10/2017 PSUSA/00010361/202705 Eva Jirsová Czech Republic NAP
10362 ciclosporin (topical use) 19/03/2015 1 year 19/03/2026 28/05/2026 19/03/2027 28/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010362/202603 PSUSA/00010362/202703 Jan Neuhauser Austria CAP NAP
10364 germanium (68Ge) chloride / gallium (68Ga) chloride 15/09/2014 5 years 15/03/2030 13/06/2030 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00010364/203003 Eva Jirsová Czech Republic CAP NAP
10366 naltrexone / bupropion 26/03/2015 1 year 09/09/2026 18/11/2026 09/09/2027 18/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010366/202609 PSUSA/00010366/202709 Dennis Lex Germany CAP
10368 oritavancin 19/03/2015 1 year 11/03/2026 20/05/2026 11/03/2027 20/05/2027 No 04/02/2026 DLP was amended on 04/02/2026
DLP was amended on 22/10/2025 PSUSA/00010368/202603 PSUSA/00010368/202703 Adam Przybylkowski Poland CAP
10369 tedizolid phosphate 20/06/2014 3 years 20/06/2026 18/09/2026 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00010369/202606 Maria del Pilar Rayon Spain CAP
10370 tobramycin (nebuliser solution) (centrally authorised product only) 18/03/2015 3 years 18/09/2028 17/12/2028 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00010370/202809 Karin Bolin Sweden CAP
10372 ceritinib 29/04/2014 3 years 28/10/2028 26/01/2029 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010372/202810 Jenny-Maria Jönsson Sweden CAP
10373 raltegravir 26/03/2015 3 years 26/09/2028 25/12/2028 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026 PSUSA/00010373/202809 Zoubida Amimour France CAP
10374 amitriptyline, amitriptyline / amitriptylinoxide, amitriptylinoxide 31/07/1961 3 years 10/01/2027 10/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010374/202701 Georgia Gkegka Greece NAP
10376 ivermectin (topical use) 22/03/2015 3 years 22/04/2027 21/07/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010376/202704 Zoubida Amimour France NAP
10377 ivermectin (systemic use) 15/10/1987 3 years 14/04/2028 13/07/2028 No 19/09/2024 PSUSA/00010377/202804 Zoubida Amimour France NAP
10378 mifepristone / misoprostol Not available* 3 years 31/05/2026 29/08/2026 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00010378/202605 Bianca Mulder Netherlands NAP
10379 nivolumab 04/09/2014 3 years 03/07/2027 01/10/2027 No 05/03/2025 DLP was amended on 05/03/2025 PSUSA/00010379/202707 Dirk Mentzer Germany CAP
10380 lenvatinib 13/02/2015 3 years 12/02/2027 13/05/2027 No 02/06/2026 PSUSA/00010380/202702 Jenny Jönsson Sweden CAP
10382 tioconazole, tioconazole / hydrocortisone 13/04/1981 13 years 01/04/2030 30/06/2030 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00010382/203004 Carla Torre Portugal NAP
10385 atorvastatin / ezetimibe 13/11/2014 7 years 15/07/2030 13/10/2030 No 27/03/2024 PSUR frequency amended and DLP updated on 27/03/2024 PSUSA/00010385/203007 Dennis Lex Germany NAP
10386 colecalciferol, colecalciferol / calcium, ergocalciferol, ergocalciferol / calcium Not available* 5 years 31/10/2029 29/01/2030 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00010386/202910 Jan Neuhauser Austria NAP
10387 edoxaban 22/04/2011 3 years 21/10/2026 19/01/2027 No 19/09/2024 PSUSA/00010387/202610 Zoubida Amimour France CAP
10388 empagliflozin, empagliflozin / metformin 17/04/2014 2 years 17/04/2026 16/07/2026 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010388/202604 Maria del Pilar Rayon Spain CAP
10389 human papillomavirus 9-valent vaccine (recombinant, adsorbed) 10/12/2014 3 years 09/06/2028 07/09/2028 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010389/202806 Jean-Michel Dogné Belgium CAP
10390 lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide 02/07/2015 5 years 21/07/2029 19/10/2029 No 02/04/2025 PSUR frequency amended and DLP updated on 02/04/2025 PSUSA/00010390/202907 Karin Erneholm Denmark NAP
10391 lutetium (177Lu) chloride 19/06/2015 3 years 19/12/2026 19/03/2027 Yes 25/09/2024 New CAP authorised on 26/03/2026
New CAP authorised on 22/11/2024
DLP was amended on 25/09/2024 PSUSA/00010391/202612 Rhea Fitzgerald Ireland CAP NAP
10392 macrogol 4000, macrogol 4000 combinations (oral use) 05/05/1995 5 years 31/05/2027 29/08/2027 No 19/09/2024 PSUSA/00010392/202705 Zoubida Amimour France NAP
10393 netupitant / palonosetron 10/10/2014 5 years 10/10/2029 08/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010393/202910 Amelia Cupelli Italy CAP
10394 tasimelteon 03/07/2015 3 years 03/07/2027 01/10/2027 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010394/202707 Adam Przybylkowski Poland CAP
10395 tolvaptan (indicated for adults with autosomal dominant polycystic kidney disease (ADPKD)) 27/05/2015 3 years 18/05/2027 16/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010395/202705 Amelia Cupelli Italy CAP
10396 valsartan, hydrochlorothiazide / valsartan 13/05/1996 5 years 30/04/2030 29/07/2030 No 02/06/2026 PSUSA/00010396/203004 Karin Bolin Sweden NAP
10398 chlorhexidine / phenol Not available* 13 years 16/03/2028 14/06/2028 No 06/10/2015 New active substance added on 06/10/2015 PSUSA/00010398/202803 NAP
10399 betamethasone dipropionate / clotrimazole / gentamicin 02/12/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00010399/202812 Petar Mas Croatia NAP
10400 tinidazole, nystatin / tinidazole 15/06/1972 10 years 01/12/2034 01/03/2035 No 05/01/2025 Correction of DLP on 20/11/2024
PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010400/203412 Adam Przybylkowski Poland NAP
10401 phenylephrine (IV, nasal or oral formulations ) 01/01/1940 13 years 01/01/2028 31/03/2028 No 29/10/2015 PSUSA/00010401/202801 NAP
10402 phenylephrine (ophthalmic formulations) 01/01/1940 5 years 01/01/2030 01/04/2030 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010402/203001 Eva Jirsová Czech Republic NAP
10403 pembrolizumab 04/09/2014 3 years 03/09/2027 02/12/2027 No 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00010403/202709 Bianca Mulder Netherlands CAP
10404 atazanavir / cobicistat 29/01/2015 5 years 28/01/2029 28/04/2029 No 19/09/2024 PSUSA/00010404/202901 Tiphaine Vaillant France CAP
10405 evolocumab 17/07/2015 3 years 17/07/2026 15/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00010405/202607 Kimmo Jaakkola Finland CAP
10406 1-propanol / isopropyl alcohol (covers other synonymous terms such as 2-propanol) / orthophenylphenol 23/10/1980 10 years 23/10/2029 21/01/2030 No 04/02/2026 Active substance name was amended on 04/02/2026
PSUR frequency and DLP were updated on 01/07/2020
Lead MS and PRAC Rapporteur name added on 03/04/2019
Entry name changed and Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?
Yes/No was updated on 07/05/2018
New substance added on 27/11/2015 PSUSA/00010406/202910 Adam Przybylkowski Poland NAP
10407 dibrompropamidine , propamidine 16/01/1959 11 years 02/04/2038 01/07/2038 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010407/203804 Rhea Fitzgerald Ireland NAP
10408 sonidegib 30/06/2015 2 years 29/06/2026 27/09/2026 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010408/202606 Petar Mas Croatia CAP
10409 panobinostat 23/02/2015 3 years 22/08/2026 20/11/2026 No 16/01/2025 PSUR frequency amended and DLP updated on 27/03/2024 PSUSA/00010409/202608 Georgia Gkegka Greece CAP
10410 human alfa1-proteinase inhibitor (centrally authorised product) 20/08/2015 5 years 31/12/2026 31/03/2027 No 22/10/2025 DLP was amended on 22/10/2025
PSUR frequency amended and DLP updated on 03/05/2023
PRAC Representative name was corrected on 29/07/2020
PSUR frequency and DLP were updated on 01/04/2020
DLP was updated on 03/04/2019
PRAC Representative updated on 26/09/2018
DLP was updated on 27/03/2018
PSUR Frequency amended and DLP updated on 17/10/2017
DLP was updated on 28/03/2017
Next DLP was updated on 22/09/2016
PRAC Representative amended on 28/06/2016
Entry name amended on 03/05/2016
New CAP was authorised on 20/08/2015 PSUSA/00010410/202612 Maria Martinez Gonzalez Spain CAP
10411 ceftolozane / tazobactam 19/12/2014 3 years 19/12/2026 19/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010411/202612 Adam Przybylkowski Poland CAP
10412 idebenone (centrally authorised products) 08/09/2015 3 years 08/09/2027 07/12/2027 No 28/05/2025 PSUR frequency amended and DLP updated on 28/05/2025
DLP was amended on 30/04/2025 PSUSA/00010412/202709 Amelia Cupelli Italy CAP
10413 guanfacine 17/09/2015 3 years 17/03/2027 15/06/2027 No 20/11/2024 New CAP authorised on 26/02/2025
DLP was amended on 20/11/2024 PSUSA/00010413/202703 Maria del Pilar Rayon Spain CAP
10414 1-propanol / isopropyl alcohol (covers other synonymous terms such as 2-propanol) / lactic acid 07/09/1981 10 years 07/09/2029 06/12/2029 No 04/02/2026 Active substance name was amended on 04/02/2026
PSUR frequency and DLP were updated on 03/06/2020
LMS and PRAC representatives were added on 31/07/2019
Procedure number was corrected on 18/11/2016
New substance added on 27/11/2015 PSUSA/00010414/202909 Adam Przybylkowski Poland NAP
10415 demeclocycline / triamcinolone Not available* 13 years 13/07/2030 11/10/2030 No 27/11/2015 DLP was updated on 27/03/2018
Lead MS and PRAC Rapporteur name was added on 20/12/2016
New active substance added on 27/11/2015 PSUSA/00010415/203007 Eva Jirsová Czech Republic NAP
10416 ethanol / orthophenylphenol 05/02/1997 10 years 05/02/2029 06/05/2029 No 13/08/2025 PSUR frequency and DLP were updated on 23/10/2019
Lead MS and PRAC Rapporteur name added on 31/07/2018
Active substance name was amended on 20/12/2016
New active substance added on 27/11/2015 PSUSA/00010416/202902 Veronika Macurová Czech Republic NAP
10417 octenidine dihydrochloride / 1-propanol / isopropyl alcohol (covers other synonymous terms such as 2-propanol) 30/01/1987 10 years 30/01/2034 30/04/2034 No 04/02/2026 Active substance name was amended on 04/02/2026
PRAC Rapporteur updated on 15/11/2023 PSUSA/00010417/203401 Barbara Kovacic Bytyqi Croatia NAP
10421 asfotase alfa 03/07/2015 3 years 03/07/2026 01/10/2026 No 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 PSUSA/00010421/202607 Eamon O Murchu Ireland CAP
10422 sebelipase alfa 28/08/2015 3 years 28/08/2027 26/11/2027 No 02/06/2026 PSUSA/00010422/202708 Karin Bolin Sweden CAP
10423 alirocumab 24/07/2015 3 years 24/07/2027 22/10/2027 No 06/10/2025 DLP was amended on 02/04/2025 PSUSA/00010423/202707 Dirk Mentzer Germany CAP
10424 glucose (apart from glucose1- phosphate), glucose in combination with calcium chloride and/or sodium chloride and/or magnesium chloride and/or sodium citrate and/or potassium chloride and/or sodium acetate (intravenous or parenteral use except haemodialysis, hemodiafiltration), potassium phosphate / sodium chloride / glucose / lactic acid / magnesium chloride / sodium lactate / potassium chloride 22/03/1971 10 years 02/09/2034 01/12/2034 Yes 17/12/2025 Active substance name was amended on 17/12/2025
Active substance name was amended on 05/06/2024
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?", PSUR frequency and DLP were amended on 26/07/2023
Active substance name, PSUR frequency and DLP were amended on 03/05/2023
Active substance name was amended on 23/10/2018
New active substance added on 21/12/2015 PSUSA/00010424/203409 none NAP
10425 inosine pranobex 01/08/1978 5 years 01/08/2028 30/10/2028 No 27/01/2026 DLP was amended on 27/03/2024 PSUSA/00010425/202808 Roxana Stefania Udrescu Romania NAP
10426 isavuconazole 06/09/2015 3 years 06/09/2027 05/12/2027 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00010426/202709 Adam Przybylkowski Poland CAP
10427 linagliptin, linagliptin / metformin 24/08/2011 3 years 02/05/2027 31/07/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010427/202705 Bianca Mulder Netherlands CAP NAP
10428 sterculia, frangula / sterculia 01/12/1955 10 years 28/02/2034 29/05/2034 No 31/07/2018 New active substances added to the entry on 31/07/2018
New Active Substance was added on 21/12/2015. PSUSA/00010428/203402 Guðrún Stefánsdóttir Iceland NAP
10429 levofloxacin (Inhalation use) 26/03/2015 5 years 26/05/2030 24/08/2030 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010429/203005 Maria del Pilar Rayon Spain CAP
10430 phenylephrine / tropicamide Not available* 5 years 08/11/2025 06/02/2026 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00010430/202511 Karin Erneholm Denmark NAP
10431 amlodipine / atorvastatin / perindopril, amlodipine / atorvastatin / ramipril 31/07/2015 5 years 22/10/2030 20/01/2031 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010431/203010 Veronika Macurová Czech Republic NAP
10432 timolol (systemic use) 06/12/1990 7 years 13/10/2031 11/01/2032 No 12/09/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010432/203110 Veronika Macurová Czech Republic NAP
10433 horse anti-T lymphocyte immunoglobulin for human use 17/11/1981 5 years 16/11/2027 14/02/2028 No 05/03/2025 Active substance name was amended on 05/03/2025
Next DLP was updated on 26/07/2023 PSUSA/00010433/202711 Zane Neikena Latvia NAP
10434 amlodipine / rosuvastatin, amlodipine / perindopril / rosuvastatin, rosuvastatin / perindopril / indapamide, rosuvastatin / perindopril, rosuvastatin / ramipril 29/07/2015 5 years 29/07/2029 27/10/2029 No 22/10/2025 Active substance name was amended on 22/10/2025
PSUR frequency amended and DLP updated on 02/04/2025 PSUSA/00010434/202907 Melinda Palfi Hungary NAP
10435 idarucizumab 16/10/2015 3 years 15/10/2027 13/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00010435/202710 Bianca Mulder Netherlands CAP
10438 sacubitril / valsartan 07/07/2015 2 years 31/07/2026 29/10/2026 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00010438/202607 Karin Erneholm Denmark CAP
10439 timolol (eye preparations) 01/12/1981 5 years 31/07/2026 29/10/2026 No 30/03/2022 DLP was updated on 30/03/2022
Next DLP was amended on 26/04/2017
EURD and DLP were amended on 07/04/2016
Active substance name was amended on 04/02/2016
Lead MS and PRAC Rapporteur name updated on 04/02/2016 PSUSA/00010439/202607 Dennis Lex Germany NAP
10440 estradiol (except cream/balm/emulsion for application in female genital area) 01/01/1946 5 years 31/08/2026 29/11/2026 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00010440/202608 Bianca Mulder Netherlands NAP
10441 estradiol, estradiol /prednisolone (only cream/balm/emulsion for application in the female genital area) Not available* 3 years 24/04/2026 23/07/2026 Yes 05/08/2025 DLP was amended on 20/12/2023 PSUSA/00010441/202604 Lina Seibokiene Lithuania NAP
10442 levonorgestrel / ethinylestradiol, ethinylestradiol (combination pack) 29/01/2015 5 years 13/01/2029 13/04/2029 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00010442/202901 Zoubida Amimour France NAP
10443 dienogest / estradiol (HRT indication) 13/12/2000 5 years 13/06/2029 11/09/2029 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010443/202906 Bianca Mulder Netherlands NAP
10444 dienogest / estradiol (contraception indication) 03/11/2008 5 years 08/09/2028 07/12/2028 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010444/202809 Bianca Mulder Netherlands NAP
10445 asparaginase (centrally authorised product) 14/01/2016 3 years 14/01/2027 14/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010445/202701 Jan Neuhauser Austria CAP
10446 birch bark extract (centrally authorised products) 14/01/2016 1 year 14/01/2026 25/03/2026 14/01/2027 25/03/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010446/202601 PSUSA/00010446/202701 Zane Neikena Latvia CAP
10447 brivaracetam 14/01/2016 3 years 14/01/2027 14/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010447/202701 Adam Przybylkowski Poland CAP
10448 carfilzomib 20/07/2012 3 years 19/07/2026 17/10/2026 No 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 PSUSA/00010448/202607 Barbara Kovacic Bytyqi Croatia CAP
10449 cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide 05/11/2015 3 years 04/11/2027 02/02/2028 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010449/202711 Amelia Cupelli Italy CAP
10450 cobimetinib 24/08/2015 3 years 23/08/2026 21/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010450/202608 Bianca Mulder Netherlands CAP
10451 efmoroctocog alfa 06/06/2014 1 year 05/06/2026 14/08/2026 05/06/2027 14/08/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010451/202606 PSUSA/00010451/202706 Sonja Radowan Austria CAP
10454 glycerol phenylbutyrate 01/02/2013 3 years 31/01/2027 01/05/2027 No 27/07/2022 PRAC representative was updated on 27/07/2022
DLP and PSUR frequency were updated on 22/09/2021
DLP was updated on 23/09/2020
DLP and PRAC representative were updated on 25/09/2019
DLP and PRAC Representative updated on 04/07/2018
European Union reference date and Next DLP were updated on 07/05/2018
PSUR frequency amended and DLP updated on 31/01/2018
Next DLP was amended on 27/06/2017
Next DLP was amended on 30/01/2017
New CAP authorised on 27/11/2015 PSUSA/00010454/202701 Amelia Cupelli Italy CAP
10455 lumacaftor / ivacaftor 19/11/2015 3 years 19/05/2028 17/08/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010455/202805 Eamon O Murchu Ireland CAP
10456 mepolizumab 02/12/2015 3 years 23/09/2028 22/12/2028 No 29/04/2026 PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00010456/202809 Dirk Mentzer Germany CAP
10457 pegaspargase (centrally authorised product) 14/01/2016 5 years 14/07/2030 12/10/2030 No 02/06/2026 PSUSA/00010457/203007 Jenny-Maria Jönsson Sweden CAP
10458 susoctocog alfa 11/11/2015 3 years 11/11/2025 09/02/2026 No 06/10/2025 PSUR frequency amended and DLP updated on 28/06/2023 PSUSA/00010458/202511 Dirk Mentzer Germany CAP
10459 talimogene laherparepvec 27/10/2015 3 years 26/10/2026 24/01/2027 No 06/10/2025 PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00010459/202610 Dirk Mentzer Germany CAP
10460 blinatumomab 03/12/2014 3 years 02/12/2025 02/03/2026 No 12/09/2025 PRAC Rapporteur name was amended on 26/07/2023
Next DLP was updated on 26/07/2023 PSUSA/00010460/202512 Veronika Macurova Czech Republic CAP
10461 diclofenac / omeprazole Not available* 5 years 30/09/2026 29/12/2026 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00010461/202609 Karin Erneholm Denmark NAP
10462 bisoprolol / perindopril 09/11/2015 7 years 22/10/2032 20/01/2033 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
PRAC representative was updated on 22/12/2021
DLP was updated on 30/06/2021
PRAC representative and LMS were added on 01/04/2020
European Union reference date updated on 07/05/2018
New entry added on 04/03/2016 PSUSA/00010462/203210 Jana Pecherova Slovakia NAP
10463 fosinopril, fosinopril / hydrochlorothiazide 03/07/1990 5 years 02/07/2026 30/09/2026 No 02/03/2022 PRAC Representative updated on 16/11/2022
PSUR frequency and DLP were updated on 02/03/2022
Next DLP was updated on 06/03/2019
PRAC Representative updated on 26/09/2018
New merged entry added on 07/04/2016
Next DLP was amended on 07/04/2016 PSUSA/00010463/202607 Maria del Pilar Rayon Spain NAP
10464 thiocolchicoside, paracetamol / thiocolchicoside 04/07/1956 3 years 04/07/2027 02/10/2027 No 05/03/2025 DLP was amended on 05/03/2025 PSUSA/00010464/202707 Amelia Cupelli Italy NAP
10465 allergen for therapy: Dactylis Glomerata L., Phleum Pratense L., Anthoxanthum Odoratum L., Lolium Perenne L., Poa Pratensis L. (sublingual tablet) 10/08/2004 3 years 24/12/2025 24/03/2026 No 06/10/2025 Active substance name was amended on 28/02/2024
Active substance name was amended on 20/12/2023
DLP amended on 20/09/2023 PSUSA/00010465/202512 Dirk Mentzer Germany NAP
10466 allergen for diagnostic: grass pollen, tree pollen, house dust mites, moulds, weed pollen, vertebrates, animal epithelia (except for hymenoptera venoms) single or mixes, positive and negative controls 26/06/1983 10 years 31/10/2026 29/01/2027 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00010466/202610 Karin Erneholm Denmark NAP
10467 cinchocaine hydrochloride / prednisolone caproate, cinchocaine hydrochloride / fluocortolone caproate / fluocortolone pivalate Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00010467/202911 NAP
10469 diphtheria / tetanus / pertussis (acellular, component) / hepatitis B (rDNA) / poliomyelitis (inactivated) / haemophilus type b conjugate vaccine (adsorbed) 15/02/2016 3 years 15/02/2026 16/05/2026 No 06/10/2025 Next DLP was updated on 18/10/2023 PSUSA/00010469/202602 Dirk Mentzer Germany CAP
10472 osimertinib 13/11/2015 3 years 12/11/2026 10/02/2027 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00010472/202611 Bianca Mulder Netherlands CAP
10473 varicella vaccine (live) 17/10/1994 3 years 16/03/2028 14/06/2028 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010473/202803 Jean-Michel Dogné Belgium NAP
10474 meloxicam 08/05/1995 5 years 09/07/2027 07/10/2027 No 05/04/2023 PSUR frequency amended and DLP updated on 05/04/2023
PRAC representative was updated on 26/05/2021
DLP was updated on 01/04/2020
PRAC Representative updated on 26/09/2018
PRAC Rapporteur name updated on 21/07/2017
DLP was updated on 28/03/2017
Lead MS and PRAC Rapporteur name was added on 28/07/2016
New active substance added on 07/04/2016 PSUSA/00010474/202707 Tiphaine Vaillant France NAP
10475 allergen for therapy: Phleum Pratense (oromucosal use, product authorised via mutually recognition procedure) 14/03/2006 5 years 13/03/2027 11/06/2027 No 02/06/2026 PSUSA/00010475/202703 Karin Bolin Sweden NAP
10476 ferric maltol 18/02/2016 3 years 18/02/2027 19/05/2027 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00010476/202702 Adam Przybylkowski Poland CAP
10477 diflucortolone valerate / chlorquinaldol Not available* 13 years 30/09/2027 29/12/2027 No 07/04/2016 New active substance added on 07/04/2016 PSUSA/00010477/202709 NAP
10478 diflucortolone valerate / salicylic acid Not available* 13 years 04/04/2027 03/07/2027 No 07/04/2016 New active substance added on 07/04/2016 PSUSA/00010478/202704 NAP
10479 carbidopa / levodopa (for centrally authorised product) 19/11/2015 6 months 01/10/2026 10/12/2026 01/04/2027 10/06/2027 No 27/05/2026 Entry re-activated on 27/05/2026
New CAP authorised on 27/04/2026
Entry deleted as CAP surrendered 30/11/2019
PRAC Rapporteur name was amended on 31/07/2018
Next DLP was amended on 27/06/2017
PSUR Frequency amended and DLP updated on 20/12/2016
New CAP authorised on 19/11/2015 PSUSA/00010479/202610 PSUSA/00010479/202704 Barbara Kovacic Bytyqi Croatia CAP
10480 dexamethasone (centrally authorised product indicated in symptomatic multiple myeloma) 16/03/2016 3 years 16/09/2026 15/12/2026 No 05/06/2024 PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00010480/202609 Tiphaine Vaillant France CAP
10481 human coagulation factor X 16/03/2016 3 years 16/03/2027 14/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010481/202703 Bianca Mulder Netherlands CAP
10482 rhubarb extract / salicylic acid Not available* 15 years 30/09/2030 29/12/2030 No 03/05/2016 New entry added on 03/05/2016 PSUSA/00010482/203009 NAP
10483 phenylpropanolamine 29/11/2005 5 years 10/06/2029 08/09/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010483/202906 Eva Jirsová Czech Republic NAP
10484 methoxyflurane 18/05/2015 3 years 17/05/2028 15/08/2028 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010484/202805 Karin Bolin Sweden NAP
10486 tauroselcholic [75Se] acid 25/06/1991 5 years 31/01/2028 30/04/2028 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00010486/202801 Melinda Palfi Hungary NAP
10488 isotretinoin (oral formulations) 07/05/1982 1 year 06/05/2026 15/07/2026 06/05/2027 15/07/2027 Yes 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010488/202605 PSUSA/00010488/202705 Maia Uusküla Estonia NAP
10489 olodaterol / tiotropium 20/05/2015 5 years 19/05/2029 17/08/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010489/202905 Bianca Mulder Netherlands NAP
10490 pitolisant 31/03/2016 3 years 30/09/2027 29/12/2027 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00010490/202709 Terhi Lehtinen Finland CAP
10491 azithromycin (systemic use formulations) 04/04/1991 3 years 30/04/2026 29/07/2026 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00010491/202604 Kimmo Jaakkola Finland NAP
10492 azithromycin (ocular use formulations) Not available* 5 years 30/04/2028 29/07/2028 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00010492/202804 Kimmo Jaakkola Finland NAP
10493 ixekizumab 22/03/2016 3 years 22/03/2027 20/06/2027 No 06/10/2025 DLP was amended on 20/11/2024 PSUSA/00010493/202703 Dirk Mentzer Germany CAP
10494 calcium chloride / glucose / magnesium chloride / sodium chloride / sodium lactate, calcium chloride / glucose / magnesium chloride / sodium chloride / sodium lactate/ sodium bicarbonate, calcium chloride / amino acids blend / magnesium chloride / sodium chloride / sodium lactate, calcium chloride / icodextrin / magnesium chloride / sodium chloride / sodium lactate (peritoneal dialysis solutions) Not available* 15 years 01/01/2027 01/04/2027 No 03/06/2016 New entry added on 03/06/2016 PSUSA/00010494/202701 NAP
10495 immunocyanine 25/03/1997 15 years 30/06/2030 28/09/2030 No 03/06/2016 New active substance added on 03/06/2016 PSUSA/00010495/203006 NAP
10496 delapril / manidipine, delapril / indapamide 17/01/1989 5 years 30/06/2027 28/09/2027 No 01/03/2023 DLP was updated on 01/03/2023
PRAC representative was updated on 17/11/2021
PRAC representative was updated on 30/06/2021
PRAC Rapporteur name amended on 04/07/2018
DLP was updated on 27/03/2018
Lead MS and PRAC Rapporteur name was added on 20/12/2016
Entry 'delapril / manidipine' replaced with 'delapril / manidipine, delapril / indapamide' on 03/06/2016 PSUSA/00010496/202706 Amelia Cupelli Italy NAP
10497 albutrepenonacog alfa 26/01/2016 3 years 26/01/2027 26/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010497/202701 Bianca Mulder Netherlands CAP
10498 daratumumab 16/11/2015 2 years 15/11/2026 13/02/2027 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010498/202611 Carla Torre Portugal CAP
10499 eftrenonacog alfa 20/03/2014 3 years 19/03/2026 17/06/2026 No 06/10/2025 DLP was amended on 15/11/2023 PSUSA/00010499/202603 Dirk Mentzer Germany CAP
10500 elotuzumab 30/11/2015 3 years 29/11/2027 27/02/2028 No 06/10/2025 DLP was amended on 30/07/2025 PSUSA/00010500/202711 Dirk Mentzer Germany CAP
10501 pandemic influenza vaccine (H5N1) (live attenuated, nasal) 20/05/2016 6 months 20/05/2026 29/07/2026 20/11/2026 29/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010501/202605 PSUSA/00010501/202611 Sonja Radowan Austria CAP
10502 pitavastatin 17/07/2003 5 years 16/07/2030 14/10/2030 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00010502/203007 Bianca Mulder Netherlands NAP
10503 selexipag 21/12/2015 3 years 20/12/2026 20/03/2027 Yes 02/04/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 02/04/2025
DLP was amended on 25/09/2024 PSUSA/00010503/202612 Zoubida Amimour France CAP
10504 ascorbic acid / rutoside, ascorbic acid / rutoside / alfatocopherol Not available* 8 years 01/12/2025 01/03/2026 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00010504/202512 Adam Przybylkowski Poland NAP
10505 autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence 26/05/2016 3 years 25/11/2025 23/02/2026 No 26/07/2023 PSUR frequency amended and DLP updated on 26/07/2023 PSUSA/00010505/202511 Liana Martirosyan Netherlands CAP
10506 dutasteride, dutasteride / tamsulosine 20/11/2001 5 years 19/11/2027 17/02/2028 No 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00010506/202711 Melinda Palfi Hungary NAP
10507 migalastat 26/05/2016 3 years 26/05/2027 24/08/2027 No 02/06/2026 PSUSA/00010507/202705 Karin Bolin Sweden CAP
10508 metronidazole / neomycin / nystatin 02/05/1997 5 years 02/09/2030 01/12/2030 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010508/203009 Zoubida Amimour France NAP
10509 pyridoxine / thiamine, arginine / pyridoxine / thiamine Not available* 9 years 03/05/2032 01/08/2032 No 11/06/2025 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010509/203205 Guðrún Stefánsdóttir Iceland NAP
10510 beta-alanine 23/09/1991 3 years 23/01/2026 23/04/2026 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00010510/202601 Barbara Kovacic Bytyqi Croatia NAP
10511 budesonide / salmeterol 23/07/2015 3 years 23/07/2027 21/10/2027 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00010511/202707 Bianca Mulder Netherlands NAP
10512 amlodipine / losartan 06/01/2014 5 years 05/01/2029 05/04/2029 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010512/202901 Melinda Palfi Hungary NAP
10513 ceftazidime / avibactam 25/02/2015 3 years 24/02/2026 25/05/2026 No 18/10/2023 PSUR frequency amended and DLP updated on 18/10/2023 PSUSA/00010513/202602 Rugile Pilviniene Lithuania CAP
10514 emtricitabine / rilpivirine / tenofovir alafenamide 01/03/2016 3 years 28/02/2026 29/05/2026 No 15/11/2023 DLP was amended on 15/11/2023 PSUSA/00010514/202602 Ana Sofia Diniz Martins Portugal CAP
10515 emtricitabine / tenofovir alafenamide 04/04/2016 3 years 03/04/2026 02/07/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00010515/202604 Ana Sofia Diniz Martins Portugal CAP
10516 opicapone 24/06/2016 3 years 24/06/2027 22/09/2027 No 05/03/2025 DLP was amended on 05/03/2025 PSUSA/00010516/202706 Maria del Pilar Rayon Spain CAP
10517 trifluridine / tipiracil 24/03/2014 3 years 24/03/2026 22/06/2026 No 02/06/2026 PSUSA/00010517/202603 Jenny-Maria Jönsson Sweden CAP
10519 elbasvir / grazoprevir 19/01/2016 5 years 18/01/2030 18/04/2030 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00010519/203001 Ana Sofia Diniz Martins Portugal CAP
10521 technetium (99mTc) edda / hynic-octreotide 03/06/2016 15 years 02/06/2032 31/08/2032 Yes 25/09/2019 Active substance name corrected on 02/02/2022
PSUR frequency and DLP were updated on 25/09/2019
Entry name, PSUR frequency amended and DLP updated on 31/01/2018
Lead MS and PRAC Rapporteur name was added on 26/04/2017
New active substance added on 20/12/2016 PSUSA/00010521/203206 Adam Przybylkowski Poland NAP
10523 reslizumab 16/08/2016 3 years 16/02/2027 17/05/2027 No 06/10/2025 PRAC representative was updated on 01/03/2023
PSUR frequency and DLP were amended on 20/10/2021
DLP was updated on 21/10/2020
DLP was updated on 25/09/2019
PSUR frequency amended and DLP updated on 03/04/2019
DLP was updated on 26/09/2018
DLP was updated on 27/03/2018
DLP was updated on 17/10/2017
New CAP authorised on 22/09/2016 PSUSA/00010523/202702 Dirk Mentzer Germany CAP
10524 sofosbuvir / velpatasvir 28/06/2016 5 years 27/06/2030 25/09/2030 No 01/04/2026 DLP was corrected on 01/04/2026
PSUR frequency amended and DLP updated on 04/03/2026 PSUSA/00010524/203006 Ana Sofia Diniz Martins Portugal CAP
10525 deoxycholic acid 29/04/2015 3 years 29/04/2027 28/07/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010525/202704 Karin Bolin Sweden NAP
10526 dequalinium, dequalinium / cinchocaine, dequalinium / lidocaine, dequalinium / enoxolone / tyrothricin/ hydrocortisone / lidocaine 01/06/1962 11 years 03/07/2039 01/10/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010526/203907 Amelia Cupelli Italy NAP
10527 diphenhydramine, ammonium chloride / diphenhydramine hydrochloride, diphenhydramine hydrochloride / levomenthol, ammonium chloride / diphenhydramine hydrochloride / levomenthol 05/03/1974 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010527/203503 Rhea Fitzgerald Ireland NAP
10529 glycopyrronium (indicated for the treatment of severe sialorhoea) 15/09/2016 3 years 14/09/2027 13/12/2027 Yes 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00010529/202709 Zane Neikena Latvia CAP NAP
10532 lisinopril, lisinopril / hydrochlorothiazide 24/09/1987 5 years 23/09/2030 22/12/2030 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00010532/203009 Carla Torre Portugal NAP
10533 etelcalcetide 11/11/2016 3 years 10/11/2027 08/02/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010533/202711 Amelia Cupelli Italy CAP
10534 irinotecan (liposomal formulations) 22/10/2015 3 years 22/10/2028 20/01/2029 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010534/202810 David Olsen Norway CAP
10535 ixazomib 20/11/2015 2 years 19/11/2025 17/02/2026 No 02/06/2026 PSUSA/00010535/202511 Jenny-Maria Jönsson Sweden CAP
10536 lactic acid / urea, urea 21/11/1969 10 years 02/09/2034 01/12/2034 No 30/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010536/203409 Polona Golmajer Slovenia NAP
10537 mesoglycan 22/12/1978 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00010537/202811 NAP
10539 empagliflozin / linagliptin 11/11/2016 3 years 10/11/2026 08/02/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010539/202611 Maria del Pilar Rayon Spain CAP
10540 olanzapine 27/09/1996 3 years 31/03/2028 29/06/2028 No 21/12/2022 DLP was updated on 21/12/2022
DLP was updated on 18/12/2019
New entry created on 20/12/2016 PSUSA/00010540/202803 Kimmo Jaakkola Finland CAP NAP
10542 sulfogaiacol, sodium benzoate / sulfogaiacol, codeine / sodium benzoate, codeine sulfogaiacol, codeine / sulfogaiacol / grindelia soft extract 12/08/1996 5 years 31/12/2027 30/03/2028 No 27/03/2024 Active substance name was amended on 27/03/2024
PRAC Rapporteur updated on 15/11/2023 PSUSA/00010542/202712 Petar Mas Croatia NAP
10544 palbociclib 03/02/2015 3 years 02/08/2026 31/10/2026 No 27/03/2024 PSUR frequency amended and DLP updated on 27/03/2024 PSUSA/00010544/202608 Marie Louise Schougaard Christiansen Denmark CAP
10545 ascorbic acid / calcium, ascorbic acid / calcium / lysine Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00010545/202905 Roxana Dondera Romania NAP
10546 benzalkonium chloride / cetrimide, cetrimide / dimeticone Not available* 9 years 03/06/2029 01/09/2029 Yes 23/10/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 23/10/2024
PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00010546/202906 Rhea Fitzgerald Ireland NAP
10547 alfa-tocopherol / vaccinium myrtillus anthocyanosides, betacarotene / vaccinium myrtillus anthocyanosides Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024 PSUSA/00010547/202903 Maia Uusküla Estonia NAP
10549 morphine, morphine / cyclizine 14/04/1969 5 years 14/10/2027 12/01/2028 No 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00010549/202710 Karin Erneholm Denmark NAP
10550 mycophenolate mofetil, mycophenolic acid 03/05/1995 3 years 02/05/2028 31/07/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010550/202805 Karin Erneholm Denmark CAP NAP
10551 mesterolone 25/05/1967 5 years 31/01/2030 01/05/2030 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00010551/203001 Petar Mas Croatia NAP
10552 edotreotide 08/12/2016 3 years 07/12/2025 07/03/2026 Yes 17/12/2025 Reference to NAP added on 17/12/2025
Reference to NAP removed on 28/05/2025
PSUR frequency amended and DLP updated on 26/07/2023 PSUSA/00010552/202512 Rhea Fitzgerald Ireland CAP NAP
10554 follitropin delta 12/12/2016 3 years 30/11/2026 28/02/2027 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00010554/202611 Bianca Mulder Netherlands CAP
10556 venetoclax 05/12/2016 3 years 04/12/2027 03/03/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010556/202712 Eva Jirsová Czech Republic CAP
10557 carbasalate calcium / metoclopramide, lysine acetylsalicylic acid / metoclopramide, paracetamol / metoclopramide 16/07/1981 15 years 16/07/2027 14/10/2027 No 30/01/2017 New entry added on 30/01/2017 PSUSA/00010557/202707 NAP
10558 cidofovir 23/04/1997 3 years 10/06/2027 08/09/2027 Yes 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010558/202706 Rugile Pilviniene Lithuania NAP
10559 lonoctocog alfa 04/01/2017 1 year 03/01/2026 14/03/2026 03/01/2027 14/03/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010559/202601 PSUSA/00010559/202701 Sonja Radowan Austria CAP
10561 sulfamethizole 15/06/1955 10 years 15/06/2032 13/09/2032 Yes 01/03/2023 PSUR frequency and DLP were updated on 01/03/2023
PRAC Rapporteur name was amended on 28/04/2022
PRAC Rapporteur name was amended on 21/11/2018
DLP was updated on 28/02/2018
Lead MS and PRAC Rapporteur name was added on 26/04/2017
New entry added on 30/01/2017
PRAC Rapporteur name updated on 05/11/2018 PSUSA/00010561/203206 Marie Louise Schougaard Christiansen Denmark NAP
10563 calcium glycerophosphate / magnesium gluconate, calcium glycerophosphate / manganese glycerophosphate / potassium glycerophosphate / sodium glycerophosphate / thiamine 14/09/1959 11 years 03/05/2039 01/08/2039 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010563/203905 NAP
10564 cetrimide, cetyltrimethylammonium naproxenate 07/12/1976 15 years 28/02/2030 29/05/2030 No 19/12/2017 Entry name amended on 19/12/2017
New active substance added on 28/02/2017 PSUSA/00010564/203002 NAP
10565 amino acid combinations / glucose / triglyceride combinations (e.g. olive oil, soya bean oil, fish oil)/ with or without electrolytes/ mineral compounds (i.v. application) - except the combination with procedure number 00010190 (drug Numeta) Not available* 5 years 03/06/2026 01/09/2026 No 02/02/2022 DLP was updated on 02/02/2022
PRAC representative and LMS were added on 23/09/2020
New active substance added on 28/02/2017 PSUSA/00010565/202606 Melinda Palfi Hungary NAP
10566 amino acid combinations/ glucose/ with or without electrolytes / mineral compounds (i.v. application) Not available* 5 years 03/06/2026 01/09/2026 No 02/02/2022 DLP was updated on 02/02/2022
PRAC representative was updated on 28/07/2021
PRAC representative was updated on 28/04/2021
PRAC representative and LMS were added on 23/09/2020
New active substance added on 28/02/2017 PSUSA/00010566/202606 Polona Golmajer Slovenia NAP
10569 Camellia sinensis, Leaf, Dry extract refined (derived from Camellia sinensis, L. O.KUNTZE) (topical use) 31/08/2009 5 years 31/12/2029 31/03/2030 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00010569/202912 Adam Przybylkowski Poland NAP
10570 landiolol 03/08/2016 3 years 02/02/2026 03/05/2026 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00010570/202602 Bianca Mulder Netherlands NAP
10571 naphazoline, naphazoline / zinc sulphate 16/10/1946 12 years 31/07/2036 29/10/2036 No 02/04/2025 DLP was amended on 02/04/2025 PSUSA/00010571/203607 Karin Erneholm Denmark NAP
10572 nitrous oxide, nitrous oxide / oxygen Not available* 3 years 23/06/2028 21/09/2028 Yes 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010572/202806 John Joseph Borg Malta NAP
10573 mercaptamine (treatment of nephropathic cystinosis) 23/06/1997 5 years 23/10/2030 21/01/2031 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010573/203010 Maria Martinez Gonzalez Spain CAP
10574 mercaptamine (Indicated for the treatment of corneal cystine crystal deposit only) 19/01/2017 3 years 18/01/2027 18/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010574/202701 Maria del Pilar Rayon Spain CAP
10575 tenofovir alafenamide 10/11/2016 3 years 09/11/2027 07/02/2028 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010575/202711 Amelia Cupelli Italy CAP
10576 bezlotoxumab 21/10/2016 5 years 20/10/2030 18/01/2031 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
PSUR frequency amended and DLP updated on 31/05/2023
DLP was updated on 29/06/2022
DLP was updated on 30/06/2021
DLP was updated on 16/12/2020
PSUR frequency and DLP were updated on 03/06/2020
DLP was updated on 20/11/2019
DLP was updated on 05/06/2019
DLP was updated on 21/11/2018
DLP was updated on 06/06/2018
DLP was updated on 19/12/2017
EURD and DLP amended on 26/04/2017
New CAP authorised on 18/01/2017 PSUSA/00010576/203010 Adam Przybylkowski Poland CAP
10577 insulin glargine / lixisenatide 11/01/2017 3 years 21/11/2026 19/02/2027 No 03/07/2024 PSUR frequency amended and DLP updated on 03/07/2024 PSUSA/00010577/202611 Bianca Mulder Netherlands CAP
10578 baricitinib 13/02/2017 1 year 13/02/2026 24/04/2026 13/02/2027 24/04/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010578/202602 PSUSA/00010578/202702 Adam Przybylkowski Poland CAP
10579 citrulline malate 31/10/1991 13 years 12/03/2034 10/06/2034 No 02/02/2022 Correction to PSUR frequency and DLP on 02/02/2022
DLP was updated on 17/11/2021
DLP was updated on 21/11/2018
PRAC representative and Lead Member State were added on 21/07/2017
New entry added on 28/03/2017 PSUSA/00010579/203403 Eva Jirsová Czech Republic NAP
10581 alectinib 04/07/2014 3 years 03/07/2028 01/10/2028 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010581/202807 Veronika Macurova Czech Republic CAP
10582 allergen for therapy: dermatophagoides pteronyssinus / dermatophagoides farina (oromucosal use, products authorised via mutually recognition procedure and decentralised procedure) 23/09/2015 3 years 22/09/2028 21/12/2028 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00010582/202809 Dirk Mentzer Germany NAP
10583 bendroflumethiazide, bendroflumethiazide / potassium chloride 28/02/1960 6 years 01/01/2030 01/04/2030 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010583/203001 Eva Jirsová Czech Republic NAP
10584 benzyl nicotinate / camphor / dimethyl sulfoxide / nonivamide / turpentine oil, Nicoboxil/ Nonivamide 01/01/1994 5 years 31/03/2028 29/06/2028 No 20/12/2023 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00010584/202803 Zane Neikena Latvia NAP
10585 budesonide / formoterol 25/08/2000 5 years 24/08/2030 22/11/2030 No 27/05/2026 DLP was corrected on 27/05/2026
PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00010585/203008 Marie Louise Schougaard Christiansen Denmark CAP NAP
10587 chlormethine 23/08/2013 3 years 22/08/2027 20/11/2027 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00010587/202708 Tiphaine Vaillant France CAP
10588 tofacitinib 06/11/2012 3 years 05/11/2027 03/02/2028 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010588/202711 Liana Martirosyan Netherlands CAP
10590 chenodeoxycholic acid (inborn error in primary bile acid synthesis, xanthomatosis - centrally authorised products only) 10/04/2017 1 year 09/10/2026 18/12/2026 09/10/2027 18/12/2027 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00010590/202610 PSUSA/00010590/202710 Adam Przybylkowski Poland CAP
10593 sulfametrole / trimethoprim, sulfadiazine / trimethoprim, sulfamethoxazole / trimethoprim (co-trimoxazole) 01/04/1969 8 years 31/03/2027 29/06/2027 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00010593/202703 Barbara Kovacic Bytyqi Croatia NAP
10594 fluciclovine (18F) 27/05/2016 3 years 27/05/2026 25/08/2026 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00010594/202605 Rugile Pilviniene Lithuania CAP
10595 nusinersen 30/05/2017 3 years 30/05/2027 28/08/2027 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010595/202705 Karin Bolin Sweden CAP
10596 cerliponase alfa 27/04/2017 3 years 26/04/2027 25/07/2027 No 02/06/2026 PSUSA/00010596/202704 Karin Bolin Sweden CAP
10597 dinutuximab beta 08/05/2017 1 year 08/11/2026 17/01/2027 08/11/2027 17/01/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010597/202611 PSUSA/00010597/202711 Dirk Mentzer Germany CAP
10598 lactobacillus all subspecies and combinations of subspecies (oral and vaginal use) 14/07/1954 10 years 13/07/2034 11/10/2034 No 28/05/2025 PSUR frequency corrected and DLP corrected on 28/05/2025
PSUR frequency amended and DLP updated on 02/04/2025 PSUSA/00010598/203407 Dennis Lex Germany NAP
10599 choline alfoscerate 27/07/1987 8 years 30/08/2030 28/11/2030 No 03/05/2023 DLP was amended on 03/05/2023
Lead MS and PRAC Rapporteur name added on 29/06/2022
New active substance added on 27/06/2017 PSUSA/00010599/203008 Rugile Pilviniene Lithuania NAP
10600 deproteinised hemoderivative of calf blood, deproteinised hemoderivative of calf blood / macrogol 400 03/01/1957 8 years 31/03/2031 29/06/2031 No 12/09/2025 DLP was amended on 20/12/2023 PSUSA/00010600/203103 Veronika Macurová Czech Republic NAP
10601 irbesartan, irbesartan / hydrochlorothiazide 12/08/1997 5 years 12/08/2026 10/11/2026 No 28/04/2022 PRAC Representative updated on 16/11/2022
DLP was updated on 28/04/2022
Correction of active substance name on 30/03/2022
PRAC Representative updated on 26/09/2018
European Union reference date, DLP and Submission date were updated on 28/02/2018
New combination of active substances added following merge on 27/06/2017
*for irbesartan containing products the next PSUR (PSUSA/00010601/202109) will cover period of 6 years, form 12/08/2015 to 30/09/2021 PSUSA/00010601/202608 Maria del Pilar Rayon Spain CAP NAP
10603 benzocaine / chlorhexidine, benzocaine / chlorhexidine / tyrothricin Not available* 18 years 01/01/2030 01/04/2030 No 21/07/2017 New entry added on 21/07/2017 PSUSA/00010603/203001 NAP
10604 chlorhexidine / tetracaine 22/12/1969 8 years 22/12/2033 22/03/2034 No 23/10/2024 PSUR frequency amended and DLP updated on 23/10/2024
Active substance name was amended on 23/10/2024
Active substance amended on 19/12/2017
New entry added on 21/07/2017 PSUSA/00010604/203312 Miroslava Gocova Slovakia NAP
10605 human plasma proteins with no less than 95% albumin 01/07/1950 5 years 01/07/2029 29/09/2029 Yes 06/10/2025 DLP was amended on 05/03/2025 PSUSA/00010605/202907 Dirk Mentzer Germany NAP
10606 itopride 30/06/1995 5 years 30/06/2028 28/09/2028 Yes 04/03/2026 PSUR frequency amended and DLP updated on 04/03/2026 PSUSA/00010606/202806 Rugile Pilviniene Lithuania NAP
10607 meningococcal group B vaccine (recombinant, adsorbed) 29/10/2014 3 years 28/10/2027 26/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00010607/202710 Jean-Michel Dogné Belgium CAP
10608 nonacog beta pegol 31/05/2017 3 years 31/05/2026 29/08/2026 No 06/10/2025 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00010608/202605 Dirk Mentzer Germany CAP
10609 sarilumab 12/01/2017 3 years 12/01/2026 12/04/2026 No 19/09/2025 DLP and PSUR frequency amended on 20/09/2023 PSUSA/00010609/202601 Maria Martinez Gonzalez Spain CAP
10610 shark liver oil / yeast extract, yeast extract (excluding saccharomyces boulardii) 01/01/1957 15 years 31/12/2031 30/03/2032 No 17/12/2025 Active substance name was amended on 17/12/2025
New entry added on 21/07/2017 PSUSA/00010610/203112 none NAP
10611 tripelennamine 04/04/1984 10 years 31/10/2026 29/01/2027 No 27/02/2026 New entry added on 21/07/2017 PSUSA/00010611/202610 Zane Neikena Latvia NAP
10612 sodium oxybate (oral use) 13/06/1961 1 year 12/10/2026 21/12/2026 12/10/2027 21/12/2027 Yes 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00010612/202610 PSUSA/00010612/202710 Ana Sofia Diniz Martins Portugal CAP NAP
10613 sodium oxybate (intravenous use) 13/06/1961 5 years 12/10/2029 10/01/2030 No 25/06/2025 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 25/06/2025
PSUR frequency amended and DLP updated on 25/06/2025
DLP was updated on 25/05/2022
PSUR frequency and DLP were updated on 05/06/2019
DLP was updated on 06/06/2018
PRAC representative added on 17/10/2017
New entry added on 21/07/2017 PSUSA/00010613/202910 Ana Sofia Diniz Martins Portugal NAP
10614 pentosan polysulfate sodium (for centrally authorised product) 02/06/2017 3 years 01/06/2027 30/08/2027 Yes 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010614/202706 Ana Sofia Diniz Martins Portugal CAP
10616 brodalumab 17/07/2017 3 years 16/07/2027 14/10/2027 No 19/09/2025 DLP was amended on 02/04/2025 PSUSA/00010616/202707 Maria Martinez Gonzalez Spain CAP
10617 beclometasone / formoterol / glycopyrronium bromide 17/07/2017 1 year 16/07/2026 24/09/2026 16/07/2027 24/09/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010617/202607 PSUSA/00010617/202707 Jan Neuhauser Austria CAP
10618 patiromer 21/10/2015 3 years 20/10/2026 18/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010618/202610 Terhi Lehtinen Finland CAP
10619 sofosbuvir / velpatasvir / voxilaprevir 18/07/2017 5 years 17/07/2030 15/10/2030 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00010619/203007 Ana Sofia Diniz Martins Portugal CAP
10620 glecaprevir / pibrentasvir 26/07/2017 5 years 25/07/2030 23/10/2030 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00010620/203007 Ana Sofia Diniz Martins Portugal CAP
10621 bismuth / lidocaine / zinc oxide, lidocaine / zinc oxide Not available* 8 years 01/01/2028 31/03/2028 Yes 23/09/2020 DLP was updated on 23/09/2020
LMS and PRAC representative were added on 31/07/2019
Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 06/02/2019
New entry introduced on 25/09/2017 PSUSA/00010621/202801 Rugile Pilviniene Lithuania NAP
10622 calcium chloride dihydrate / magnesium chloride hexahydrate / malic acid / sodium acetate trihydrate / sodium chloride / potassium chloride, calcium chloride dihydrate / sodium chloride / sodium lactate / potassium chloride, calcium chloride / sodium chloride / potassium chloride Not available* 13 years 01/01/2036 31/03/2036 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00010622/203601 Polona Golmajer Slovenia NAP
10623 cariprazine 13/07/2017 3 years 05/10/2027 03/01/2028 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010623/202710 Ana Sofia Diniz Martins Portugal CAP
10624 cenegermin 06/07/2017 1 year 05/07/2026 13/09/2026 05/07/2027 13/09/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010624/202607 PSUSA/00010624/202707 Jan Neuhauser Austria CAP
10625 mucopolysaccharide polysulfuric acid ester (chondroitin), mucopolysaccharide polysulfuric acid ester (chondroitin)/salicylic acid, mucopolysaccharide polysulfuric acid ester (chondroitin)/salicylic acid/flufenamic acid, mucopolysaccharide polysulfuric acid ester (chondroitin)/salicylic acid/suprarenal extract [cutaneous use] Not available* 9 years 02/12/2031 01/03/2032 No 23/10/2024 PSUR frequency amended and DLP updated on 23/10/2024
Active substance name was amended on 23/10/2024
New active sustance combination added following merge on 25/09/2017 PSUSA/00010625/203112 none NAP
10626 mucopolysaccharide polysulfuric acid ester (chondroitin), mucopolysaccharide polysulfuric acid ester (chondroitin)/ glucosamine [oral and intramuscular use] Not available* 9 years 02/12/2031 01/03/2032 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010626/203112 NAP
10627 benzyl benzoate / disulfiram 22/10/1982 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUR frequency and DLP amended on 31/07/2024 PSUSA/00010627/202812 Sweden NAP
10628 gentamicin (implant) 28/02/1973 5 years 31/03/2027 29/06/2027 No 21/12/2022 DLP was updated on 21/12/2022
PRAC representative was updated on 19/10/2022
PRAC representative was updated on 27/07/2022
LMS and PRAC representative were added on 20/10/2021
New active substance added on 25/09/2017 PSUSA/00010628/202703 Amelia Cupelli Italy NAP
10629 hamamelis water Not available* 13 years 01/01/2040 31/03/2040 No 25/09/2017 New active substance added on 25/09/2017 PSUSA/00010629/204001 NAP
10630 spheroids of human autologous matrix-associated chondrocytes 10/07/2017 3 years 09/07/2027 07/10/2027 No 06/10/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00010630/202707 Dirk Mentzer Germany CAP
10631 testosterone (all formulations apart from topical use) 01/07/1978 3 years 31/12/2027 30/03/2028 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010631/202712 Maia Uusküla Estonia NAP
10632 zinc oxide, zinc oxide/calamine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010632/203211 Dennis Lex Germany NAP
10633 ribociclib 13/03/2017 3 years 12/03/2028 10/06/2028 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00010633/202803 Marie Louise Schougaard Christiansen Denmark CAP
10634 cladribine (multiple sclerosis) 08/07/2010 3 years 07/07/2027 05/10/2027 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00010634/202707 Carla Torre Portugal CAP
10635 avelumab 23/03/2017 3 years 22/03/2026 20/06/2026 No 15/11/2023 PSUR frequency amended and DLP updated on 15/11/2023 PSUSA/00010635/202603 Karin Erneholm Denmark CAP
10636 tivozanib 24/08/2017 3 years 23/02/2028 23/05/2028 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010636/202802 Rugile Pilviniene Lithuania CAP
10637 trientine 05/09/2017 3 years 05/09/2028 04/12/2028 No 27/05/2026 DLP was corrected on 27/05/2026
PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00010637/202809 Ana Sofia Diniz Martins Portugal CAP NAP
10638 midostaurin 28/04/2017 5 years 27/10/2029 25/01/2030 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010638/202910 Carla Torre Portugal CAP
10639 telotristat 28/02/2017 3 years 27/02/2027 28/05/2027 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00010639/202702 Adam Przybylkowski Poland CAP
10640 benzalkonium chloride / isopropyl myristate / paraffin liquid, benzalkonium chloride / chlorhexidine / isopropyl myristate / paraffin liquid Not available* 8 years 01/12/2025 01/03/2026 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00010640/202512 Rhea Fitzgerald Ireland NAP
10641 eucalyptus oil Not available* 13 years 01/01/2030 01/04/2030 No 17/10/2017 New entry added on 17/10/2017 PSUSA/00010641/203001 NAP
10643 lutetium (177Lu) oxodotreotide 26/09/2017 3 years 19/12/2025 19/03/2026 No 26/07/2023 PSUR frequency amended and DLP updated on 26/07/2023 PSUSA/00010643/202512 Adam Przybylkowski Poland CAP
10644 atezolizumab 18/05/2016 2 years 17/05/2027 15/08/2027 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010644/202705 Carla Torre Portugal CAP
10645 dupilumab 28/03/2017 1 year 28/03/2026 06/06/2026 28/03/2027 06/06/2027 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010645/202603 PSUSA/00010645/202703 Kimmo Jaakkola Finland CAP
10646 darunavir / cobicistat / emtricitabine / tenofovir alafenamide 21/09/2017 3 years 20/09/2027 19/12/2027 No 28/04/2022 PSUR frequency and DLP were updated on 28/04/2022
DLP was updated on 28/04/2021
DLP was updated on 06/05/2020
PSUR frequency amended on 20/11/2019
DLP was updated on 23/10/2019
DLP was updated on 30/04/2019
Lead MS and PRAC Rapporteur name updated on 23/10/2018
DLP was updated on 23/10/2018
New CAP authorised on 21/09/2017 PSUSA/00010646/202709 Ana Sofia Diniz Martins Portugal CAP
10647 dimethyl fumarate (psoriasis) 23/06/2017 3 years 23/03/2028 21/06/2028 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00010647/202803 Karin Bolin Sweden CAP
10648 triglyceride combinations (e.g. olive oil, soya bean oil, fish oil)/ with or without mineral compounds/electrolytes (i.v. application) 06/02/2014 5 years 03/06/2026 01/09/2026 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00010648/202606 Petar Mas Croatia NAP
10649 ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus), ibuprofen / caffeine 19/02/1969 3 years 18/02/2026 19/05/2026 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00010649/202602 John Joseph Borg Malta NAP
10650 clodronic acid, clodronic acid / lidocaine 13/02/1985 5 years 28/02/2027 29/05/2027 Yes 16/11/2022 DLP was updated on 16/11/2022
PRAC Representative amended on 28/04/2022
New entry added following merge on 15/11/2017 PSUSA/00010650/202702 Jean-Michel Dogné Belgium NAP
10651 ozenoxacin 19/05/2017 5 years 18/05/2030 16/08/2030 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010651/203005 Maria Martinez Gonzalez Spain NAP
10652 guselkumab 13/07/2017 1 year 12/07/2026 20/09/2026 12/07/2027 20/09/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010652/202607 PSUSA/00010652/202707 Dirk Mentzer Germany CAP
10653 fluticasone furoate / umeclidinium / vilanterol 18/09/2017 3 years 17/03/2027 15/06/2027 No 02/06/2026 PSUSA/00010653/202703 Karin Bolin Sweden CAP
10654 padeliporfin 10/11/2017 3 years 09/11/2025 07/02/2026 No 28/06/2023 PSUR frequency amended and DLP updated on 28/06/2023 PSUSA/00010654/202511 Maia Uusküla Estonia CAP
10655 niraparib 27/03/2017 1 year 26/03/2026 04/06/2026 26/03/2027 04/06/2027 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010655/202603 PSUSA/00010655/202703 Jan Neuhauser Austria CAP
10656 methohexital 24/01/1977 5 years 01/01/2027 01/04/2027 No 21/09/2022 DLP was updated on 21/09/2022
PRAC representative and LMS were added on 26/05/2021
New entry added on 19/17/2017 PSUSA/00010656/202701 Liana Martirosyan Netherlands NAP
10657 naloxone (for use in non-medical settings) 06/06/2016 2 years 09/05/2026 07/08/2026 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010657/202605 Liana Martirosyan Netherlands CAP NAP
10658 methyl salicylate,
menthol / methyl salicylate,
menthol / methyl salicylate / camphor,
methyl salicylate/ camphor, methyl salicylate / menthol / camphor / tocopherol,
methyl salicylate / camphor / menthol / turpentine (essence, oil),
methyl salicylate / menthol / camphor / hydroxyethyl salicylate,
methyl salicylate / menthol / camphor / hydroxyethyl salicylate / benzyl nicotinate 23/06/1989 5 years 20/04/2027 19/07/2027 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00010658/202704 Carla Torre Portugal NAP
10659 inotuzumab ozogamicin 29/06/2017 1 year 28/12/2025 08/03/2026 28/12/2026 08/03/2027 No 06/10/2025 DLP was amended on 30/07/2025 PSUSA/00010659/202512 PSUSA/00010659/202612 Dirk Mentzer Germany CAP
10660 letermovir 01/11/2017 3 years 01/11/2027 30/01/2028 No 25/06/2025 DLP was amended on 25/06/2025 PSUSA/00010660/202711 Terhi Lehtinen Finland CAP
10661 benralizumab 14/11/2017 3 years 13/11/2025 11/02/2026 No 28/06/2023 PSUR frequency amended and DLP updated on 28/06/2023 PSUSA/00010661/202511 David Olsen Norway CAP
10662 ocrelizumab 28/03/2017 3 years 27/03/2027 25/06/2027 No 06/10/2025 DLP was amended on 20/11/2024 PSUSA/00010662/202703 Dirk Mentzer Germany CAP
10663 rurioctocog alfa pegol 13/11/2018 3 years 12/11/2027 10/02/2028 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010663/202711 Bianca Mulder Netherlands CAP
10664 budesonide (for centrally authorised products indicated for eosinophilic esophagitis only) 08/01/2018 3 years 07/07/2028 05/10/2028 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026
DLP was amended on 04/03/2026 PSUSA/00010664/202807 Zane Neikena Latvia CAP
10665 loperamide, loperamide / simeticone 31/05/1973 5 years 31/05/2029 29/08/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010665/202905 Adam Przybylkowski Poland NAP
10667 pseudoephedrine, acetylsalicylic acid / pseudoephedrine 01/02/1986 3 years 28/06/2026 26/09/2026 No 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 PSUSA/00010667/202606 Maia Uusküla Estonia NAP
10668 emicizumab 16/11/2017 3 years 15/11/2027 13/02/2028 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010668/202711 Amelia Cupelli Italy CAP
10669 burosumab 19/02/2018 1 year 18/02/2026 29/04/2026 18/02/2027 29/04/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010669/202602 PSUSA/00010669/202702 Dirk Mentzer Germany CAP
10670 opium 01/10/1986 7 years 30/09/2031 29/12/2031 Yes 16/10/2023 PRAC Rapporteur name was amended on 18/10/2023 PSUSA/00010670/203109 Marie Louise Schougaard Christiansen Denmark NAP
10671 semaglutide (all other indications) 05/12/2017 2 years 31/05/2027 29/08/2027 No 02/06/2026 PSUSA/00010671/202705 Karin Bolin Sweden CAP
10672 prasterone (vaginal use/Pessary) 16/11/2016 2 years 15/11/2025 13/02/2026 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00010672/202511 Bianca Mulder Netherlands CAP
10673 sitagliptin, metformin / sitagliptin 21/03/2007 3 years 03/08/2026 01/11/2026 No 30/07/2025 Active substance name was amended on 30/07/2025
DLP was amended on 30/04/2024 PSUSA/00010673/202608 Bianca Mulder Netherlands CAP NAP
10674 hydrocortisone (centrally authorised products for adrenal insufficiency, paediatric use only) 09/02/2018 3 years 08/08/2026 06/11/2026 No 27/03/2024 PSUR frequency amended and DLP updated on 27/03/2024 PSUSA/00010674/202608 Karin Bolin Sweden CAP
10675 sodium zirconium cyclosilicate 22/03/2018 3 years 21/03/2028 19/06/2028 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010675/202803 Terhi Lehtinen Finland CAP
10677 velmanase alfa 23/03/2018 3 years 22/03/2028 20/06/2028 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00010677/202803 Jan Neuhauser Austria CAP
10678 herpes zoster vaccine (recombinant, adjuvanted) 13/10/2017 1 year 12/10/2026 21/12/2026 12/10/2027 21/12/2027 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00010678/202610 PSUSA/00010678/202710 Sonja Radowan Austria CAP
10683 Krypton (81 mKr) 31/01/1995 10 years 30/01/2026 30/04/2026 No 20/06/2025 New active substance added on 06/06/2018 PSUSA/00010683/202601 Zane Neikena Latvia NAP
10684 coal tar, distilled coal tar, coconut oil / distilled coal tar / salicylic acid, coal tar solution / salicylic acid / sulfur, coal tar / salicylic acid, coal tar / menthol 16/02/1989 8 years 16/02/2033 17/05/2033 No 23/10/2024 PSUR frequency amended and DLP updated on 23/10/2024
Active substance name was amended on 23/10/2024
EURD added on 23/10/2024
New entry added on 06/06/2018 PSUSA/00010684/203302 Liana Martirosyan Netherlands NAP
10685 lisinopril / torasemide 12/12/2017 5 years 11/12/2028 11/03/2029 Yes 13/08/2025 DLP was amended on 31/07/2024 PSUSA/00010685/202812 Veronika Macurová Czech Republic NAP
10686 enterococcus faecium 27/07/1955 10 years 26/07/2026 24/10/2026 No 18/11/2025 New active substance added on 06/06/2018 PSUSA/00010686/202607 Polona Golmajer Slovenia NAP
10688 gemtuzumab ozogamicin 17/05/2000 3 years 16/05/2026 14/08/2026 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00010688/202605 Carla Torre Portugal CAP
10689 dolutegravir / rilpivirine 16/05/2018 3 years 15/05/2028 13/08/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010689/202805 Zoubida Amimour France CAP
10690 glibenclamide (for centrally authorised products only) 24/05/2018 3 years 23/05/2028 21/08/2028 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010690/202805 Maria del Pilar Rayon Spain CAP
10691 heparin / zinc sulphate 30/11/1998 12 years 29/11/2027 27/02/2028 No 31/07/2018 New combination of active substances added on 31/07/2018 PSUSA/00010691/202711 NAP
10693 allergen for therapy: Ambrosia Artemisiifolia (302) (sublingual use, products authorised via decentralised procedure)” 10/04/2014 3 years 09/04/2027 08/07/2027 No 06/10/2025 DLP was amended on 18/12/2024 PSUSA/00010693/202704 Dirk Mentzer Germany NAP
10694 rucaparib 19/12/2016 2 years 19/12/2025 19/03/2026 No 02/06/2026 PSUSA/00010694/202512 Jenny-Maria Jönsson Sweden CAP
10695 bictegravir / emtricitabine / tenofovir alafenamide 07/02/2018 3 years 06/02/2028 06/05/2028 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010695/202802 Liana Martirosyan Netherlands CAP
10696 iron dextran Not available* 3 years 01/01/2027 01/04/2027 Yes 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010696/202701 Zane Neikena Latvia NAP
10697 inotersen 06/07/2018 2 years 05/07/2027 03/10/2027 No 27/05/2026 DLP was corrected on 27/05/2026
PSUR frequency amended and DLP updated on 29/04/2026
DLP was amended on 04/03/2026 PSUSA/00010697/202707 Rhea Fitzgerald Ireland CAP
10698 brexpiprazole 10/07/2015 3 years 09/07/2027 07/10/2027 No 05/03/2025 DLP was amended on 05/03/2025 PSUSA/00010698/202707 Miroslava Gocova Slovakia CAP
10699 erenumab 17/05/2018 3 years 16/05/2027 14/08/2027 No 18/12/2024 PSUR frequency amended and DLP updated on 18/12/2024 PSUSA/00010699/202705 Terhi Lehtinen Finland CAP
10700 metreleptin 25/03/2013 1 year 24/01/2026 04/04/2026 24/01/2027 04/04/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010700/202601 PSUSA/00010700/202701 Adam Przybylkowski Poland CAP
10701 daunorubicin / cytarabine 03/08/2017 3 years 02/08/2028 31/10/2028 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00010701/202808 Carla Torre Portugal CAP
10702 tisagenlecleucel 30/08/2017 1 year 12/08/2026 21/10/2026 12/08/2027 21/10/2027 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00010702/202608 PSUSA/00010702/202708 Dirk Mentzer Germany CAP
10703 axicabtagene ciloleucel 18/10/2017 1 year 17/10/2026 26/12/2026 17/10/2027 26/12/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010703/202610 PSUSA/00010703/202710 Karin Erneholm Denmark CAP
10706 sodium fluoride (18F) 14/11/1994 5 years 13/11/2027 11/02/2028 Yes 26/07/2023 PSUR frequency amended and DLP updated on 26/07/2023 PSUSA/00010706/202711 Kimmo Jaakkola Finland NAP
10707 soybean phospholipids (oral use) 02/10/1957 5 years 01/10/2026 30/12/2026 No 15/11/2023 PRAC Rapporteur updated on 15/11/2023 PSUSA/00010707/202610 Petar Mas Croatia NAP
10708 fluorocholine (18F) 02/04/2010 3 years 01/04/2026 30/06/2026 No 23/08/2023 DLP was amended on 23/08/2023
DLP updated on 02/02/2022
LMS and PRAC representative were added on 25/09/2019
New entry added on 26/09/2018 PSUSA/00010708/202604 Eva Jirsová Czech Republic NAP
10709 vestronidase alfa 15/11/2017 3 years 14/11/2026 12/02/2027 No 03/07/2024 PSUR frequency amended and DLP updated on 03/07/2024 PSUSA/00010709/202611 Maria del Pilar Rayon Spain CAP
10710 alitretinoin (oral use) Not available* 1 year 18/01/2026 29/03/2026 18/01/2027 29/03/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010710/202601 PSUSA/00010710/202701 Jan Neuhauser Austria NAP
10712 neratinib 17/07/2017 3 years 16/07/2026 14/10/2026 No 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 PSUSA/00010712/202607 Bianca Mulder Netherlands CAP
10713 caplacizumab 31/08/2018 1 year 30/08/2026 08/11/2026 30/08/2027 08/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010713/202608 PSUSA/00010713/202708 Jan Neuhauser Austria CAP
10714 vonicog alfa 08/12/2015 3 years 31/12/2026 31/03/2027 No 02/06/2026 PSUSA/00010714/202612 Karin Bolin Sweden CAP
10715 patisiran 10/08/2018 2 years 09/08/2027 07/11/2027 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00010715/202708 Rhea Fitzgerald Ireland CAP
10716 Symphytum officinale L., radix (comfrey root) 07/01/1966 13 years 31/12/2027 30/03/2028 No 23/10/2018 New active substance added on 23/10/2018 PSUSA/00010716/202712 NAP
10717 binimetinib 27/06/2018 3 years 26/06/2028 24/09/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010717/202806 Carla Torre Portugal CAP
10718 eravacycline 27/08/2018 3 years 26/08/2027 24/11/2027 No 02/04/2025 PSUR frequency amended and DLP updated on 02/04/2025 PSUSA/00010718/202708 Adam Przybylkowski Poland CAP
10719 encorafenib 27/06/2018 3 years 26/06/2028 24/09/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010719/202806 Rugile Pilviniene Lithuania CAP
10720 tildrakizumab 20/03/2018 1 year 19/03/2026 28/05/2026 19/03/2027 28/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010720/202603 PSUSA/00010720/202703 Adam Przybylkowski Poland CAP
10721 allergen for diagnostic and/or therapy: Vespula SPP. (802) (with or without adjuvant), Wasp venom 03/07/1980 5 years 02/07/2027 30/09/2027 No 02/06/2026 PSUSA/00010721/202707 Karin Bolin Sweden NAP
10722 allergen for diagnostic and/or therapy: Apis mellifera (801) (with or without adjuvant), Apis mellifera venom 03/07/1980 5 years 02/07/2027 30/09/2027 No 02/06/2026 DLP was updated on 01/03/2023
PRAC Rapporteur name was amended on 22/09/2022
DLP was updated on 31/03/2021
PRAC representative and LMS were added on 18/11/2020
New active substance added on 21/11/2018 PSUSA/00010722/202707 Karin Bolin Sweden NAP
10723 durvalumab 01/05/2017 1 year 30/04/2026 09/07/2026 30/04/2027 09/07/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010723/202604 PSUSA/00010723/202704 David Olsen Norway CAP
10724 abemaciclib 28/09/2017 3 years 28/09/2027 27/12/2027 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010724/202709 Carla Torre Portugal CAP
10725 interferon beta-1a (intramuscular use) 13/03/1997 5 years 03/05/2029 01/08/2029 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010725/202905 Maria del Pilar Rayon Spain CAP
10726 interferon beta-1a (subcutaneous use) 04/05/1998 5 years 03/05/2026 01/08/2026 No 02/06/2026 PSUSA/00010726/202605 Karin Bolin Sweden CAP
10727 meropenem / vaborbactam 29/08/2017 3 years 28/08/2026 26/11/2026 No 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00010727/202608 Maria del Pilar Rayon Spain CAP
10728 brigatinib 28/04/2017 3 years 27/04/2026 26/07/2026 No 20/12/2023 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00010728/202604 Carla Torre Portugal CAP
10729 doravirine 30/08/2018 5 years 29/08/2030 27/11/2030 No 27/05/2026 DLP was corrected on 27/05/2026
PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00010729/203008 Ana Sofia Diniz Martins Portugal CAP
10730 tezacaftor / ivacaftor 12/02/2018 1 year 11/02/2026 22/04/2026 11/02/2027 22/04/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010730/202602 PSUSA/00010730/202702 Eamon O Murchu Ireland CAP
10731 doravirine / lamivudine / tenofovir disoproxil 30/08/2018 5 years 29/08/2030 27/11/2030 No 27/05/2026 DLP was corrected on 27/05/2026
PSUR frequency amended and DLP updated on 29/04/2026 PSUSA/00010731/203008 Ana Sofia Diniz Martins Portugal CAP
10732 damoctocog alfa pegol 29/08/2018 2 years 28/08/2027 26/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010732/202708 Bianca Mulder Netherlands CAP
10733 galcanezumab 27/09/2018 3 years 27/09/2026 26/12/2026 No 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00010733/202609 Terhi Lehtinen Finland CAP
10734 ceftobiprole 20/11/2013 3 years 19/11/2027 17/02/2028 No 02/06/2026 PSUSA/00010734/202711 Jenny Jönsson Sweden NAP
10735 valsartan / rosuvastatin 12/10/2016 3 years 11/10/2028 09/01/2029 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010735/202810 Polona Golmajer Slovenia NAP
10736 activated attapulgite mormoiron,
activated attapulgite / aluminium / pectin 30/03/1956 10 years 31/12/2026 31/03/2027 No 19/12/2018 New entry added on 19/12/18 PSUSA/00010736/202612 NAP
10737 influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 12/12/2018 1 year 15/03/2026 24/05/2026 15/03/2027 24/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010737/202603 PSUSA/00010737/202703 Dirk Mentzer Germany CAP
10738 mexiletine (centrally authorised products only) 18/12/2018 3 years 17/12/2025 17/03/2026 No 26/07/2023 Next DLP was updated on 26/07/2023 PSUSA/00010738/202512 Eva Jirsová Czech Republic CAP
10739 glycopyrronium bromide / formoterol 25/04/2016 3 years 24/04/2026 23/07/2026 No 20/12/2023 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00010739/202604 Jan Neuhauser Austria CAP
10741 mogamulizumab 30/03/2012 3 years 29/03/2026 27/06/2026 No 15/11/2023 PSUR frequency amended and DLP updated on 15/11/2023 PSUSA/00010741/202603 Marie Louise Schougaard Christiansen Denmark CAP
10742 voretigene neparvovec 19/12/2017 1 year 23/07/2026 01/10/2026 23/07/2027 01/10/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010742/202607 PSUSA/00010742/202707 Dirk Mentzer Germany CAP
10743 lanadelumab 23/08/2018 3 years 22/08/2026 20/11/2026 No 27/03/2024 PSUR frequency amended and DLP updated on 27/03/2024 PSUSA/00010743/202608 Terhi Lehtinen Finland CAP
10744 isopropyl alcohol , isopropyl alcohol (covers other synonymous terms such as 2-propanol) / benzalkonium 03/12/1982 10 years 02/12/2029 02/03/2030 No 04/02/2026 Active substance name was amended on 04/02/2026
Entry name updated on 22/10/2025
Entry name updated on 30/07/2025
New entry introduced on 06/03/2019 PSUSA/00010744/202912 none NAP
10745 apalutamide 14/02/2018 3 years 13/02/2028 13/05/2028 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00010745/202802 Tiphaine Vaillant France CAP
10746 macimorelin 11/01/2019 5 years 10/01/2030 10/04/2030 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00010746/203001 Liana Martirosyan Netherlands CAP NAP
10747 calcium dobesilate / lidocaine, 'calcium dobesilate / dexamethasone / lidocaine 30/12/1975 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010747/203503 NAP
10748 octenidine 18/07/2018 10 years 17/07/2035 15/10/2035 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00010748/203507 Petar Mas Croatia NAP
10749 argipressin 01/04/1979 3 years 31/03/2027 29/06/2027 Yes 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010749/202703 Terhi Lehtinen Finland NAP
10750 magnesium / pyridoxine 24/07/1991 13 years 23/07/2026 21/10/2026 No 18/11/2025 New entry introduced on 06/03/2019 PSUSA/00010750/202607 Guðrún Stefánsdóttir Iceland NAP
10753 naldemedine 23/03/2017 2 years 22/03/2026 20/06/2026 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010753/202603 Eamon O Murchu Ireland CAP
10754 amidotrizoic acid and combination 05/03/1956 11 years 01/12/2036 01/03/2037 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010754/203612 Karin Erneholm Denmark NAP
10755 lusutrombopag 28/09/2015 3 years 27/09/2026 26/12/2026 No 02/06/2026 PSUSA/00010755/202609 Mari Thorn Sweden CAP
10756 ropeginterferon alfa-2b 15/02/2019 3 years 14/02/2026 15/05/2026 No 18/10/2023 PSUR frequency amended and DLP updated on 18/10/2023 PSUSA/00010756/202602 Carla Torre Portugal CAP
10757 dacomitinib 27/09/2018 3 years 26/09/2027 25/12/2027 No 03/05/2023 PSUR frequency amended and DLP updated on 03/05/2023
DLP was updated on 25/05/2022
DLP was updated on 17/11/2021
PSUR frequency and DLP were updated on 26/05/2021
DLP was updated on 18/11/2020
DLP was updated on 06/05/2020
New CAP authorised on 02/04/2019 PSUSA/00010757/202709 Bianca Mulder Netherlands CAP
10758 fremanezumab 14/09/2018 3 years 13/09/2026 12/12/2026 No 30/04/2024 PSUR frequency amended and DLP updated on 30/04/2024 PSUSA/00010758/202609 Terhi Lehtinen Finland CAP
10759 infliximab 16/11/2000 3 years 23/08/2028 21/11/2028 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010759/202808 Karin Bolin Sweden CAP
10760 lorlatinib 21/09/2018 1 year 20/09/2026 29/11/2026 20/09/2027 29/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010760/202609 PSUSA/00010760/202709 Barbara Kovacic Bytyqi Croatia CAP
10761 pegvaliase 24/05/2018 3 years 23/05/2028 21/08/2028 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010761/202805 Rhea Fitzgerald Ireland CAP
10762 volanesorsen 03/05/2019 6 months 02/05/2026 11/07/2026 02/11/2026 11/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010762/202605 PSUSA/00010762/202611 Dennis Lex Germany CAP
10763 zanamivir (centrally authorised products only) 09/02/1999 3 years 31/01/2027 01/05/2027 No 02/06/2026 PSUSA/00010763/202701 Karin Bolin Sweden CAP
10764 andexanet alfa 26/04/2019 6 months 25/04/2026 04/07/2026 25/10/2026 03/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010764/202604 PSUSA/00010764/202610 Bianca Mulder Netherlands CAP
10765 risankizumab 26/03/2019 5 years 25/03/2030 23/06/2030 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00010765/203003 Liana Martirosyan Netherlands CAP
10767 levofloxacin (intravenous and oral use) 01/10/1993 3 years 01/10/2026 30/12/2026 No 05/06/2024 PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00010767/202610 Dennis Lex Germany NAP
10768 levofloxacin (ocular use) 01/10/1993 5 years 01/10/2028 30/12/2028 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00010768/202810 Dennis Lex Germany NAP
10771 anthrax vaccine 06/01/1994 3 years 31/12/2027 30/03/2028 No 06/10/2025 DLP was amended on 24/09/2025 PSUSA/00010771/202712 Dirk Mentzer Germany NAP
10772 metergoline 15/01/1990 5 years 31/08/2028 29/11/2028 No 03/07/2019 Lead MS and PRAC reperesentative were updated on 21/12/2022
New entry added on 03/07/2019 PSUSA/00010772/202808 Amelia Cupelli Italy NAP
10774 amlodipine / ramipril, amlodipine / hydrochlorothiazide / ramipril, hydrochlorothiazide / ramipril 31/03/2012 3 years 31/03/2027 29/06/2027 No 22/10/2025 Active substance name was amended on 22/10/2025
DLP was amended on 18/12/2024 PSUSA/00010774/202703 Jan Neuhauser Austria NAP
10775 ursodeoxycholic acid, tauroursodeoxycholic acid 27/11/1979 10 years 30/11/2026 28/02/2027 No 08/04/2026 Entry name updated on 03/07/2019 PSUSA/00010775/202611 Benjamin Micallef Malta NAP
10776 pramocaine, hydrocortisone / pramocaine 12/12/1965 11 years 02/12/2039 01/03/2040 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010776/203912 NAP
10777 treosulfan (for centrally authorised product) 20/06/2019 3 years 19/06/2026 17/09/2026 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00010777/202606 Julia Pallos Hungary CAP
10779 avatrombopag 21/05/2018 3 years 20/05/2027 18/08/2027 No 19/09/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010779/202705 Maria Martinez Gonzalez Spain CAP
10780 cemiplimab 28/09/2018 2 years 27/09/2026 26/12/2026 No 03/05/2023 PSUR frequency amended and DLP updated on 03/05/2023
PSUR frequency corrected on 21/12/2022
DLP was updated on 25/05/2022
PSUR frequency corrected on 30/03/2022
DLP was updated on 17/11/2021
PSUR frequency and DLP were updated on 26/05/2021
DLP was updated on 18/11/2020
DLP was updated on 06/05/2020
New CAP authorised on 28/06/2019 PSUSA/00010780/202609 Bianca Mulder Netherlands CAP
10781 talazoparib 16/10/2018 3 years 15/10/2027 13/01/2028 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00010781/202710 Carla Torre Portugal CAP
10782 turoctocog alfa pegol 20/06/2019 3 years 19/06/2027 17/09/2027 No 06/10/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010782/202706 Dirk Mentzer Germany CAP
10783 adalimumab 08/09/2003 3 years 31/12/2025 31/03/2026 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00010783/202512 Karin Bolin Sweden CAP
10784 ertugliflozin / metformin, ertugliflozin / sitagliptin, ertugliflozin 19/12/2017 2 years 18/12/2025 18/03/2026 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010784/202512 Bianca Mulder Netherlands CAP
10785 angiotensin II 21/12/2017 2 years 20/12/2025 20/03/2026 No 31/07/2024 PSUR frequency amended and DLP updated on 31/07/2024 PSUSA/00010785/202512 Bianca Mulder Netherlands CAP
10786 l-lysine hydrochloride / l-arginine hydrochloride 25/07/2019 3 years 24/07/2026 22/10/2026 Yes 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 PSUSA/00010786/202607 Adam Przybylkowski Poland CAP
10787 ravulizumab 01/01/2019 3 years 31/12/2027 30/03/2028 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00010787/202712 Kimmo Jaakkola Finland CAP
10788 technetium (99mtc) N,N'-ethylene-(L,L)-dicysteine 28/09/2010 15 years 27/09/2033 26/12/2033 Yes 25/09/2019 New entry added on 25/09/2019 PSUSA/00010788/203309 NAP
10789 technetium (99mtc) 3,3-diphosphono-1,2-propanedicarboxylic acid 31/01/1995 15 years 30/01/2032 29/04/2032 Yes 25/09/2019 New entry added on 25/09/2019 PSUSA/00010789/203201 NAP
10790 aniracetam 20/08/1993 10 years 19/08/2031 17/11/2031 No 12/09/2025 PSUR frequency and DLP were updated on 28/04/2022
PRAC representative and LMS were added on 03/02/2021
New entry added on 25/09/2019 PSUSA/00010790/203108 Veronika Macurová Czech Republic NAP
10791 bovine lung phospholipid 22/12/1989 5 years 30/06/2026 28/09/2026 Yes 28/10/2025 PSUR frequency and DLP were updated on 02/03/2022
PRAC representative and LMS were added on 18/11/2020
New entry added on 25/09/2019 PSUSA/00010791/202606 Kimmo Jaakkola Finland NAP
10792 cod-liver oil (oral and parental use) Not available* 15 years 01/01/2034 01/04/2034 Yes 25/09/2019 New entry added on 25/09/2019 PSUSA/00010792/203401 NAP
10793 cod-liver oil (topical use), cod-liver oil/zinc oxide Not available* 15 years 01/01/2034 01/04/2034 Yes 25/09/2019 New entry added on 25/09/2019 PSUSA/00010793/203401 NAP
10794 ispaghula husk, ispaghula husk / ispaghula seed, ispaghula husk / ispaghula seed / senna Tinnervelly pod, psyllium, psyllium husk, psyllium seed 13/09/1954 10 years 12/09/2034 11/12/2034 No 27/05/2026 Entry re-activated on 27/05/2026
Active substance name was updated on 21/10/2020
New entry added on 25/09/2019 PSUSA/00010794/203409 none NAP
10795 etanercept 03/02/2000 5 years 02/02/2028 02/05/2028 No 19/09/2025 New CAP authorised on 23/04/2026
PSUR frequency amended and DLP updated on 18/10/2023 PSUSA/00010795/202802 Maria Martinez Gonzalez Spain CAP
10796 botulinum toxin type A (for centrally authorised products only) 01/02/2019 3 years 31/01/2027 01/05/2027 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00010796/202701 Adam Przybylkowski Poland CAP
10798 cannabidiol (for centrally authorised products only) 25/06/2018 3 years 24/06/2027 22/09/2027 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010798/202706 Ana Sofia Diniz Martins Portugal CAP
10799 larotrectinib 26/11/2018 6 months 25/05/2026 03/08/2026 25/11/2026 03/02/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010799/202605 PSUSA/00010799/202611 Rugile Pilviniene Lithuania CAP
10800 ethanol extracts of: Iberis amara L., planta tota recens / Angelica archangelica L., radix / Matricaria recutita L., flos / Carum carvi L., fructus / Silybum marianum (L.) Gaertn., fructus / Melissa officinalis L., folium / Mentha piperita L., folium / Chelidonium majus L., herba / Glycyrrhiza glabra L., radix 23/01/1968 3 years 30/11/2026 28/02/2027 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00010800/202611 Dennis Lex Germany NAP
10801 poliovirus type 1 / poliovirus type 2 / poliovirus type 3 vaccine (oral, live, attenuated), poliovirus type 1 / poliovirus type 3 vaccine (oral, live, attenuated),poliovirus type 1 (oral, live, attenuated) vaccine, poliovirus type 2 (oral, live, attenuated) vaccine,poliovirus type 3 (oral, live, attenuated) vaccine 01/01/1964 3 years 26/07/2028 24/10/2028 Yes 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00010801/202807 Jean-Michel Dogné Belgium NAP
10802 highly refined fish oil / glycerol / purified egg phosphatide 30/03/1998 5 years 29/03/2029 27/06/2029 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010802/202903 Polona Golmajer Slovenia NAP
10803 copper chloride dihydrate / manganese chloride tetrahydrate / potassium iodide / sodium fluoride / sodium selenite anhydrous / zinc chloride 05/02/1993 8 years 03/08/2033 01/11/2033 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00010803/203308 Rugile Pilviniene Lithuania NAP
10805 docusate, docusate/sorbitol 01/01/1976 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010805/203503 Zoubida Amimour France NAP
10806 rubidium (82Rb) chloride 22/11/2016 3 years 31/10/2026 29/01/2027 No 05/06/2024 PSUR frequency amended and DLP updated on 05/06/2024 PSUSA/00010806/202610 Dennis Lex Germany NAP
10807 thiamine / riboflavin/ pyridoxine / ascorbic acid / nicotinamide / glucose, thiamine / riboflavin / pyridoxine / ascorbic acid / nicotinamide, ascorbic acid / biotin / cyanocobalamin / folic acid / nicotinamide / pantothenic acid / pyridoxine hydrochloride / riboflavin / thiamine, riboflavin / thiamine / calcium folinate / cyanocobalamin / nicotinamide, calcium pantothenate / nicotinamide / pyridoxine / riboflavin / thiamine, dexpanthenol / nicotinamide / pyridoxine / riboflavin / thiamine, biotin / calcium pantothenate / cyanocobalamin / nicotinamide / pyridoxine / riboflavin / thiamine 27/09/1968 10 years 27/09/2027 26/12/2027 No 30/07/2025 Active substance name was amended on 30/07/2025
Active substance amended on 28/04/2022
Entry name was amended on 03/06/2020
EURD ID corrected on 05/02/2020
New entry following merge on 20/11/2019 PSUSA/00010807/202709 none NAP
10808 erythromycin (systemic use) 11/03/1954 3 years 11/03/2028 09/06/2028 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010808/202803 Eamon O'Murchu Ireland NAP
10809 erythromycin (topical use) 11/03/1954 5 years 11/03/2029 09/06/2029 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010809/202903 Eamon O'Murchu Ireland NAP
10810 lavender oil 26/06/2009 5 years 27/04/2028 26/07/2028 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00010810/202804 Guðrún Stefánsdóttir Iceland NAP
10811 valine / histidine / isoleucine / leucine / lysine / methionine / phenylalanine / threonine / tyrosine / tryptophan 19/04/1991 10 years 01/08/2028 30/10/2028 No 05/02/2020 New entry added on 05/02/2020 PSUSA/00010811/202808 NAP
10812 sodium thiosulfate (except centrally authorised products) 11/11/2003 10 years 30/09/2027 29/12/2027 No 28/06/2023 Active substance name was amended on 28/06/2023
New entry added on 05/02/2020 PSUSA/00010812/202709 none NAP
10813 inactivated leptospire vaccine 04/04/1979 5 years 30/11/2027 28/02/2028 No 19/09/2024 PSUSA/00010813/202711 Zoubida Amimour France NAP
10814 aviptadil / phentolamine mesilate 10/07/1998 5 years 28/02/2027 29/05/2027 No 16/11/2022 DLP was updated on 16/11/2022
PRAC Rapporteur name was amended on 28/04/2022
LMS and PRAC representative were added on 28/07/2021
New entry added on 05/02/2020 PSUSA/00010814/202702 Marie Louise Schougaard Christiansen Denmark NAP
10815 allergen for therapy: betula verrucosa (sublingual use) 02/07/2019 3 years 02/07/2026 30/09/2026 No 28/02/2024 PSUR frequency amended and DLP updated on 28/02/2024 PSUSA/00010815/202607 Terhi Lehtinen Finland NAP
10816 lactic acid/oxalic acid / nitric acid / cupric nitrate/ acetic acid 27/09/1985 10 years 26/09/2029 25/12/2029 No 05/02/2020 New entry added on 05/02/2020 PSUSA/00010816/202909 NAP
10817 polatuzumab vedotin 10/06/2019 1 year 09/06/2026 18/08/2026 09/06/2027 18/08/2027 No 02/06/2026 PSUSA/00010817/202606 PSUSA/00010817/202706 Jenny-Maria Jönsson Sweden CAP
10818 siponimod 26/03/2019 3 years 25/03/2027 23/06/2027 No 20/11/2024 PSUR frequency amended and DLP updated on 20/11/2024 PSUSA/00010818/202703 Maria del Pilar Rayon Spain CAP
10819 fostamatinib 17/04/2018 3 years 16/04/2028 15/07/2028 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00010819/202804 Bianca Mulder Netherlands CAP
10820 osilodrostat 09/01/2020 3 years 08/01/2027 08/04/2027 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00010820/202701 Maria del Pilar Rayon Spain CAP
10822 delafloxacin 19/06/2017 2 years 18/06/2026 16/09/2026 No 05/02/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUSA/00010822/202606 Petar Mas Croatia CAP
10823 upadacitinib 16/08/2019 3 years 15/08/2028 13/11/2028 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00010823/202808 Petar Mas Croatia CAP
10824 romosozumab 08/01/2019 1 year 07/01/2026 18/03/2026 07/01/2027 18/03/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010824/202601 PSUSA/00010824/202701 Tiphaine Vaillant France CAP
10825 esketamine (for centrally authorised product only) 05/03/2019 3 years 04/03/2027 02/06/2027 No 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00010825/202703 Terhi Lehtinen Finland CAP
10826 glucagon (for centrally authorised product only) 24/07/2019 1 year 24/07/2026 02/10/2026 24/07/2027 02/10/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010826/202607 PSUSA/00010826/202707 Rhea Fitzgerald Ireland CAP
10827 levonorgestrel (for emergency contraception only) 09/05/1990 5 years 08/05/2030 06/08/2030 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010827/203005 Dennis Lex Germany NAP
10828 levonorgestrel (all indications except emergency contraception) 09/05/1990 3 years 08/05/2026 06/08/2026 No 31/01/2024 PSUR frequency amended and DLP updated on 31/01/2024 PSUSA/00010828/202605 Dennis Lex Germany NAP
10829 brolucizumab 07/10/2019 1 year 06/10/2026 15/12/2026 06/10/2027 15/12/2027 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00010829/202610 PSUSA/00010829/202710 Dirk Mentzer Germany CAP
10830 imipenem / cilastatin / relebactam 16/07/2019 3 years 15/07/2027 13/10/2027 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00010830/202707 Adam Przybylkowski Poland CAP
10831 solriamfetol 20/03/2019 3 years 19/03/2028 17/06/2028 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00010831/202803 Julia Pallos Hungary CAP NAP
10832 gilteritinib 21/09/2018 3 years 20/09/2027 19/12/2027 No 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00010832/202709 Dennis Lex Germany CAP
10833 enoxaparin 15/09/2016 3 years 03/04/2027 02/07/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010833/202704 Bianca Mulder Netherlands CAP NAP
10834 recombinant vesicular stomatitis virus - zaire ebolavirus vaccine (live) 11/11/2019 3 years 10/05/2028 08/08/2028 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00010834/202805 Liana Martirosyan Netherlands CAP
10835 allergen products for treatment: grass pollen, tree pollen, house dust mites, moulds, weed pollen, vertebrates, animal epithelia (except for hymenoptera venoms) single or mixes (subcutaneous use) 29/06/1984 8 years 31/07/2027 29/10/2027 No 01/04/2020 New entry added on 01/04/2020 PSUSA/00010835/202707 NAP
10836 human serum albumin (medical dilution) 25/11/1980 15 years 02/07/2035 30/09/2035 No 01/04/2020 New entry due to split on 01/04/2020 PSUSA/00010836/203507 NAP
10837 calcium carbonate/
magnesium carbonate/
simeticone 28/01/1988 10 years 01/01/2029 01/04/2029 No 01/04/2020 New entry added on 01/04/2020 PSUSA/00010837/202901 NAP
10839 givosiran 20/11/2019 1 year 19/05/2026 28/07/2026 19/05/2027 28/07/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010839/202605 PSUSA/00010839/202705 Dennis Lex Germany CAP
10840 remdesivir (Veklury) 07/05/2020 3 years 06/05/2028 04/08/2028 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00010840/202805 Eva Jirsová Czech Republic CAP
10841 bempedoic acid, bempedoic acid / ezetimibe 21/02/2020 3 years 20/02/2028 20/05/2028 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00010841/202802 Kimmo Jaakkola Finland CAP
10843 darolutamide 30/07/2019 1 year 30/07/2026 08/10/2026 30/07/2027 08/10/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010843/202607 PSUSA/00010843/202707 Jan Neuhauser Austria CAP
10844 dronabinol/cannabidiol 15/04/2005 5 years 14/04/2028 13/07/2028 No 20/12/2023 PSUR frequency amended and DLP updated on 20/12/2023 PSUSA/00010844/202804 Liana Martirosyan Netherlands NAP
10847 lidocaine hydrochloride / neomycin sulfate / polymyxin b, lidocaine hydrochloride monohydrate / fludrocortisone acetate / neomycin sulfate / polymyxin b Not available* 8 years 03/11/2026 01/02/2027 No 27/02/2026 PSUR frequency and DLP amended on 23/10/2024 PSUSA/00010847/202611 Tiphaine Vaillant France NAP
10848 onasemnogene abeparvovec 24/05/2019 1 year 23/05/2026 01/08/2026 23/05/2027 01/08/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010848/202605 PSUSA/00010848/202705 Karin Bolin Sweden CAP
10849 cefiderocol 14/11/2019 3 years 13/11/2027 11/02/2028 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010849/202711 Dennis Lex Germany CAP
10850 indacaterol / mometasone furoate 30/05/2020 1 year 29/05/2026 07/08/2026 29/05/2027 07/08/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010850/202605 PSUSA/00010850/202705 Jan Neuhauser Austria CAP
10851 isatuximab 02/03/2020 2 years 01/03/2027 30/05/2027 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010851/202703 Maria Martinez Gonzalez Spain CAP
10852 ozanimod 20/05/2020 3 years 19/05/2028 17/08/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010852/202805 Maria del Pilar Rayon Spain CAP
10853 drospirenone 12/11/2019 3 years 12/11/2027 10/02/2028 No 02/06/2026 PSUSA/00010853/202711 Jenny Jönsson Sweden NAP
10854 dexamethasone / netilmicin 08/04/2006 5 years 08/04/2026 07/07/2026 No 22/12/2021 DLP was updated on 22/12/2021
PRAC representative and LMS were added on 23/09/2020
New entry added on 29/07/2020 PSUSA/00010854/202604 Dennis Lex Germany NAP
10855 hydrocortisone (systemic formulations except for products indicated in adrenal insufficiency in a modified release tablet formulation and except for centrally authorised products for adrenal insufficiency in paediatric use only) 05/08/1952 5 years 31/08/2029 29/11/2029 No 25/06/2025 Active substance name was corrected on 25/06/2025
DLP was amended on 30/04/2025 PSUSA/00010855/202908 Barbara Kovacic Bytyqi Croatia NAP
10856 hydrocortisone (all formulations apart from systemic use) 05/08/1952 5 years 31/08/2029 29/11/2029 No 30/04/2025 DLP was amended on 30/04/2025 PSUSA/00010856/202908 Barbara Kovacic Bytyqi Croatia NAP
10857 ebola vaccine (Ad26.ZEBOV-GP [recombinant], MVA-BN-Filo [recombinant]) 27/09/2019 1 year 26/09/2026 05/12/2026 26/09/2027 05/12/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010857/202609 PSUSA/00010857/202709 Jean-Michel Dogné Belgium CAP
10859 glasdegib 21/11/2018 3 years 20/11/2027 18/02/2028 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010859/202711 Bianca Mulder Netherlands CAP
10860 luspatercept 25/06/2020 1 year 24/06/2026 02/09/2026 24/06/2027 02/09/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010860/202606 PSUSA/00010860/202706 Jo Robays Belgium CAP
10861 indacaterol / glycopyrronium / mometasone 03/07/2020 1 year 02/07/2026 10/09/2026 02/07/2027 10/09/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010861/202607 PSUSA/00010861/202707 Jan Neuhauser Austria CAP
10862 cholera vaccine, oral, live 10/06/2016 3 years 09/06/2028 07/09/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010862/202806 Jean-Michel Dogné Belgium CAP
10863 pretomanid 14/08/2019 1 year 13/08/2026 22/10/2026 13/08/2027 22/10/2027 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00010863/202608 PSUSA/00010863/202708 Liana Martirosyan Netherlands CAP
10864 iron sucrose (parenteral use) 06/12/1949 3 years 01/01/2027 01/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010864/202701 Zane Neikena Latvia NAP
10865 ferric carboxymaltose (parenteral use) 06/12/1949 3 years 01/01/2027 01/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010865/202701 Zane Neikena Latvia NAP
10866 ferric derisomaltose (parenteral use) 06/12/1949 3 years 01/01/2027 01/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010866/202701 Zane Neikena Latvia NAP
10867 sodium iron gluconate (parenteral use) 06/12/1949 3 years 01/01/2027 01/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010867/202701 Zane Neikena Latvia NAP
10868 ivacaftor / tezacaftor / elexacaftor 21/10/2019 1 year 20/10/2026 29/12/2026 20/10/2027 29/12/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010868/202610 PSUSA/00010868/202710 Dennis Lex Germany CAP
10869 belantamab mafodotin 17/04/2025 6 months 16/04/2026 25/06/2026 16/10/2026 25/12/2026 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010869/202604 PSUSA/00010869/202610 Ulla Wändel Liminga Sweden CAP
10870 imlifidase 25/08/2020 6 months 25/02/2026 06/05/2026 25/08/2026 03/11/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00010870/202602 PSUSA/00010870/202608 Bianca Mulder Netherlands CAP
10871 alpelisib 24/05/2019 3 years 23/05/2028 21/08/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010871/202805 Bianca Mulder Netherlands CAP
10872 lefamulin 19/08/2019 3 years 18/08/2028 16/11/2028 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00010872/202808 Eva Jirsová Czech Republic CAP
10873 bulevirtide 31/07/2020 1 year 30/07/2026 08/10/2026 30/07/2027 08/10/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010873/202607 PSUSA/00010873/202707 Adam Przybylkowski Poland CAP
10874 entrectinib 18/06/2019 6 months 17/12/2025 25/02/2026 17/06/2026 26/08/2026 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010874/202512 PSUSA/00010874/202606 Bianca Mulder Netherlands CAP
10875 sodium oleate 06/09/1956 13 years 01/01/2033 01/04/2033 No 21/10/2020 New entry added on 21/10/2020 PSUSA/00010875/203301 NAP
10876 amlodipine/irbesartan 14/06/2020 5 years 14/06/2030 12/09/2030 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010876/203006 Maia Uusküla Estonia NAP
10877 leuprorelin (depot formulations) 31/07/1984 2 years 31/07/2027 29/10/2027 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00010877/202707 Amelia Cupelli Italy CAP NAP
10878 avapritinib 09/01/2020 6 months 08/01/2026 19/03/2026 08/07/2026 16/09/2026 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010878/202601 PSUSA/00010878/202607 Bianca Mulder Netherlands CAP
10879 filgotinib 24/09/2020 1 year 23/09/2026 02/12/2026 23/09/2027 02/12/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010879/202609 PSUSA/00010879/202709 Petar Mas Croatia CAP
10881 levofloxacin/dexamethasone (ocular use) 13/06/2020 3 years 12/06/2028 10/09/2028 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010881/202806 Amelia Cupelli Italy NAP
10882 amikacin (centrally authorised product only) 28/09/2018 1 year 27/09/2026 06/12/2026 27/09/2027 06/12/2027 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00010882/202609 PSUSA/00010882/202709 Jean-Michel Dogné Belgium CAP
10883 carvedilol / ivabradine 25/04/2005 3 years 25/04/2028 24/07/2028 No 31/01/2024 PRAC representative updated on 31/01/2024 PSUSA/00010883/202804 Bianca Mulder Netherlands NAP
10884 lumasiran 19/11/2020 2 years 18/11/2026 16/02/2027 No 02/06/2026 PSUSA/00010884/202611 Karin Bolin Sweden CAP
10886 quadrivalent influenza vaccine (recombinant, prepared in cell culture) 16/01/2013 1 year 15/01/2026 26/03/2026 15/01/2027 26/03/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010886/202601 PSUSA/00010886/202701 Zoubida Amimour France CAP
10887 acalabrutinib 31/10/2017 1 year 30/10/2026 08/01/2027 30/10/2027 08/01/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010887/202610 PSUSA/00010887/202710 Barbara Kovacic Bytyqi Croatia CAP
10889 bupivacaine (liposomal formulations) 28/10/2011 1 year 27/10/2026 05/01/2027 27/10/2027 05/01/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010889/202610 PSUSA/00010889/202710 Eamon O Murchu Ireland CAP
10890 serenoa repens 26/06/1981 5 years 26/06/2026 24/09/2026 No 28/10/2025 New entry added on 03/02/2021 PSUSA/00010890/202606 Gudrun Stefansdottir Iceland NAP
10891 methacholine 31/10/1986 5 years 31/10/2028 29/01/2029 No 12/09/2025 DLP was amended on 03/07/2024 PSUSA/00010891/202810 Veronika Macurová Czech Republic NAP
10892 ascorbic acid / acid folic / alfa-tocopherol / biotin / cholecalciferol / cyanocobalamin / nicotinamide / pantothenic acid / pyridoxine hydrochloride / retinol / riboflavin / thiamine 22/01/2001 8 years 22/01/2029 22/04/2029 No 28/04/2022 Active substance and DLP amended on 28/04/2022
New entry added on 03/02/2021 PSUSA/00010892/202901 NAP
10893 acetylsalicylic acid/rosuvastatin 26/06/2020 5 years 26/06/2028 24/09/2028 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00010893/202806 Polona Golmajer Slovenia NAP
10894 trastuzumab deruxtecan 20/12/2019 6 months 19/12/2025 27/02/2026 19/06/2026 28/08/2026 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010894/202512 PSUSA/00010894/202606 Carla Torre Portugal CAP
10895 baloxavir marboxil 23/02/2018 3 years 22/02/2028 22/05/2028 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00010895/202802 Sonja Radowan Austria CAP
10896 tagraxofusp 21/12/2018 2 years 20/12/2025 20/03/2026 No 28/08/2024 PSUR frequency amended and DLP updated on 28/08/2024
DLP was amended on 31/07/2024 PSUSA/00010896/202512 Bianca Mulder Netherlands CAP
10897 COVID-19 mRNA vaccine (Spikevax) 18/12/2020 2 years 17/12/2026 17/03/2027 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00010897/202612 Marie Louise Schougaard Christiansen Denmark CAP
10898 COVID-19 mRNA vaccine (Comirnaty) 19/12/2020 2 years 18/12/2026 18/03/2027 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00010898/202612 Liana Martirosyan Netherlands CAP
10899 atidarsagene autotemcel 17/12/2020 3 years 16/12/2027 15/03/2028 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025
DLP was amended on 30/07/2025 PSUSA/00010899/202712 Dirk Mentzer Germany CAP
10900 cabotegravir (for treatment of human immunodeficiency virus type 1 (HIV-1) 18/03/2020 1 year 17/03/2026 26/05/2026 17/03/2027 26/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010900/202603 PSUSA/00010900/202703 Dennis Lex Germany CAP
10901 rilpivirine (for intramuscular use) 18/03/2020 1 year 17/03/2026 26/05/2026 17/03/2027 26/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010901/202603 PSUSA/00010901/202703 Liana Martirosyan Netherlands CAP
10902 defatted powder of Arachis hypogaea L., semen (peanuts) 31/01/2020 3 years 30/01/2028 29/04/2028 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00010902/202801 Terhi Lehtinen Finland CAP
10903 brexucabtagene autoleucel 24/07/2020 6 months 23/01/2026 03/04/2026 23/07/2026 01/10/2026 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010903/202601 PSUSA/00010903/202607 Bianca Mulder Netherlands CAP
10904 inclisiran 09/12/2020 1 year 31/12/2025 11/03/2026 31/12/2026 11/03/2027 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010904/202512 PSUSA/00010904/202612 Kimmo Jaakkola Finland CAP
10905 latanoprost / netarsudil 07/01/2021 3 years 17/06/2028 15/09/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010905/202806 Adam Przybylkowski Poland CAP
10906 pertuzumab / trastuzumab 29/06/2020 1 year 28/06/2026 06/09/2026 28/06/2027 06/09/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010906/202606 PSUSA/00010906/202706 Dirk Mentzer Germany CAP
10907 fenfluramine 25/06/2020 2 years 24/06/2027 22/09/2027 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010907/202706 Dennis Lex Germany CAP
10908 formoterol fumarate dihydrate / glycopyrronium bromide / budesonide 18/06/2019 1 year 17/06/2026 26/08/2026 17/06/2027 26/08/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010908/202606 PSUSA/00010908/202706 Jan Neuhauser Austria CAP
10909 fedratinib 16/08/2019 1 year 15/02/2026 26/04/2026 15/02/2027 26/04/2027 No 29/04/2026 PSUR frequency amended and DLP updated on 29/04/2026
DLP was amended on 01/04/2026 PSUSA/00010909/202602 PSUSA/00010909/202702 Sonja Radowan Austria CAP
10911 fostemsavir 04/02/2021 3 years 03/02/2027 04/05/2027 No 25/09/2024 PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00010911/202702 Liana Martirosyan Netherlands CAP
10913 oxytocin (systemic use) 02/06/1955 3 years 30/06/2026 28/09/2026 Yes 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00010913/202606 Karen Pernille Harg Norway NAP
10914 oxytocin (nasal spray) 02/06/1955 3 years 30/06/2026 28/09/2026 Yes 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00010914/202606 Karen Pernille Harg Norway NAP
10915 Rosuvastatin/ Omega-3-acid ethyl esters 15/01/2020 5 years 14/01/2030 14/04/2030 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010915/203001 Bianca Mulder Netherlands NAP
10917 selpercatinib 08/05/2020 6 months 08/05/2026 17/07/2026 08/11/2026 17/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010917/202605 PSUSA/00010917/202611 Bianca Mulder Netherlands CAP
10918 tucatinib 17/04/2020 1 year 16/04/2026 25/06/2026 16/04/2027 25/06/2027 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010918/202604 PSUSA/00010918/202704 Jean-Michel Dogné Belgium CAP
10919 hepatitis B surface antigen, CpG 1018 adjuvant 09/11/2017 3 years 08/11/2027 06/02/2028 No 06/10/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010919/202711 Dirk Mentzer Germany CAP
10920 somapacitan 28/08/2020 3 years 31/08/2027 29/11/2027 No 30/04/2025 PSUR frequency amended and DLP updated on 30/04/2025 PSUSA/00010920/202708 Dennis Lex Germany CAP
10921 cenobamate 21/11/2019 1 year 26/09/2026 05/12/2026 26/09/2027 05/12/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010921/202609 PSUSA/00010921/202709 Jo Robays Belgium CAP
10922 icosapent ethyl 26/07/2012 3 years 25/07/2027 23/10/2027 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00010922/202707 Bianca Mulder Netherlands CAP
10923 pemigatinib 17/04/2020 1 year 16/04/2026 25/06/2026 16/04/2027 25/06/2027 No 17/12/2025 DLP was amended on 17/12/2025
DLP was amended on 19/11/2025 PSUSA/00010923/202604 PSUSA/00010923/202704 Bianca Mulder Netherlands CAP
10924 remimazolam 23/01/2020 1 year 22/07/2026 30/09/2026 22/07/2027 30/09/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010924/202607 PSUSA/00010924/202707 Eamon O Murchu Ireland CAP
10925 risdiplam 07/08/2020 1 year 06/08/2026 15/10/2026 06/08/2027 15/10/2027 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00010925/202608 PSUSA/00010925/202708 Jan Neuhauser Austria CAP
10926 selinexor 26/03/2021 3 years 25/03/2028 23/06/2028 No 19/11/2025 PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00010926/202803 Bianca Mulder Netherlands CAP
10927 ofatumumab 26/03/2021 1 year 25/09/2026 04/12/2026 25/09/2027 04/12/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010927/202609 PSUSA/00010927/202709 Amelia Cupelli Italy CAP
10928 salmeterol / fluticasone propionate (for centrally authorised products) 27/01/2017 3 years 27/01/2028 26/04/2028 No 19/11/2025 Correction of DLP on 19/11/2025
PSUR frequency amended and DLP updated on 22/10/2025
DLP was amended on 24/09/2025 PSUSA/00010928/202801 Amelia Cupelli Italy CAP
10929 trifarotene 04/10/2019 3 years 03/10/2027 01/01/2028 No 29/06/2022 Next DLP was updated on 31/05/2023 PSUSA/00010929/202710 Karin Bolin Sweden NAP
10930 berotralstat 03/12/2020 3 years 02/12/2027 01/03/2028 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00010930/202712 Julia Pallos Hungary CAP
10931 dostarlimab 21/04/2021 1 year 20/04/2026 29/06/2026 20/04/2027 29/06/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010931/202604 PSUSA/00010931/202704 Carla Torre Portugal CAP
10932 potassium citrate / potassium hydrogen carbonate 30/04/2021 3 years 29/04/2028 28/07/2028 No 17/12/2025 PSUR frequency amended and DLP updated on 17/12/2025 PSUSA/00010932/202804 Adam Przybylkowski Poland CAP
10933 lidocaine (topical use) 01/10/1948 8 years 30/09/2028 29/12/2028 No 30/06/2021 New active substance added on 30/06/2021 following split of previous entry PSUSA/00010933/202809 NAP
10934 lidocaine (systemic use) 01/10/1948 8 years 30/09/2028 29/12/2028 No 30/06/2021 New active substance added on 30/06/2021 following split of previous entry PSUSA/00010934/202809 NAP
10936 selumetinib 10/04/2020 6 months 09/04/2026 18/06/2026 09/10/2026 18/12/2026 No 02/06/2026 PSUSA/00010936/202604 PSUSA/00010936/202610 Karin Bolin Sweden CAP
10937 tralokinumab 17/06/2021 1 year 16/12/2025 24/02/2026 16/12/2026 24/02/2027 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010937/202512 PSUSA/00010937/202612 Kimmo Jaakkola Finland CAP NAP
10938 drospirenone / estetrol 19/05/2021 1 year 19/05/2026 28/07/2026 19/05/2027 28/07/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010938/202605 PSUSA/00010938/202705 Dennis Lex Germany CAP
10940 ponesimod 18/03/2021 2 years 17/03/2027 15/06/2027 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00010940/202703 Karin Erneholm Denmark CAP
10941 setmelanotide 25/11/2020 1 year 24/11/2026 02/02/2027 24/11/2027 02/02/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010941/202611 PSUSA/00010941/202711 Miroslava Gocova Slovakia CAP
10942 relugolix / estradiol / norethisterone acetate 26/05/2021 3 years 25/05/2028 23/08/2028 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010942/202805 Dennis Lex Germany CAP
10943 tirbanibulin 14/12/2020 1 year 13/12/2025 21/02/2026 13/12/2026 21/02/2027 No 17/02/2026 DLP was amended on 30/07/2025 PSUSA/00010943/202512 PSUSA/00010943/202612 Jana Pecherova Slovakia CAP
10944 satralizumab (for centrally authorised products) 01/06/2020 1 year 31/05/2026 09/08/2026 31/05/2027 09/08/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010944/202605 PSUSA/00010944/202705 Jan Neuhauser Austria CAP
10945 evinacumab 11/02/2021 1 year 11/02/2026 22/04/2026 11/02/2027 22/04/2027 No 02/06/2026 DLP was amended on 24/09/2025 PSUSA/00010945/202602 PSUSA/00010945/202702 Karin Bolin Sweden CAP
10946 glycerol / urea 18/03/2021 13 years 17/03/2034 15/06/2034 No 28/07/2021 New entry added on 28/07/2021 PSUSA/00010946/203403 NAP
10947 telmisartan / indapamide 08/02/2021 5 years 07/02/2026 08/05/2026 No 20/06/2025 New entry added on 28/07/2021 PSUSA/00010947/202602 Carla Torre Portugal NAP
10949 odevixibat 16/07/2021 1 year 15/07/2026 23/09/2026 15/07/2027 23/09/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010949/202607 PSUSA/00010949/202707 Adam Przybylkowski Poland CAP NAP
10950 vericiguat 19/01/2021 1 year 18/01/2026 29/03/2026 18/01/2027 29/03/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010950/202601 PSUSA/00010950/202701 Kimmo Jaakkola Finland CAP
10951 tafasitamab 31/07/2020 6 months 30/01/2026 10/04/2026 30/07/2026 08/10/2026 No 02/06/2026 PSUSA/00010951/202601 PSUSA/00010951/202607 Jenny-Maria Jönsson Sweden CAP
10952 vosoritide 26/08/2021 1 year 25/08/2026 03/11/2026 25/08/2027 03/11/2027 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00010952/202608 PSUSA/00010952/202708 Zane Neikena Latvia CAP
10953 bimekizumab 20/08/2021 3 years 19/08/2027 17/11/2027 No 02/04/2025 PSUR frequency amended and DLP updated on 02/04/2025 PSUSA/00010953/202708 Liana Martirosyan Netherlands CAP
10954 idecabtagene vicleucel 26/03/2021 1 year 25/03/2026 03/06/2026 25/03/2027 03/06/2027 No 02/06/2026 PSUSA/00010954/202603 PSUSA/00010954/202703 Jenny-Maria Jönsson Sweden CAP
10955 roxadustat 17/12/2018 1 year 16/12/2025 24/02/2026 16/12/2026 24/02/2027 No 17/02/2026 DLP was amended on 30/07/2025 PSUSA/00010955/202512 PSUSA/00010955/202612 Jana Pecherova Slovakia CAP
10956 phentermine/ topiramate 17/07/2012 3 years 17/07/2027 15/10/2027 No 05/03/2025 PSUR frequency amended and DLP updated on 05/03/2025 PSUSA/00010956/202707 Karin Bolin Sweden NAP
10957 mometasone furoate/olopatadine 26/04/2021 3 years 25/04/2026 24/07/2026 No 02/06/2026 PSUSA/00010957/202604 Karin Bolin Sweden NAP
10958 artesunate 23/06/2020 2 years 22/06/2027 20/09/2027 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026 PSUSA/00010958/202706 Dennis Lex Germany CAP
10959 sacituzumab govitecan 22/04/2020 3 years 21/04/2028 20/07/2028 No 18/12/2024 PSUR frequency amended and DLP updated on 18/12/2024
DLP was amended on 20/12/2023 PSUSA/00010959/202804 Bianca Mulder Netherlands CAP
10960 zanubrutinib 14/11/2019 1 year 13/11/2026 22/01/2027 13/11/2027 22/01/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010960/202611 PSUSA/00010960/202711 Bianca Mulder Netherlands CAP
10962 ripretinib 15/05/2020 1 year 14/05/2026 23/07/2026 14/05/2027 23/07/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010962/202605 PSUSA/00010962/202705 Barbara Kovacic Bytyqi Croatia CAP
10965 dexamethasone / tobramycin (systemic formulations) Not available* 5 years 31/03/2026 29/06/2026 No 19/10/2022 PRAC representative was updated on 19/10/2022
PRAC representative was updated on 27/07/2022
New entry due to splitting of entries on 22/12/2021 PSUSA/00010965/202603 Amelia Cupelli Italy NAP
10966 eptinezumab 21/02/2020 3 years 20/02/2028 20/05/2028 No 22/10/2025 PSUR frequency amended and DLP updated on 22/10/2025 PSUSA/00010966/202802 Liana Martirosyan Netherlands CAP
10967 avacopan 27/09/2021 1 year 26/09/2026 05/12/2026 26/09/2027 05/12/2027 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00010967/202609 PSUSA/00010967/202709 Liana Martirosyan Netherlands CAP
10968 glucarpidase 17/01/2012 3 years 16/07/2028 14/10/2028 No 01/04/2026 DLP was corrected on 01/04/2026
PSUR frequency amended and DLP updated on 04/03/2026 PSUSA/00010968/202807 Dennis Lex Germany CAP
10969 lonapegsomatropin 25/08/2021 3 years 25/08/2028 23/11/2028 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00010969/202808 Dennis Lex Germany CAP
10970 sotorasib 28/05/2021 6 months 27/05/2026 05/08/2026 27/11/2026 05/02/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010970/202605 PSUSA/00010970/202611 Marie Louise Schougaard Christiansen Denmark CAP
10971 tecovirimat 13/07/2018 1 year 12/01/2026 23/03/2026 12/01/2027 23/03/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010971/202601 PSUSA/00010971/202701 Dennis Lex Germany CAP
10972 COVID-19 Vaccine (recombinant, adjuvanted) (Nuvaxovid) 20/12/2021 1 year 19/12/2025 27/02/2026 19/12/2026 27/02/2027 No 01/07/2026 Active substance name was amended on 01/07/2026
DLP was amended on 30/07/2025 PSUSA/00010972/202512 PSUSA/00010972/202612 Dirk Mentzer Germany CAP
10974 pegcetacoplan 14/05/2021 1 year 13/11/2026 22/01/2027 13/11/2027 22/01/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00010974/202611 PSUSA/00010974/202711 Kimmo Jaakkola Finland CAP
10975 pneumococcal polysaccharide conjugate vaccine (15 valent, adsorbed) 16/07/2021 1 year 15/01/2026 26/03/2026 15/01/2027 26/03/2027 No 06/10/2025 DLP was amended on 24/09/2025 PSUSA/00010975/202601 PSUSA/00010975/202701 Dirk Mentzer Germany CAP
10976 abrocitinib 08/09/2021 1 year 07/09/2026 16/11/2026 07/09/2027 16/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00010976/202609 PSUSA/00010976/202709 Petar Mas Croatia CAP
10977 amivantamab 21/05/2021 1 year 20/05/2026 29/07/2026 20/05/2027 29/07/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010977/202605 PSUSA/00010977/202705 Dirk Mentzer Germany CAP
10978 finerenone 09/07/2021 1 year 08/07/2026 16/09/2026 08/07/2027 16/09/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010978/202607 PSUSA/00010978/202707 Bianca Mulder Netherlands CAP
10979 tepotinib 25/03/2020 1 year 24/03/2026 02/06/2026 24/03/2027 02/06/2027 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00010979/202603 PSUSA/00010979/202703 Bianca Mulder Netherlands CAP
10980 anifrolumab 30/07/2021 1 year 29/07/2026 07/10/2026 29/07/2027 07/10/2027 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00010980/202607 PSUSA/00010980/202707 Liana Martirosyan Netherlands CAP
10981 pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) 08/06/2021 1 year 07/12/2025 15/02/2026 07/06/2026 16/08/2026 No 04/02/2026 PRAC Rapporteur name was amended on 04/02/2026
DLP was amended on 30/07/2025 PSUSA/00010981/202512 PSUSA/00010981/202606 Jean-Michel Dogné Belgium CAP
10982 somatrogon 26/10/2021 3 years 26/10/2027 24/01/2028 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010982/202710 Liana Martirosyan Netherlands CAP
10983 voxelotor 14/02/2022 6 months 13/02/2026 24/04/2026 13/08/2026 22/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00010983/202602 PSUSA/00010983/202608 Jo Robays Belgium CAP
10984 nirmatrelvir / ritonavir 31/12/2021 1 year 30/12/2025 10/03/2026 30/12/2026 10/03/2027 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010984/202512 PSUSA/00010984/202612 Dennis Lex Germany CAP
10986 sodium citrate (extracorporeal use) 22/10/1990 8 years 31/01/2031 01/05/2031 Yes 18/10/2023 Next DLP was updated on 18/10/2023 PSUSA/00010986/203101 Polona Golmajer Slovenia NAP
10987 myristalkonium, benzalkonium (vaginal use only) 17/02/1986 13 years 01/01/2038 01/04/2038 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010987/203801 Lina Šeibokienė Lithuania NAP
10988 ascorbic acid / magnesium aspartate / leucine L / lysine L / phenylalanine L / valine L 09/11/2007 10 years 28/10/2034 26/01/2035 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00010988/203410 Guðrún Stefánsdóttir Iceland NAP
10989 enfortumab vedotin 18/12/2019 1 year 17/12/2025 25/02/2026 17/12/2026 25/02/2027 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00010989/202512 PSUSA/00010989/202612 Eva Jirsová Czech Republic CAP
10990 lisocabtagene maraleucel / lisocabtagene maraleucel 05/02/2021 1 year 04/02/2026 15/04/2026 04/02/2027 15/04/2027 No 06/10/2025 DLP was amended on 24/09/2025 PSUSA/00010990/202602 PSUSA/00010990/202702 Dirk Mentzer Germany CAP
10991 tebentafusp 25/01/2022 1 year 24/01/2026 04/04/2026 24/01/2027 04/04/2027 No 05/03/2025 Next DLP was updated on 05/03/2025
PSUR frequency amended and DLP updated on 25/09/2024 PSUSA/00010991/202601 PSUSA/00010991/202701 Bianca Mulder Netherlands CAP
10993 daridorexant 07/01/2022 1 year 06/01/2026 17/03/2026 06/01/2027 17/03/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010993/202601 PSUSA/00010993/202701 Ana Sofia Diniz Martins Portugal CAP
10994 relugolix 08/01/2019 1 year 07/01/2026 18/03/2026 07/01/2027 18/03/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00010994/202601 PSUSA/00010994/202701 Karin Erneholm Denmark CAP
10995 difelikefalin 23/08/2021 2 years 22/08/2027 20/11/2027 No 02/06/2026 PSUSA/00010995/202708 Karin Bolin Sweden CAP
10996 inebilizumab 11/06/2020 1 year 10/06/2026 19/08/2026 10/06/2027 19/08/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00010996/202606 PSUSA/00010996/202706 Amelia Cupelli Italy CAP
10997 rimegepant 27/02/2021 1 year 26/02/2026 07/05/2026 26/02/2027 07/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00010997/202602 PSUSA/00010997/202702 Karin Erneholm Denmark CAP
10998 linzagolix choline 14/06/2022 1 year 05/05/2026 14/07/2026 05/05/2027 14/07/2027 No 30/07/2025 DLP was corrected on 30/07/2025
PSUR frequency amended and DLP updated on 25/06/2025
DLP was amended on 18/12/2024 PSUSA/00010998/202605 PSUSA/00010998/202705 Dennis Lex Germany CAP
10999 mosunetuzumab 03/06/2022 6 months 02/12/2025 10/02/2026 02/06/2026 11/08/2026 No 02/06/2026 PSUSA/00010999/202512 PSUSA/00010999/202606 Jenny-Maria Jönsson Sweden CAP
11000 ciltacabtagene autoleucel 28/02/2022 1 year 27/02/2026 08/05/2026 27/02/2027 08/05/2027 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00011000/202602 PSUSA/00011000/202702 Jo Robays Belgium CAP
11002 avalglucosidase alfa 06/08/2021 3 years 06/08/2027 04/11/2027 No 02/04/2025 PSUR frequency amended and DLP updated on 02/04/2025 PSUSA/00011002/202708 Liana Martirosyan Netherlands CAP
11003 olipudase alfa 28/03/2022 1 year 28/03/2026 06/06/2026 28/03/2027 06/06/2027 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00011003/202603 PSUSA/00011003/202703 Dennis Lex Germany CAP
11004 eladocagene exuparvovec 18/07/2022 1 year 16/06/2026 25/08/2026 16/06/2027 25/08/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00011004/202606 PSUSA/00011004/202706 Dirk Mentzer Germany CAP
11005 lonafarnib 20/11/2020 1 year 19/11/2026 28/01/2027 19/11/2027 28/01/2028 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011005/202611 PSUSA/00011005/202711 Adam Przybylkowski Poland CAP
11006 eptacog beta (activated) 15/07/2022 2 years 14/07/2027 12/10/2027 No 29/04/2026 Correction of DLP on 29/04/2026
PSUR frequency amended and DLP updated on 04/03/2026 PSUSA/00011006/202707 Bianca Mulder Netherlands CAP
11007 budesonide (for centrally authorised products indicated for primary immunoglobulin A nephropathy only) 15/12/2021 1 year 14/12/2025 22/02/2026 14/12/2026 22/02/2027 No 30/07/2025 PSUR frequency amended and DLP updated on 30/07/2025 PSUSA/00011007/202512 PSUSA/00011007/202612 Marie Louise Schougaard Christiansen Denmark CAP
11008 asciminib 29/10/2021 1 year 28/04/2026 07/07/2026 28/04/2027 07/07/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00011008/202604 PSUSA/00011008/202704 Eva Jirsová Czech Republic CAP
11010 teclistamab 23/08/2022 6 months 22/02/2026 03/05/2026 22/08/2026 31/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011010/202602 PSUSA/00011010/202608 Veronika Macurova Czech Republic CAP
11011 lasmiditan 11/10/2019 1 year 11/10/2026 20/12/2026 11/10/2027 20/12/2027 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00011011/202610 PSUSA/00011011/202710 Jana Pecherova Slovakia CAP
11012 lenacapavir 17/08/2022 1 year 16/08/2026 25/10/2026 16/08/2027 25/10/2027 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011012/202608 PSUSA/00011012/202708 Ana Sofia Diniz Martins Portugal CAP
11013 melphalan, melphalan flufenamide 06/02/2022 3 years 06/02/2028 06/05/2028 No 01/07/2026 Active substance name was amended on 01/07/2026
Reference to CAP added on 27/05/2026
Reference to NAP added on 01/04/2026
Active substance name was amended on 01/04/2026
PSUR frequency amended and DLP updated on 24/09/2025 PSUSA/00011013/202802 Dennis Lex Germany CAP NAP
11014 efgartigimod alfa 17/12/2021 1 year 16/12/2025 24/02/2026 16/12/2026 24/02/2027 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00011014/202512 PSUSA/00011014/202612 Rhea Fitzgerald Ireland CAP
11015 tezepelumab 17/12/2021 1 year 16/12/2025 24/02/2026 16/12/2026 24/02/2027 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00011015/202512 PSUSA/00011015/202612 Eva Jirsová Czech Republic CAP
11016 faricimab 28/01/2022 1 year 27/01/2026 07/04/2026 27/01/2027 07/04/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00011016/202601 PSUSA/00011016/202701 Carla Torre Portugal CAP
11017 fosdenopterin 26/02/2021 1 year 25/02/2026 06/05/2026 25/02/2027 06/05/2027 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00011017/202602 PSUSA/00011017/202702 Dennis Lex Germany CAP
11018 nivolumab / relatlimab 18/03/2022 1 year 17/03/2026 26/05/2026 17/03/2027 26/05/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00011018/202603 PSUSA/00011018/202703 Dirk Mentzer Germany CAP
11019 tirzepatide 13/05/2022 1 year 13/05/2026 22/07/2026 13/05/2027 22/07/2027 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025
DLP was amended on 18/12/2024 PSUSA/00011019/202605 PSUSA/00011019/202705 Bianca Mulder Netherlands CAP
11020 voclosporin 22/01/2021 1 year 21/01/2026 01/04/2026 21/01/2027 01/04/2027 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025
DLP was amended on 05/03/2025 PSUSA/00011020/202601 PSUSA/00011020/202701 Adam Przybylkowski Poland CAP
11021 vutrisiran 13/06/2022 1 year 12/06/2026 21/08/2026 12/06/2027 21/08/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00011021/202606 PSUSA/00011021/202706 Liana Martirosyan Netherlands CAP
11022 capmatinib 06/05/2020 1 year 05/05/2026 14/07/2026 05/05/2027 14/07/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00011022/202605 PSUSA/00011022/202705 Carla Torre Portugal CAP
11023 sutimlimab 04/02/2022 1 year 04/02/2026 15/04/2026 04/02/2027 15/04/2027 No 24/09/2025 DLP was amended on 24/09/2025 PSUSA/00011023/202602 PSUSA/00011023/202702 Jan Neuhauser Austria CAP
11024 maribavir 23/11/2021 1 year 22/11/2026 31/01/2027 22/11/2027 31/01/2028 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00011024/202611 PSUSA/00011024/202711 Adam Przybylkowski Poland CAP
11025 mitapivat 17/02/2022 1 year 16/02/2026 27/04/2026 16/02/2027 27/04/2027 No 22/10/2025 DLP was amended on 22/10/2025 PSUSA/00011025/202602 PSUSA/00011025/202702 Adam Przybylkowski Poland CAP
11026 nirsevimab 31/10/2022 1 year 30/04/2026 09/07/2026 30/04/2027 09/07/2027 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025
DLP was amended on 18/12/2024 PSUSA/00011026/202604 PSUSA/00011026/202704 Kimmo Jaakkola Finland CAP
11027 loncastuximab tesirine 23/04/2021 6 months 22/04/2026 01/07/2026 22/10/2026 31/12/2026 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011027/202604 PSUSA/00011027/202610 Eva Jirsová Czech Republic CAP
11028 tabelecleucel 16/12/2022 1 year 15/12/2025 23/02/2026 15/12/2026 23/02/2027 No 30/07/2025 DLP was amended on 30/07/2025 PSUSA/00011028/202512 PSUSA/00011028/202612 Amelia Cupelli Italy CAP
11029 abaloparatide 28/04/2017 1 year 27/04/2026 06/07/2026 27/04/2027 06/07/2027 No 01/04/2026 Correction of PSUR frequency on 01/04/2026
Correction of DLP on 04/02/2026
DLP was amended on 25/06/2025 PSUSA/00011029/202604 PSUSA/00011029/202704 Karin Erneholm Denmark CAP
11030 gozetotide 23/03/2022 1 year 22/03/2026 31/05/2026 22/03/2027 31/05/2027 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00011030/202603 PSUSA/00011030/202703 John Joseph Borg Malta CAP NAP
11031 lutetium (177LU) vipivotide tetraxetan 23/03/2022 1 year 22/03/2026 31/05/2026 22/03/2027 31/05/2027 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00011031/202603 PSUSA/00011031/202703 John Joseph Borg Malta CAP
11032 maralixibat 29/09/2021 6 months 28/03/2026 06/06/2026 28/09/2026 07/12/2026 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00011032/202603 PSUSA/00011032/202609 Adam Przybylkowski Poland CAP
11033 spesolimab 01/09/2022 6 months 01/03/2026 10/05/2026 01/09/2026 10/11/2026 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011033/202603 PSUSA/00011033/202609 Zoubida Amimour France CAP
11034 dengue tetravalent vaccine (live, attenuated) 19/08/2022 1 year 18/08/2026 27/10/2026 18/08/2027 27/10/2027 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011034/202608 PSUSA/00011034/202708 Liana Martirosyan Netherlands CAP
11036 octreotide (for centrally authorised products) 30/06/2025 6 months 01/12/2025 09/02/2026 01/06/2026 10/08/2026 No 24/09/2025 Correction of DLP on 24/09/2025
New CAP authorised on 30/06/2025 PSUSA/00011036/202512 PSUSA/00011036/202606 Eamon O Murchu Ireland CAP
11037 etranacogene dezaparvovec 22/11/2022 6 months 21/05/2026 30/07/2026 21/11/2026 30/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011037/202605 PSUSA/00011037/202611 Bianca Mulder Netherlands CAP
11038 tremelimumab 21/10/2022 1 year 30/04/2026 09/07/2026 30/04/2027 09/07/2027 No 28/05/2025 PSUR frequency amended and DLP updated on 28/05/2025
DLP was amended on 18/12/2024 PSUSA/00011038/202604 PSUSA/00011038/202704 David Olsen Norway CAP
11039 donepezil / memantine 27/07/2020 5 years 26/07/2028 24/10/2028 No 12/09/2025 DLP was amended on 27/03/2024 PSUSA/00011039/202807 Veronika Macurová Czech Republic NAP
11041 ramipril / bisoprolol 11/05/2022 7 years 22/10/2032 20/01/2033 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
New entry added on 03/05/2023 PSUSA/00011041/203210 Jana Pecherova Slovakia NAP
11042 meldonium 14/04/2003 8 years 13/04/2031 12/07/2031 Yes 03/05/2023 New entry added on 03/05/2023 PSUSA/00011042/203104 none NAP
11043 nifedipine / lidocaine 01/02/2004 10 years 03/03/2035 01/06/2035 Yes 03/05/2023 New entry added on 03/05/2023 PSUSA/00011043/203503 none NAP
11044 ipidacrine 12/05/2008 8 years 11/05/2031 09/08/2031 Yes 03/05/2023 New entry added on 03/05/2023 PSUSA/00011044/203105 none NAP
11045 COVID-19 Vaccine (recombinant, adjuvanted) (Bimervax) 30/03/2023 1 year 29/03/2026 07/06/2026 29/03/2027 07/06/2027 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00011045/202603 PSUSA/00011045/202703 Zane Neikena Latvia CAP
11046 deucravacitinib 09/09/2022 1 year 08/09/2026 17/11/2026 08/09/2027 17/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011046/202609 PSUSA/00011046/202709 Liana Martirosyan Netherlands CAP
11047 cipaglucosidase alfa 20/03/2023 1 year 19/03/2026 28/05/2026 19/03/2027 28/05/2027 No 02/06/2026 DLP was amended on 22/10/2025 PSUSA/00011047/202603 PSUSA/00011047/202703 Karin Bolin Sweden CAP
11048 ivosidenib 04/05/2023 1 year 03/05/2026 12/07/2026 03/05/2027 12/07/2027 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025
DLP was amended on 18/12/2024 PSUSA/00011048/202605 PSUSA/00011048/202705 Marie Louise Schougaard Christiansen Denmark CAP
11049 pegunigalsidase alfa 04/05/2023 3 years 03/11/2027 01/02/2028 No 25/06/2025 PSUR frequency amended and DLP updated on 25/06/2025 PSUSA/00011049/202711 Liana Martirosyan Netherlands CAP
11050 vadadustat 29/06/2020 1 year 28/12/2025 08/03/2026 28/06/2026 06/09/2026 No 04/03/2026 PSUR frequency corrected on 04/03/2026
DLP was amended on 04/02/2026 PSUSA/00011050/202512 PSUSA/00011050/202606 Eva Jirsová Czech Republic CAP
11051 niraparib / abiraterone acetate 19/04/2023 6 months 19/04/2026 28/06/2026 19/10/2026 28/12/2026 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011051/202604 PSUSA/00011051/202610 Jan Neuhauser Austria CAP
11052 ruxolitinib (for non-segmental vitiligo) 21/09/2021 1 year 20/09/2026 29/11/2026 20/09/2027 29/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011052/202609 PSUSA/00011052/202709 Adam Przybylkowski Poland CAP
11053 Insulin icodec 01/03/2024 6 months 28/02/2026 09/05/2026 28/08/2026 06/11/2026 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011053/202602 PSUSA/00011053/202608 Sonja Hrabcik Austria CAP
11054 iptacopan 05/12/2023 6 months 04/12/2025 12/02/2026 04/06/2026 13/08/2026 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00011054/202512 PSUSA/00011054/202606 Lina Seibokiene Lithuania CAP
11055 aztreonam / avibactam 22/04/2024 6 months 21/04/2026 30/06/2026 21/10/2026 30/12/2026 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011055/202604 PSUSA/00011055/202610 Lina Seibokiene Lithuania CAP
11056 danicopan 18/01/2024 1 year 17/01/2026 28/03/2026 17/01/2027 28/03/2027 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025
DLP was amended on 05/03/2025 PSUSA/00011056/202601 PSUSA/00011056/202701 Dennis Lex Germany CAP
11057 pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures), prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures) 31/01/2020 6 months 31/01/2026 11/04/2026 31/07/2026 09/10/2026 No 02/06/2026 PSUSA/00011057/202601 PSUSA/00011057/202607 Jenny Jönsson Sweden CAP
11058 chikungunya vaccine (live) 09/11/2023 6 months 08/05/2026 17/07/2026 08/11/2026 17/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011058/202605 PSUSA/00011058/202611 Dirk Mentzer Germany CAP
11059 retifanlimab 22/03/2023 6 months 21/03/2026 30/05/2026 21/09/2026 30/11/2026 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011059/202603 PSUSA/00011059/202609 Dirk Mentzer Germany CAP
11060 sparsentan 17/02/2023 1 year 16/02/2026 27/04/2026 16/02/2027 27/04/2027 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00011060/202602 PSUSA/00011060/202702 Dennis Lex Germany CAP
11061 capivasertib 16/11/2023 6 months 15/05/2026 24/07/2026 15/11/2026 24/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011061/202605 PSUSA/00011061/202611 Sonja Hrabcik Austria CAP
11062 efanesoctocog alfa 22/02/2023 1 year 22/02/2026 03/05/2026 22/02/2027 03/05/2027 No 01/04/2026 PSUR frequency amended and DLP updated on 01/04/2026 PSUSA/00011062/202602 PSUSA/00011062/202702 Amelia Cupelli Italy CAP
11063 dantrolene sodium hemiheptahydrate 29/05/2024 1 year 28/05/2026 06/08/2026 28/05/2027 06/08/2027 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00011063/202605 PSUSA/00011063/202705 Liana Martirosyan Netherlands CAP NAP
11064 tofersen 25/04/2023 1 year 24/04/2026 03/07/2026 24/04/2027 03/07/2027 No 01/07/2026 New CAP authorised on 29/05/2024 PSUSA/00011064/202604 PSUSA/00011064/202704 Kimmo Jaakkola Finland CAP
11065 bevacizumab gamma 27/05/2024 1 year 26/05/2026 04/08/2026 26/05/2027 04/08/2027 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
DLP was amended on 04/02/2026 PSUSA/00011065/202605 PSUSA/00011065/202705 Karin Erneholm Denmark CAP
11066 dopamine hydrochloride 27/05/2024 6 months 26/05/2026 04/08/2026 26/11/2026 04/02/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011066/202605 PSUSA/00011066/202611 Maia Uusküla Estonia CAP
11067 aprocitentan 19/03/2024 1 year 18/03/2026 27/05/2026 18/03/2027 27/05/2027 No 29/04/2026 PSUR frequency amended and DLP updated on 29/04/2026
DLP was amended on 22/10/2025 PSUSA/00011067/202603 PSUSA/00011067/202703 Maria del Pilar Rayon Spain CAP
11068 vibegron 21/09/2018 6 months 20/03/2026 29/05/2026 20/09/2026 29/11/2026 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011068/202603 PSUSA/00011068/202609 Jan Neuhauser Austria CAP
11069 fruquintinib 04/09/2018 1 year 03/09/2026 12/11/2026 03/09/2027 12/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011069/202609 PSUSA/00011069/202709 Bianca Mulder Netherlands CAP
11071 crovalimab 06/02/2024 6 months 05/02/2026 16/04/2026 05/08/2026 14/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011071/202602 PSUSA/00011071/202608 Bianca Mulder Netherlands CAP
11072 erdafitinib 12/04/2019 1 year 11/04/2026 20/06/2026 11/04/2027 20/06/2027 No 19/11/2025 DLP was amended on 19/11/2025 PSUSA/00011072/202604 PSUSA/00011072/202704 Bianca Mulder Netherlands CAP
11073 flortaucipir (18F) 28/05/2020 6 months 28/11/2025 06/02/2026 28/05/2026 06/08/2026 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00011073/202511 PSUSA/00011073/202605 Adam Przybylkowski Poland CAP
11074 odronextamab 22/08/2024 6 months 21/02/2026 02/05/2026 21/08/2026 30/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011074/202602 PSUSA/00011074/202608 Veronika Macurová Czech Republic CAP
11075 respiratory syncytial virus mRNA vaccine 31/05/2024 6 months 29/11/2025 07/02/2026 29/05/2026 07/08/2026 No 01/07/2026 Active substance name was amended on 01/07/2026
Next DLP was updated on 27/05/2026
DLP was amended on 04/02/2026 PSUSA/00011075/202511 PSUSA/00011075/202605 Jean-Michel Dogné Belgium CAP
11076 sotatercept 26/03/2024 6 months 25/03/2026 03/06/2026 25/09/2026 04/12/2026 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011076/202603 PSUSA/00011076/202609 Zoubida Amimour France CAP
11077 rADAMTS13 09/08/2024 1 year 08/05/2026 17/07/2026 08/05/2027 17/07/2027 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
DLP was amended on 25/06/2025 PSUSA/00011077/202605 PSUSA/00011077/202705 Maia Uusküla Estonia CAP
11080 sugemalimab 20/12/2021 6 months 19/12/2025 27/02/2026 19/06/2026 28/08/2026 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00011080/202512 PSUSA/00011080/202606 Petar Mas Croatia CAP
11081 epinephrine (for nasal use) 09/08/2024 6 months 08/02/2026 19/04/2026 08/08/2026 17/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011081/202602 PSUSA/00011081/202608 Terhi Lehtinen Finland CAP
11082 polihexanide 22/08/2024 6 months 21/02/2026 02/05/2026 21/08/2026 30/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011082/202602 PSUSA/00011082/202608 Adam Przybylkowski Poland CAP
11083 fluoroethyltyrosine (18F) 23/12/2015 3 years 23/12/2027 22/03/2028 Yes 25/09/2024 New entry added on 25/09/2024 PSUSA/00011083/202712 not yet assigned none NAP
11084 dienogest / ethinylestradiol (prolonged-release tablet) 13/03/2024 1 year 15/03/2026 24/05/2026 15/03/2027 24/05/2027 No 02/06/2026 PSUSA/00011084/202603 PSUSA/00011084/202703 Jenny Jönsson Sweden NAP
11085 valsartan / indapamide 10/05/2024 5 years 10/05/2029 08/08/2029 No 25/09/2024 New entry added on 25/09/2024 PSUSA/00011085/202905 not yet assigned none NAP
11086 isothipendyl 12/08/2011 10 years 12/08/2034 10/11/2034 No 25/09/2024 PSUSA/00011086/203408 not yet assigned none NAP
11087 methylprednisolone (topical use) 18/12/1957 5 years 30/11/2028 28/02/2029 No 25/09/2024 New entry added on 25/09/2024 PSUSA/00011087/202811 not yet assigned none NAP
11088 nifurtimox 08/01/1970 3 years 08/01/2026 08/04/2026 No 26/05/2025 New entry added on 23/10/2024 PSUSA/00011088/202601 Maria del Pilar Rayon Spain NAP
11089 allergen for therapy: Dactylis Glomerata L., Phleum Pratense L., Anthoxanthum Odoratum L., Lolium Perenne L., Poa Pratensis L. Salsola Kali L., Blomia Tropicalis, Zea Mays L., Fraxinus Excelsior L., Arrhenatherum Elatius, Cynodon Dactylon (L.) pers., latex, Festuca Pratensis Hudson, Parietaria Officinalis L., Cat Epithelia, Dog Epithelia, Triticum Aestivum, Dermatophagoides Farinae, Juniperus Ashei Buchholz, Hordeum Vulgare L., Alnus Glutinosa L., Agrostis Capillaris L., Corylus Avellana L., Secale Cereale L., Avena Fatua whole., Holcus Lanatus, Artemisia Vulgaris L., Olea Europaea L., Ambrosia Artemisiifolia, Dermatophagoides Pteronyssinus, Carpinus Betulus L., Avena Sativa L., Bromus Inermis whole, Parietaria Judaica L., Betula single or mixes (Staloral) 10/08/2004 8 years 10/08/2033 08/11/2033 No 23/10/2024 New entry added on 23/10/2024 PSUSA/00011089/203308 not yet assigned none NAP
11090 macitentan / tadalafil 14/10/2024 1 year 13/10/2026 22/12/2026 13/10/2027 22/12/2027 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00011090/202610 PSUSA/00011090/202710 Maria del Pilar Rayon Spain CAP
11091 delgocitinib 23/01/2020 1 year 22/01/2026 02/04/2026 22/01/2027 02/04/2027 No 24/09/2025 PSUR frequency amended and DLP updated on 24/09/2025
Reference to NAP added on 05/03/2025
New CAP authorised on 19/09/2024 PSUSA/00011091/202601 PSUSA/00011091/202701 Liana Martirosyan Netherlands CAP NAP
11092 elafibranor 10/06/2024 6 months 09/12/2025 17/02/2026 09/06/2026 18/08/2026 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00011092/202512 PSUSA/00011092/202606 Rugile Pilviniene Lithuania CAP
11094 toripalimab 17/12/2018 1 year 16/12/2025 24/02/2026 16/12/2026 24/02/2027 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026
DLP was amended on 30/07/2025 PSUSA/00011094/202512 PSUSA/00011094/202612 Karin Erneholm Denmark CAP
11095 zolbetuximab 26/03/2024 1 year 25/03/2026 03/06/2026 25/03/2027 03/06/2027 No 17/12/2025 DLP was amended on 17/12/2025
PSUR frequency amended and DLP updated on 19/11/2025 PSUSA/00011095/202603 PSUSA/00011095/202703 Bianca Mulder Netherlands CAP
11097 mirvetuximab soravtansine 14/11/2022 1 year 13/11/2026 22/01/2027 13/11/2027 22/01/2028 No 01/07/2026 PSUR frequency amended and DLP updated on 01/07/2026
Correction of DLP on 18/12/2024
New CAP authorised on 14/11/2024 PSUSA/00011097/202611 PSUSA/00011097/202711 Maria del Pilar Rayon Spain CAP
11098 furazidine 24/10/2025 5 years 28/02/2026 29/05/2026 Yes 05/08/2025 New entry added on 18/12/2024 PSUSA/00011098/202602 Polona Golmajer Slovenia NAP
11099 magnesium chloride Not available* 20 years 02/09/2044 01/12/2044 Yes 18/12/2024 New entry added on 18/12/2024 PSUSA/00011099/204409 not yet assigned none NAP
11100 sodium acetate Not available* 20 years 02/09/2044 01/12/2044 Yes 18/12/2024 New entry added on 18/12/2024 PSUSA/00011100/204409 not yet assigned none NAP
11101 marstacimab 11/10/2024 1 year 10/04/2026 19/06/2026 10/04/2027 19/06/2027 No 01/07/2026 Correction of DLP on 01/07/2026
PSUR frequency amended and DLP updated on 27/05/2026
DLP was amended on 19/11/2025 PSUSA/00011101/202604 PSUSA/00011101/202704 Marie Louise Schougaard Christiansen Denmark CAP
11102 repotrectinib 15/11/2023 6 months 14/05/2026 23/07/2026 14/11/2026 23/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011102/202605 PSUSA/00011102/202611 Barbara Kovacic Bytyqi Croatia CAP
11103 vilobelimab 04/04/2023 1 year 03/04/2026 12/06/2026 03/04/2027 12/06/2027 No 27/05/2026 PSUR frequency amended and DLP updated on 27/05/2026
DLP was amended on 19/11/2025 PSUSA/00011103/202604 PSUSA/00011103/202704 Liana Martirosyan Netherlands CAP
11104 rdESAT-6 / rCFP-10 09/05/2022 6 months 08/05/2026 17/07/2026 08/11/2026 17/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011104/202605 PSUSA/00011104/202611 Sonja Hrabcik Austria CAP
11105 concizumab 10/03/2023 1 year 30/03/2026 08/06/2026 10/04/2027 19/06/2027 No 01/07/2026 Next DLP was updated on 01/07/2026
PSUR frequency amended and DLP updated on 27/05/2026
DLP was amended on 19/11/2025 PSUSA/00011105/202603 PSUSA/00011105/202704 Marie Louise Schougaard Christiansen Denmark CAP
11106 acoramidis 22/11/2024 6 months 21/05/2026 30/07/2026 21/11/2026 30/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011106/202605 PSUSA/00011106/202611 Rhea Fitzgerald Ireland CAP
11107 belzutifan 13/08/2021 6 months 12/02/2026 23/04/2026 12/08/2026 21/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011107/202602 PSUSA/00011107/202608 Dennis Lex Germany CAP
11108 catumaxomab 10/02/2025 6 months 09/02/2026 20/04/2026 09/08/2026 18/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011108/202602 PSUSA/00011108/202608 Bianca Mulder Netherlands CAP
11109 garadacimab 14/01/2025 6 months 13/01/2026 24/03/2026 13/07/2026 21/09/2026 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00011109/202601 PSUSA/00011109/202607 Marie Louise Schougaard Christiansen Denmark CAP
11110 lazertinib 21/05/2021 6 months 20/05/2026 29/07/2026 20/11/2026 29/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011110/202605 PSUSA/00011110/202611 Petar Mas Croatia CAP
11111 nemolizumab 28/03/2022 1 year 27/09/2026 06/12/2026 27/09/2027 06/12/2027 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00011111/202609 PSUSA/00011111/202709 Liana Martirosyan Netherlands CAP
11112 serplulimab 22/03/2022 6 months 21/03/2026 30/05/2026 21/09/2026 30/11/2026 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011112/202603 PSUSA/00011112/202609 Jan Neuhauser Austria CAP
11113 sipavibart 27/12/2024 1 year 26/12/2025 06/03/2026 26/12/2026 06/03/2027 No 04/02/2026 PSUR frequency amended and DLP updated on 04/02/2026
New CAP authorised on 20/01/2025 PSUSA/00011113/202512 PSUSA/00011113/202612 Kimmo Jaakkola Finland CAP
11114 tiratricol 12/02/2025 6 months 11/02/2026 22/04/2026 11/08/2026 20/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011114/202602 PSUSA/00011114/202608 Zoubida Amimour France CAP
11115 COVID-19 sa-mRNA Vaccine (Kostaive) 28/11/2023 1 year 27/11/2026 05/02/2027 27/11/2027 05/02/2028 No 01/07/2026 Active substance name was amended on 01/07/2026
DLP was amended on 04/02/2026 PSUSA/00011115/202611 PSUSA/00011115/202711 Dirk Mentzer Germany CAP
11117 imetelstat 06/06/2024 6 months 05/12/2025 13/02/2026 05/06/2026 14/08/2026 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00011117/202512 PSUSA/00011117/202606 Bianca Mulder Netherlands CAP
11118 chikungunya vaccine (recombinant, adsorbed) 14/02/2025 6 months 13/02/2026 24/04/2026 13/08/2026 22/10/2026 No 01/04/2026 DLP was amended on 01/04/2026
Active substance name was amended on 01/04/2026
Correction of EURD and DLP on 30/04/2025
New CAP authorised on 28/02/2025 PSUSA/00011118/202602 PSUSA/00011118/202608 Liana Martirosyan Netherlands CAP
11119 seladelpar lysine dihydrate 14/08/2024 6 months 13/02/2026 24/04/2026 13/08/2026 22/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011119/202602 PSUSA/00011119/202608 Amelia Cupelli Italy CAP
11120 eplontersen 21/12/2023 6 months 20/12/2025 28/02/2026 20/06/2026 29/08/2026 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00011120/202512 PSUSA/00011120/202606 Jan Neuhauser Austria CAP
11121 pneumococcal polysaccharide conjugate vaccine (21-valent) 17/06/2024 6 months 16/12/2025 24/02/2026 16/06/2026 25/08/2026 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00011121/202512 PSUSA/00011121/202606 Jean-Michel Dogné Belgium CAP
11122 indigo carmine 11/11/2003 13 years 10/11/2035 08/02/2036 Yes 02/04/2025 New entry added on 02/04/2025 PSUSA/00011122/203511 not yet assigned none NAP
11123 paraffin liquid / paraffin yellow soft 01/08/1977 12 years 28/12/2032 28/03/2033 Yes 25/06/2025 Active substance name was corrected on 25/06/2025
New entry added on 02/04/2025 PSUSA/00011123/203212 not yet assigned none NAP
11124 lactobacillus all subspecies and combinations of subspecies (intramuscular use) 14/07/1954 5 years 13/07/2029 11/10/2029 No 28/05/2025 PSUR frequency and DLP corrected on 28/05/2025
New entry added on 30/04/2025 PSUSA/00011124/202907 Dirk Mentzer Germany NAP
11127 tisotumab vedotin 20/09/2021 6 months 19/03/2026 28/05/2026 19/09/2026 28/11/2026 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011127/202603 PSUSA/00011127/202609 Jo Robays Belgium CAP
11129 datopotamab deruxtecan 27/12/2024 6 months 26/12/2025 06/03/2026 26/06/2026 04/09/2026 No 02/06/2026 PSUSA/00011129/202512 PSUSA/00011129/202606 Jenny Jönsson Sweden CAP
11130 linvoseltamab 23/04/2025 6 months 22/04/2026 01/07/2026 22/10/2026 31/12/2026 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011130/202604 PSUSA/00011130/202610 Veronika Macurová Czech Republic CAP
11131 beremagene geperpavec 19/05/2023 6 months 18/05/2026 27/07/2026 18/11/2026 27/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011131/202605 PSUSA/00011131/202611 Liana Martirosyan Netherlands CAP
11132 lecanemab 06/01/2023 6 months 05/01/2026 16/03/2026 05/07/2026 13/09/2026 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00011132/202601 PSUSA/00011132/202607 Eva Jirsová Czech Republic CAP
11133 CARBO VEGETABILIS C4, RESINA PICEAE C4, ROBINIA PSEUDOACACIA C4, STRYCHNOS NUX-VOMICA C4 19/12/2005 18 years 18/12/2043 17/03/2044 Yes 28/05/2025 New active substance added on 28/05/2025 PSUSA/00011133/204312 none none NAP
11134 cinitapride 13/12/1989 13 years 12/12/2036 12/03/2037 Yes 28/05/2025 New active substance added on 28/05/2025 PSUSA/00011134/203612 none none NAP
11135 magnesium sulfate heptahydrate, potassium chloride, xylitol, procaine hydrochloride 04/04/2024 3 years 03/04/2027 02/07/2027 No 28/05/2025 New entry added on 28/05/2025 PSUSA/00011135/202704 none none NAP
11136 ATROPA BELLA-DONNA C6 / VIBURNUM OPULUS C6 / CHELIDONIUM MAJUS C6 / ACONITUM NAPELLUS C6 / CALENDULA OFFICINALIS C6 / ABRUS PRECATORIUS C6 11/07/2008 18 years 10/07/2044 08/10/2044 Yes 28/05/2025 New active substance added on 28/05/2025 PSUSA/00011136/204407 None none NAP
11137 papain / trypsin / chymotrypsin 25/11/2013 10 years 24/11/2035 22/02/2036 No 28/05/2025 New entry added on 28/05/2025 PSUSA/00011137/203511 none none NAP
11138 populi cortex et folium, extractum / fraxini cortex, extractum / european goldenrod extract 12/03/2015 13 years 11/03/2035 09/06/2035 No 28/05/2025 New entry added on 28/05/2025 PSUSA/00011138/203503 none none NAP
11139 bencyclane 23/11/1966 13 years 22/11/2035 20/02/2036 No 28/05/2025 New entry added on 28/05/2025 PSUSA/00011139/203511 none none NAP
11140 ferric citrate coordination complex 11/06/2025 6 months 10/12/2025 18/02/2026 10/06/2026 19/08/2026 No 01/04/2026 Reference to NAP added on 01/04/2026
New CAP authorised on 25/06/2025 PSUSA/00011140/202512 PSUSA/00011140/202606 Kimmo Jaakkola Finland CAP NAP
11141 givinostat 20/12/2024 6 months 20/12/2025 28/02/2026 20/06/2026 29/08/2026 No 04/02/2026 DLP was amended on 04/02/2026 PSUSA/00011141/202512 PSUSA/00011141/202606 Liana Martirosyan Netherlands CAP
11142 atropine (myopia indication) 31/08/1945 1 year 31/08/2026 09/11/2026 31/08/2027 09/11/2027 No 29/04/2026 DLP was amended on 29/04/2026 PSUSA/00011142/202608 PSUSA/00011142/202708 Dennis Lex Germany CAP NAP
11143 candesartan / indapamide 11/09/2024 5 years 10/09/2029 09/12/2029 No 30/07/2025 New entry added on 30/07/2025 PSUSA/00011143/202909 not yet assigned none NAP
11144 amino acid combinations (only combinations of pure amino acids or combination of amino acids with mineral compounds / electrolytes, oral use) 18/10/2006 7 years 17/10/2026 15/01/2027 No 27/02/2026 New entry added on 30/07/2025 PSUSA/00011144/202610 Polona Golmajer Slovenia NAP
11145 sepiapterin 19/06/2025 6 months 19/12/2025 27/02/2026 19/06/2026 28/08/2026 No 30/07/2025 New CAP authorised on 19/06/2025 PSUSA/00011145/202512 PSUSA/00011145/202606 David Olsen Norway CAP
11146 deutivacaftor / tezacaftor / vanzacaftor 20/12/2024 6 months 19/12/2025 27/02/2026 19/06/2026 28/08/2026 No 30/07/2025 New CAP authorised on 30/06/2025 PSUSA/00011146/202512 PSUSA/00011146/202606 Dennis Lex Germany CAP
11147 zanidatamab 20/11/2024 6 months 19/05/2026 28/07/2026 19/11/2026 28/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011147/202605 PSUSA/00011147/202611 Jenny Jönsson Sweden CAP
11148 teprotumumab 21/01/2020 6 months 20/01/2026 31/03/2026 20/07/2026 28/09/2026 No 04/03/2026 DLP was amended on 04/03/2026 PSUSA/00011148/202601 PSUSA/00011148/202607 Sonja Radowan Austria CAP
11149 Glycine / L-ALANINE / L-ARGININE / L-ASPARTIC ACID / L-CYSTEINE HYDROCHLORIDE MONOHYDRATE / L-HISTIDINE / L-METHIONINE / L-PHENYLALANINE / L-PROLINE / L-SERINE / L-THREONINE / L-TRYPTOPHAN / L-TYROSINE / L-glutamic acid / L-lysine monohydrate / Taurine 28/07/2025 6 months 27/01/2026 07/04/2026 27/07/2026 05/10/2026 Yes 22/10/2025 DLP was amended on 22/10/2025
New CAP authorised on 28/07/2025 PSUSA/00011149/202601 PSUSA/00011149/202607 Amelia Cupelli Italy CAP
11150 diflunisal (for centrally authorised products) 03/11/2025 3 years 03/11/2028 01/02/2029 No 24/09/2025 PSUSA/00011150/202811 Karin Bolin Sweden CAP
11151 dorocubicel / allogeneic umbilical cord-derived CD34- cells, non-expanded 25/08/2025 6 months 24/02/2026 05/05/2026 24/08/2026 02/11/2026 No 02/06/2026 PSUSA/00011151/202602 PSUSA/00011151/202608 Karin Bolin Sweden CAP
11152 sargramostim 05/03/1991 6 months 04/03/2026 13/05/2026 04/09/2026 13/11/2026 No 02/06/2026 PSUSA/00011152/202603 PSUSA/00011152/202609 Jenny Jönsson Sweden CAP
11153 erysimum 12/11/1999 8 years 12/11/2030 10/02/2031 No 22/10/2025 New entry added on 22/10/2025 PSUSA/00011153/203011 not yet assigned none NAP
11154 sebetralstat 03/07/2025 6 months 02/01/2026 13/03/2026 02/07/2026 10/09/2026 No 22/10/2025 New CAP authorised on 17/09/2025 PSUSA/00011154/202601 PSUSA/00011154/202607 Zane Neikena Latvia CAP
11155 olezarsen 19/12/2024 6 months 18/12/2025 26/02/2026 18/06/2026 27/08/2026 No 22/10/2025 New CAP authorised on 17/09/2025 PSUSA/00011155/202512 PSUSA/00011155/202606 Kimmo Jaakkola Finland CAP
11156 vimseltinib 14/02/2025 6 months 13/02/2026 24/04/2026 13/08/2026 22/10/2026 No 22/10/2025 New CAP authorised on 17/09/2025 PSUSA/00011156/202602 PSUSA/00011156/202608 Karin Erneholm Denmark CAP
11157 vorasidenib 06/08/2024 6 months 05/02/2026 16/04/2026 05/08/2026 14/10/2026 No 19/11/2025 EURD and DLP updated on 19/11/2025
New CAP authorised on 17/09/2025 PSUSA/00011157/202602 PSUSA/00011157/202608 Jo Robays Belgium CAP
11158 zuranolone 04/08/2023 6 months 03/02/2026 14/04/2026 03/08/2026 12/10/2026 No 22/10/2025 New CAP authorised on 17/09/2025 PSUSA/00011158/202602 PSUSA/00011158/202608 Guðrún Stefánsdóttir Iceland CAP
11159 resmetirom 14/03/2024 6 months 13/03/2026 22/05/2026 13/09/2026 22/11/2026 No 22/10/2025 New CAP authorised on 18/08/2025 PSUSA/00011159/202603 PSUSA/00011159/202609 Lina Seibokiene Lithuania CAP
11160 obecabtagene autoleucel 08/11/2024 6 months 07/05/2026 16/07/2026 07/11/2026 16/01/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011160/202605 PSUSA/00011160/202611 Karin Erneholm Denmark CAP
11161 mirdametinib 11/02/2025 6 months 10/02/2026 21/04/2026 10/08/2026 19/10/2026 No 01/04/2026 DLP was amended on 01/04/2026 PSUSA/00011161/202602 PSUSA/00011161/202608 Bianca Mulder Netherlands CAP
11162 clascoterone 17/10/2025 6 months 16/04/2026 25/06/2026 16/10/2026 25/12/2026 No 19/11/2025 New CAP authorised on 17/10/2025 PSUSA/00011162/202604 PSUSA/00011162/202610 Zane Neikena Latvia CAP
11163 nirogacestat 27/11/2023 6 months 27/05/2026 05/08/2026 27/11/2026 05/02/2027 No 01/07/2026 DLP was amended on 01/07/2026 PSUSA/00011163/202605 PSUSA/00011163/202611 Terhi Lehtinen Finland CAP
11164 inavolisib 10/10/2024 6 months 09/04/2026 18/06/2026 09/10/2026 18/12/2026 No 27/05/2026 DLP was amended on 27/05/2026 PSUSA/00011164/202604 PSUSA/00011164/202610 Bianca Mulder Netherlands CAP
11165 donanemab 02/07/2024 6 months 02/01/2026 13/03/2026 02/07/2026 10/09/2026 No 04/02/2026 DLP was amended on 04/02/2026
New CAP authorised on 24/09/2025 PSUSA/00011165/202601 PSUSA/00011165/202607 Amelia Cupelli Italy CAP
11166 thiamine / cyanocobalamine / riboflavin / pyridoxine 27/09/1999 3 years 03/06/2028 01/09/2028 Yes 26/05/2026 PSUR frequency amended and DLP updated on 26/05/2026
New entry added on 17/12/2025 PSUSA/00011166/202806 not yet assigned none NAP
11167 gentian root / verbena herb / common sorrel herb / primula flower with calyx / sambucus nigra flower 27/06/2007 13 years 26/06/2036 24/09/2036 No 17/12/2025 New entry added 17/12/2025 PSUSA/00011167/203606 not yet assigned none NAP
11168 nipocalimab 29/04/2025 6 months 28/04/2026 07/07/2026 28/10/2026 06/01/2027 No 17/12/2025 New CAP authorised on 28/11/2025 PSUSA/00011168/202604 PSUSA/00011168/202610 Dirk Mentzer Germany CAP
11169 insulin icodec / semaglutide 05/12/2017 6 months 04/06/2026 13/08/2026 04/12/2026 12/02/2027 No 17/12/2025 New CAP authorised on 18/11/2025 PSUSA/00011169/202606 PSUSA/00011169/202612 Petar Mas Croatia CAP
11170 brensocatib 12/08/2025 6 months 11/02/2026 22/04/2026 11/08/2026 20/10/2026 No 17/12/2025 New CAP authorised on 18/11/2025 PSUSA/00011170/202602 PSUSA/00011170/202608 Zane Neikena Latvia CAP
11171 elinzanetant 08/07/2025 6 months 07/01/2026 18/03/2026 07/07/2026 15/09/2026 No 17/12/2025 New CAP authorised on 17/11/2025 PSUSA/00011171/202601 PSUSA/00011171/202607 Guðrún Stefánsdóttir Iceland CAP
11172 donidalorsen 21/08/2025 6 months 20/02/2026 01/05/2026 20/08/2026 29/10/2026 No 04/02/2026 New CAP authorised on 19/01/2026 PSUSA/00011172/202602 PSUSA/00011172/202608 Julia Pallos Hungary CAP
11173 etuvetidigene autotemcel 09/01/2026 6 months 08/07/2026 16/09/2026 08/01/2027 19/03/2027 No 04/02/2026 New CAP authorised on 09/01/2026 PSUSA/00011173/202607 PSUSA/00011173/202701 Jo Robays Belgium CAP
11174 levacetylleucine 24/09/2024 6 months 23/03/2026 01/06/2026 23/09/2026 02/12/2026 No 04/02/2026 New CAP authorised on 19/01/2026 PSUSA/00011174/202603 PSUSA/00011174/202609 Dennis Lex Germany CAP
11175 imlunestrant 25/09/2025 6 months 25/03/2026 03/06/2026 25/09/2026 04/12/2026 No 02/06/2026 DLP updated on 04/03/2026
New CAP authorised on 09/01/2026 PSUSA/00011175/202603 PSUSA/00011175/202609 Jenny Jönsson Sweden CAP
11176 pertussis vaccine (recombinant, acellular, component, adsorbed) 30/09/2016 6 months 29/03/2026 07/06/2026 29/09/2026 08/12/2026 No 04/02/2026 New CAP authorised on 09/01/2026 PSUSA/00011176/202603 PSUSA/00011176/202609 Amelia Cupelli Italy CAP
11177 deutetrabenazine 08/01/2026 1 year 31/03/2026 09/06/2026 31/03/2027 09/06/2027 No 01/04/2026 PSUR frequency corrected on 01/04/2026
New CAP authorised on 08/01/2026 PSUSA/00011177/202603 PSUSA/00011177/202703 Liana Martirosyan Netherlands CAP
11178 teplizumab 17/11/2022 6 months 16/05/2026 25/07/2026 16/11/2026 25/01/2027 No 04/02/2026 New CAP authorised on 08/01/2026 PSUSA/00011178/202605 PSUSA/00011178/202611 Terhi Lehtinen Finland CAP
11179 rilzabrutinib 19/06/2025 6 months 18/06/2026 27/08/2026 18/12/2026 26/02/2027 No 04/02/2026 New CAP authorised on 22/12/2025 PSUSA/00011179/202606 PSUSA/00011179/202612 Dennis Lex Germany CAP
11180 depemokimab 29/08/2017 6 months 28/02/2026 09/05/2026 28/08/2026 06/11/2026 No 04/03/2026 New CAP authorised on 12/02/2026 PSUSA/00011180/202602 PSUSA/00011180/202608 Dirk Mentzer Germany CAP
11181 aficamten 16/12/2025 6 months 15/06/2026 24/08/2026 15/12/2026 23/02/2027 No 04/03/2026 New CAP authorised on 12/02/2026 PSUSA/00011181/202606 PSUSA/00011181/202612 Eva Jirsová Czech Republic CAP
11182 aumolertinib 17/03/2020 6 months 16/03/2026 25/05/2026 16/09/2026 25/11/2026 No 04/03/2026 New CAP authorised on 12/02/2026 PSUSA/00011182/202603 PSUSA/00011182/202609 Bianca Mulder Netherlands CAP
11183 COVID-19 mRNA vaccine (mNEXSPIKE) 30/05/2025 1 year 29/05/2027 07/08/2027 29/05/2028 07/08/2028 No 01/07/2026 Active substance name was amended on 01/07/2026
Correction of PSUR frequency and DLP on 01/04/2026
New CAP authorised on 12/02/2026 PSUSA/00011183/202705 PSUSA/00011183/202805 Marie Louise Schougaard Christiansen Denmark CAP
11184 standardised bacterial culture suspension, standardised bacterial culture suspension / hydrocortisone, inactivated E. coli, inactivated E. coli / hydrocortisone 16/09/2008 15 years 16/09/2034 15/12/2034 No 01/04/2026 New entry added on 01/04/2026 PSUSA/00011184/203409 not yet assigned none NAP
11185 povidone, polyvinyl alcohol / povidone, dextran 70 / hypromellose, white soft paraffin / white soft paraffin combinations (ocular indications) 01/01/1981 13 years 30/06/2040 28/09/2040 No 01/04/2026 New entry added on 01/04/2026 PSUSA/00011185/204006 not yet assigned none NAP
11186 chlorhexidine / hydrocortisone 05/08/1952 8 years 03/03/2033 01/06/2033 Yes 01/04/2026 New entry added on 01/04/2026 PSUSA/00011186/203303 not yet assigned none NAP
11187 efinaconazole 19/03/2025 5 years 19/03/2029 17/06/2029 No 01/04/2026 New entry added on 01/04/2026 PSUSA/00011187/202903 not yet assigned none NAP
11188 penfluridol 05/11/2018 3 years 05/11/2027 03/02/2028 Yes 01/04/2026 New entry added on 01/04/2026 PSUSA/00011188/202711 not yet assigned none NAP
11189 ezetimibe / pitavastatin 17/04/2025 5 years 16/07/2030 14/10/2030 No 01/04/2026 New entry added on 01/04/2026 PSUSA/00011189/203007 not yet assigned none NAP
11190 anamirta cocculus / strychnos nux-vomica / petroleum / nicotiana tabacum 19/12/2001 18 years 19/12/2028 19/03/2029 Yes 01/04/2026 New entry added on 01/04/2026 PSUSA/00011190/202812 not yet assigned none NAP
11191 fenofibrate / rosuvastatin 26/08/2013 5 years 06/11/2027 04/02/2028 No 01/04/2026 New entry added on 01/04/2026 PSUSA/00011191/202711 not yet assigned none NAP
11192 ginkgo biloba L., folium (ginkgo leaf) 26/06/1986 10 years 25/06/2034 23/09/2034 No 01/04/2026 New entry added on 01/04/2026 PSUSA/00011192/203406 not yet assigned none NAP
11193 primaquine 12/04/1972 5 years 12/04/2031 11/07/2031 Yes 01/04/2026 New entry added on 01/04/2026 PSUSA/00011193/203104 not yet assigned none NAP
11194 nogapendekin alfa inbakicept 04/07/2025 6 months 03/07/2026 11/09/2026 03/01/2027 14/03/2027 No 01/04/2026 New CAP added on 01/04/2026 PSUSA/00011194/202607 PSUSA/00011194/202701 Jean-Michel Dogné Belgium CAP
11195 clesrovimab 09/06/2025 6 months 08/06/2026 17/08/2026 08/12/2026 16/02/2027 No 27/05/2026 DLP was amended on 27/05/2026
New CAP authorised on 15/04/2026 PSUSA/00011195/202606 PSUSA/00011195/202612 Dirk Mentzer Germany CAP
11196 doxecitine / doxribtimine 03/11/2025 6 months 02/05/2026 11/07/2026 02/11/2026 11/01/2027 No 29/04/2026 New CAP authorised on 26/03/2026 PSUSA/00011196/202605 PSUSA/00011196/202611 Barbara Kovacic Bytyqi Croatia CAP
11197 estetrol 26/03/2026 6 months 25/09/2026 04/12/2026 25/03/2027 03/06/2027 No 29/04/2026 New CAP authorised on 26/03/2026 PSUSA/00011197/202609 PSUSA/00011197/202703 Sonja Radowan Austria CAP
11198 belumosudil 16/07/2021 6 months 15/07/2026 23/09/2026 15/01/2027 26/03/2027 No 27/05/2026 DLP was corrected on 27/05/2026
New CAP authorised on 24/03/2026 PSUSA/00011198/202607 PSUSA/00011198/202701 Karin Erneholm Denmark CAP
11199 trivalent influenza vaccine (recombinant, prepared in cell culture) 30/03/2026 6 months 29/09/2026 08/12/2026 29/03/2027 07/06/2027 No 29/04/2026 New CAP authorised on 30/03/2026 PSUSA/00011199/202609 PSUSA/00011199/202703 Zoubida Amimour France CAP
11200 semaglutide (treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis with liver fibrosis) 26/03/2026 6 months 25/09/2026 04/12/2026 25/03/2027 03/06/2027 No 03/06/2026 New CAP authorised on 26/03/2026 PSUSA/00011200/202609 PSUSA/00011200/202703 Karin Bolin Sweden CAP
11201 secale cereale L., phleum pratense, zea mays L. single or mixes (genitourinary therapy) 28/10/2004 5 years 28/10/2030 26/01/2031 No 27/05/2026 New entry added 27/05/2026 PSUSA/00011201/203010 not yet assigned none NAP
11202 salicylic acid (ocular use) Not available* 6 years 02/12/2029 02/03/2030 No 27/05/2026 New entry added on 27/05/2026 PSUSA/00011202/202912 not yet assigned none NAP
11203 viperae beri venenum / camphor / salicylic acid / turpentine oil Not available* 6 years 02/12/2029 02/03/2030 No 27/05/2026 New entry added on 27/05/2026 PSUSA/00011203/202912 not yet assigned none NAP
11204 tovorafenib 23/04/2024 6 months 22/10/2026 31/12/2026 22/04/2027 01/07/2027 No 27/05/2026 New CAP authorised on 20/04/2026 PSUSA/00011204/202610 PSUSA/00011204/202704 Marie Louise Schougaard Christiansen Denmark CAP
11205 influenza mRNA vaccine / COVID-19 mRNA vaccine (mCombriax) 20/04/2026 6 months 19/10/2026 28/12/2026 19/04/2027 28/06/2027 No 01/07/2026 Active substance name was amended on 01/07/2026
New CAP authorised on 20/04/2026 PSUSA/00011205/202610 PSUSA/00011205/202704 Georgia Gkegka Greece CAP
11206 remibrutinib 30/09/2025 6 months 29/09/2026 08/12/2026 29/03/2027 07/06/2027 No 27/05/2026 New CAP authorised on 23/04/2026 PSUSA/00011206/202609 PSUSA/00011206/202703 Terhi Lehtinen Finland CAP
11207 paltusotine 25/09/2025 6 months 31/08/2026 09/11/2026 28/02/2027 09/05/2027 No 27/05/2026 New CAP authorised on 23/04/2026 PSUSA/00011207/202608 PSUSA/00011207/202702 Liana Martirosyan Netherlands CAP
11208 mavorixafor 15/05/2015 6 months 14/05/2026 23/07/2026 14/11/2026 23/01/2027 No 27/05/2026 New CAP authorised on 27/04/2026 PSUSA/00011208/202605 PSUSA/00011208/202611 Karin Erneholm Denmark CAP
11210 lurbinectedin 15/06/2020 6 months 14/12/2026 22/02/2027 14/06/2027 23/08/2027 No 01/07/2026 New CAP authorised on 29/05/2026 PSUSA/00011210/202612 PSUSA/00011210/202706 Jenny-Maria Jönsson Sweden CAP
11211 tarlatamab 16/05/2024 6 months 15/11/2026 24/01/2027 15/05/2027 24/07/2027 No 01/07/2026 New CAP authorised on 29/05/2026 PSUSA/00011211/202611 PSUSA/00011211/202705 Sonja Radowan Austria CAP
11212 nadofaragene firadenovec 16/12/2025 6 months 15/06/2026 24/08/2026 15/12/2026 23/02/2027 No 01/07/2026 New CAP authorised on 28/05/2026 PSUSA/00011212/202606 PSUSA/00011212/202612 Amelia Cupelli Italy CAP
11213 leniolisib 24/03/2023 6 months 23/09/2026 02/12/2026 23/03/2027 01/06/2027 No 01/07/2026 New CAP authorised on 21/05/2026 PSUSA/00011213/202609 PSUSA/00011213/202703 Petar Mas Croatia CAP
11214 plozasiran 18/11/2025 6 months 31/07/2026 09/10/2026 31/01/2027 11/04/2027 No 01/07/2026 New CAP authorised on 19/06/2026 PSUSA/00011214/202607 PSUSA/00011214/202701 Terhi Lehtinen Finland CAP
107800 levodopa 21/12/2018 1 year 20/12/2025 28/02/2026 20/12/2026 28/02/2027 No 01/04/2026 Reference to NAP added on 01/04/2026
DLP was amended on 30/07/2025 PSUSA/00107800/202512 PSUSA/00107800/202612 Barbara Kovacic Bytyqi Croatia CAP NAP
107812 netarsudil 18/12/2017 3 years 17/06/2027 15/09/2027 No 04/03/2026 PSUR frequency amended and DLP updated on 04/03/2026 PSUSA/00107812/202706 Maria del Pilar Rayon Spain CAP
&"Calibri"&11&K000000&"Verdana,Regular"&6© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged._x000D_&1#&"Verdana"&7&K737373 Classified as internal/staff & contractors by the Europ &"Verdana,Regular"&9Page &P / &N
An agency of the European Union
https://www.ema.europa.eu/documents/template-form/template-request-amendments-addition-active-substances-combinations-active-substances-european-union_en-1.docxhttps://www.ema.europa.eu/documents/other/timetable-periodic-safety-update-report-psur-psur-single-assessment-psusa_en.pdfhttp://www.ema.europa.eu/ema/index.jsp?curl=pages/contacts/PRAC/people_listing_000112.jsp&mid=WC0b01ac058058f328https://www.ema.europa.eu/documents/other/introductory-cover-note-list-european-union-reference-dates-frequency-submission-periodic-safety_en.pdf
Removed entries
Active substances and combinations of active substances removed from the EURD list Comments Month removed
aminosalicylic acid Entry removed as only authorised in 1 MS Jun-26
cocaine Entry deleted due to no products in scope Jun-26
ergometrine Entry deleted due to no products in scope Jun-26
fludrocortisone / gramicidin / neomycin Entry deleted due to no products in scope Jun-26
furazolidone Entry deleted due to no products in scope Jun-26
plasma protein fraction Entry removed as only authorised in 1 MS Jun-26
glutaral Entry deleted due to no products in scope Jun-26
chloroquine phosphate / proguanil hydrochloride Entry deleted due to no products in scope Jun-26
insulin degludec / liraglutide Entry deleted due to merge (See EURD ID: 1892) Jun-26
tilmanocept Entry deleted due to no products in scope Jun-26
ivabradine / metoprolol Entry deleted due to no products in scope Jun-26
sodium benzoate / grindelia tincture / polygala syrup Entry deleted due to no products in scope Jun-26
parathyroid hormone Entry deleted as Natpar (CAP) withdrawn Jun-26
hydroxyprogesterone caproate Entry deleted due to no products in scope Jun-26
dasiglucagon Entry deleted as Zegalogue (CAP) withdrawn Jun-26
melphalan Entry deleted due to merge (see EURD ID: 11013) May-26
copper sulfate / zinc oxide Entry removed as only authorised in 1 MS May-26
calcium carbonate / sodium alginate / sodium bicarbonate, sodium alginate / sodium bicarbonate, sodium alginate/ potassium hydrogen carbonate, sodium alginate/magnesium alginate Entry deleted due to merge (see entry ID 123 and/or 500) May-26
duvelisib Entry deleted as Copiktra (CAP) withdrawn May-26
casirivimab / imdevimab (Ronapreve) Entry deleted as Ronapreve (CAP) withdrawn May-26
valoctocogene roxaparvovec Entry deleted as Roctavian (CAP) withdrawn May-26
clotrimazole / zinc oxide Entry removed as only authorised in 1 MS Apr-26
codeine / erysimum Entry removed as only authorised in 1 MS Apr-26
codeine / ethylmorphine hydrochloride Entry removed as only authorised in 1 MS Apr-26
disodium phosphate dodecahydrate / sodium dihydrogen phosphate dihydrate Entry deleted - Art 57 has no products/products covered by other entry (See EURD ID: 2737) Apr-26
ibritumomab tiuxetan Entry deleted as Zevalin (CAP) expired Apr-26
levamisole Entry deleted due to revocation of all levamisole-containing products from the EU market Apr-26
bendroflumethiazide / timolol maleate Entry removed as only authorised in 1 MS Apr-26
chymotrypsin / trypsin Entry deleted - Art 57 has no products Apr-26
benzocaine / tyrothricin Entry removed as only authorised in 1 MS Apr-26
bromelain Entry removed as only authorised in 1 MS Apr-26
acetic acid Entry removed as only authorised in 1 MS Mar-26
atropine sulfate / hyoscine hydrobromide / hyoscyamine sulfate / phenobarbital Entry deleted - Art 57 has no products Mar-26
benzoxonium chloride Entry removed as only authorised in 1 MS Mar-26
carbutamide Entry deleted - Art 57 has no products Mar-26
dextran 70 / hypromellose Entry deleted due to merge (See EURD IDs 11185 or 9280) Mar-26
dextromethorphan hydrobromide / pseudoephedrine hydrochloride Entry deleted - Art 57 has no products Mar-26
dichlorobenzyl alcohol Entry deleted - Art 57 has no products Mar-26
dropropizine Entry removed as only authorised in 1 MS Mar-26
doederlein bacillus selected strain (lactobacillus casei ssp rhamnosus) / estriol / progesterone Entry removed as only authorised in 1 MS Mar-26
melarsoprol Entry removed as only authorised in 1 MS Mar-26
panthenol Entry deleted - Art 57 has no products Mar-26
dicyclomine hydrochloride / paracetamol Entry deleted due to active substance(s) already covered by EURD ID 1051 Mar-26
sodium chromate (51cr) Entry deleted - Art 57 has no products Mar-26
salicylate / triethanolamine Entry deleted - Art 57 has no products Mar-26
arginine glutamate Entry deleted - Art 57 has no products Mar-26
ascorbic acid / cyanocobalamin / folic acid / nicotinamide Entry removed as only authorised in 1 MS Mar-26
gentamicin sulfate / indometacin Entry removed as only authorised in 1 MS Mar-26
chlorpheniramine / dextromethorphan / paracetamol / pseudoephedrine Entry removed as only authorised in 1 MS Mar-26
ascorbic acid / potassium bicarbonate Entry removed as only authorised in 1 MS Mar-26
fluorescein sodium / proxymetacaine hydrochloride Entry deleted - Art 57 has no products Mar-26
sargramostim Entry deleted - Art 57 has no products Mar-26
cinacalcet Entry removed as Mimpara (CAP) withdrawn Feb-26
idebenone (non centrally authorised products) Entry removed as only authorised in 1 MS Feb-26
mometasone / salicylic acid Entry removed as only authorised in 1 MS Feb-26
pranoprofen Entry removed as only authorised in 1 MS Feb-26
aluminium phosphate Entry deleted as other entry covers same products (See EURD ID: 500) Feb-26
ocriplasmin Entry removed as Jetrea (CAP) withdrawn Feb-26
rabbit anti-human thymocyte immunoglobulin Entry deleted due to merge (see EURD ID: 10252) Feb-26
phenylephrine / ketorolac Entry removed as Omidria (CAP) withdrawn Feb-26
atorvastatin / perindopril Entry deleted - Art 57 has no products Feb-26
13C-methacetin Entry deleted - Art 57 has no products Feb-26
sotrovimab Entry removed as XEVUDY (CAP) withdrawn Feb-26
eptifibatide Entry removed as Integrilin (CAP) withdrawn Jan-26
lixisenatide Entry deleted - Art 57 has no products Jan-26
cytidine / uridine triphosphate sodium Entry deleted - Art 57 has no products Dec-25
trandolapril / verapamil Entry deleted due to merge (see EURD ID: 3004) Nov-25
dengue tetravalent vaccine (live, attenuated) [Chimeric yellow fever dengue virus serotype 1 (live, attenuated) / Chimeric yellow fever dengue virus serotype 2 (live, attenuated) / Chimeric yellow fever dengue virus serotype 3 (live, attenuated) / Chimeric yellow fever dengue virus serotype 4 (live, attenuated)] Entry removed as Dengavia (CAP) withdrawn Nov-25
dirithromycin Entry deleted - Art 57 has no products Oct-25
etofylline Entry deleted due to merge (see EURD ID: 1329) Oct-25
moexipril Entry deleted - Art 57 has no products Oct-25
nisoldipine Entry deleted - Art 57 has no products Oct-25
parnaparin Entry removed as only authorised in 1 MS Oct-25
dihydroergocristine / etofylline Entry deleted due to merge (see EURD ID: 1329) Oct-25
ephedrine hydrochloride / resorcinol Entry deleted - Art 57 has no products Oct-25
amlexanox Entry deleted - Art 57 has no products Oct-25
rosuvastatin/ perindopril /indapamide Entry removed due to merge (see EURD ID:10434) Oct-25
tixagevimab / cilgavimab (Evusheld) Entry deleted as Evusheld (CAP) withdrawn Oct-25
rosuvastatin / ramipril Entry removed due to merge (see EURD ID:10434) Sep-25
gemeprost Entry deleted - Art 57 has no products Sep-25
human leucocyte interferon-alfa Entry deleted as there are no products in Art 57 Sep-25
ascorbic acid / paracetamol / pheniramine hydrogenomaleate / phenylephrine hydrochloride Entry removed as only authorised in 1 MS Sep-25
dexketoprofen / tramadol Entry removed due to merge (see EURD ID: 997) Sep-25
cefotiam Entry deleted as there are no products in Art 57 Jul-25
cefpirome Entry deleted as there are no products in Art 57 Jul-25
codeine / diclofenac Entry deleted as there are no products in Art 57 Jul-25
etizolam Entry removed as only authorised in 1 MS Jul-25
methocarbamol / paracetamol Entry deleted due to merge (see EURD ID: 2011) Jul-25
nizatidine Entry removed as only authorised in 1 MS Jul-25
propyphenazone Entry deleted as there are no products in Art 57 Jul-25
sulfafurazole Entry removed as only authorised in 1 MS Jul-25
buprenorphine (implant) Entry deleted due to Sixmo (CAP) withdrawal Jul-25
josamycin Entry removed as only authorised in 1 MS Jun-25
pralsetinib Entry deleted due to product(s) withdrawn Jun-25
alverine / simeticone Entry deleted due to merge (see EURD ID: 124) May-25
amylmetacresol / dichlorobenzyl alcohol Entry deleted due to merge (see EURD ID: 204) May-25
cyanocobalamin / folic acid Entry deleted due to merge (see EURD ID: 892) May-25
dextromethorphan / guaifenesin Entry deleted due to merge (see EURD ID: 1009) May-25
ammonium chloride / codeine phosphate hemihydrate / guaifenesin / thyme oil Entry deleted due to merge (see EURD ID: 1576) May-25
isoniazid / pyridoxine hydrochloride Entry deleted due to merge (see EURD ID: 1789) May-25
isoniazid / rifampicin Entry deleted due to merge (see EURD ID: 1789) May-25
bromelain / trypsin Entry deleted as there are no products in Art 57 May-25
isoniazid / pyrazinamide / rifampicin, ethambutol / isoniazid / pyrazinamide / rifampicin Entry deleted due to merge (see EURD ID: 1789) May-25
dapagliflozin / metformin Entry deleted due to merge (see EURD ID: 10029) May-25
saxagliptin / dapagliflozin Entry deleted due to merge (see EURD ID: 10029) May-25
fidanacogene elaparvovec Entry deleted due to BEQVEZ (CAP) withdrawal May-25
cocarboxylase Entry deleted as there are no products in Art 57 Apr-25
dextromethorphan hydrobromide / dichlorobenzyl alcohol Entry removed as only authorised in 1 MS Apr-25
diethylstilbestrol Entry removed as only authorised in 1 MS Apr-25
dimethyl sulfoxide Entry removed as only authorised in 1 MS Apr-25
diphenhydramine hydrochloride / zinc oxide Entry deleted as there are no products in Art 57 Apr-25
misoprostol / naproxen Entry deleted as there are no products in Art 57 Apr-25
oxaprozin Entry removed as only authorised in 1 MS Apr-25
guaifenesin / oxolamine citrate Entry deleted as there are no products in Art 57 Apr-25
pentobarbital Entry deleted as there are no products in Art 57 Apr-25
phenindione Entry removed as only authorised in 1 MS Apr-25
codeine phosphate hemihydrate / fenpiverinium bromide / paracetamol / pitofenone hydrochloride Entry deleted as there are no products in Art 57 Apr-25
magnesium chloride hexahydrate / potassium chloride / procaine hydrochloride Entry removed as only authorised in 1 MS Apr-25
ephedrine hydrochloride / sulfathiazole Entry removed as only authorised in 1 MS Apr-25
nitrofural / phenazone / tetracaine hydrochloride Entry removed as only authorised in 1 MS Apr-25
shingles (herpes zoster) vaccine (live) Entry deleted due to Zostavax (CAP) withdrawal Apr-25
regdanvimab (Regkirona) Entry deleted due to Regkirona(CAP) withdrawal Apr-25
nifurtimox Entry deleted due to duplicate entry (see EURD ID: 11088) Apr-25
dectaflur / olaflur / sodium fluoride Entry deleted due to merge (See EURD ID: 863) Mar-25
enflurane Entry deleted as there are no products in Art 57 Mar-25
etynodiol Entry deleted as there are no products in Art 57 Mar-25
hydrocortisone / propanocaine Entry removed as only authorised in 1 MS Mar-25
norgestimate Entry deleted as there are no products in Art 57 Mar-25
phenylephrine / zinc sulfate Entry deleted as there are no products in Art 57 Mar-25
pidotimod Entry removed as only authorised in 1 MS Mar-25
epinephrine / prilocaine hydrochloride Entry removed as only authorised in 1 MS Mar-25
doxylamine hydrogen succinate / paracetamol / pseudoephedrine hydrochloride Entry removed as only authorised in 1 MS Mar-25
trifluridine Entry removed as only authorised in 1 MS Mar-25
octreotide (for centrally authorised products) Entry deleted as Mycapssa (CAP) is withdrawn Mar-25
allantoin / aminoacridine / peru balsam / prednisolone Entry deleted as there are no products in Art 57 Feb-25
dextromethorphan hydrobromide / triprolidine hydrochloride Entry deleted as there are no products in Art 57 Feb-25
latanoprost (products with paediatric indication) Entry deleted due to merge with EURD ID: 1832 Feb-25
allantoin / aminoacridine / hydrocortisone hemisuccinate / lidocaine hydrochloride Entry deleted as there are no products in Art 57 Feb-25
mequitazine Entry removed as only authorised in 1 MS Feb-25
phenylephrine hydrochloride / prednisolone acetate Entry deleted as there are no products in Art 57 Feb-25
meningococcal group A, B, C, W and Y vaccine Entry deleted as Penbraya (CAP) is withdrawn Feb-25
quinidine Entry (EURD ID 2595) deleted as there is a duplicate entry EURD ID: 1688 "quinidine, hydroquinidine" Jan-25
obeticholic acid Entry deleted as the marketing authorisation for Ocaliva is revoked by the Commission Implementing Decision of 30 August Jan-25
darvadstrocel Entry deleted as Alofisel (CAP) is withdrawn Jan-25
azacitidine (oral formulations) Entry (EURD ID: 10935) deleted due to merge with EURD ID: 274 Jan-25
chlortalidone / metoprolol Entry removed as only authorised in 1 MS Dec-24
dextromethorphan hydrobromide / mepyramine maleate Entry deleted as there are no products in Art 57 Dec-24
dextromethorphan hydrobromide / guaifenesin / mepyramine maleate Entry deleted as there are no products in Art 57 Dec-24
dextromethorphan hydrobromide / guaifenesin / mepyramine maleate / phenylephrine hydrochloride Entry deleted as there are no products in Art 57 Dec-24
magnesium oxide Entry deleted due to merge (See EURD ID: 1929) Dec-24
pixantrone Entry deleted as Pixuvri (CAP) withdrawn Nov-24
pralsetinib Entry deleted as Gavreto (CAP) withdrawn Nov-24
acetylsalicylic acid / calcium carbonate Entry deleted as there are no products in Art 57 Oct-24
amitriptyline hydrochloride / chlordiazepoxide Entry deleted due to merge (See EURD ID: 661) Oct-24
ascorbic acid / dextromethorphan / paracetamol / pseudoephedrine Entry deleted due to merge (See EURD ID: 2307) Oct-24
alum / benzalkonium chloride Entry removed as only authorised in 1 MS Oct-24
benzalkonium chloride / dimethicone Entry deleted as there are no products in Art 57 Oct-24
benzalkonium chloride / dimethicone / hydrocortisone / nystatin Entry deleted as there are no products in Art 57 Oct-24
benzalkonium chloride / hexylresorcinol Entry deleted due to merge (See EURD ID: 332) Oct-24
benzalkonium chloride / lidocaine Entry removed as only authorised in 1 MS Oct-24
benzalkonium chloride / tolnaftate Entry removed as only authorised in 1 MS Oct-24
chlorhexidine / neomycin Entry removed as only authorised in 1 MS Oct-24
chlorocresol combinations Entry removed as only authorised in 1 MS Oct-24
acetylsalicylic acid / ascorbic acid / caffeine / chlorphenamine maleate Entry removed as only authorised in 1 MS Oct-24
cinchocaine hydrochloride / esculin / framycetin sulfate / hydrocortisone acetate Entry deleted as there are no products in Art 57 Oct-24
clopamide / pindolol Entry removed as only authorised in 1 MS Oct-24
clopamide / reserpine Entry deleted as there are no products in Art 57 Oct-24
codeine polysulfonate / phenyltoloxamine polysulfonate Entry removed as only authorised in 1 MS Oct-24
dextromethorphan / paracetamol Entry deleted due to merge (See EURD ID 2307) Oct-24
dextromethorphan hydrobromide / paracetamol / pseudoephedrine hydrochloride Entry deleted due to merge (See EURD ID 2307) Oct-24
caffeine / codeine phosphate / doxylamine succinate / paracetamol Entry removed as only authorised in 1 MS Oct-24
guaifenesin / pseudoephedrine Entry deleted due to merge (See EURD ID: 1580) Oct-24
measles vaccine (live attenuated) Entry deleted as there are no products in Art 57 Oct-24
menadiol Entry deleted due to merge (See EURD ID: 2400) Oct-24
miglitol Entry deleted as there are no products in Art 57 Oct-24
neomycin sulfate / polymyxin b sulfate Entry removed as only authorised in 1 MS Oct-24
orphenadrine Entry deleted due to merge (See EURD ID: 2224) Oct-24
acetylsalicylic acid / caffeine / codeine / paracetamol Entry deleted due to merge (See EURD ID: 2312) Oct-24
caffeine / codeine / paracetamol Entry deleted due to merge (See EURD ID: 448) Oct-24
quinidine / verapamil hydrochloride Entry deleted as there are no products in Art 57 Oct-24
acetylsalicylic acid / citric acid / sodium hydrogen carbonate Entry deleted due to merge (See EURD ID: 241) Oct-24
ketoprofen / sucralfate Entry removed as only authorised in 1 MS Oct-24
zaleplon Entry removed as only authorised in 1 MS Oct-24
acetylsalicylic acid / codeine phosphate / paracetamol Entry deleted due to merge (See EURD ID: 448) Oct-24
dihydrocodeine / paracetamol Entry removed as only authorised in 1 MS Oct-24
ferrimanitol ovoalbumin Entry removed as only authorised in 1 MS Oct-24
neomycin sulphate / polymyxin b sulfate / prednisolone acetate Entry deleted as there are no products in Art 57 Oct-24
calcium folinate / iron succinyl-protein complex Entry deleted due to merge (See EURD ID 10234) Oct-24
macrogol 3350 combinations (oral use) Entry deleted due to merge (See EURD ID: 1924) Oct-24
dasabuvir, ombitasvir / paritaprevir / ritonavir Entry deleted as Exviera & Viekirax (CAPs) withdrawn on 25/09/2024 Oct-24
dibromotyrosine Entry deleted as there are no products in Art 57 Sep-24
dihydroxyaluminum sodium carbonate Entry deleted due to merge (see EURD ID: 1098) Sep-24
hydrocortisone / oxytetracycline Entry deleted due to merge (see EURD ID: 2262) Sep-24
hydrocortisone acetate / oxytetracycline hydrochloride / polymyxin b Entry deleted due to merge (see EURD ID: 2262) Sep-24
sodium citrate / sodium lauryl sulfoacetate Entry deleted due to merge (see EURD ID: 2735) Sep-24
dibromotyrosine / thiamazole Entry deleted as there are no products in Art 57 Sep-24
magnesium citrate / magnesium lactate Entry deleted dut to merge (see EURD ID 1928) Sep-24
ulipristal acetate (treatment of moderate to severe symptoms of uterine fibroids) Entry deleted as CAP (Esmya) withdrawn on 18/07/2024
Sep-24
obiltoxaximab Entry deleted as CAP (NYXTHRACIS) withdrawn on 02/08/2024
Sep-24
COVID-19 vaccine (Ad26.COV2-S [recombinant]) (JCOVDEN) Entry deleted as CAP (JCOVDEN) withdrawn on 26/07/2024
Sep-24
ethambutol / isoniazid / pyrazinamide / rifampicine Entry deleted as there are no products in Art 57 Jul-24
amifostine Entry deleted as there are no products in Art 57 Jul-24
clemastine / dexamethasone Entry removed as only authorised in 1 MS Jul-24
azidamfenicol Entry removed as only authorised in 1 MS Jun-24
benzalkonium chloride / benzyl alcohol / chlorhexedine Entry removed as only authorised in 1 MS Jun-24
benzododecinium / polysorbate 80, benzododecinium Entry removed as only authorised in 1 MS Jun-24
beractant Entry removed as only authorised in 1 MS Jun-24
chloroxylenol / edetic acid / triclosan Entry deleted as there are no products in Art 57 Jun-24
eberconazole Entry removed as only authorised in 1 MS Jun-24
fluocortolone Entry deleted as there are no products in Art 57 Jun-24
lofexidine Entry deleted as there are no products in Art 57 Jun-24
talinolol Entry deleted as there are no products in Art 57 Jun-24
tiopronin Entry removed as only authorised in 1 MS Jun-24
lamivudine / tenofovir disoproxil Entry removed as only authorised in 1 MS Jun-24
citric acid / potassium / sodium Entry deleted as there are no products in Art 57 May-24
dexamethasone / neomycin Entry deleted due to merge (See EURD ID: 977) May-24
dexamethasone acetate / hydroxyethyl salicylate / salicylamide Entry deleted as there are no products in Art 57 May-24
piretanide Entry deleted due to merge (See EURD ID: 2434) May-24
proguanil Entry deleted as there are no products in Art 57 May-24
tazarotene Entry deleted as there are no products in Art 57 May-24
dexamethasone sodium / framycetin sulfate Entry removed as only authorised in 1 MS May-24
caffeine / chlorphenamine maleate / paracetamol Entry removed as only authorised in 1 MS Apr-24
acetylsalicylic acid / ascorbic acid / chlorphenamine maleate / phenylephrine hydrochloride Entry deleted as there are no products in Art 57 Apr-24
biclotymol / chlorphenamine maleate / phenylephrine hydrochloride Entry deleted as there are no products in Art 57 Apr-24
chlorphenamine / paracetamol / phenylephrine Entry deleted due to merge (See EURD ID: 693) Apr-24
chlorphenamine maleate / codeine phosphate / pseudoephedrine hydrochloride Entry deleted as there are no products in Art 57 Apr-24
acetic acid glacial / dexamethasone / neomycin Entry removed as only authorised in 1 MS Apr-24
mephenesin Entry deleted as there are no products in Art 57 Apr-24
mephenesin / methyl nicotinate Entry deleted as there are no products in Art 57 Apr-24
naloxone / tilidine Entry removed as only authorised in 1 MS Apr-24
glucose anhydrous / nikethamide Entry removed as only authorised in 1 MS Apr-24
chlorphenamine / phenylephrine Entry deleted due to merge (See EURD ID: 710) Apr-24
pirenzepine Entry removed as only authorised in 1 MS Apr-24
propantheline Entry removed as only authorised in 1 MS Apr-24
acetylsalicylic acid / ascorbic acid / chlorphenamine / colae semen Entry deleted as there are no products in Art 57 Apr-24
caffeine / chlorphenamine / paracetamol / phenylephrine Entry removed as only authorised in 1 MS Apr-24
belantamab mafodotin Entry deleted as Blenrep (CAP) expired Apr-24
COVID-19 Vaccine (ChAdOx1-S [recombinant]) (Vaxzevria) Entry deleted as Vaxzevria (CAP) withdrawn Apr-24
benzathine benzylpenicillin, benzathine benzylpenicillin / lidocaine Entry deleted due to merge with EURD ID: 383 Mar-24
cetylpyridinium / menthol Entry deleted as there are no products in Art 57 Mar-24
ciprofloxacin hydrochloride / dexamethasone acetate Entry deleted as already covered under EURD ID: 10012 Mar-24
homatropine Entry removed as only authorised in 1 MS Mar-24
lauromacrogol / lidocaine / matricariae tinctura Entry removed as only authorised in 1 MS Mar-24
mezlocillin Entry deleted as there are no products in Art 57 Mar-24
orciprenaline Entry deleted as there are no products in Art 57 Mar-24
procaine benzylpenicillin Entry deleted due to merge with EURD ID: 383 Mar-24
sulfogaiacol Entry deleted due to merge with EURD ID: 10542 Mar-24
codeine phosphate / sulfogaiacol Entry deleted due to merge with EURD ID: 10542 Mar-24
SARS-CoV-2, B.1.351 variant, prefusion Spike delta TM protein, recombinant Entry deleted as Vidprevtyn Beta (CAP) withdrawn on 11 March 2024 Mar-24
ascorbic acid / caffeine citrate / chlorphenamine maleate / dextromethorphan hydrobromide / paracetamol Entry removed as only authorised in 1 MS Mar-24
chlorphenamine maleate / diphenhydramine hydrochloride / phenylephrine hydrochloride Entry removed as only authorised in 1 MS Mar-24
chlortalidone / clonidine hydrochloride Entry removed as only authorised in 1 MS Mar-24
calcium pantothenate / cystine / keratin / p-aminobenzoic acid / thiamine / yeast Entry deleted as there are no products in Art 57 Mar-24
demoxytocin Entry removed as only authorised in 1 MS Mar-24
diclofenamide Entry deleted as there are no products in Art 57 Mar-24
pandemic influenza vaccine (H5N1) (whole virion, Vero cell derived, inactivated) Entry deleted as there are no products in Art 57 Mar-24
dichlorobenzyl alcohol / sodium benzoate Entry removed as only authorised in 1 MS Mar-24
dextropropoxyphene hydrochloride Entry removed as only authorised in 1 MS Mar-24
benzododecinium bromide Entry deleted due to merge with EURD ID: 369 Feb-24
chorionic gonadotrophin Entry deleted due to merge with EURD ID: 736 Feb-24
dihydralazine Entry deleted due to merge with EURD ID: 1646 Feb-24
dihydralazine / hydrochlorothiazide / reserpine Entry deleted as there are no products in Art 57 Feb-24
dimethoxanate Entry deleted as there are no products in Art 57 Feb-24
framycetin sulfate / lidocaine hydrochloride / salicylates / triamcinolone acetonide Entry deleted as there are no products in Art 57 Feb-24
hydralazine hydrochloride / hydrochlorothiazide / metoprolol tartrate Entry deleted as there are no products in Art 57 Feb-24
chlortalidone / hydralazine hydrochloride / oxprenolol hydrochloride Entry deleted as there are no products in Art 57 Feb-24
hydralazine hydrochloride / propranolol hydrochloride Entry deleted as there are no products in Art 57 Feb-24
polyvinyl alcohol / povidone Entry 2477 deleted due to merge with EURD ID: 2475 Feb-24
reteplase Entry deleted as Rapilysin (CAP) withdrawn on 26 Jan 2024 Feb-24
copper (64Cu) chloride Entry deleted as Cuprymina (CAP) withdrawn on 25 Jan 2024 Feb-24
estradiol / medroxyprogesterone acetate
Entry deleted due to merge with EURD ID: 582 Jan-24
ornithine Entry deleted due to merge with EURD ID: 10187 Jan-24
perazine
Entry deleted due to merge with EURD ID: 2426 & 2536 Jan-24
thiethylperazine
Entry deleted due to merge with EURD ID: 2426 & 2536 Jan-24
trifluoperazine
Entry deleted due to merge with EURD ID: 2426 & 2536 Jan-24
caffeine / indomethacin / proclorperazine maleate Entry removed as no products identified in Art 57 Jan-24
acetylsalicylic acid / dipyridamole Entry removed as only authorised in 1 MS Jan-24
abciximab Entry removed as no products identified in Art 57 Dec-23
acrivastine / pseudoephedrine Deletion of entry due to merge with EURD ID 54 Dec-23
altretamine Entry removed as only authorised in 1 MS Dec-23
aluminium hydroxide gel / calcium carbonate Entry removed as no products identified in Art 57 Dec-23
amiloride Deletion due to merge entries EURD ID: 145, 146, 147, 149 and 151 with entry EURD ID: 148 Dec-23
amiloride / bumetanide Deletion due to merge entries EURD ID: 145, 146, 147, 149 and 151 with entry EURD ID: 148 Dec-23
amiloride / chlortalidone Deletion due to merge entries EURD ID: 145, 146, 147, 149 and 151 with entry EURD ID: 148 Dec-23
amiloride / hydrochlorthiazide Deletion due to merge entries EURD ID: 145, 146, 147, 149 and 151 with entry EURD ID: 148 Dec-23
amiloride / hydrochlorthiazide / timolol Deletion due to merge entries EURD ID: 145, 146, 147, 149 and 151 with entry EURD ID: 148 Dec-23
amitriptyline hydrochloride / medazepam Entry removed as only authorised in 1 MS Dec-23
bacitracin / neomycin Entry deleted due to merge all the bacitracin containing entries (EURD ID: 288, 289, 291, 292 and 9072) in a single one (EURD ID: 285) Dec-23
bacitracin / hydrocortisone / neomycin Entry deleted due to merge all the bacitracin containing entries (EURD ID: 288, 289, 291, 292 and 9072) in a single one (EURD ID: 285) Dec-23
bacitracin zinc / cystein / glycine / neomycin sulfate / threonine Entry deleted due to merge all the bacitracin containing entries (EURD ID: 288, 289, 291, 292 and 9072) in a single one (EURD ID: 285) Dec-23
bacitracin zinc / neomycin sulfate / polymyxin b sulfate Entry deleted due to merge all the bacitracin containing entries (EURD ID: 288, 289, 291, 292 and 9072) in a single one (EURD ID: 285) Dec-23
bisacodyl combinations Entry deleted due to merge with EURD ID: 416 Dec-23
canrenone Entry removed as only authorised in 1 MS Dec-23
chloroxine Entry removed as only authorised in 1 MS Dec-23
colecalciferol Entry deleted due to merge entries EURD ID: 862, 1249 and 9089 with entry EURD ID: 10386 Dec-23
cyanamide Entry removed as no products identified in Art 57 Dec-23
caffeine / cyclizine / ergotamine Entry removed as only authorised in 1 MS Dec-23
dimemorfan Entry removed as no products identified in Art 57 Dec-23
efavirenz / emtricitabine / tenofovir
Entry removed as Atripla (CAP) surrendered Dec-23
ergocalciferol Entry deleted due to merge entries EURD ID: 862, 1249 and 9089 with entry EURD ID: 10386 Dec-23
lomefloxacin Entry removed as only authorised in 1 MS Dec-23
neostigmine Entry deleted due to merge with EURD ID: 1557 Dec-23
nilvadipine Entry removed as only authorised in 1 MS Dec-23
pneumococcal polysaccharide conjugate vaccine (adsorbed) - 7 valent
Entry removed as Prevenar (CAP) surrendered Dec-23
quazepam Entry removed as no products identified in Art 57 Dec-23
cinchonidine / cinchonine / quinidine / quinine Entry removed as only authorised in 1 MS Dec-23
saquinavir
Entry removed as Invirase (CAP) surrendered Dec-23
bacitracin / polymyxine Entry deleted due to merge all the bacitracin containing entries (EURD ID: 288, 289, 291, 292 and 9072) in a single one (EURD ID: 285) Dec-23
calcium / ergocalciferol Entry deleted due to merge entries EURD ID: 862, 1249 and 9089 with entry EURD ID: 10386 Dec-23
bupivacaine/meloxicam
Entry removed as Zynrelef (CAP) withdrawn on 05.10.23 Nov-23
chlorphenamine maleate / pholcodine Entry removed due to referral 107i/1521 adopted in Dec 2022:
CMDh AR conclusions: The Committee, as a consequence, considers that the benefit-risk balance of pholcodine-containing medicinal products is not favourable.
Therefore, pursuant to Article 116 of Directive 2001/83/EC, the Committee recommends the revocation of the marketing authorisations for pholcodine-containing medicinal products. Nov-23
paracetamol / pholcodine / pseudoephedrine Entry removed due to referral 107i/1521 adopted in Dec 2022:
CMDh AR conclusions: The Committee, as a consequence, considers that the benefit-risk balance of pholcodine-containing medicinal products is not favourable.
Therefore, pursuant to Article 116 of Directive 2001/83/EC, the Committee recommends the revocation of the marketing authorisations for pholcodine-containing medicinal products. Nov-23
pholcodine / biclotymol / chlorphenamine maleate Entry removed due to referral 107i/1521 adopted in Dec 2022:
CMDh AR conclusions: The Committee, as a consequence, considers that the benefit-risk balance of pholcodine-containing medicinal products is not favourable.
Therefore, pursuant to Article 116 of Directive 2001/83/EC, the Committee recommends the revocation of the marketing authorisations for pholcodine-containing medicinal products. Nov-23
SARS-CoV-2 virus, strain wuhan hCoV-19/Italy/INMI1-isl/2020, inactivated (Valneva) Entry removed as COVID-19 Vaccine (inactivated, adjuvanted) Valneva was withdrawn on 12.10.23 Nov-23
dimenhydrinate Entry removed due to merge (See EURD ID: 1088) Oct-23
hydrochlorothiazide / propranolol / triamterene Entry removed due to merge (See EURD ID: 1644) Oct-23
metildigoxin Entry removed due to merge (See EURD ID: 1065) Oct-23
nitrofurantoin / pyridoxine hydrochloride Entry removed due to merge (See EURD ID: 2174) Oct-23
pancreatic enzymes, pancreatic extracts, pancreatin (except for the centrally authorised product) Entry removed due to merge (See EURD ID: 2705) Oct-23
pancreatin / simeticone Entry removed due to merge (See EURD ID: 2705) Oct-23
dimethicone / pancreatin Entry removed due to merge (See EURD ID: 2705) Oct-23
selenite sodium Entry removed due to merge (See EURD ID: 2690) Oct-23
hydrochlorothiazide / triamterene / verapamil hydrochloride Entry removed due to merge (See EURD ID: 3107) Oct-23
xipamide Entry removed due to merge (See EURD ID: 3133) Oct-23
crizanlizumab
Entry for deletion as Adakveo (CAP) is revoked Oct-23
iodohippurate sodium (123i) Entry removed as no products identified in Art 57 Sep-23
elivaldogene autotemcel
Entry for deletion as Skysona (CAP) is withdrawn Sep-23
naphazoline nitrate / prednisolone Entry removed as only authorised in 1 MS Aug-23
dextromethorphan hydrobromide / quinidine sulfate Entry removed as no products identified in Art 57 Aug-23
neridronic acid Entry removed as no products identified in Art 57 Aug-23
penfluridol Entry removed as only authorised in 1 MS Aug-23
chlorphenoxamine Entry removed as only authorised in 1 MS Aug-23
acrivastine / pseudoephedrine Entry removed due to merge with EURD ID 54 “Acrivastine, acrivastine / pseudoephedrine” Jul-23
pholcodine Entry removed due to products' revocation (following Referral procedure) Jul-23
rufloxacin Entry removed as only authorised in 1 MS Jul-23
risperidone (centrally authorised products only) Entry removed due to merge with EURD ID: 2649 Jul-23
iodohippurate sodium (123i) Entry removed as no products identified in Art 57 Jun-23
betamethasone / diprophylline / guaifenesin Entry removed as only authorised in 1 MS Jun-23
ioxaglic acid Entry removed as no products identified in Art 57 Jun-23
lysine acetylsalicylate Entry removed due to merge with EURD ID: 39 (acetylsalicylic acid) Jun-23
lidocaine / norepinephrine Entry removed as only authorised in 1 MS Jun-23
sodium benzoate / grindelia tincture / polygala syrup Entry removed as only authorised in 1 MS Jun-23
calcium chloride / glucose monohydrate / magnesium chloride hexahydrate Entry removed due to merge (see EURD ID: 10424) Apr-23
piretanide Entry removed due to merge (see EURD ID: 2434) Apr-23
peppermint oil Entry removed as no longer fulfils requirements for inclusion in EURD list Apr-23
nilvadipine Entry removed as only authorised in 1 MS Mar-23
sulbactam Entry removed as only authorised in 1 MS Mar-23
xenon Entry removed as only authorised in 1 MS Mar-23
indinavir Entry removed as Crixivan (CAP) was withdrawn Jan-23
metformin / saxagliptin Entry removed due to merge with EURD ID: 2685 (saxagliptin) Jan-23
telbivudine Entry removed as Sebivo (CAP) was withdrawn Jan-23
telithromycin Entry removed as Ketek (CAP) was withdrawn Jan-23
ibalizumab Entry removed as Trogarzo (CAP) was withdrawn Jan-23
equine tetanus immunoglobulin Entry removed as no products identified in Art 57 Jan-23
adefovir Entry removed as Hepsera (CAP) was withdrawn Dec-22
peginterferon alpha-2b Entry removed as PegIntron & ViraferonPeg (CAP) were withdrawn Dec-22
botulinum toxin type b Entry removed as NeuroBloc (CAP) was withdrawn Dec-22
aminotridecane adipate Entry removed as no products identified in Art 57 Nov-22
strontium [89sr] chloride Entry removed as only authorised in 1 MS Nov-22
atenolol / nifedipine Entry removed as only authorised in 1 MS Nov-22
diphtheria / tetanus / pertussis (acellular, component) / haemophilus type b conjugate vaccine (adsorbed) Entry removed as no products identified in Art 57 Oct-22
leuprorelin (except for depot formulations) Entry removed as only authorised in 1 MS Oct-22
hydrochlorothiazide / moexipril Entry removed as only authorised in 1 MS Oct-22
halofantrine Entry removed as no products identified in Art 57 Sep-22
ertugliflozin Entry ID removed due to merge (see entry ID: 10784) Sep-22
ceftibuten Entry removed as only authorised in 1 MS Jul-22
interferon alpha-2a Entry removed as only authorised in 1 MS Jul-22
calcium chloride / glucose / magnesium chloride hexahydrate / sodium chloride / sodium hydrogen carbonate Entry removed as no products identified in Art 57 (Products covered/moved to EURD ID: 2724) Jul-22
cloxazolam Entry removed as only authorised in 1 MS Jul-22
sotagliflozin Entry removed as Zynquista (CAP) was withdrawn Jun-22
nateglinide Entry removed as Starlix (CAP) was withdrawn May-22
moxetumomab pasudotox Entry removed as Lumoxiti (CAP) was withdrawn May-22
cefodizime Entry removed as only authorised in 1 MS May-22
benzalkonium chloride (incl ocular) Entry removed due to merge. See EURD ID: 10987 Apr-22
sodium aurothiomalate Entry removed as no products identified in Art 57 Apr-22
calcium pantothenate / nicotinamide / pyridoxine / riboflavin / thiamine Entry removed due to merge. See EURD ID: 10807 Apr-22
dicobalt edetate Entry removed as only authorised in 1 MS Apr-22
betibeglogene autotemcel Entry removed as Zynteglo (CAP) was withdrawn Apr-22
flubendazole Entry removed as only authorised in 1 MS Mar-22
oxatomide Entry removed as only authorised in 1 MS Mar-22
pergolide Entry removed as only authorised in 1 MS Mar-22
lesinurad Entry removed as Zurampic (CAP) was withdrawn Mar-22
naltrexone Entry removed as only authorised in 1 MS Feb-22
crisaborole Entry removed as Staquis (CAP) was withdrawn Feb-22
didanosine Entry removed as no products identified in Art 57 Jan-22
fenoterol (obsteric indications) Entry removed as only authorised in 1 MS Jan-22
influenza vaccine (split virion, inactivated, prepared in cell cultures) Entry removed as no products identified in Art 57 Jan-22
benzoyl peroxide hydrous / potassium hydroxyquinoline sulphate Entry removed as only authorised in 1 MS Jan-22
allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2) Entry removed as Zalmoxis (CAP) was withdrawn Jan-22
allopurinol / lesinurad Entry removed as no products identified in Art 57 Jan-22
cinoxacin Entry removed as only authorised in 1 MS Dec-21
enoxacin Entry removed as no products identified in Art 57 Dec-21
fluocinolone acetonide / framycetin Entry ID removed due to merge (see entry ID: 1952) Dec-21
fluocinolone acetonide / ketocaine hydrochloride Entry ID removed due to merge (see entry ID: 1952) Dec-21
interferon alpha-2b Entry removed as IntronA (CAP) was withdrawn Dec-21
erythromycin / isotretinoin, isotretinoin (topical formulations) Entry removed as only authorised in 1 MS Dec-21
nalidixic acid Entry removed as no products identified in Art 57 Dec-21
pipemidic acid Entry removed as no products identified in Art 57 Dec-21
dihydroergocryptine Entry removed as no products identified in Art 57 Oct-21
dihydroergotoxine Entry removed as only authorised in 1 MS Oct-21
ispaghula husk, ispaghula husk/ ispaghula seed, ispaghula husk/ispaghula seed/senna Tinnervelly pod, psyllium, psyllium husk, psyllium seed Entry removed as GPAG outcome adopted by PRAC Oct-21
senna glycosides standardised 60% Entry removed as GPAG outcome adopted by PRAC Oct-21
eluxadoline Entry removed due to Truberzi (CAP) surrendered Aug-21
necitumumab Entry removed due to Portrazza (CAP) expiry of MA Jul-21
lidocaine Entry removed due to split (see entry ID: 10933 and 10934) Jun-21
collagenase clostridium histolyticum (treatment of Dupuytren’s contracture and treatment of Peyronie’s disease) Entry removed due to Xiapex (CAP) withdrawal Jun-21
methionine Entry removed as only authorised in 1 MS May-21
meningococcal group a and c polysaccharide vaccine Entry removed as only authorised in 1 MS May-21
benzathine benzylpenicillin / procaine benzylpenicillin Entry removed as only products authorised under WEU May-21
furosemide / ramipril Entry removed as only authorised in 1 MS Apr-21
cholic acid (CTX, AMACR or cholesterol 7α-hydroxylase deficiency indication) Entry removed as Kolbam was withdrawn Mar-21
meningococcal group a, c, w135, y polysaccharide vaccine Entry removed as no products identified in Art 57 Mar-21
alendronate / alfacalcidol Entry removed as only authorised in 1 MS Mar-21
peramivir Entry removed as Alpivab was withdrawn Mar-21
alitretinoin (cutaneous use) Entry removed as Panretin was withdrawn Feb-21
oxytocin Entry removed due to split (see entry ID: 10913 and 10914) Feb-21
indoramin Entry removed as only authorised in 1 MS Jan-21
quizartinib Entry removed as no products identified in Art 57 Jan-21
fluticasone / salmeterol (for centrally authorised products) Entry removed as product no longer authrorised Jan-21
ivabradine Entry ID removed due to merge (see entry ID: 10883) Dec-20
carvedilol / ivabradine Entry ID removed due to merge (see entry ID: 10883) Dec-20
strontium ranelate Entry removed as Protelos and Osseor were withdrawn in April 2020 Nov-20
benzocain / neomycin sulfate Entry removed as only authorised in 1 MS Oct-20
stavudine Entry removed as Zerit was withdrawn in June 2020 Sep-20
iron (parenteral preparations, except for iron dextran) Entry removed due to split (see entry ID: 10864, 10865, 10866 and 10867) Sep-20
ingenol mebutate Entry removed as product no longer authrorised Jul-20
hydrocortisone (except for products indicated in adrenal insufficiency in a modified release tablet formulation) Entry removed due to split (See entries ID: 10855, 10856) Jul-20
rubella vaccine (live, attenuated) Entry removed as only authorised in 1 MS Jun-20
technetium (99mtc) tiatide Entry removed as no products identified in Art 57 Jun-20
rolapitant Entry removed as Varuby was withdrawn in Jan 2020 Jun-20
rimexolone Entry removed as no products identified in Art 57 May-20
ferric citrate coordination complex Entry removed as product no longer authrorised May-20
chlorpropamide Entry removed as no products identified in Art 57 May-20
lidocaine hydrochloride monohydrate / fludrocortisone acetate / neomycin sulfate / polymyxin b Entry removed due to merge (See entry ID: 10847) May-20
lidocaine / paraformaldehyde Entry removed as no products identified in Art 57 May-20
lidocaine / pentosan polysulfate sodium / triamcinolone,
lidocaine / triamcinolone Entry removed as no products identified in Art 57 May-20
lidocaine hydrochloride / neomycin sulfate / polymyxin b Entry removed due to merge (See entry ID: 10847) May-20
pheniramine maleate / tetryzoline hydrochloride Entry removed as only authorised in 1 MS May-20
ergocalciferol / retinol acetate Entry removed as no products identified in Art 57 May-20
a-tocopherol / ergocalciferol / phytomenadion / retinol palmitate Entry removed as no products identified in Art 57 May-20
calcium carbonate / sodium alginate / sodium bicarbonate Entry removed due to merge (See entry ID: 10845) May-20
sodium alginate / sodium bicarbonate Entry removed due to merge (See entry ID: 10845) May-20
sulfanilamide Entry removed as no products identified in Art 57 May-20
adenosine 5' triphosphate / disodium salt Entry removed as only authorised in 1 MS Apr-20
125i-human serum albumin Entry removed as only authorised in 1 MS Mar-20
acetyldigoxin combinations Entry removed as only authorised in 1 MS Mar-20
adenosine / cytochrome c / nicotinamide / sodium succinate / sorbitol Entry removed as no products identified in Art 57 Mar-20
adenosine 5' triphosphate / disodium salt / glycine Entry removed as no products identified in Art 57 Mar-20
alpha amylase / bacitracin Entry removed as no products identified in Art 57 Mar-20
alpha chymotrypsin Entry removed as no products identified in Art 57 Mar-20
aluminium / calcium / sodium Entry removed as no products identified in Art 57 Mar-20
aminocaproic acid / esculina / hesperidina metil chalcona / menadiona / menadione sodium bisulfite Entry removed as no products identified in Art 57 Mar-20
amylsalicylate / levomenthol / methylnicotinate Entry removed as no products identified in Art 57 Mar-20
anatoxin staphylococcal native mixed alpha / beta and delta Entry removed as no products identified in Art 57 Mar-20
benzalkonium chloride / oxymetazoline Entry removed as no products identified in Art 57 Mar-20
benzylnicotinate / hydroxyethyl salicylate Entry removed as no products identified in Art 57 Mar-20
dihydroergocristine / esculinum / rutoside Entry removed as only authorised in 1 MS Mar-20
dihydroergocristine mesilate / raubasine Entry removed as no products identified in Art 57 Mar-20
caffeine / dihydroergotamine / propyphenazone Entry removed as no products identified in Art 57 Mar-20
dihydroergotoxin / hydrochlorothiazide / reserpine Entry removed as no products identified in Art 57 Mar-20
anthracene glycosides / glycosides hidroxiantracénicos / iodine Entry removed due to merge (See entry ID: 10838) Mar-20
lidocaine / matricariae extract Entry removed as no products identified in Art 57 Mar-20
potassium / sodium / triclosan Entry removed as no products identified in Art 57 Mar-20
codeine phosphate / promethazine hydrochloride Entry removed as no products identified in Art 57 Mar-20
ascorbic acid / calcium hydrogenphosphate / calcium panthotenate / colecalciferol / cyanocobalamin / folic acid / nicotinamide / pyridoxine hydrochloride / retinol / riboflavine / thiamin nitrate, ascorbic acid / cyanocobalamin / ergocalciferol / nicotinamide / pyridoxine / retinol / riboflavin / thiamine hydrochloride, ascorbic acid / colecalciferol / dexpanthenol / nicotinamide / pyridoxine / retinol / riboflavin / thiamine Entry removed as only authorised in 1 MS Mar-20
a-tocopheryl acetate / retinol acetate Entry removed as only authorised in 1 MS Mar-20
pyridoxine hydrochloride / retinol acetate / tocopheryl acetate Entry removed as no products identified in Art 57 Mar-20
a-tocoferol acetate / aurantii aetheroleum / citri aetheroleum / retinol palmitate / terpineol Entry removed as no products identified in Art 57 Mar-20
sacarose / trioxymethylene Entry removed as no products identified in Art 57 Mar-20
saccharomyces cerevisiae / sodium sulfate Entry removed as no products identified in Art 57 Mar-20
sulfabenzamide / sulfacetamide / sulfathiazole Entry removed as no products identified in Art 57 Mar-20
pyrimethamine / sulfalene Entry removed as only authorised in 1 MS Mar-20
aminopropylone / sulodexide Entry removed as no products identified in Art 57 Mar-20
sulphur / triclosan Entry removed as no products identified in Art 57 Mar-20
oxydation product / terebenthin essential oil Entry removed as no products identified in Art 57 Mar-20
calcium carbonate / magnesium carbonate / sodium bicarbonate Entry removed due to merge (See entry ID: 10837) Mar-20
allethrin (isomers and mixtures of isomers) / piperonyl butoxide Entry removed as only authorised in 1 MS Mar-20
cibenzoline Entry removed as only authorised in 1 MS Feb-20
formaldehyde Entry removed as only authorised in 1 MS Feb-20
pristinamycin Entry removed as only authorised in 1 MS Feb-20
guanosine / inosine / miconazole nitrate / vitamin f Entry removed due to merge (See entry ID: 10425) Jan-20
levonorgestrel Entry removed due to split (See entry ID: 107831 and 107832) Jan-20
nilvadipine Entry removed as it no longer fulfills the criteria for remaining on the list Jan-20
phentermine Entry removed as it no longer fulfills the criteria for remaining on the list Jan-20
charcoal activated / sodium thiosulphate Entry removed due to merge (See entry ID: 107816) Jan-20
androstanolone Entry removed as only authorised in 1 MS Dec-19
acetyldigoxin Entry removed as only authorised in 1 MS Nov-19
allobarbital / aminophenazone Entry removed as no products identified in Art 57 Nov-19
allopurinol / benzbromarone Entry removed as only authorised in 1 MS Nov-19
ambucetamide Entry removed as no products identified in Art 57 Nov-19
amiloride / hydrochlorthiazide / methyldopa Entry removed as no products identified in Art 57 Nov-19
aminaftone Entry removed as only authorised in 1 MS Nov-19
amlodipine / benazepril Entry removed as no products identified in Art 57 Nov-19
amoxicillin / metronidazole Entry removed as no products identified in Art 57 Nov-19
amoxicillin trihydrate / clarithromycin / lansoprazole Entry removed as no products identified in Art 57 Nov-19
amphetamine Entry removed as no products identified in Art 57 Nov-19
amphetamine / dextroamfetamine Entry removed as no products identified in Art 57 Nov-19
ascorbic acid / biotin / cyanocobalamin / folic acid / niacinamide / pantothenic acid / pyridoxine hydrochloride / riboflavin / thiamine mononitrate, biotine / cyanocobalamin / nicotinamide / pantothenic acid / pyridoxine / riboflavin / thiamine Entry removed due to merge (See entry ID: 107808) Nov-19
auranofin Entry removed as only authorised in 1 MS Nov-19
azepentacene polysulfonate sodium Entry removed as no products identified in Art 57 Nov-19
bacitracin / neomycin / prednisolone Entry removed as no products identified in Art 57 Nov-19
benfotiamine / biotin / cyanocobalamin / pantothenic acid / pyridoxine / retinol Entry removed as no products identified in Art 57 Nov-19
benfotiamine / cyanocobalamin Entry removed as only authorised in 1 MS Nov-19
benfotiamine / cyanocobalamin / pyridoxine Entry removed as only authorised in 1 MS Nov-19
benfotiamine / caffeine / codeine / paracetamol / propyphenazone Entry removed as no products identified in Art 57 Nov-19
benfotiamine / pyridoxine Entry removed as only authorised in 1 MS Nov-19
benidipine Entry removed as no products identified in Art 57 Nov-19
benzalkonium chloride / chloroxylenol / disodium edetate Entry removed as no products identified in Art 57 Nov-19
benzatropine Entry removed as no products identified in Art 57 Nov-19
benzonatate Entry removed as no products identified in Art 57 Nov-19
brompheniramine maleate / codeine phosphate / guaifenesin Entry removed as no products identified in Art 57 Nov-19
buclizine hydrochloride / cyanocobalamin / lysine hydrochloride / pyridoxine hydrochloride / tryptophan Entry removed as no products identified in Art 57 Nov-19
bupranolol Entry removed as no products identified in Art 57 Nov-19
buprenorphine hydrochloride / salicylic acid Entry removed as no products identified in Art 57 Nov-19
butalbital / paracetamol Entry removed as no products identified in Art 57 Nov-19
butalbital / caffeine / paracetamol Entry removed as no products identified in Art 57 Nov-19
butalbital / caffeine / codeine phosphate / paracetamol Entry removed as no products identified in Art 57 Nov-19
butenafine Entry removed as no products identified in Art 57 Nov-19
butriptyline Entry removed as no products identified in Art 57 Nov-19
cafedrine Entry removed as no products identified in Art 57 Nov-19
calamine Entry removed as no products identified in Art 57 Nov-19
calcium / magnesium / phosphorus Entry removed as only authorised in 1 MS Nov-19
cannabidiol (except for centrally authorised product) Entry removed as no products identified in Art 57 Nov-19
carbenicillin Entry removed as no products identified in Art 57 Nov-19
carbimide Entry removed as no products identified in Art 57 Nov-19
carbinoxamine maleate / phenylephrine hydrochloride Entry removed as no products identified in Art 57 Nov-19
carmellose (except for eye preparation) Entry removed as no products identified in Art 57 Nov-19
adenine / benfotiamine / carnitine orotate / fructose / nicotinamide / pantothenic acid / potassium orotate / pyridoxine / riboflavin / xanthine Entry removed as no products identified in Art 57 Nov-19
cefcapene Entry removed as no products identified in Art 57 Nov-19
cefpiramide Entry removed as no products identified in Art 57 Nov-19
cefsulodin Entry removed as no products identified in Art 57 Nov-19
cefteram Entry removed as no products identified in Art 57 Nov-19
ceftezole Entry removed as no products identified in Art 57 Nov-19
cefapirin Entry removed as no products identified in Art 57 Nov-19
cerivastatin Entry removed as no products identified in Art 57 Nov-19
benzoyl peroxide / cetylpyridinium chloride Entry removed as no products identified in Art 57 Nov-19
chlormadinone / estradiol Entry removed as no products identified in Art 57 Nov-19
chlornitrofenol Entry removed as no products identified in Art 57 Nov-19
chlorobutanol / levomenthol / pine oils / terpineol / thymol Entry removed as only authorised in 1 MS Nov-19
chlorothiazide Entry removed as no products identified in Art 57 Nov-19
chloroxylenol / disodium edetate Entry removed as no products identified in Art 57 Nov-19
chlorphenamine maleate / hydrocodone bitartrate / phenylephrine hydrochloride Entry removed as no products identified in Art 57 Nov-19
chlorphenamine maleate / hydrocodone polistirex Entry removed as no products identified in Art 57 Nov-19
chlorphenamine maleate / paracetamol / phenylephrine hydrochloride / phenyltoloxamine citrate Entry removed as no products identified in Art 57 Nov-19
chlorproethazine Entry removed as no products identified in Art 57 Nov-19
chlortetracycline / demeclocycline / tetracycline Entry removed as no products identified in Art 57 Nov-19
chlorxylenol / cinchocaine Entry removed as no products identified in Art 57 Nov-19
chlorzoxazone / paracetamol Entry removed as no products identified in Art 57 Nov-19
cilastatin Entry removed as no products identified in Art 57 Nov-19
bismuth subgallate / cinchocaine hydrochloride / oxidised cellulose calcium salt Entry removed as no products identified in Art 57 Nov-19
clofibrate Entry removed as no products identified in Art 57 Nov-19
clorazepate / pyridoxine Entry removed as no products identified in Art 57 Nov-19
codeine / creosote Entry removed as no products identified in Art 57 Nov-19
codeine / diphenhydramine Entry removed as no products identified in Art 57 Nov-19
codeine / ephedrine hydrochloride / guaifenesin Entry removed as no products identified in Art 57 Nov-19
codeine polysulfonate / guaifenesin / phenyltoloxamine Entry removed as no products identified in Art 57 Nov-19
codeine polysulfonate / guaifenesin / phenyltoloxamine / thyme Entry removed as no products identified in Art 57 Nov-19
codeine polysulfonate resin Entry removed as no products identified in Art 57 Nov-19
cyanocobalamin / folic acid / nicotinamide / pantothenic acid / pyridoxine hydrochloride / riboflavin / thiamine nitrate Entry deleted due to merge (see Entry ID: 107808) Nov-19
cyproheptadine hydrochloride / dimethylaminoethanol acetylglutamate / metoclopramide hydrochloride Entry removed as no products identified in Art 57 Nov-19
dantrone / poloxamer Entry removed as no products identified in Art 57 Nov-19
delavirdine Entry removed as no products identified in Art 57 Nov-19
dexbudesonide Entry removed as no products identified in Art 57 Nov-19
dexetimide Entry removed as no products identified in Art 57 Nov-19
dextranomer Entry removed as no products identified in Art 57 Nov-19
dextromethorphan hydrobromide / phenylpropanolamine hydrochloride Entry removed as no products identified in Art 57 Nov-19
dextromethorphan hydrobromide / guaifenesin / pseudoephedrine hydrochloride Entry removed as no products identified in Art 57 Nov-19
dextromethorphan hydrobromide / guaifenesin / paracetamol / pseudoephedrine hydrochloride Entry removed as only authorised in 1 MS Nov-19
chlorphenamine / dextromethorphan hydrochloride / phenylephrine hydrochloride Entry removed as no products identified in Art 57 Nov-19
dibenzepine Entry removed as no products identified in Art 57 Nov-19
diclofenac / gentamicin Entry removed as no products identified in Art 57 Nov-19
diclofenac / tobramycin Entry removed as no products identified in Art 57 Nov-19
diclofenac sodium / lidocaine Entry removed as no products identified in Art 57 Nov-19
dipivefrine Entry removed as no products identified in Art 57 Nov-19
dipivefrine hydrochloride / guanethidine Entry removed as no products identified in Art 57 Nov-19
docusate Entry deleted due to merge (See Entry ID: 107806) Nov-19
doxercalciferol Entry removed as no products identified in Art 57 Nov-19
erythromycin Entry removed due to split (See entry ID: 10808 and 10809) Nov-19
ethambutol / isoniazid Entry removed as no products identified in Art 57 Nov-19
ethambutol / isoniazid / rifampicine Entry removed as no products identified in Art 57 Nov-19
etoperidone Entry removed as no products identified in Art 57 Nov-19
etynodiol / mestranol Entry removed as no products identified in Art 57 Nov-19
fenbufen Entry removed as no products identified in Art 57 Nov-19
fendiline Entry removed as no products identified in Art 57 Nov-19
flurithromycin Entry removed as no products identified in Art 57 Nov-19
guaifenesin / hydrocodone Entry removed as no products identified in Art 57 Nov-19
guaifenesin / pentoxyverine Entry removed as no products identified in Art 57 Nov-19
hyaluronate zinc Entry removed as no products identified in Art 57 Nov-19
hydrochlorothiazide / methyldopa Entry removed as no products identified in Art 57 Nov-19
hydrochlorothiazide / reserpine / triamterene Entry removed as no products identified in Art 57 Nov-19
hydrocodone Entry removed as no products identified in Art 57 Nov-19
homatropine methylbromide / hydrocodone bitartrate Entry removed as no products identified in Art 57 Nov-19
hydrocodone bitartrate / ibuprofen Entry removed as no products identified in Art 57 Nov-19
hydrocodone bitartrate / paracetamol Entry removed as no products identified in Art 57 Nov-19
guaifenesin / hydrocodone bitartrate / phenylephrine hydrochloride Entry removed as no products identified in Art 57 Nov-19
hydrocodone bitartrate / phenyltoloxamine citrate Entry removed as no products identified in Art 57 Nov-19
escherichia coli / hydrocortisone acetate Entry removed as no products identified in Art 57 Nov-19
atropine / hydromorphone Entry removed as no products identified in Art 57 Nov-19
calcium oxide / ichthammol / potassium aluminium sulfate / salicylic acid / sodium perborate Entry removed as no products identified in Art 57 Nov-19
iodamide Entry removed as no products identified in Art 57 Nov-19
acidum malicum levogirum / calcium chloride dihydrate / glucose monohydrate / glycine / l proline / l-alanine / l-arginine / l-histidine / l-isoleucine / l-leucine / l-lysine hydrochloride / l-methionine / l-phenylalanine / l-threonine / l-tryptophane / l-valine / magnesium chloride hexahydrate / potassium chloride / sodium chloride / sodium glycerophosphate pentahydrate / zinc chloride Entry removed as no products identified in Art 57 Nov-19
lovastatin / nicotinic acid Entry removed as no products identified in Art 57 Nov-19
lumiracoxib Entry removed as no products identified in Art 57 Nov-19
meclofenamate Entry removed as no products identified in Art 57 Nov-19
mepenzolate Entry removed as no products identified in Art 57 Nov-19
mesuximide Entry removed as it no longer fulfills the criteria for remaining on the list Nov-19
methenamine / methylene blue Entry removed as no products identified in Art 57 Nov-19
methenamine / phenazopyridine Entry removed as no products identified in Art 57 Nov-19
acetylsalicylic acid / methocarbamol Entry removed as no products identified in Art 57 Nov-19
methyl diethylacetylsalicylate Entry removed as no products identified in Art 57 Nov-19
methylprednisolone acetate / neomycin sulfate Entry removed as no products identified in Art 57 Nov-19
metipamide Entry removed as no products identified in Art 57 Nov-19
metizoline Entry removed as no products identified in Art 57 Nov-19
metronidazole / minocycline / nystatine Entry removed as no products identified in Art 57 Nov-19
mitiglinide Entry removed as no products identified in Art 57 Nov-19
mofebutazone Entry removed as no products identified in Art 57 Nov-19
morphine sulfate / naltrexone hydrochloride Entry removed as no products identified in Art 57 Nov-19
nafcillin Entry removed as no products identified in Art 57 Nov-19
naloxone hydrochloride / pentazocine hydrochloride Entry removed as no products identified in Art 57 Nov-19
neomycin / phenylephrine / polymyxin b Entry removed as no products identified in Art 57 Nov-19
norfenefrine Entry removed as no products identified in Art 57 Nov-19
nystatin / triamcinolone Entry removed as no products identified in Art 57 Nov-19
oxiglutatione Entry removed as no products identified in Art 57 Nov-19
parethoxycaine Entry removed as no products identified in Art 57 Nov-19
pentosan polyester / phenylephrine Entry removed as no products identified in Art 57 Nov-19
pentoxyverine hydrogen citrate / terpine hydrate Entry removed as no products identified in Art 57 Nov-19
phenazone / tetracaine Entry removed as no products identified in Art 57 Nov-19
oxytetracycline / phenazopyridine hydrochloride / sulfamethizole Entry removed as no products identified in Art 57 Nov-19
phendimetrazine Entry removed as no products identified in Art 57 Nov-19
glibenclamide / phenformin hydrochloride Entry removed as no products identified in Art 57 Nov-19
guaifenesin / phenylephrine hydrochloride Entry removed as no products identified in Art 57 Nov-19
isoprenaline / phenylephrine hydrochloride Entry removed as no products identified in Art 57 Nov-19
phenylephrine hydrochloride / promethazine hydrochloride Entry removed as no products identified in Art 57 Nov-19
phenylsalicylate Entry removed as only authorised in 1 MS Nov-19
paracetamol / phenyltoloxamine citrate Entry removed as no products identified in Art 57 Nov-19
phosphorus (32p) sodium phosphate / sodium carbonate Entry removed as no products identified in Art 57 Nov-19
betaxolol / pilocarpine Entry removed as no products identified in Art 57 Nov-19
poliovirus type 1 (oral, live, attenuated) vaccine Entry deleted due to merge (see Entry ID: 107802) Nov-19
poliovirus type 1 / poliovirus type 2 / poliovirus type 3 vaccine (oral, live, attenuated) Entry deleted due to merge (see Entry ID: 107802) Nov-19
poliovirus type 2 (oral, live, attenuated) vaccine Entry deleted due to merge (see Entry ID: 107802) Nov-19
poliovirus type 3 (oral, live, attenuated) vaccine Entry deleted due to merge (see Entry ID: 107802) Nov-19
pranlukast Entry removed as no products identified in Art 57 Nov-19
prenoxdiazine Entry removed as no products identified in Art 57 Nov-19
progabide Entry removed as no products identified in Art 57 Nov-19
quinaprilat Entry removed as no products identified in Art 57 Nov-19
rebamipide Entry removed as no products identified in Art 57 Nov-19
reserpine Entry removed as no products identified in Art 57 Nov-19
rofecoxib Entry removed as no products identified in Art 57 Nov-19
rokitamycin Entry removed as no products identified in Art 57 Nov-19
rosoxacin Entry removed as no products identified in Art 57 Nov-19
sermorelin Entry removed as no products identified in Art 57 Nov-19
streptodornase Entry removed as no products identified in Art 57 Nov-19
tegaserod Entry removed as no products identified in Art 57 Nov-19
thenoate sodium Entry removed as no products identified in Art 57 Nov-19
teprenone Entry removed as no products identified in Art 57 Nov-19
terconazole Entry removed as no products identified in Art 57 Nov-19
terguride Entry removed as no products identified in Art 57 Nov-19
thyroglobulin Entry removed as no products identified in Art 57 Nov-19
tiotixene Entry removed as no products identified in Art 57 Nov-19
tolazamide Entry removed as no products identified in Art 57 Nov-19
tolmetin Entry removed as no products identified in Art 57 Nov-19
vidarabine Entry removed as no products identified in Art 57 Nov-19
boceprevir Entry for removal: Victrelis (CAP) surrendered. No other products in Art 57. Nov-19
carbidopa / levodopa (for centrally authorised product) Entry deleted as Numient (CAP) surrendered Nov-19
olaratumab Entry deleted as Lartruvo (CAP) revoked following Referral in July 2019 Nov-19
enoxaparin (biosimilars) Entry deleted due to merge (see Entry ID: 107810) Nov-19
enoxaparin (except for biosimilars) Entry deleted due to merge (see Entry ID: 107810) Nov-19
poliovirus type 1 / poliovirus type 3 (oral, live, attenuated) vaccine Entry deleted due to merge (see Entry ID: 107802) Nov-19
F(ab’)2 fragments of equine antirabies immunoglobulin Entry to be removed: produtcts authorised in only 1 MS Sep-19
fenspiride Entry to be removed as no products identified in Art 57 Sep-19
benzathine phenoxymethylpenicillin Entry deleted as medicinal products containing ‘benzathine phenoxymethylpenicillin’ are covered by the ‘phenoxymethylpenicillin’ entry Sep-19
daclatasvir Entry to be removed due to MA expiry Sep-19
dihydroergotamine / etilefrine Entry to be removed as no products identified in Art 57 Sep-19
etanercept (except for biosimilars) Entry deleted due to merge Sep-19
ertugliflozin / metformin Entry deleted due to merge Sep-19
ertugliflozin / sitagliptin Entry deleted due to merge Sep-19
etanercept (biosimilars) Entry deleted due to merge Sep-19
zafirlukast Entry to be removed as no products identified in Art 57 Sep-19
adalimumab (biosimilars) Entry deleted due to merge Jul-19
adalimumab (except for biosimilars) Entry deleted due to merge Jul-19
ursodeoxycholic acid Entry to be removed as no products identified in Art 57 Jun-19
pramocaine Entry deleted due to merge Jun-19
amlodipine besilate / ramipril Entry deleted due to merge Jun-19
chenodeoxycholic acid (for gallstone dissolution) Entry deleted due to merge Jun-19
dasabuvir
Entry deleted due to merge Jun-19
hydrochlorothiazide / ramipril Entry deleted due to merge Jun-19
hydrocortisone acetate / pramocaine hydrochloride Entry deleted due to merge Jun-19
malathion / permethrin / piperonyl butoxide Entry to be removed as no products identified in Art 57 Jun-19
ombitasvir / paritaprevir / ritonavir Entry deleted due to merge Jun-19
tauroursodeoxycholic acid Entry deleted due to merge Jun-19
antithrombin alpha Entry to be removed due to MA withdrawal May-19
ethinylestradiol / gestodene (transdermal application) Entry removed from the EURD list since products containing this active substance are authorised only in one MS May-19
levofloxacin (except for the centrally authorised product) Entry deleted due to merge May-19
ofatumumab Entry to be removed due to MA withdrawal May-19
acetylcysteine / tuaminoheptane Entry deleted due to merge Apr-19
colchicine / dicycloverine hydrochloride GPAG outcome adopted by PRAC April 2019 entry removed Apr-19
colchicine / probenecid GPAG outcome adopted by PRAC April 2019 entry removed Apr-19
dicycloverine hydrochloride / metochalcone / procaine hydrochloride GPAG outcome adopted by PRAC April 2019 entry removed Apr-19
aluminium oxide hydrated / dicycloverine hydrochloride / magnesium oxide light / simeticone GPAG outcome adopted by PRAC April 2019 entry removed Apr-19
fluorometholone / tetryzoline GPAG outcome adopted by PRAC April 2019 entry removed Apr-19
fluorometholone / urea GPAG outcome adopted by PRAC April 2019 entry removed Apr-19
retapamulin Entry removed due to withdrawal of CAP (only authorisation) Apr-19
infliximab (biosimilars) Entry merged with 'infliximab (except biosimilars). New entry named "Infliximab". Apr-19
infliximab (except for biosimilars) Entry merged with 'infliximab (biosimilars). New entry named "Infliximab". Apr-19
lubiprostone Entry removed: no products in the procedure Apr-19
amidotrizoic acid Entry to be removed because covered by "amidotrizoic acid and combination" Feb-19
aluminium salicylate / sulfaguanidine Entry removed since no products have been identified containing this combination of active substances Feb-19
amfetamine aspartate / amfetamine sulfate / dexamfetamine saccharate / dexamfetamine sulfate Entry removed since no products have been identified containing this combination of active substances Feb-19
biodastase / dehydrocholic acid / lipase / papain / procaine hydrochloride Entry removed since no products have been identified containing this combination of active substances Feb-19
calcium / dexamethasone / lidocaine Entry to be removed: duplicate of "calcium dobesilate / dexamethasone / lidocaine" Feb-19
calcium / lidocaine Entry to be removed: duplicate of "calcium dobesilate / lidocaine" Feb-19
calcium carbonate / simeticone Entry removed since no products have been identified containing this combination of active substances Feb-19
calcium dobesilate / dexamethasone / lidocaine Entry removed because merged with "calcium dobesilate / lidocaine" Feb-19
calcium dobesilate / lidocaine Entry removed because merged with "calcium dobesilate / dexamethasone / lidocaine" Feb-19
pegaptanib Entry to be removed due to MA withdrawal Feb-19
ibuprofen / isopropyl myristate Entry removed since no products have been identified containing this combination of active substances Feb-19
lysine amidotrizoate / sodium amidotrizoate Entry removed because covered by "amidotrizoic acid and combination" Feb-19
meglumine amidotrizoate / sodium amidotrizoate Entry removed because covered by "amidotrizoic acid and combination" Feb-19
metaxalone Entry removed since no products have been identified containing this active substance Feb-19
metoxybutropate Entry removed since no products have been identified containing this active substance Feb-19
pipobroman Entry removed from the EURD list since product containing this active substance is authorised only in one MS Feb-19
polycarbophil Entry removed since no products have been identified containing this combination of active substances Feb-19
acetylsalicylic acid / magnesium hydroxide Entry removed since no products have been identified containing this active substance Jan-19
albiglutide Entry removed since no products have been identified containing this active substance Jan-19
amrinone Entry removed since no products have been identified containing this active substance Jan-19
calcium pantothenate / dimeticone / magnesium polygalacturonate Entry removed since no products have been identified containing this active substance Jan-19
chloramphenicol / medroxyprogesterone / tetryzoline Entry removed since no products have been identified containing this active substance Jan-19
chloramphenicol / methyluracil Entry removed from the EURD list since products containing this active substance are authorised only in one MS Jan-19
choline magnesium trisalicylate Entry removed since no products have been identified containing this active substance Jan-19
coprecipitate of aluminium hydroxide / magnesium carbonate Entry to be removed because covered by "antacids: combinations or monocomponents of aluminium / calcium / magnesium / potassium / sodium salts" Jan-19
cromoglicate sodium / tetryzoline hydrochloride Entry removed since no products have been identified containing this active substance Jan-19
dienestrol Entry removed since no products have been identified containing this active substance Jan-19
diphenhydramine hydrochloride / naphazoline hydrochloride / neomycin sulfate Entry removed from the EURD list since products containing this active substance are authorised only in one MS Jan-19
estradiol / gestodene Entry removed since no products have been identified containing this active substance Jan-19
estrogen / methyltestosterone Entry removed since no products have been identified containing this active substance Jan-19
estrone sodium sulfate Entry removed since no products have been identified containing this active substance Jan-19
ethinylestradiol / etynodiol Entry removed since no products have been identified containing this active substance Jan-19
ethinylestradiol / lynestrenol Entry removed since no products have been identified containing this active substance Jan-19
ethinylestradiol / norgestrel Entry removed since no products have been identified containing this active substance Jan-19
fluorometholone / gentamicin Entry removed since no products have been identified containing this active substance Jan-19
fluorometholone / miconazole nitrate / neomycin sulfate Entry removed since no products have been identified containing this active substance Jan-19
fluorometholone acetate / tobramycin Entry removed since no products have been identified containing this active substance Jan-19
heptaminol Entry removed from the EURD list since products containing this active substance are authorised only in one MS Jan-19
magnesium peroxide Entry removed since no products have been identified containing this active substance Jan-19
mebhydroline Entry removed since no products have been identified containing this active substance Jan-19
medroxyprogesterone acetate / tetryzoline hydrochloride Entry removed since no products have been identified containing this active substance Jan-19
metipranolol Entry removed since no products have been identified containing this active substance Jan-19
metipranolol hydrochloride / pilocarpine hydrochloride Entry removed since no products have been identified containing this active substance Jan-19
oxamniquine Entry removed since no products have been identified containing this active substance Jan-19
oxandrolone Entry removed since no products have been identified containing this active substance Jan-19
oxymetholone Entry removed since no products have been identified containing this active substance Jan-19
pegademase Entry removed since no products have been identified containing this active substance Jan-19
pimethixene Entry removed from the EURD list since products containing this active substance are authorised only in one MS Jan-19
polyestradiol Entry removed since no products have been identified containing this active substance Jan-19
polythiazide Entry removed since no products have been identified containing this active substance Jan-19
polythiazide / reserpine Entry removed since no products have been identified containing this active substance Jan-19
pramocaine hydrochloride / zinc sulfate Entry removed since no products have been identified containing this active substance Jan-19
prednisolone acetate / sulfacetamide sodium Entry removed since no products have been identified containing this active substance Jan-19
sodium bicarbonate / sodium citrate / sodium fluoride Entry removed since no products have been identified containing this active substance Jan-19
sodium bromide Entry removed from the EURD list since products containing this active substance are authorised only in one MS Jan-19
ribavirin (aerosol application) Entry to be removed: no products authorised in Art.57.
The last product which was authorised, Virazole in Spain, was withdrawn on 19/10/2018. Dec-18
fentanyl (transdermal system - centrally authorised product) Entry to be removed: no products authorised , as the CAP Ionsys belonging to the procedure has now been withdrawn. Dec-18
aluminium lactate / benzydamine Entry removed since no products have been identified containing this active substance Nov-18
bacitracin / colistimethate sodium / hydrocortisone acetate Entry removed from the EURD list since products containing this active substance are authorised only in one MS Nov-18
cobamamide / cyproheptadine Entry removed from the EURD list since products containing this active substance are authorised only in one MS Nov-18
copper acetate / lactic acid / salicylic acid Entry removed from the EURD list since products containing this active substance are authorised only in one MS Nov-18
olpadronic acid Entry removed since no products have been identified containing this active substance Nov-18
ticarcillin Entry removed from the EURD list since products containing this active substance are authorised only in one MS Nov-18
amyl nitrite Entry removed since no products have been identified containing this active substance Oct-18
chloramphenicol / collagenase Entry removed from the EURD list since products containing this active substance are authorised only in one MS Oct-18
chlorcyclizine hydrochloride / cinnarizine Entry removed from the EURD list since products containing this active substance are authorised only in one MS Oct-18
cilnidipine Entry removed since no products have been identified containing this active substance Oct-18
clemastine fumarate / phenylpropanolamine hydrochloride Entry removed since no products have been identified containing this active substance Oct-18
clocinizine / phenylpropanolamine hydrochloride Entry removed from the EURD list since products containing this active substance are authorised only in one MS Oct-18
co-danthrusate Entry removed from the EURD list since products containing this active substance are authorised only in one MS Oct-18
desipramine Entry removed since no products have been identified containing this active substance Oct-18
eptotermin alpha Entry removed since no products have been identified containing this active substance Oct-18
fructose Entry removed since no products have been identified containing this active substance Oct-18
ibacitabine Entry removed from the EURD list since products containing this active substance are authorised only in one MS Oct-18
influenza vaccine (split virion, inactivated) (centrally authorised products only) The marketing authorisation has expired on 1 July 2018. Oct-18
acebutolol / mefruside Entry removed since no products have been identified containing this active substance Sep-18
acebutolol / nifedipine Entry removed since no products have been identified containing this active substance Sep-18
acepromazine / aceprometazine / clorazepate dipotassium Entry removed since no products have been identified containing this active substance Sep-18
acetylsalicylic acid / carisoprodol Entry removed since no products have been identified containing this active substance Sep-18
actinoquinol / oxedrine tartrate Entry removed since no products have been identified containing this active substance Sep-18
activated attapulgite / attapulgite / morphine hydrochloride Entry removed since no products have been identified containing this active substance Sep-18
aluminium hydroxide / attapulgite / kaolin / pectin Entry removed since no products have been identified containing this active substance Sep-18
amineptine Entry removed since no products have been identified containing this active substance Sep-18
amylocaine hydrochloride / dodeclonium bromide Entry removed since no products have been identified containing this active substance Sep-18
avobenzone / ensulizole / octisalate Entry removed since no products have been identified containing this active substance Sep-18
azintamide / hyoscine Entry removed since no products have been identified containing this active substance Sep-18
benzalkonium chloride / furazolidone Entry removed since no products have been identified containing this active substance Sep-18
bile-dispert / pancreatin Entry removed since no products have been identified containing this active substance Sep-18
bretylium Entry removed since no products have been identified containing this active substance Sep-18
broxaterol Entry removed since no products have been identified containing this active substance Sep-18
buformin Entry removed since no products have been identified containing this active substance Sep-18
butorphanol Entry removed since no products have been identified containing this active substance Sep-18
buzepide metiodide / haloperidol Entry removed since no products have been identified containing this active substance Sep-18
caffeine / carisoprodol / diclofenac sodium / paracetamol Entry removed since no products have been identified containing this active substance Sep-18
calcium pidolate Entry removed since no products have been identified containing this active substance Sep-18
camostat Entry removed since no products have been identified containing this active substance Sep-18
carisoprodol Entry removed since no products have been identified containing this active substance Sep-18
carisoprodol / paracetamol Entry removed since no products have been identified containing this active substance Sep-18
carmofur Entry removed since no products have been identified containing this active substance Sep-18
carmoisine Entry removed since no products have been identified containing this active substance Sep-18
carmoisine / paracetamol Entry removed since no products have been identified containing this active substance Sep-18
centella extract / hydrocortisone acetate / neomycine Entry removed since no products have been identified containing this active substance Sep-18
cetylpyridinium / dequalinium chloride Entry removed since no products have been identified containing this active substance Sep-18
cevimeline Entry removed since no products have been identified containing this active substance Sep-18
chymopapain Entry removed since no products have been identified containing this active substance Sep-18
cinnarizine / heptaminol acefylline Entry removed since no products have been identified containing this active substance Sep-18
corticotropin Entry removed since no products have been identified containing this active substance Sep-18
cyanocobalamin / hydroxocobalamin Entry removed since no products have been identified containing this active substance Sep-18
cyclandelate Entry removed since no products have been identified containing this active substance Sep-18
d,l-1-(p-hydroxyphenyl)-propylamine hydroiodide / muramidase hydrochloride / thonzylamine hydrochloride Entry removed since no products have been identified containing this active substance Sep-18
dalfopristin / quinupristin Entry removed since no products have been identified containing this active substance Sep-18
denileukin diftitox Entry removed since no products have been identified containing this active substance Sep-18
deslanoside Entry removed since no products have been identified containing this active substance Sep-18
dextromoramide Entry removed since no products have been identified containing this active substance Sep-18
dimefline Entry removed since no products have been identified containing this active substance Sep-18
diphemanil Entry removed since no products have been identified containing this active substance Sep-18
dipivefrine hydrochloride / pilocarpine hydrochloride Entry removed since no products have been identified containing this active substance Sep-18
dipotassium clorazepate / gabob / pyridoxine hydrochloride Entry removed since no products have been identified containing this active substance Sep-18
diprophylline / oxidation product / terebenthin essential oil Entry removed since no products have been identified containing this active substance Sep-18
diprophylline / proxyphylline / theophylline Entry removed since no products have been identified containing this active substance Sep-18
disodium inosinate Entry removed since no products have been identified containing this active substance Sep-18
dixyrazine Entry removed since no products have been identified containing this active substance Sep-18
domiphen Entry removed since no products have been identified containing this active substance Sep-18
drofenine / propyphenazone Entry removed since no products have been identified containing this active substance Sep-18
dronabinol Entry removed since no products have been identified containing this active substance Sep-18
eledoisin Entry removed since no products have been identified containing this active substance Sep-18
embramine Entry removed since no products have been identified containing this active substance Sep-18
emetine Entry removed since no products have been identified containing this active substance Sep-18
epervudine Entry removed since no products have been identified containing this active substance Sep-18
equilin sulfate sodium / estrone sodium sulfate Entry removed since no products have been identified containing this active substance Sep-18
estropipate Entry removed since no products have been identified containing this active substance Sep-18
eszopiclone Entry removed since no products have been identified containing this active substance Sep-18
ethylmorphine hydrochloride / indometacin Entry removed since no products have been identified containing this active substance Sep-18
etofylline / hexobendine Entry removed since no products have been identified containing this active substance Sep-18
etretinate Entry removed since no products have been identified containing this active substance Sep-18
fluocortin Entry removed since no products have been identified containing this active substance Sep-18
framycetin sulfate / oxedrine / polymyxin b sulphate Entry removed since no products have been identified containing this active substance Sep-18
fursultiamine / riboflavin Entry removed since no products have been identified containing this active substance Sep-18
gastric mucin Entry removed since no products have been identified containing this active substance Sep-18
glibornuride Entry removed since no products have been identified containing this active substance Sep-18
gramicidin / neomycin Entry removed since no products have been identified containing this active substance Sep-18
gramicidin s / framycetin sulfate / polymyxin b sulfate Entry removed since no products have been identified containing this active substance Sep-18
ibudilast Entry removed since no products have been identified containing this active substance Sep-18
iopanoic acid Entry removed since no products have been identified containing this active substance Sep-18
edrophonium Entry removed since no products have been identified containing this active substance Sep-18
prenoxdiazine Entry removed since no products have been identified containing this active substance Sep-18
propacetamol Entry removed since no products have been identified containing this active substance Sep-18
proscillaridin Entry removed since no products have been identified containing this active substance Sep-18
quinfamide Entry removed since no products have been identified containing this active substance Sep-18
resorcinol / sulphur Entry removed since no products have been identified containing this active substance Sep-18
sibutramine Entry removed since no products have been identified containing this active substance Sep-18
sivelestat Entry removed since no products have been identified containing this active substance Sep-18
sodium aurothiosulfate Entry removed since no products have been identified containing this active substance Sep-18
sodium bromebrate Entry removed since no products have been identified containing this active substance Sep-18
sodium medronate / stannous fluoride Entry removed since no products have been identified containing this active substance Sep-18
sodium pidolate Entry removed since no products have been identified containing this active substance Sep-18
stannous fluoride Entry removed since no products have been identified containing this active substance Sep-18
sulesomab Entry removed since no products have been identified containing this active substance Sep-18
tedisamil Entry removed since no products have been identified containing this active substance Sep-18
tinidazole / tioconazole Entry removed since no products have been identified containing this active substance Sep-18
ascorbic acid / macrogol 3350 / potassium chloride / sodium ascorbate / sodium chloride / sodium sulphate Entry was merged with "macrogol 3350 combinations (oral use)", therefore it had to be deleted from the list Sep-18
hydroxocobalamin (except for products for chemical poisoning) Entry was merged with "cobamamide"ID 838 due to the similarity in therapeutical indication, therefore it had to be deleted from the list Sep-18
macrogol 3350 / potassium chloride / sodium bicarbonate / sodium chloride Entry was merged with "macrogol 3350 combinations (oral use)", therefore it had to be deleted from the list Sep-18
macrogol 3350 / potassium chloride / sodium sulphate anhydrous / sodium chloride / sodium hydrogen carbonate Entry was merged with "macrogol 3350 / potassium chloride / sodium bicarbonate / sodium chloride ; ascorbic acid / macrogol 3350 / potassium chloride / sodium ascorbate / sodium chloride / sodium sulphate"
in new entry "macrogol 3350 combinations (oral use)", therefore it had to be deleted from the list Sep-18
retigabine Entry removed due to product withdrawal on 19 July 2018 Sep-18
sodium fluoride Entry removed because this substance is covered by the general "fluoride" entry Sep-18
amylocaine hydrochloride / sodium benzoate Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
catalase Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
catalase / neomycin Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
cellulase Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
cetalkonium / lidocaine Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
chlorquinaldol / hydrocortisone butyrate Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
cicletanine Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
clofoctol Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
desoxycortone acetate Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
dimecrotate magnesium Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
eperisone Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
ephedrine hydrochloride / naphazoline nitrate Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
ethionamide Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
fenoldopam Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
fluoride sodium / strontium acetate hemihydrate Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
gramicidin / naphazoline / neomycin / phenylephrine Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
halcinonide Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
hydroxocobalamin / pyridoxine / thiamine Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
ibopamine Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
metixene Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
naphazoline nitrate / thonzylamine hydrochloride Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
procaterol Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
rociverine Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
takadiastase Entry removed from the EURD list since products containing this active substance are authorised only in one MS Sep-18
alitretinoin Entry removed from the EURD list due to splitting existing entry into two separate entries: alitretinoin (cutaneous use) and alitretinoin (oral use) Sep-18
rabbit anti-human T-lymphocyte immunoglobulin (powder for solution for infusion) Entry removed from the EURD list due to procedure scope change and merging with "rabbit anti-humanT-lymphocyte immunoglobulin (concentrate for solution for infusion)" entry. New entry: "rabbit anti-humanT-lymphocyte immunoglobulin". Sep-18
acetylaminonitropropoxybenzene Entry to be removed since no products have been identified containing this active substance Jul-18
acetylleucine Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Jul-18
aconitine / histamine disalicylate Entry to be removed since no products have been identified containing this combination of active substances Jul-18
acriflavinium chloride / menthol / resorcinol Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. Jul-18
algeldrate, algeldrate / magnesium hydroxide Removal from EURD list; Entry: "antacids: combinations or monocomponents of aluminium / calcium / magnesium / potassium / sodium salts" to be followed (PSUSA/00000500) Jul-18
alibendole Entry to be removed since no products have been identified containing this active substance Jul-18
altizide Entry to be removed since no products have been identified containing this active substance Jul-18
amezinium Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Jul-18
amilomer Entry to be removed since no products have been identified containing this active substance Jul-18
aminoglutethimide Entry to be removed since no products have been identified containing this active substance Jul-18
aminohippurate Entry to be removed since no products have been identified containing this active substance Jul-18
aminotridecane undecylenate Entry to be removed since no products have been identified containing this active substance Jul-18
ampicillin / flucloxacillin Entry to be removed from the EURD list since only products in one MS identified containing this combination of active substances. Jul-18
azulenolum Entry to be removed since no products have been identified containing this active substance Jul-18
barbexaclone Entry to be removed since no products have been identified containing this active substance Jul-18
benexate Entry to be removed since no products have been identified containing this active substance Jul-18
benorilate Entry to be removed since no products have been identified containing this active substance Jul-18
bopindolol Entry to be removed since no products have been identified containing this active substance Jul-18
buclizine Entry to be removed since no products have been identified containing this active substance Jul-18
cadralazine Entry to be removed since no products have been identified containing this active substance Jul-18
calcium carbonate / magnesium carbonate Removal from EURD list; Entry: "antacids: combinations or monocomponents of aluminium / calcium / magnesium / potassium / sodium salts" to be followed (PSUSA/00000500) Jul-18
cortivazol Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Jul-18
detajmium Entry to be removed since no products have been identified containing this active substance Jul-18
ditazole Entry to be removed since no products have been identified containing this active substance Jul-18
flavodate Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Jul-18
glycol salicylate / methyl nicotinate Entry to be removed from the EURD list since only products in one MS identified containing this combination of active substances. Jul-18
idrocilamide Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Jul-18
iotrolan Entry to be removed since no products have been identified containing this active substance Jul-18
lidoflazine Entry to be removed since no products have been identified containing this active substance Jul-18
limaprost Entry to be removed since no products have been identified containing this active substance Jul-18
linsidomine Entry to be removed since no products have been identified containing this active substance Jul-18
mabuprofen Entry to be removed since no products have been identified containing this active substance Jul-18
matrix-applied characterised autologous cultured chondrocytes The marketing authorisation has expired on 1 July 2018, therefore this entry is deleted. Jul-18
mitoguazone Entry to be removed since no products have been identified containing this active substance Jul-18
nimorazole Entry to be removed since no products have been identified containing this active substance Jul-18
nitrogen Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Jul-18
nonivamide Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Jul-18
oxilofrine Entry to be removed since no products have been identified containing this active substance Jul-18
oxitropium Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Jul-18
oxymetazoline hydrochloride / prednisolone sodium phosphate Entry to be removed from the EURD list since only products in one MS identified containing this combination of active substances. Jul-18
pemoline Entry to be removed since no products have been identified containing this active substance Jul-18
pipazetate Entry to be removed since no products have been identified containing this active substance Jul-18
pipotiazine Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Jul-18
pitofenone Entry to be removed since no products have been identified containing this active substance Jul-18
ramelteon Entry to be removed since no products have been identified containing this active substance Jul-18
stanozolol Entry to be removed since no products have been identified containing this active substance Jul-18
thioproperazine Entry to be removed since no products have been identified containing this active substance Jul-18
triclabendazole Entry to be removed since no products have been identified containing this active substance Jul-18
trimethobenzamide Entry to be removed from the EURD list since only products in one MS identified containing this combination of active substances. Jul-18
tropatepine Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Jul-18
troxipide Entry to be removed since no products have been identified containing this active substance Jul-18
tulobuterol Entry to be removed since no products have been identified containing this active substance Jul-18
unoprostone Entry to be removed since no products have been identified containing this active substance Jul-18
valethamate Entry to be removed since no products have been identified containing this active substance Jul-18
vasopressin Entry to be removed since no products have been identified containing this active substance Jul-18
viloxazine Entry to be removed since no products have been identified containing this active substance Jul-18
viminol Entry to be removed from the EURD list since only products in one MS identified containing this combination of active substances. Jul-18
voglibose Entry to be removed since no products have been identified containing this active substance Jul-18
vorinostat Entry to be removed since no products have been identified containing this active substance Jul-18
xantinol nicotinate Entry to be removed from the EURD list since only products in one MS identified containing this combination of active substances. Jul-18
zalcitabine Entry to be removed since no products have been identified containing this active substance Jul-18
simeprevir Product was withdrawn on 05/03/2018, therefore entry is deleted Jun-18
flupirtine Marketing authorisations for flupirtine containing priducts have been revoked with the CMDh position dated 21 March 2018, therefore entry to be removed Jun-18
acetylsalicylic acid / ibuprofen Entry to be removed since no products have been identified containing this combination of active substances Jun-18
benzathine benzylpenicillin / lidocaine hydrochloride Entry to be removed since no products have been identified containing this combination of active substances Jun-18
cefonicid / lidocaine hydrochloride Entry to be removed since no products have been identified containing this combination of active substances Jun-18
cetylpyridinium chloride / dichlorobenzyl alcohol / lidocaine hydrochloride Entry to be removed since no products have been identified containing this combination of active substances Jun-18
indometacin / methocarbamol Entry to be removed since no products have been identified containing this combination of active substances Jun-18
lidocaine hydrochloride / metacresol / paraformaldehyde Entry to be removed since no products have been identified containing this combination of active substances Jun-18
lidocaine hydrochloride / phenylbutazone Entry to be removed since no products have been identified containing this combination of active substances Jun-18
lidocaine hydrochloride / phenylephrine hydrochloride / sodium propionate Entry to be removed since no products have been identified containing this combination of active substances Jun-18
lidocaine hydrochloride / piperacillin sodium Entry to be removed since no products have been identified containing this combination of active substances Jun-18
lidocaine hydrochloride / tolperisone hydrochloride Entry to be removed since no products have been identified containing this combination of active substances Jun-18
pheniramine Entry to be removed since no products have been identified containing this combination of active substances Jun-18
acediasulfone Entry to be removed since no products have been identified containing this active substance May-18
acediasulfone / cinchocaine / dihydroxymethyl carbamide Entry to be removed since no products have been identified containing this active substance May-18
alfoscerate olamine Entry to be removed since no products have been identified containing this active substance May-18
aloxiprin Entry to be removed since no products have been identified containing this active substance May-18
benzethonium chloride Entry to be removed since no products have been identified containing this active substance May-18
benzfetamine Entry to be removed since no products have been identified containing this active substance May-18
calcium phosphate / cyanocobalamin / cyproheptadine hydrochloride Entry to be removed since no products have been identified containing this combination of active substances May-18
coal tar, distilled coal tar Removal from EURD list following merge. Entry: "coal tar, distilled coal tar, distilled coal tar / lecithin, coconut oil / distilled coal tar / salicylic acid, coal tar solution / salicylic acid / sulfur, coal tar / salicylic acid, coal tar / menthol, coal tar solution / salicylic acid / benzalkonium chloride solution / polyoxyethylene 4 lauryl ether / polyoxyethylene 23 lauryl ether" to be followed (PSUSA/00010684) May-18
coal tar / menthol Removal from EURD list following merge. Entry: "coal tar, distilled coal tar, distilled coal tar / lecithin, coconut oil / distilled coal tar / salicylic acid, coal tar solution / salicylic acid / sulfur, coal tar / salicylic acid, coal tar / menthol, coal tar solution / salicylic acid / benzalkonium chloride solution / polyoxyethylene 4 lauryl ether / polyoxyethylene 23 lauryl ether" to be followed (PSUSA/00010684) May-18
coconut oil / distilled coal tar / salicylic acid, coal tar solution / salicylic acid / sulfur Removal from EURD list following merge. Entry: "coal tar, distilled coal tar, distilled coal tar / lecithin, coconut oil / distilled coal tar / salicylic acid, coal tar solution / salicylic acid / sulfur, coal tar / salicylic acid, coal tar / menthol, coal tar solution / salicylic acid / benzalkonium chloride solution / polyoxyethylene 4 lauryl ether / polyoxyethylene 23 lauryl ether" to be followed (PSUSA/00010684) May-18
cholecalciferol concentrate / sodium fluoride Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. May-18
colchicine / opium / tiemonium Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. May-18
delapril Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. May-18
distilled coal tar / lecithin Removal from EURD list following merge. Entry: "coal tar, distilled coal tar, distilled coal tar / lecithin, coconut oil / distilled coal tar / salicylic acid, coal tar solution / salicylic acid / sulfur, coal tar / salicylic acid, coal tar / menthol, coal tar solution / salicylic acid / benzalkonium chloride solution / polyoxyethylene 4 lauryl ether / polyoxyethylene 23 lauryl ether" to be followed (PSUSA/00010684) May-18
mebutizide Entry to be removed since no products have been identified containing this active substance May-18
reviparin Entry to be removed since no products have been identified containing this active substance May-18
trilostane Entry to be removed since no products have been identified containing this active substance May-18
abarelix Entry to be removed since no products have been identified containing this active substance Apr-18
peramivir Entry to be removed since no products have been identified containing this active substance Apr-18
prasterone Products currently authorised only in PL, therefore entry is deleted Apr-18
tiemonium Entry to be removed since no products have been identified containing this active substance Apr-18
telavancin Product was withdrawn on 23/03/2018, therefore entry is deleted Apr-18
ipecacuanha / potassium sulfoguaiacolate / promethazine Products currently authorised only in NL and as generic, therefore entry is deleted Apr-18
nesiritide Entry to be removed since no products have been identified containing this active substance Apr-18
aceclidine Entry to be removed since no products have been identified containing this active substance Apr-18
ammonium chloride / dextromethorphan hydrobromide / diphenhydramine hydrochloride / pseudoephedrine hydrochloride Entry to be removed since no products have been identified containing this active substance Apr-18
benzocaine / chlorobutanol Entry to be removed since no products have been identified containing this active substance Apr-18
caffeine / propyphenazone Products currently authorised only in ES and under WEU, therefore entry is deleted Apr-18
calcium carbonate / vitamin d / zinc Entry to be removed since no products have been identified containing this active substance Apr-18
chlorphenamine maleate / hyoscine methobromide / pseudoephedrine hydrochloride Entry to be removed since no products have been identified containing this active substance Apr-18
cimetidine / sodium alginate Entry to be removed since no products have been identified containing this active substance Apr-18
cineole / codeine phosphate Product currently authorised only in FR, therefore entry is deleted Apr-18
cineole / thymol Entry to be removed since no products have been identified containing this active substance Apr-18
clorprenaline / codeine / pseudoephedrine Entry to be removed since no products have been identified containing this active substance Apr-18
colistimethate sodium / erythromycin lactobionate Entry to be removed since no products have been identified containing this active substance Apr-18
daclizumab Entry should be removed as the Marketing Authorisation has been withdrawn on 27 March 2018 Apr-18
caffeine (apnea, centrally authorised product only) Removal from EURD list; Entry: "caffeine (apnea)" to be followed (PSUSA/0000482) Mar-18
estradiol (17-beta) / trimegestone Entry to be removed since no products have been identified containing this active substance combination Mar-18
lactobacillus acidophilus Removal from EURD list; Entry: "lactobacillus all subspecies and combinations of subspecies" to be followed (PSUSA/00010598) Mar-18
metformin hydrochloride / sitagliptin Removal from EURD list following merge. Entry: "sitagliptin, metformin hydrochloride / sitagliptin" to be followed (PSUSA/00010673) Mar-18
sitagliptin Removal from EURD list following merge. Entry: "sitagliptin, metformin hydrochloride / sitagliptin" to be followed (PSUSA/00010673) Mar-18
triglyceride combinations (e.g. olive oil, soya bean oil, fish oil)/ with or without mineral compounds/electrolytes (i.v. application) Removal from EURD list; Entry: "triglyceride combinations (e.g. olive oil, soya bean oil, fish oil)/ with or without mineral compounds/electrolytes (i.v. application) to be followed (PSUSA/00010648) Mar-18
acetylsalicylic acid / pseudoephedrine hydrochloride Entry was merged with "pseudoephedrine" and "acetylsalicylic acid / pseudoephedrine hydrochloride" entries, therefore it had to be deleted from the list Feb-18
pseudoephedrine MERGED with "pseudoephedrine" and "acetylsalicylic acid / pseudoephedrine hydrochloride" in a new entry, therefore entry is deleted Feb-18
a-tocopherol / ascorbic acid / cupric oxide / sodium selenate / vitamin a / zinc oxide Entry to be removed since no products have been identified containing this active substance combination. Feb-18
boric acid / guaiazulen / ichthammol / zinc oxide Entry to be removed since no products have been identified containing this active substance combination. Feb-18
brompheniramine / pseudoephedrine Entry to be removed since no products have been identified containing this active substance combination. Feb-18
calcium levomefolate / mecobalamin / pyridoxal phosphate Entry to be removed since no products have been identified containing this active substance combination. Feb-18
carbethopendecinium bromide / ephedrine hydrochloride Entry to be removed since no products have been identified containing this active substance combination. Feb-18
carbinoxamine maleate / pseudoephedrine hydrochloride Entry to be removed since no products have been identified containing this active substance combination. Feb-18
cefdinir Entry to be removed since no products have been identified containing this active substance combination. Feb-18
clocortolone hexanoate / clocortolone pivalate Entry to be removed since no products have been identified containing this active substance combination. Feb-18
estradiol / norgestimate Entry to be removed since no products have been identified containing this active substance combination. Feb-18
glaucine hydrobromide / pseudoephedrine hydrochloride Entry to be removed since no products have been identified containing this active substance combination. Feb-18
insulin porcine Products currently authorised only in UK and under WEU, therefore entry is deleted Feb-18
iotalamic acid Entry to be removed since no products have been identified containing this active substance combination. Feb-18
lisuride Product authorised in 1 MS (FR), therefore should be deleted Feb-18
loperamide MERGED with "loperamide hydrochloride/simeticon" in a new entry, therefore entry is deleted Feb-18
loperamide hydrochloride / simeticone MERGED with "loperamide" in a new entry, therefore entry is deleted Feb-18
macrogol 3350 / potassium chloride / sodium chloride / sodium bicarbonate / potassium sulfate Entry to be removed since no products have been identified containing this active substance combination. Feb-18
chlorphenesin Entry to be removed since no products have been identified containing this active substance combination. Feb-18
adenosine / allopurinol / glutathione / lactobionic acid / magnesium sulphate / poly (0-2-hydroxyethyl) starch (pentafraction) / potassium dihydrogen phosphate / potassium hydroxide / raffinose / sodium hydroxide Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. Jan-18
azoximer bromide Entry to be removed from the EURD list since only one product in one MS identified containing this active substances. Jan-18
brompheniramine Entry to be removed from the EURD list since only one product in one MS identified containing this active substances. Jan-18
dolasetron Entry to be removed from the EURD list since only one product in one MS identified containing this active substances. Jan-18
ketanserin Entry to be removed from the EURD list since only one product in one MS identified containing this active substances. Jan-18
methyl salicylate / levomenthol Removal from EURD list following merge: Entry: "menthol / methyl salicylate / camphor, menthol / methyl salicylate" to be followed (PSUSA/00010658) Jan-18
methyl salicylate / levomenthol / DL-camphor Removal from EURD list following merge: Entry: "menthol / methyl salicylate / camphor, menthol / methyl salicylate" to be followed (PSUSA/00010658) Jan-18
catumaxomab Entry should be removed as the Marketing Authorisation has been withdrawn on 2nd June 2017. Dec-17
desirudin Entry should be removed as the Marketing Authorisation was withdrawn on 29/07/2014. Dec-17
alipogene tiparvovec Entry should be removed as the marketing authorisation expired on 25/10/2017. No additional PSURs are required to be submitted. Dec-17
gadoversetamide Entry should be removed as the marketing authorisation has expired on has expired on 23/07/2017. Dec-17
influenza vaccine (surface antigen, inactivated, prepared in cell cultures) Entry should be removed as the marketing authorisation has expired on has expired on 01/06/2017. Dec-17
influenza vaccine (surface antigen, inactivated, virosome) Entry should be removed as no products are currently authorised in EU with this active substance. Dec-17
mestranol / norethisterone Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. Dec-17
hepatitis A vaccine (inactivated, virosome) Entry to be removed from the EURD list as there are currently no products authorised in the EU Dec-17
dihydroergocristine Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Nov-17
bemetizide / triamterene Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. Nov-17
ebastine / pseudoephedrine Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. Nov-17
fish oil / olive oil / soybean oil / triglycerides medium-chain Removal from EURD list following merge: Entry: "triglyceride combinations (e.g. olive oil, soya bean oil, fish oil)/ with or without mineral compounds/electrolytes (i.v. application)" to be followed (PSUSA/00010648) Nov-17
clodronic acid Removal from EURD list following merge: Entry: "clodronic acid, clodronic acid / lidocaine" to be followed (PSUSA/00010650) Nov-17
ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus) Removal from EURD list following merge: Entry: "ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus), ibuprofen / caffeine" to be followed (PSUSA/00010649) Nov-17
vorapaxar Product withdrawn, therefore entry should be removed. Nov-17
roxatidine Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Oct-17
tiludronic acid Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Oct-17
eucalyptol Entry "eucalyptol" is deleted as there a no products authorised in Art 57. New entry "eucalyptus oil" is created as per MAH request Oct-17
tropisetron Only 1 valid generic product identified in ES. Products in FR expired due to sunset clause, products in other MSs are withdrawn. Therefore entry is deleted. Oct-17
calcium chloride dihydrate / lactic acid / magnesium chloride hexahydrate / sodium chloride / sodium hydrogen carbonate All Products currently authorised in EU are authorised under WEU, therefore entry is deleted Oct-17
benzalkonium chloride / isopropyl myristate / paraffin liquid The entry will be merged with 'benzalkonium chloride / chlorhexidine / isopropyl myristate / paraffin liquid' therfore the current entry is deleted Oct-17
pancreas powder (centrally authorised product only) Product withdrawn on 27 July 2017, therefore entry should be removed. Oct-17
buflomedil Entry removed, as only 2 generic products identified in Art. 57 DB. No submissions have been received. Oct-17
influenza vaccine (H1N1)ν (split virion, inactivated, adjuvanted) Entry removed, as this medicine is withdrawn from use in the European Union Oct-17
alcium chloride dihydrate / magnesium chloride hexahydrate / malic acid / sodium acetate trihydrate / sodium chloride / potassium chloride Removal from EURD list following merge: Entry: "calcium chloride dihydrate / magnesium chloride hexahydrate / malic acid / sodium acetate trihydrate / sodium chloride / potassium chloride, calcium chloride dihydrate / sodium chloride / sodium lactate / potassium chloride" to be followed (PSUSA/00010622) Sep-17
bismuth subnitrate / lidocaine / zinc oxide Removal from EURD list following merge: Entry: "bismuth / lidocaine / zinc oxide, lidocaine / zinc oxide" to be followed (PSUSA/00010621) Sep-17
cefminox Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Sep-17
chondroitin Removal from EURD list following merge: Entries to be followed: PSUSA/00010625 or PSUSA/00010626 accordingly Sep-17
chondroitin / glucosamine Removal from EURD list following merge: Entries to be followed PSUSA/00010625 or PSUSA/00010626 accordingly Sep-17
D-camphor / hydroxyethyl salicylate / levomenthol / methyl salicylate Entry to be removed from the EURD list since only one product in one MS identified containing this active substance. Sep-17
dornase alpha / fibrinolysin Entry to be removed since no products have been identified containing this active substance combination. Sep-17
fructose / glycerin Entry to be removed since no products have been identified containing this active substance combination. Sep-17
glycerine Entry to be removed from the EURD list due to duplication with "glycerol" entry. Sep-17
hexamidine / tetravacaine Entry to be removed since no products have been identified containing this active substance. Sep-17
icodextrin Entry to be removed since no products have been identified containing this active substance. Sep-17
methysergide Entry to be removed since no products have been identified containing this active substance. Sep-17
testosterone undecanoate (injection) Removal from EURD list: Entry: "testosterone (all formulations apart from topical use)" to be followed (PSUSA/00010631) Sep-17
testosterone (all formulations apart from topical use and testosterone undecanoate injection) Removal from EURD list: Entry: "testosterone (all formulations apart from topical use)" to be followed (PSUSA/00010631) Sep-17
tetrazepam Entry to be removed from the EURD list following suspension of the products. Sep-17
zinc oxide Removal from EURD list following merge: Entry: "zinc oxide, zinc oxide/calamine" to be followed (PSUSA/00010632) Sep-17
caffeine / ephedrine sulfate / promethazine hydrochloride Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. Jul-17
sodium oxybate Removal from EURD list: Entry deleted due to merging of sodium oxybate (oral use) and sodium oxybate (intravenous use) Jul-17
acetic acid / calcium chloride / glucose anhydrous / magnesium chloride / potassium chloride / sodium chloride Entry to be removed since no products have been identified containing this active substance combination. Jul-17
acetic acid glacial / calcium chloride dihydrate / glucose monohydrate / magnesium chloride hexahydrate / potassium chloride / sodium chloride / sodium dihydrogen phosphate dihydrate / sodium hydrogen carbonate Entry to be removed since only 2 WEU products in CZ identified. Jul-17
acetylsalicylic acid / pravastatin Entry to be removed since no products have been identified containing this active substance combination. Jul-17
arsenic trioxide / ephedrine hydrochloride / lidocaine Entry to be removed since no products are authorised containing this active substance combination. Jul-17
benzocaine / chlorhexidine Removal from EURD list: Entry deleted due to merging 'benzocaine / chlorhexidine' with 'benzocaine / chlorhexidine / tyrothricin'. Jul-17
benzocaine / chlorhexidine / tyrothricin Removal from EURD list: Entry deleted due to merging 'benzocaine / chlorhexidine' with 'benzocaine / chlorhexidine / tyrothricin'. Jul-17
calcium chloride / glucose / potassium chloride / sodium chlorid / sodium lactate / sodium saccharin Entry to be removed since no products are authorised containing this active substance combination. Jul-17
chlorhexidine gluconate / oxybuprocaine hydrochloride Removal from EURD list: Entry deleted due to merging ‘chlorhexidine gluconate / oxybuprocaine hydrochloride’ with ‘chlorhexidine gluconate / tetracaine hydrochloride'. Jul-17
chlorhexidine gluconate / tetracaine hydrochloride Removal from EURD list: Entry deleted due to merging ‘chlorhexidine gluconate / oxybuprocaine hydrochloride’ with ‘chlorhexidine gluconate / tetracaine hydrochloride'. Jul-17
chondroitin sulphate sodium / sodium hyaluronate Entry to be removed since no products are authorised containing this active substance combination. Jul-17
fexofenadine combinations Entry to be removed since no products are authorised containing this active substance combination. Jul-17
glucosamine / lidocaine Entry to be removed since product is only authorised in 1 MS (PL). Jul-17
human albumin solution Entry to be removed. The products of this entry will fall into the scope of the newly introduced entry "human plasma proteins with not less than 95% albumin". Jul-17
human plasma proteins with not less than 96% albumin Entry to be removed. The products of this entry will fall into the scope of the newly introduced entry "human plasma proteins with not less than 95% albumin". Jul-17
mangafodipir Product withdrawn on 21 June 2012, therefore entry should be removed. Jul-17
methyl salicylate bp / octafonium chloride / phenol / zinc oxide Entry to be removed since no products have been identified containing this active substance combination. Jul-17
lactobacillus rhamnosus Removal from EURD list: Entry: "lactobacillus all subspecies and combinations of subspecies" to be followed (PSUSA/00010598) Jun-17
lactobacillus acidophilus Removal from EURD list: Entry: "lactobacillus all subspecies and combinations of subspecies" to be followed (PSUSA/00010598) Jun-17
lactobacillus fermentum / lactobacillus rhamnosus / lactobacillus salivarius / lactobacillus vaginalis Removal from EURD list: Entry: "lactobacillus all subspecies and combinations of subspecies" to be followed (PSUSA/00010598) Jun-17
guaifenesin / salbutamol sulfate Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. Jun-17
hydrochlorothiazide / irbesartan Removal from EURD list: Entry: "hydrochlorothiazide / irbesartan, irbesartan" to be followed (PSUSA/00010601) Jun-17
irbesartan Removal from EURD list: Entry: "hydrochlorothiazide / irbesartan, irbesartan" to be followed (PSUSA/00010601) Jun-17
propiomazine Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. Jun-17
sulfametrole / trimethoprim, sulfadiazine trimethoprim New entry was created by merging 'sulfametrole / trimethoprim, sulfadiazine / trimethoprim’ with ‘sulfamethoxazole / trimethoprim (co-trimoxazole), therefore entry for “'sulfametrole / trimethoprim, sulfadiazine / trimethoprim” should be deleted. May-17
palifermin Product withdrawn on 24.02.2016, therefore entry is removed. May-17
hetastarch / sodium chloride The entry removed from the list as a duplicate (to 1694 'hydroxyethyl starch'). May-17
elvitegravir Product withdrawn on 03.11.2016, therefore entry is removed. May-17
co-trimoxazole New entry was created by merging 'sulfametrole / trimethoprim, sulfadiazine / trimethoprim’ with ‘sulfamethoxazole / trimethoprim (co-trimoxazole), therefore entry for “co-trimoxazole” should be deleted. May-17
bendroflumethiazide / hydralazine / propanolol Entry to be removed since only one product identified in Art. 57 DB in one MSs (DE). Entry to be deleted. May-17
clarithromycin / lansoprazole / tinidazole Entry to be removed since only one generic product identified in Art. 57 DB in one MSs (LV). May-17
amyleine / chlorhexidine Entry to be removed since no products have been identified containing this active substance combination. Apr-17
bacitracin / chlorhexidine Entry to be removed since no products have been identified containing this active substance combination. Apr-17
bendroflumethiazide Removal from EURD list: New entry: "bendroflumethiazide, bendroflumethiazide / potassium chloride" to be followed (PSUSA/00010583) Apr-17
benzalkonium chloride / chlorhexidine dihydrochloride / isopropyl myristate / paraffin liquid Entry to be removed from the EURD list since products in only one MS identified containing this combination of active substances. Apr-17
collagen Entry to be removed since no products have been identified containing this active substance combination. Apr-17
collagenase clostridium histolyticum (all indications except for treatment of Dupuytren’s contracture and Peyronie’s disease) Entry to be removed since no products have been identified containing this active substance combination. Apr-17
characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins Entry to be removed following withdrawal of marketing authorisation Apr-17
benzylnicotine / camphora / dimethyl sulphate / turpentine oil Entry to be removed since no products have been identified containing this active substance combination. Apr-17
dinutuximab Entry to be removed following withdrawal of marketing authorisation Apr-17
budesonide / formoterol (apart from centrally authorised products) Removal from EURD list: New entry: "budesonide / formoterol" to be followed (PSUSA/00010585) Apr-17
budesonide / formoterol (only centrally authorised products) Removal from EURD list: New entry: "budesonide / formoterol" to be followed (PSUSA/00010585) Apr-17
chlorhexidine / hydrocortisone Entry to be removed since no products have been identified containing this active substance combination. Apr-17
chlorhexidine / sodium fluoride Entry to be removed since no products have been identified containing this active substance combination. Apr-17
chlorhexidine / tolnaftate Entry to be removed since no products have been identified containing this active substance combination. Apr-17
chlorhexidine hydrochloride / hydrocortisone acetate / nystatin Entry to be removed since no products have been identified containing this active substance combination. Apr-17
chlorhexidine hydrochloride / nystatin Entry to be removed since no products have been identified containing this active substance combination. Apr-17
mycobacterium bovis Removal from EURD list: Entry: "BCG vaccine (freeze-dried)" to be followed (PSUSA/00000304) Apr-17
dextromethorphan hydrobromide / salbutamol sulfate Entry to be removed since no products have been identified containing this fixed dose active substance combination. Mar-17
oagulation factor ii / human coagulation factor ix / human coagulation factor vii / human coagulation factor x / protein c Entry to be removed since no products are authorised in EU containing this fixed dose active substance combination. Mar-17
calcium carbonate / etidronate disodium Entry to be removed since no products have been identified containing this fixed dose active substance combination. Mar-17
chelidonium majus L., herba Entry to be removed from the EURD list since only one product in one MS identified containing this combination of active substances. Mar-17
cyanocobalamin / dexamethasone / lidocaine hydrochloride / thiamine Entry to be removed from the EURD list since this fixed dose combination is authorised only in one Member State. Mar-17
dehydrocholic acid / homatropine / papaverine Entry to be removed from the EURD list since this fixed dose combination is authorised only in one Member State. Mar-17
ferucarbotran Entry to be removed since no products have been identified containing this active substance. Mar-17
fusafungine Entry to be removed since no products are authorised in EU containing this active substance. Mar-17
rimantadine Entry to be removed as all products containing this active substance are authorised under Article 10(a). Mar-17
nicotinic acid Entry to be removed from the EURD list since products with this active substance are authorised only in one Member State. Mar-17
oxedrine Entry to be removed from the EURD list since products with this active substance are authorised only in one Member State. Mar-17
oxybuprocaine hydrochloride / tetracaine hydrochloride Entry to be removed from the EURD list since only one WEU product is authorised in only one Member State. Mar-17
penamecillin Entry to be removed from the EURD list since products with this active substance are authorised only in one Member State. Mar-17
phenolphthalein Entry to be removed from the EURD list since products with this active substance are authorised only in one Member State. Mar-17
poliovirus type 1 / poliovirus type 3 (oral, live, attenuated) vaccine Entry to be removed since no products have been identified containing this fixed dose active substance combination. Mar-17
sulfamethoxazole Entry to be removed since no products have been identified containing this combination of active substances. Mar-17
aluminium oxide / hydrated / magnesium hydroxide / oxetacaine Entry to be removed since the combination of active substances is only authorised in 1 MS Feb-17
antazoline phosphate / naphazoline hydrochloride / zinc sulfate Entry to be removed since no products have been identified containing this active substance combination. Feb-17
biclotymol / cineole / pholcodine Entry to be removed since no products have been identified containing this active substance combination. Feb-17
charcoal activated / magnesium hydroxide Entry to be removed since the combination of active substances is only authorised in 1 MS Feb-17
chlorhexidine gluconate / oxedrine tartrate Entry to be removed since no products have been identified containing this active substance combination. Feb-17
chlorhexidine hydrochloride / phenobarbital / valerian extract Entry to be removed since no products have been identified containing this active substance combination. Feb-17
enterococcus faecalis / escherichia coli / klebsiella pneumoniae / morganella morganii / proteus mirabilis Entry to be removed since the combination of active substances is only authorised in 1 MS Feb-17
ethanolic extracts of camellia sinensis (L.) kuntze, non fermentatum folium Entry to be removed since no products have been identified containing this active substance combination. Feb-17
influenza vaccine (H1N1)ν (split virion, inactivated) Entry to be removed following withdrawal of marketing authorisation Feb-17
meprobamate Entry to be removed since the combination of active substances is only authorised in 1 MS Feb-17
mercaptamine Removal from EURD list: Entry split to two entries: "mercaptamine (treatment of nephropathic cystinosis)" to be followed (PSUSA/00010573) Feb-17
oxetacaine Entry to be removed since no products have been identified containing this active substance. Feb-17
influenza vaccine (H1N1)ν (whole virion, inactivated, prepared in cell culture) Entry removed from the list due to withdrawal of the product. Feb-17
nitrous oxide Removal from EURD list: Entry merged with combination of active substances containing nitrous oxide / oxygen. New entry: "nitrous oxide, nitrous oxide/oxygen" to be followed (PSUSA/00010572) Feb-17
naphazoline hydrochloride / pheniramine maleate Entry to be removed since no products have been identified containing this active substance combination. Feb-17
naphazoline Removal from EURD list: Entry merged with combination of active substances containing naphazoline/zinc sulphate. New entry: "naphazoline, naphazoline/zinc sulphate" to be followed (PSUSA/00010571) Feb-17
methotrexate (for centrally authorised product) Removal from EURD list: This entry was wrongly updated in the previous version of the EURDlist Jan-17
calcium glycerophosphate / magnesium gluconate Removal from EURD list: Entry merged with an existing entry “calcium glycerophosphate / magnesium gluconate”, therefore entry for “calcium glycerophosphate / magnesium gluconate” is deleted Jan-17
carbasalate calcium / metoclopramide Removal from EURD list: Entry merged with with other combination of active substances containing metoclopramide Jan-17
enoxaparin Removal from EURD list: Entry split to two entries: one entry only for biosimilar products and another entry for all products except for biosimilars. Jan-17
lysine acetylsalicylic acid / metoclopramide Removal from EURD list: Entry merged with with other combination of active substances containing metoclopramide Jan-17
sulfametrole / trimethoprim Removal from EURD list: Entry to be removed following merging with sulfadiazine trimethoprim Jan-17
phenothrin / piperonyl butoxide Removal from EURD list: Entry to be removed from the EURD list since no products have been identified containing this active substance combination. Dec-16
betamethasone sodium phosphate / framycetin sulfate Removal from EURD list: Entry to be removed from the EURD list since no products have been identified containing this active substance combination. Dec-16
sulpiride Removal from EURD list: substance was merged with levosulpiride, in line with the principles set in the EURDlist introductory cover note. Entry: "levosulpiride, sulpiride" to be followed (PSUSA/00001859) Dec-16
mycophenolate mofetil Removal from the EURD List: New entry "'mycophenolate mofetil, mycophenolic acid" to be followed (PSUSA/00010550) Dec-16
mycophenolic acid (apart from mycophenolate mofetil) Removal from the EURD List: New entry "'mycophenolate mofetil, mycophenolic acid" to be followed (PSUSA/00010550) Dec-16
morphine Removal from the EURD List: New entry "morphine, morphine / cyclizine" to be followed (PSUSA/00010549) Dec-16
ascorbic acid / calcium Removal from EURD list: ascorbic acid / calcium / lysine” was merged with the entry “ascorbic acid / calcium”, therefore the existing entry “ascorbic acid / calcium” should be deleted. Dec-16
benzalkonium chloride / cetrimide Removal from EURD list: “cetrimide/dimeticone” was merged with an existing entry “benzalkonium chloride/cetrimide”, therefore entry for “benzalkonium chloride/cetrimide” should be deleted. Dec-16
betacarotene / vaccinium myrtillus anthocyanosides Removal from EURD list: New entry: "alpha-tocopherol / vaccinium myrtillus anthocyanosides, betacarotene / vaccinium myrtillus anthocyanosides" to be followed (PSUSA/00010547) Dec-16
factor x / human coagulation factor ix / human coagulation factor vii / protein c / protein s / prothrombin Removal from EURD list: Entry: “human prothrombin complex" to be followed (PSUSA/00001638) Dec-16
ferumoxsil (siloxane coated superparamagnetic ironoxide) Entry to be removed since the active substance is only authorised in 1 MS Dec-16
itopride Entry to be removed from the EURD list since only one product authorised in 1 MS has been identified. Dec-16
olanzapine Removal from EURD list: olanzapine and olanzapine pamoate entries were merged. New entry to be followed: "olanzapine" (PSUSA/0010540) Dec-16
olanzapine pamoate Removal from EURD list: olanzapine and olanzapine pamoate entries were merged. Entry to be followed: "olanzapine" (PSUSA/0010540) Dec-16
coconut oil / distilled coal tar / salicylic acid Removal from EURD list: New entry: coconut oil / distilled coal tar / salicylic acid, coal tar solution / salicylic acid / sulfur to be followed (PSUSA/00010548) Dec-16
diazepam / sulpiride Entry to be removed from the EURD list since only one product authorised in 1 MS has been identified. Dec-16
urea Removal from the EURD List: New entry "'lactic acid / urea, urea" to be followed (PSUSA/00010536) Dec-16
lisinopril Removal from EURD list: merge of lisonopril with lisinopril / hydrochlorothiazide Nov-16
pegloticase Removal from EURD list: the product has not been renewed and Rapporteur notified us that no more PSUR are expected for this product. Nov-16
hydrochlorothiazide / lisinopril Removal from EURD list: merge of lisonopril with lisinopril / hydrochlorothiazide Nov-16
telaprevir Removal from EURD list: entry to be removed from the EURD List following PRAC AR in October 2016 and the MAH's wish to not renew the MA Nov-16
acidic acid / nitric acid / oxolinic acid / zinc nitrate Entry to be removed since no products have been identified containing this active substance combination. Oct-16
ajmaline Entry to be removed from the EURD list since only one product authorised in 1 MS has been identified. Oct-16
ammonium chloride / diphenhydramine hydrochloride Entry removed and merged with diphenhydramine, diphenhydramine hydrochloride / levomenthol. Entry to be followed: "diphenhydramine, ammonium chloride / diphenhydramine hydrochloride, diphenhydramine hydrochloride / levomenthol, ammonium chloride / diphenhydramine hydrochloride / levomenthol" Oct-16
borax / calcium carbonate / cholecalciferol / copper oxide / magnesium oxide / manganese sulfate / zinc oxide Entry to be removed since no products have been identified containing this active substance combination. Oct-16
calcium levulinate / cetylpyridinium chloride / diphenhydramine hydrochloride / essential sage oil / panthenol / phenylephrine hydrochloride Entry to be removed since no products have been identified containing this active substance combination. Oct-16
cineole / gaiacol / pholcodine Entry to be removed since no products have been identified containing this active substance combination. Oct-16
codeine phosphate / ibuprofen / paracetamol Entry to be removed since no products have been identified containing this active substance combination. Oct-16
hypericin Entry to be removed since no products have been identified containing this active substance.
Additionally, a duplicate entry "hypericum perforatum L., herba" has been identified. Oct-16
lidocaine / zinc oxide Entry to be removed since no products have been identified containing this active substance combination. Oct-16
nicotinic acid / simvastatin Entry to be removed since no products have been identified containing this active substance combination. Oct-16
tegafur / uracil Entry to be removed since no products have been identified containing this active substance combination. Oct-16
dequalinium Removal from EURD list: new entry "dequalinium, dequalinium / cinchocaine, dequalinium / lidocaine" (PSUSA/00010526) should be followed Oct-16
dequalinium chloride / lidocaine Removal from EURD list: new entry "dequalinium, dequalinium / cinchocaine, dequalinium / lidocaine" (PSUSA/00010526) should be followed Oct-16
diphenhydramine Removal from EURD list: new entry "diphenhydramine, ammonium chloride / diphenhydramine hydrochloride, diphenhydramine hydrochloride / levomenthol, ammonium chloride / diphenhydramine hydrochloride / levomenthol" (PSUSA/00010527) should be followed Oct-16
diphenhydramine hydrochloride / levomenthol Removal from EURD list: new entry "diphenhydramine, ammonium chloride / diphenhydramine hydrochloride, diphenhydramine hydrochloride / levomenthol, ammonium chloride / diphenhydramine hydrochloride / levomenthol" (PSUSA/00010527) should be followed Oct-16
levobunolol Removal from EURD list: entry "levobunolol (ophthalmic indication)" (PSUSA/00010109) should be followed Oct-16
magnesium / potassium / sodium / water for injection Entry to be removed since no products have been identified containing this active substance combination. Jul-16
spirapril Entry to be removed from the EURD list since only one product authorised in 1 MS has been identified. Jul-16
dutasteride / tamsulosin hydrochloride Entry removed due to merging the entries for dutasteride and dutasteride/tamsulosine Jun-16
sodium molybdate [99mo] / sodium pertechnetate [99mtc] Entry removed due to it being duplicate to entry 'technetium (99mTc) pertechnetate' Jun-16
pyridoxin / thiamine Entry removed from the EURD List following the merging with another combination of active substances Jun-16
dutasteride Entry removed due to merging the entries for dutasteride and dutasteride/tamsulosine Jun-16
ascorbic acid / rutoside This product is only authorised in France under Article 8(3) of Directive 2001/83/EC, therefore it should be removed from the list Jun-16
artemether / lumefantrin (dispersible tablet) Product authorised only in 1 Member State, therefore it should be removed from the list Jun-16
delapril / manidipine Removal from EURD list: new entry 'delapril / manidipine, delapril / indapamide' (PSUSA/00010496) should be followed. May-16
calcium chloride / icodextrin / magnesium chloride / sodium chloride / sodium lactate Entry removed and merged with 3 other combinations of active substances for peritoneal dialysis.
New entry: 'calcium chloride / glucose / magnesium chloride / sodium chloride / sodium lactate, calcium chloride / glucose / magnesium chloride / sodium chloride / sodium lactate/ sodium bicarbonate, calcium chloride / amino acids blend / magnesium chloride / sodium chloride / sodium lactate, calcium chloride / icodextrin / magnesium chloride / sodium chloride / sodium lactate’ to be followed May-16
azithromycin Removal from EURD list: new entries “azithromycin (systemic use formulations)”(PSUSA/00010491/) and azithromycin (ocular use formulations)” (PSUSA/00010492) should be followed. May-16
ambroxol / doxycycline Entry to be removed since products identified in Art. 57 are only authorised in 1 MS (DE) Apr-16
ascorbic acid / cyanocobalamin / ergocalciferol / nicotinamide / pyridoxine / retinol / riboflavin / thiamine hydrochloride This entry should be removed from the EURD List since this combination of active substance is already covered by the following entry:
'ascorbic acid / calcium hydrogenphosphate / calcium panthotenate / colecalciferol / cyanocobalamin / folic acid / nicotinamide / pyridoxine hydrochloride / retinol / riboflavine / thiamin nitrate, ascorbic acid / cyanocobalamin / ergocalciferol / nicotinamide / pyridoxine / retinol / riboflavin / thiamine hydrochloride, ascorbic acid / colecalciferol / dexpanthenol / nicotinamide / pyridoxine / retinol / riboflavin / thiamine Apr-16
bromhexine / oxymetazoline Entry to be removed since products identified in Art. 57 are only authorised in 1 MS (HU) Apr-16
citric acid / epoetin alpha / human albumin / sodium chloride / sodium citrate Entry to be removed since no products containing this particular combination have been identified in the Article 57 database Apr-16
histrelin Entry to be removed from the EURD list as no products containing the active substance histrelin have been identified in article 57. In addition, no submissions were received during the reconcilliation process for PSUSA/00001611/201511 Apr-16
human coagulation factor xiii / human fibrinogen Entry to be removed since no authorised products were identified in Article 57 Apr-16
influenza vaccine (H1N1)ν (surface antigens, inactivated, adjuvanted) Entry to be removed following withdrawal of marketing authorisation for CAP Focetria on 11/02/2016 Apr-16
influenza vaccine (H1N1)ν (surface antigens, inactivated, prepared in cell cultures, adjuvanted) Entry to be removed since only the product Celtura (authorised in DE) was identified in Article 57 Apr-16
lansoprazole / metronidazole / tetracycline Entry to be removed since no authorised products were identified in Article 57 Apr-16
leucocytes dialysate Entry to be removed since no authorised products were identified in Article 57 Apr-16
selenomethionine (75Se) Entry to be removed since no authorised products were identified in Article 57 Apr-16
thrombin Entry to be removed since no products were identified in Article 57 referencing “thrombin” as standalone active substance, apart from 2 products containing bovine thrombin (only authorised in PL)) Apr-16
almagate Removal from EURD List: only authorised in one Member State (ES). Therefore the active substance almagate should be removed from the EURDlist. Apr-16
erythromycin / isotretinoin Removal from EURD list: new entries “erythromycin / isotretinoin, isotretinoin (topical formulations)”(PSUSA/00010487/) and “isotretinoin (oral formulations)” (PSUSA/00010488) should be followed. Apr-16
isotretinoin Removal from EURD list: new entries “erythromycin / isotretinoin, isotretinoin (topical formulations)”(PSUSA/00010487/) and “isotretinoin (oral formulations)” (PSUSA/00010488) should be followed. Apr-16
dextromethorphan hydrobromide / quinidine sulfate (treatment of pseudobulbar affect (PBA)) CAP Nuedexta no longer authorised. MA has been withdrawn on 02/03/2016 Mar-16
fosinopril Entry "fosinopril, fosinopril / hydrochlorothiazide" should be followed Mar-16
fosinopril / hydrochlorothiazide Entry "fosinopril, fosinopril / hydrochlorothiazide" should be followed Mar-16
thiocolchicoside Entry "thiocolchicoside, paracetamol / thiocolchicoside" should be followed Mar-16
paracetamol / thiocolchicoside Entry "thiocolchicoside, paracetamol / thiocolchicoside" should be followed Mar-16
metopimazine Not authorised in EEA or in more than 1 Member state. Mar-16
estradiol The estradiol entry has been split into the following 2 new entries:
-estradiol (without cream/balm/emulsion for application in the female genital area)
-estradiol, estradiol / prednisolone (only cream/balm/emulsion for application in the female genital area) Feb-16
terfenadine Not authorised in EEA or in more than 1 Member state. Feb-16
parathyroid hormone (rdna) CAP Preotact no longer authorised. MA has been withdrawn on 16/05/2014. Feb-16
dienogest / estradiol Entry dienogest / estradiol split into 2 new entries with a different scope based on the different indication. The 2 new entries to be followed are:
dienogest / estradiol (HRT indication)
dienogest / estradiol (contraception indication) Feb-16
alfatradiol Not authorised in EEA or in more than 1 Member state Jan-16
almitrine Not authorised in EEA or in more than 1 Member state Dec-15
betamethasone / dexchlorpheniramine maleate Not authorised in EEA or in more than 1 Member state Dec-15
butizide / spironolactone Not authorised in EEA or in more than 1 Member state Dec-15
calcium chloride dihydrate / glucose / potassium chloride / sodium chloride Entry "glucose (apart from glucose1- phosphate) / glucose in combination with calcium chloride and/or sodium chloride and/or magnesium chloride and/or sodium citrate and/or potassium chloride (intravenous or parenteral use)" should be followed. Dec-15
calcium chloride dihydrate / glucose monohydrate Entry "glucose (apart from glucose1- phosphate) / glucose in combination with calcium chloride and/or sodium chloride and/or magnesium chloride and/or sodium citrate and/or potassium chloride (intravenous or parenteral use)" should be followed. Dec-15
calcium chloride dihydrate / glucose monohydrate / sodium chloride Entry "glucose (apart from glucose1- phosphate) / glucose in combination with calcium chloride and/or sodium chloride and/or magnesium chloride and/or sodium citrate and/or potassium chloride (intravenous or parenteral use)" should be followed. Dec-15
calcium chloride dihydrate / potassium chloride / sodium chloride Entry "glucose (apart from glucose1- phosphate) / glucose in combination with calcium chloride and/or sodium chloride and/or magnesium chloride and/or sodium citrate and/or potassium chloride (intravenous or parenteral use)" should be followed. Dec-15
chlortalidone / spironolactone Not authorised in EEA or in more than 1 Member state Dec-15
'dexbrompheniramine / pseudoephedrine Not authorised in EEA or in more than 1 Member state Dec-15
dexchlorpheniramine / guaiafenesin / pseudoephedrine Not authorised in EEA or in more than 1 Member state Dec-15
dexchlorpheniramine / pseudoephedrine Not authorised in EEA or in more than 1 Member state Dec-15
galactose Not authorised in EEA or in more than 1 Member state Dec-15
glucose Entry "glucose (apart from glucose1- phosphate) / glucose in combination with calcium chloride and/or sodium chloride and/or magnesium chloride and/or sodium citrate and/or potassium chloride (intravenous or parenteral use)" should be followed. Dec-15
glucose / potassium chloride Entry "glucose (apart from glucose1- phosphate) / glucose in combination with calcium chloride and/or sodium chloride and/or magnesium chloride and/or sodium citrate and/or potassium chloride (intravenous or parenteral use)" should be followed. Dec-15
glucose / potassium chloride / sodium chloride / sodium citrate Entry "glucose (apart from glucose1- phosphate) / glucose in combination with calcium chloride and/or sodium chloride and/or magnesium chloride and/or sodium citrate and/or potassium chloride (intravenous or parenteral use)" should be followed. Dec-15
glucose / sodium chloride Entry "glucose (apart from glucose1- phosphate) / glucose in combination with calcium chloride and/or sodium chloride and/or magnesium chloride and/or sodium citrate and/or potassium chloride (intravenous or parenteral use)" should be followed. Dec-15
linagliptin Entry "linagliptin, linagliptin / metformin" should be followed. Dec-15
linagliptin / metformin Entry "linagliptin, linagliptin / metformin" should be followed. Dec-15
dibrompropamidine Entry "dibrompropamidine , propamidine" should be followed. Nov-15
trapidil Not authorised in EEA or in more than 1 Member state Nov-15
empagliflozin Entry "empagliflozin, empagliflozin / metformin" should be followed. Nov-15
tacrolimus (systemic formulations) - for CAP Envarsus Entry "tacrolimus (systemic formulations)" should be followed. Nov-15
tocopherol / tretinoin Not authorised in EEA or in more than 1 Member state Oct-15
tioconazole Entry "tioconazole, tioconazole / hydrocortisone" should be followed. Oct-15
phenylephrine Entry divided according to indication. Entry "phenylephrine (IV, nasal or oral formulations )" or "phenylephrine (ophthalmic formulations)" should be followed. Oct-15
nystatin / tinidazole Entry "tinidazole / nystatin, tinidazole" should be followed Oct-15
tinidazole Entry "tinidazole / nystatin, tinidazole" should be followed Oct-15
beclometasone dipropionate / formoterol fumarate Entry "beclometasone / formoterol (inhalative application)" should be followed Sep-15
calcium carbonate / colecalciferol Entry "calcium salts / colecalciferol" should be followed Sep-15
calcium phosphate / colecalciferol Entry "calcium salts / colecalciferol" should be followed Sep-15
macrogol 4000 Entry "macrogol 4000 and combinations (systemic use)" to be followed Sep-15
'macrogol 4000 and combinations Entry "macrogol 4000 and combinations (systemic use)" to be followed Sep-15
macrogol 4000 / potassium chloride / sodium bicarbonate / sodium chloride / sodium sulfate anhydrous Entry "macrogol 4000 and combinations (systemic use)" to be followed Sep-15
rosiglitazone Not authorised in EEA or in more than 1 Member state Sep-15
valsartan Entry "valsartan, hydrochlorothiazide / valsartan" to be followed Sep-15
hydrochlorothiazide / valsartan Entry "valsartan,/ hydrochlorothiazide / valsartan" to be followed Sep-15
budipine Not authorised in EEA or in more than 1 Member state Jul-15
cidofovir Not authorised in EEA or in more than 1 Member state Jul-15
ferumoxytol Not authorised in EEA or in more than 1 Member state Jul-15
floctafenine Not authorised in EEA or in more than 1 Member state Jul-15
human fibrinogen / human thrombin (all pharmaceutical dose forms except for sealant matrix) Entry "human fibrinogen / human thrombin" should be followed Jul-15
raltegravir Entry "raltegravir, lamivudine / raltegravir " should be followed Jul-15
amitriptyline Entry "amitriptyline, amitriptyline / amitriptylinoxide, amitriptylinoxide" should be followed Jun-15
amitriptylinoxide Entry "amitriptyline, amitriptyline / amitriptylinoxide, amitriptylinoxide" should be followed Jun-15
amitriptyline / amitriptylinoxide Entry "amitriptyline, amitriptyline / amitriptylinoxide, amitriptylinoxide" should be followed Jun-15
colestilan Not authorised in EEA or in more than 1 Member state Jun-15
bacterial lysate Entry “bacterial lysates” removed and more specific entries are introduced Jun-15
allergen diagnostics: all prick and provocation tests of all species; intracutan tests (allergens) Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergen products for treatment: epithelia and feathers, single or mixes (parenteral preparations) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergen products for treatment: grass and cereal pollen, single or mixes (oral preparations, solid forms) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergen products for treatment: grass and cereal pollen, single or mixes (parenteral preparations) allergoid Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergen products for treatment: grass and cereal pollen, single or mixes (parenteral preparations) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergen products for treatment: insects venoms (parenteral preparations) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergen products for treatment: mites, single or mixes (oral presentation- liquid and semi-solid forms) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergen products for treatment: mites, single or mixes (parenteral preparations) allergoid Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergen products for treatment: mites, single or mixes (parenteral preparations) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergen products for treatment: moulds, single or mixes (parenteral preparations) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergen products for treatment: tree pollen, single or mixes (oral presentation – liquid and semi-solid forms) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergen products for treatment: tree pollen, single or mixes (parenteral preparations) allergoid Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergen products for treatment: tree pollen, single or mixes (parenteral preparations) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergen products for treatment: weed pollen, single or mixes (oral presentation – liquid) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergen products for treatment: weed pollen, single or mixes (parenteral preparations) allergoid Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergen products for treatment: weed pollen, single or mixes (parenteral preparations) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
allergens from vertebrates, single or mixes (parenteral presentations) native Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
products used in connection with allergen diagnostics: products for positive and negative control for allergy prick tests and negative control for allergy provocation tests; diluents (no active substance) for prick test and treatment products; positive and negative control for intracutan tests Allergen group entry is temporarily removed from the EURD list. For more details regarding this decision please refer to the PRAC minutes (May 2015 - Item 12.10.4.)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp May-15
guanfacine Not authorised in EEA or in more than 1 Member state May-15
dimethyl fumarate / ethyl fumarate calcium / ethyl fumarate magnesium / ethyl fumarate zinc Not authorised in EEA or in more than 1 Member state May-15
autologous peripheral-blood mononuclear cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor (sipuleucel-T) Not authorised in EEA or in more than 1 Member state May-15
amlodipine / indapamide Entry "'amlodipine / indapamide, amlodipine / indapamide / perindopril" should be followed May-15
amlodipine / indapamide / perindopril Entry "'amlodipine / indapamide, amlodipine / indapamide / perindopril" should be followed May-15
budipine Not authorised in EEA or in more than 1 Member state May-15
adrafinil Not authorised in EEA or in more than 1 Member state May-15
human fibrinogen / human thrombin (sealant matrix) Entry "human fibrinogen / human thrombin" should be followed Apr-15
phloroglucinol / trimethylphloroglucinol Entry "phloroglucinol, phloroglucinol / trimethylphloroglucinol" should be followed Apr-15
phloroglucinol Entry "phloroglucinol, phloroglucinol / trimethylphloroglucinol" should be followed Apr-15
niaprazine Not authorised in EEA or in more than 1 Member state Apr-15
misoprostol (gynaecological indication) Entries "misoprostol (gynaecological indication - labor induction)" and "misoprostol (gynaecological indication - termination of pregnancy)" should be followed accordingly Apr-15
mazindol Not authorised in EEA or in more than 1 Member state Apr-15
human spongiosa Not authorised in EEA or in more than 1 Member state Apr-15
human fascia lata collagen Not authorised in EEA or in more than 1 Member state Apr-15
ferumoxtran-10 (superparamagnetic ironoxide) Not authorised in EEA or in more than 1 Member state Apr-15
ferumoxides Not authorised in EEA or in more than 1 Member state Apr-15
chlorphenamine / dexchlorpheniramine / pseudoephedrine Not authorised in EEA or in more than 1 Member state Apr-15
carmustine Entries "carmustine (powder and solvent for solution for infusion)" and "carmustine (implant)" should be followed accordingly Apr-15
caffeine / dexchlorpheniramine / dextromethorphan Not authorised in EEA or in more than 1 Member state Apr-15
atorvastatin (paediatric indication) Entry "atorvastatin" should be followed Apr-15
atorvastatin (adult indication) Entry "atorvastatin" should be followed Apr-15
aprotinin / human fibrinogen / thrombin (calcium chloride) Entry "aprotinin / calcium chloride / human factor xiii / human fibrinogen / human thrombin, aprotinin / fibrinogen / fibronectin / human coagulation factor XIII / plasma protein fraction / plasminogen / thrombin, aprotinin / human fibrinogen / thrombin (calcium chloride)" should be followed Apr-15
aprotinin / fibrinogen / fibronectin / human coagulation factor XIII / plasma protein fraction / plasminogen / thrombin Entry "aprotinin / calcium chloride / human factor xiii / human fibrinogen / human thrombin, aprotinin / fibrinogen / fibronectin / human coagulation factor XIII / plasma protein fraction / plasminogen / thrombin, aprotinin / human fibrinogen / thrombin (calcium chloride)" should be followed Apr-15
aprotinin / calcium chloride / human factor xiii / human fibrinogen / human thrombin Entry "aprotinin / calcium chloride / human factor xiii / human fibrinogen / human thrombin, aprotinin / fibrinogen / fibronectin / human coagulation factor XIII / plasma protein fraction / plasminogen / thrombin, aprotinin / human fibrinogen / thrombin (calcium chloride)" should be followed Apr-15
codergocrine mesilate Entry "dihydroergotoxine" should be followed Mar-15
ibuprofen lysine Entry "ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus)" should be followed Mar-15
ibuprofen Entry "ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus)" should be followed Mar-15
sodium bicarbonate Entry "'sodium hydrogen carbonate" should be followed Mar-15
diclofenac (ophtalmic formulations) Entry "diclofenac (topical formulations)" should be followed Mar-15
diclofenac (cutaneous formulations) Entry "diclofenac (topical formulations)" should be followed Mar-15
amlodipine / valsartan Entry "'amlodipine / valsartan, amlodipine / hydrochlorothiazide, valsartan" should be followed Mar-15
amlodipine / hydrochlorothiazide / valsartan Entry "'amlodipine / valsartan, amlodipine / hydrochlorothiazide, valsartan" should be followed Mar-15
aluminium / calcium or aluminium / magnesium Not authorised in EEA or in more than 1 Member state Feb-15
acidic acid / nitric acid / oxalic acid / zinc nitrate Not authorised in EEA or in more than 1 Member state Feb-15
pegaspargase Entry "asparaginase" should be followed Jan-15
crisantaspase (erwinia L-asparaginase) Entry "asparaginase" should be followed Jan-15
cilazapril / hydrochlorothiazide Entry "'cilazapril, cilazapril / hydrochlorothiazide" should be followed Jan-15
bromhexine / ephedrine Not authorised in EEA or in more than 1 Member state Jan-15
anise oil / bromhexine / fennel oil / levomenthol Not authorised in EEA or in more than 1 Member state Jan-15
ambroxol hydrochloride / theophylline Not authorised in EEA or in more than 1 Member state Jan-15
canagliflozin / metformin Entry "'canagliflozin, canagliflozin / metformin" should be followed Dec-14
acethylthyrosine / acetylcysteine / alanine / arginine / asparagine monohydrate / aspartic acid / glutamic acid / glycine / histidine / isoleucine / leucine / lysine acetate / methionine / ornithine hydrochloride / phenylalanine / proline / serine / threonine / tryptophane / valine Entry "'amino acid combinations (only combinations of pure amino acids or combination of amino acids with mineral compounds/electrolytes, i.v. application)" should be followed Dec-14
metformin / vildagliptin Entry "'vildagliptin, metformin / vildagliptin" should be followed Nov-14
caffeine / opium / paracetamol Not authorised in EEA or in more than 1 Member state Nov-14
hydroxyzine Entry removed as duplicate to "hydroxyzine chloride / hydroxyzine pamoate and all fixed combination, hydroxyzine" Nov-14
doripenem Not authorised in EEA or in more than 1 Member state Nov-14
camphor / eucalyptus oil / menthol / thymol / turpentine oil Entry "'camphor, camphor and other terpene derivates" should be followed Nov-14
camphor / eucalyptus oil / menthol / turpentine oil Entry "'camphor, camphor and other terpene derivates" should be followed Nov-14
camphor / menthol Entry "'camphor, camphor and other terpene derivates" should be followed Nov-14
camphor / ichtamol Entry "'camphor, camphor and other terpene derivates" should be followed Nov-14
sodium salt of gamma-hydroxybutyric acid Entry "sodium oxybate" should be followed Oct-14
bendroflumethiazide / spironolactone Not authorised in EEA or in more than 1 Member state Sep-14
nelfinavir Not authorised in EEA or in more than 1 Member state Sep-14
chlorazepate Entry clorazepate in the EURD list to be followed Sep-14
cetylpyridinium chloride / muramidase hydrochloride Entry cetylpyridinium, lysozyme in the EURD list to be followed Sep-14
calcium pantothenate / dl-methionine / l-cystine / pa / pyridoxine hcl / thiamine hcl Not authorised in EEA or in more than 1 Member state Sep-14
benztropine mesylate Entry benztropine in the EURD list to be followed Sep-14
benfotiamine / calcium hydrogen phosphate dihydrate / magnesium estearate Entry benfotiamine in the EURD list to be followed Sep-14
benfotiamine / calcium hydrogen phosphate dihydrate / cyanocobalamin / magnesium estearate / pyridoxine Entry benfotiamine, cyanocobalamin, pyridoxine in the EURD list to be followed Sep-14
ammonium salt / glycine / glycyrrhizic acid / l-station sun cysteine hydrochloride hydrate Not authorised in EEA or in more than 1 Member state Sep-14
aluminium hydroxide dried / magnesium hydroxide / simeticone Entry aluminium oxide, magnesium hydroxide, simeticone in the EURD list to be followed Sep-14
benzalkonium chloride / potassium alum Entry alum, benzalkonium chloride in the EURD list to be followed Sep-14
sodium ferrous citrate Entry iron, oral preparations in the EURD list to be followed Jul-14
sodium ferric gluconate complex Entry iron, parenteral preparations in the EURD list to be followed Jul-14
iron / sodium feredetate Entry sodium feredetate in the EURD list to be followed Jul-14
folic acid / iron Entry iron in combination with folic acid and other substances in the EURD list to be followed Jul-14
ferrous sulphate / folic acid Entry iron in combination with folic acid and other substances in the EURD list to be followed Jul-14
ferrous sulfate / serine Entry iron in combination with folic acid and other substances in the EURD list to be followed Jul-14
ferrous sulfate Entry iron, oral preparations in the EURD list to be followed Jul-14
ferrous salts Entry iron, oral preparations in the EURD list to be followed Jul-14
ferrous lactate Entry iron, oral preparations in the EURD list to be followed Jul-14
ferrous glycine sulfate Entry iron, oral preparations in the EURD list to be followed Jul-14
ferrous gluconate Entry iron, oral preparations in the EURD list to be followed Jul-14
ferrous fumarate Entry iron, oral preparations in the EURD list to be followed Jul-14
ferrous aspartate Entry iron, oral preparations in the EURD list to be followed Jul-14
ferric polymaltose / folic acid Entry iron in combination with folic acid and other substances in the EURD list to be followed Jul-14
ferric hydroxide sucrose complex Entry iron, parenteral preparations in the EURD list to be followed Jul-14
dextriferron Entry iron, parenteral preparations in the EURD list to be followed Jul-14
cyanocobalamin / ferrous sulfate / folic acid Entry iron in combination with folic acid and other substances in the EURD list to be followed Jul-14
cyanocobalamin / dl-serine / ferrous sulfate / folic acid Entry iron in combination with folic acid and other substances in the EURD list to be followed Jul-14
copper gluconate / ferrous gluconate / manganese gluconate Entry iron in any combination including one or more of the following: multivitamins, minerals, aminoacids, herbal extracts, lecithine (except for combinations with folic acid)to be followed Jul-14
chromium trichloride hexahydrate / copper chloride dihydrate / ferric chloride hexahydrate / manganese chloride tetrahydrate / potassium iodide / sodium fluoride / sodium molybdate dihydrate / sodium selenite / water for injection / zinc chloride Entry iron in any combination including one or more of the following: multivitamins, minerals, aminoacids, herbal extracts, lecithine (except for combinations with folic acid)to be followed Jul-14
calcium panthotenate / copper / d /l-methionine / faex medicinalis / iron / l-cystine / milium semen extract / paraaminobenzoic acid / pyridoxine hydrochloride / thiamine hydrochloride / triticum germs extract / zinc Entry iron in any combination including one or more of the following: multivitamins, minerals, aminoacids, herbal extracts, lecithine (except for combinations with folic acid)to be followed Jul-14
calcium folinate / iron protein succinylate Entry calcium folinate, iron succinyl-protein complex in the EURD list to be followed Jul-14
ascorbic acid / ferrous sulfate Entry iron in any combination including one or more of the following: multivitamins, minerals, aminoacids, herbal extracts, lecithine (except for combinations with folic acid)to be followed Jul-14
ascorbic acid / calcium hydrogenphosphate / calcium panthotenate / colecalciferol / copper sulfate / cyanocobalamin / ferrous fumarate / folic acid / magnesium lactate / manganese sulfate / nicotinamide / pyridoxine hydrochloride / retinol / riboflavine / sodium molybdenate / thiamin nitrate / tocopherol acetate / zinc sulfate Entry iron in combination with folic acid and other substances in the EURD list to be followed Jul-14
ascorbic acid / betacarotene / biotine / calcium hydrogenphosphate / colecalciferol / copper sulfate / cyanocobalamin / ferrous sulfate / folic acid / ginseng radix extract / magnesium oxide / manganese sulfate / nicotinamide / pyridoxine hydrochloride / riboflavine / sodium selenate / thiamin nitrate / tocopherol alpha dl acetate / zinc sulfate Entry iron in combination with folic acid and other substances in the EURD list to be followed Jul-14
ascorbic acid / calcium hydrogenphosphate / calcium lactate / calcium panthotenate / colecalciferol / cyanocobalamin / ferrous fumarate / folic acid / nicotinamide / pyridoxine hydrochloride / retinol palmitate / riboflavine / thiamin nitrate / tocoferol acetate Entry iron in combination with folic acid and other substances in the EURD list to be followed Jul-14
ascorbic acid / calcium fluoride / calcium hydrogenphosphate / calcium panthotenate / copper sulfate / cyanocobalamin / deanol hydrogentartrate / ergocalciferol / ferrous sulfate / ginseng radix extract / lecithine / magnesium sulfate / manganese sulfate / nicotinamide / potassium sulfate / pyridoxine hydrochloride / retinol palmitate / riboflavine / rutoside / soy lecithine / thiamine nitrate / tocopherol alpha dl acetate / zinc oxide Entry iron in any combination including one or more of the following: multivitamins, minerals, aminoacids, herbal extracts, lecithine (except for combinations with folic acid) in the EURD list to be followed Jul-14
ammonium molybdate tetrahydrate / chromium trichloride hexahydrate / cobalt gluconate / copper gluconate / ferrous gluconate / manganese gluconate / sodium fluoride / sodium iodide / sodium selenite / zinc gluconate Entry iron in any combination including one or more of the following: multivitamins, minerals, aminoacids, herbal extracts, lecithine (except for combinations with folic acid) in the EURD list to be followed Jul-14
valpromide Entry valproic acid / sodium valproate / valproate pivoxil / valproate semisodium / valpriomide / valproate bismuth / calcium valproate / valproate magnesium in the EURD list to be followed Jul-14
divalproex sodium Entry valproic acid / sodium valproate / valproate pivoxil / valproate semisodium / valpriomide / valproate bismuth / calcium valproate / valproate magnesium in the EURD list to be followed Jul-14
valproic acid Entry valproic acid / sodium valproate / valproate pivoxil / valproate semisodium / valpriomide / valproate bismuth / calcium valproate / valproate magnesium in the EURD list to be followed Jul-14
alphatocopherol / ascorbic acid / betacarotene / cyanocobalamin / extractum ginseng / ferrous fumarate / nicotinamide / pyridoxine hydrochloride / thiamine mononitrate Entry iron in any combination including one or more of the following: multivitamins, minerals, aminoacids, herbal extracts, lecithine (except for combinations with folic acid) in the EURD list to be followed Jul-14
methotrimeprazine Entry levomepromazine in the EURD list to be followed May-14
diacethyl-midecamycin Entry midecamycin acetate in the EURD list to be followed May-14
aliskiren / amlodipine / hydrochlorothiazide Not authorised in EEA or in more than 1 Member state Feb-14
anti-human t-lymphocyte immunoglobulin from rabbits Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Feb-14
desvenlafaxine Not authorised in EEA or in more than 1 Member state Feb-14
diphtheria / tetanus / pertussis (whole cell) and hepatitis B(Rdna) (Hbv) vaccine (adsorbed) Not authorised in EEA or in more than 1 Member state Feb-14
iobitridol Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Feb-14
prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) Merged entry with pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) Feb-14
docosahexaenoic acid / eicosapentanoic acid Entry omega-3-acid-ethyl esters in the PSUR WS List to be followed Feb-14
human albumin solution Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Feb-14
laropiprant / nicotinic acid Not authorised in EEA or in more than 1 Member state Feb-14
metformin hydrochloride / rosiglitazone Not authorised in EEA or in more than 1 Member state Feb-14
rilonacept Not authorised in EEA or in more than 1 Member state Feb-14
tetrofosmin Merged entry with technetium (99mTc) tetrofosmin Feb-14
articaine hydrochloride / ephedrine Not authorised in EEA or in more than 1 Member state Jan-14
alogliptin / metformin Included in shared entry "alogliptin, alogliptin / metformin, alogliptin / pioglitazone" Jan-14
porfimer Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Jan-14
flupirtine Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Nov-13
clarithromycin Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Oct-13
doconexent / eicosapentaenoic acid / omega-3 acid ethyl esters Replaced with "omega-3-acid-ethyl esters" which is placed temporarily in the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Oct-13
testosterone enantate injection Replaced with "testosterone (all formulations apart from transdermal application and testosterone undecylate injection)" Oct-13
carbamoylphenoxyacetic acid / theophylline Not authorised in EEA or in more than 1 Member state Sep-13
cilostazol Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Sep-13
quinine combinations Entry too general, specific combinations will be specified in the EURD List if those are authorised in EEA or in more than 1 Member state. Sep-13
defibrotide Not authorised in EEA or in more than 1 Member state Jul-13
diphtheria / tetanus / pertussis (acellular, component) / hepatitis b (rdna) / poliomyelitis (inactivated) vaccines (adsorbed) Not authorised in EEA or in more than 1 Member state Jul-13
alemtuzumab Not authorised in EEA or in more than 1 Member state Jul-13
chlorhexidine gluconate / tixocortol pivalate Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Jul-13
aloe barbadensis miller / aloe ferox miller, folium Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
aloe barbadensis miller / aloe ferox miller, folium Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
arctostaphylos uva-ursi (L.) spreng., folium Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
capsicum annuum L. var. minimum (Miller) heiser, fructus Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
cassia senna L.; cassia angustifolia vahl, fructus // cassia senna L.; cassia angustifolia vahl, folium Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
cephaelis ipecacuanha (brot.) a. rich.; cephaelis acuminata karsten, radix
Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
echinacea pallida (nutt.) nutt.; echinacea purpurea (L.) moench; echinacea angustifolia dc, radix // echinacea purpurea (L.) moench, herba Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
eucalyptus globulus labill., aetheroleum Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
ginkgo biloba L., folium Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
glycyrrhiza glabra L.; glycyrrhiza inflata bat.; glycyrrhiza uralensis fisch., radix Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
melaleuca alternifolia (maiden and betche) cheel, aetheroleum Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
melaleuca viridiflora, (melaleuca quinquenervia)
Broad-leaved paperbark,
aetheroleum
Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
mentha x piperita l., aetheroleum Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
pinus sylvestris L., aetheroleum Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
plantago ovata forssk., semen Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
plantago ovata forssk., seminis tegumentum Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
rhamnus purshianus dc, cortex Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
rheum palmatum L.; rheum officinale baillon, radix Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
serenoa repens (bartram) small (sabal serrulata (michaux) nichols, fructus Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
symphytum officinale L.
radix Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
thymus vulgaris L.; thymus zygis loefl. ex L., aetheroleum Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
valeriana officinalis L., radix Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
xysmalobium undulatum L.
Aiton f. var. undulatatum, radix Products which do not fall in the scope of Article 10(1), 10a, 16, 14a of Directive 2001/83/EC as amended should follow national requirements for the submission of PSURs May-13
paracetamol (IV formulation) Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” May-13
cyproterone / ethinylestradiol Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” May-13
gentamicin / zyrconium Not authorised in EEA or in more than 1 Member state Apr-13
amcinonide / neomycin Not authorised in EEA or in more than 1 Member state Apr-13
ascorbic acid / cetylpyridinium Not authorised in EEA or in more than 1 Member state Apr-13
deltamethrin Not authorised in EEA or in more than 1 Member state Apr-13
human plasma protease C1 inhibitor Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Apr-13
doxylamine Moved temporarily to the “List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised” Apr-13
almitrine dimesilate / raubasine Not authorised in EEA or in more than 1 Member state Feb-13
amylase / lipase / protease Please refer to entry: pancreatic enzymes / pancreatic extracts / pancreatin Jan-13
grepafloxacin hydrochloride Not authorised in EEA or in more than 1 Member state Dec-12
_x000D_&1#&"Verdana"&7&K737373 Classified as internal/staff & contractors by the European Medicines Agency
02.07.2026
Datei
PD
Die EURD-Liste führt umfassend Wirkstoffe und Wirkstoffkombinationen auf, für die die Einreichungsdaten und -frequenzen für die Übermittlung von Periodic Safety Update Reports (PSURs) in der EU harmonisiert festgelegt sind. Die EURD-Liste wird in der Regel monatlich überarbeitet und wird jeweils 6 Monate nach Bekanntmachung rechtswirksam. Die aktuelle EURD-Liste mit den farblich markierten Änderungen und allen Details kann auch auf der Webseite der EMA eingesehen werden.
02.07.2026
Beitrag
PD
Bundesinstitut
für Arzneimittel und Medizinprodukte
557. Bekanntmachung
über die Zulassung von Arzneimitteln sowie andere Amtshandlungen
Vom 21. Januar 2026
Gemäß § 34 Absatz 1 Satz 2 des Arzneimittelgesetzes (AMG) in der Fassung der Bekanntmachung vom 12. Dezember
2005 (BGBl. I S. 3394), das zuletzt durch Artikel 2 des Gesetzes vom 23. Oktober 2024 (BGBl. 2024 I Nr. 324) geändert
worden ist, wird Folgendes bekannt gemacht:
I.
Erteilung einer Zulassung
Bezeichnung des Arzneimittels Zul.-Nr.
Datum der
Zulassung Zulassungsinhaber
Arzneimittel zur Anwendung am Menschen
Adabencutan 1 mg/g + 25 mg/g Gel 7017475.00.00 09.08.2025 Dermapharm Aktiengesellschaft
Adabencutan 3 mg/g + 25 mg/g Gel 7017476.00.00 09.08.2025 Dermapharm Aktiengesellschaft
Adapaben forte 3 mg/g + 25 mg/g Gel 7014613.00.00 09.08.2025 Klinge Pharma GmbH
Adapalen/Benzoylperoxid AL
1 mg/g + 25 mg/g Gel
7017471.00.00 09.08.2025 ALIUD PHARMA GmbH
Adapalen/Benzoylperoxid AL
3 mg/g + 25 mg/g Gel
7017472.00.00 09.08.2025 ALIUD PHARMA GmbH
Adapalen/Benzoylperoxid Glenmark
1 mg/g + 25 mg/g Gel
7017473.00.00 09.08.2025 Glenmark Arzneimittel GmbH
Adapalen/Benzoylperoxid Glenmark
3 mg/g + 25 mg/g Gel
7017474.00.00 09.08.2025 Glenmark Arzneimittel GmbH
Adapalen/Benzoylperoxid Zentiva
1 mg/g + 25 mg/g Gel
7014208.00.00 07.08.2025 Zentiva Pharma GmbH
Adapalen/Benzoylperoxid Zentiva
3 mg/g + 25 mg/g Gel
7014209.00.00 07.08.2025 Zentiva Pharma GmbH
Aforbe 200 Mikrogramm/6 Mikrogramm
pro Sprühstoß Druckgasinhalation, Lösung
7015192.00.00 29.08.2025 Mylan Germany GmbH
Aicisi 10 mg/ml Augentropfensuspension 7013255.00.00 17.08.2025 OmniVision GmbH
Aknegalen 1 mg/g + 25 mg/g Gel 7014410.00.00 09.08.2025 GALENpharma GmbH
Aknegalen forte 3 mg/g + 25 mg/g Gel 7014411.00.00 09.08.2025 GALENpharma GmbH
Alcaridin 0,15 mg/ml Injektionslösung 7007193.00.00 17.08.2025 Carinopharm GmbH
Alendronsäure Xeolas 70 mg Lösung
zum Einnehmen
7018668.00.00 02.08.2025 Xeolas Pharmaceuticals
Designated Activity Company
Alluzience 200 Speywood-Einheiten/ml
Injektionslösung
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7019882.00.00 14.08.2025 EMRA-MED Arzneimittel GmbH
Amiodaron STADA 200 mg Tabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7020728.00.00 09.08.2025 BB Farma s.r.l.
Anginosan 1,2 mg/0,6 mg Lutschtabletten
mit Honig-Zitronengeschmack
7012741.00.00 09.08.2025 tetesept Pharma GmbH
Anginosan 1,2 mg/0,6 mg Lutschtabletten
mit Minzegeschmack
7012742.00.00 09.08.2025 tetesept Pharma GmbH
Apixaban Macleods 2,5 mg Filmtabletten 7007248.00.00 08.08.2025 Macleods Pharma Espana, S.L.U.
Apixaban Macleods 5 mg Filmtabletten 7007249.00.00 08.08.2025 Macleods Pharma Espana, S.L.U.
Bekanntmachung
Veröffentlicht am Mittwoch, 1. Juli 2026
BAnz AT 01.07.2026 B9
Seite 1 von 12
Bezeichnung des Arzneimittels Zul.-Nr.
Datum der
Zulassung Zulassungsinhaber
Apremilast Eignapharma 10 mg + 20 mg +
30 mg Filmtabletten
7014001.00.00 17.08.2025 Eignapharma S.L.
Apremilast Eignapharma 30 mg Filmtabletten 7014002.00.00 17.08.2025 Eignapharma S.L.
AQUETIA 25 mg/ml Suspension zum Einnehmen 7016740.00.00 02.08.2025 ITF PHARMA GmbH
Aribec
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7020667.00.00 18.08.2025 kohlpharma GmbH
Arimidex 1 mg
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7020005.00.00 15.08.2025 B2B Medical GmbH
Atorvastatin beta 30 mg Filmtabletten 7013347.00.00 30.08.2025 betapharm Arzneimittel GmbH
Atorvastatin beta 60 mg Filmtabletten 7013348.00.00 30.08.2025 betapharm Arzneimittel GmbH
Bilastin PUREN 20 mg Tabletten 7014409.00.00 12.08.2025 PUREN Pharma GmbH & Co. KG
Bocouture 100 Einheiten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7020659.00.00 13.08.2025 kohlpharma GmbH
Bortezomib beta 2,5 mg/ml Injektionslösung 7012548.00.00 08.08.2025 betapharm Arzneimittel GmbH
Bosentan PUREN 125 mg Filmtabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7021505.00.00 27.08.2025 B2B Medical GmbH
Bosentan PUREN 62,5 mg Filmtabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7021506.00.00 27.08.2025 B2B Medical GmbH
Bosentan Teva 125 mg Filmtabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7019626.00.00 27.08.2025 B2B Medical GmbH
Bosentan Teva 62,5 mg Filmtabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7019625.00.00 27.08.2025 B2B Medical GmbH
Brinzo-Vision sine 10 mg/ml
Augentropfensuspension
7013256.00.00 17.08.2025 OmniVision GmbH
Caramlo 16 mg/10 mg
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7020188.00.00 29.08.2025 axicorp Pharma B.V.
Caramlo 8 mg/5 mg
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7020187.00.00 29.08.2025 axicorp Pharma B.V.
Certican 0,25 mg Tabletten zur Herstellung
einer Suspension zum Einnehmen
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7020174.00.00 18.08.2025 kohlpharma GmbH
Clobazam Desitin 1mg/ml Suspension
zum Einnehmen
7017396.00.00 19.08.2025 Desitin Arzneimittel GmbH
Clonidin-Carinopharm 0,15 mg/ml
Injektionslösung
7007192.00.00 17.08.2025 Carinopharm GmbH
Colchicine CF 0,5 mg
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7020739.00.00 13.08.2025 kohlpharma GmbH
Colchicine Strides 0,5 mg
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7020711.00.00 18.08.2025 kohlpharma GmbH
Colchicine Teva 0,5 mg
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7020740.00.00 13.08.2025 kohlpharma GmbH
Colecalciferol Heumann 20 000 I.E.
Weichkapseln
7019627.00.00 01.08.2025 Heumann Pharma GmbH
& Co. Generica KG
Bekanntmachung
Veröffentlicht am Mittwoch, 1. Juli 2026
BAnz AT 01.07.2026 B9
Seite 2 von 12
Bezeichnung des Arzneimittels Zul.-Nr.
Datum der
Zulassung Zulassungsinhaber
Cyclophosphamid Seacross 1000 mg Pulver
zur Herstellung einer Injektions-/Infusionslösung
7013318.00.00 08.08.2025 Seacross Pharma (Europe)
Limited
Cyclophosphamid Seacross 2000 mg Pulver
zur Herstellung einer Injektions-/Infusionslösung
7013319.00.00 08.08.2025 Seacross Pharma (Europe)
Limited
Cyclophosphamid Seacross 200 mg Pulver
zur Herstellung einer Injektions-/Infusionslösung
7013316.00.00 08.08.2025 Seacross Pharma (Europe)
Limited
Cyclophosphamid Seacross 500 mg Pulver
zur Herstellung einer Injektions-/Infusionslösung
7013317.00.00 08.08.2025 Seacross Pharma (Europe)
Limited
Dapagliflozin PUREN 5 mg Filmtabletten 7009034.00.00 16.08.2025 PUREN Pharma GmbH & Co. KG
Dapagliflozin PUREN Pharma 10 mg
Filmtabletten
7009216.00.00 19.08.2025 PUREN Pharma GmbH & Co. KG
Dapagliflozin PUREN Pharma 5 mg Filmtabletten 7009215.00.00 19.08.2025 PUREN Pharma GmbH & Co. KG
Deferasirox Jubilant 180 mg Filmtabletten 2203897.00.00 04.08.2025 Jubilant Pharmaceuticals NV
Deferasirox Jubilant 360 mg Filmtabletten 2203898.00.00 04.08.2025 Jubilant Pharmaceuticals NV
Deferasirox Jubilant 90 mg Filmtabletten 2203896.00.00 04.08.2025 Jubilant Pharmaceuticals NV
Dexketoprofen Inresa 50 mg
Injektions-/Infusionslösung
7018940.00.00 08.08.2025 Inresa Arzneimittel GmbH
Diclofenac Diamed 40 mg/g Spray
zur Anwendung auf der Haut, Lösung
7017589.00.00 22.08.2025 DiaMed Beratungsgesellschaft
für pharmazeutische
Unternehmen mbH
Efudix 5 % Creme
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7019955.00.00 27.08.2025 European Pharma B.V.
ELIGARD 45 mg
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7019903.00.00 29.08.2025 axicorp Pharma B.V.
Eltrombopag – 1 A Pharma 12,5 mg Filmtabletten 7019297.00.00 08.08.2025 1 A Pharma GmbH
Eltrombopag – 1 A Pharma 25 mg Filmtabletten 7019298.00.00 08.08.2025 1 A Pharma GmbH
Eltrombopag – 1 A Pharma 50 mg Filmtabletten 7019299.00.00 08.08.2025 1 A Pharma GmbH
Eltrombopag – 1 A Pharma 75 mg Filmtabletten 7019300.00.00 08.08.2025 1 A Pharma GmbH
Endovelle
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7020821.00.00 18.08.2025 kohlpharma GmbH
Estrogel Dosiergel
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7019914.00.00 29.08.2025 EMRA-MED Arzneimittel GmbH
Fingolimod Olpha 0,5 mg Hartkapseln 7015773.00.00 17.08.2025 Akciju sabiedrība „Olpha“
Flucloxacillin Noridem 1000 mg Pulver
zur Herstellung einer Injektions-/Infusionslösung
7011301.00.00 18.08.2025 Noridem Enterprises Limited
Flucloxacillin Noridem 2000 mg Pulver
zur Herstellung einer Injektions-/Infusionslösung
7011302.00.00 18.08.2025 Noridem Enterprises Limited
Flucloxacillin Noridem 500 mg Pulver
zur Herstellung einer Injektions-/Infusionslösung
7011300.00.00 18.08.2025 Noridem Enterprises Limited
Fludrocortison Novumgen 0,1 mg Tabletten 7012797.00.00 12.08.2025 NOVUMGEN LIMITED
FOSAMAX einmal wöchentlich 70 mg Tabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7019956.00.00 27.08.2025 European Pharma B.V.
Humatrope für Pen 6 mg Pulver und Lösungs-
mittel zur Herstellung einer Injektionslösung
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7019890.00.00 15.08.2025 Orifarm GmbH
Hyalgan Durchstechflasche mit 2 ml
Injektionslösung
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7020157.00.00 26.08.2025 Abacus Medicine A/S
Bekanntmachung
Veröffentlicht am Mittwoch, 1. Juli 2026
BAnz AT 01.07.2026 B9
Seite 3 von 12
Bezeichnung des Arzneimittels Zul.-Nr.
Datum der
Zulassung Zulassungsinhaber
Hydromorphon Orifarm long 16 mg
Retardtabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7019891.00.00 19.08.2025 Orifarm GmbH
Hydromorphon Orifarm long 32 mg
Retardtabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7019902.00.00 19.08.2025 Orifarm GmbH
Hydromorphon Orifarm long 4 mg
Retardtabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7019881.00.00 19.08.2025 Orifarm GmbH
Hydromorphon Orifarm long 8 mg
Retardtabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7019884.00.00 19.08.2025 Orifarm GmbH
Hydromorphon-ratiopharm 4 mg Retardtabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7020217.00.00 14.08.2025 Allomedic GmbH
Hydromorphon-ratiopharm 4 mg Retardtabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7021443.00.00 16.08.2025 EurimPharm Arzneimittel GmbH
Jublia 89 mg/ml Lösung zur Anwendung
auf der Haut
7009117.00.00 25.08.2025 Almirall, S.A.
Kacital 1 080 mg Tabletten mit veränderter
Wirkstofffreisetzung
7018111.00.00 30.08.2025 XGX Pharma ApS
Lenalidomid Qilu 10 mg Hartkapseln 7006909.00.00 09.08.2025 Qilu Pharma Spain S.L.
Lenalidomid Qilu 15 mg Hartkapseln 7006910.00.00 09.08.2025 Qilu Pharma Spain S.L.
Lenalidomid Qilu 20 mg Hartkapseln 7006911.00.00 09.08.2025 Qilu Pharma Spain S.L.
Lenalidomid Qilu 2,5 mg Hartkapseln 7006906.00.00 09.08.2025 Qilu Pharma Spain S.L.
Lenalidomid Qilu 25 mg Hartkapseln 7006912.00.00 09.08.2025 Qilu Pharma Spain S.L.
Lenalidomid Qilu 5 mg Hartkapseln 7006907.00.00 09.08.2025 Qilu Pharma Spain S.L.
Lenalidomid Qilu 7,5 mg Hartkapseln 7006908.00.00 09.08.2025 Qilu Pharma Spain S.L.
Linezolid – 1 A Pharma 600 mg Filmtabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7019907.00.00 22.08.2025 BB Farma s.r.l.
Liraglutid Zentiva 6 mg/ml Injektionslösung
in einem Fertigpen
7012087.00.00 07.08.2025 Zentiva Pharma GmbH
Melatonin Orifarm 2 mg Filmtabletten 7019703.00.00 17.08.2025 Orifarm Generics A/S
Melatonin Orifarm 3 mg Filmtabletten 7019704.00.00 17.08.2025 Orifarm Generics A/S
Melatonin Orifarm 4 mg Filmtabletten 7019705.00.00 17.08.2025 Orifarm Generics A/S
Melatonin Orifarm 5 mg Filmtabletten 7019706.00.00 17.08.2025 Orifarm Generics A/S
Migoutine 0,5 mg Filmtabletten 7010105.00.00 02.08.2025 PHARMASCIENCE
INTERNATIONAL LIMITED
Mirabegron Glenmark 50 mg Retardtabletten 7014032.00.00 25.08.2025 Glenmark Arzneimittel GmbH
Mirabegron Heumann 50 mg Retardtabletten 7016280.00.00 26.08.2025 Heumann Pharma GmbH
& Co. Generica KG
Mirabegron-ratiopharm 50 mg Retardtabletten 7016354.00.00 21.08.2025 ratiopharm GmbH
Morphin Basi 10 mg/ml Injektionslösung 7014026.00.00 22.08.2025 Laboratórios Basi - Indústria
Farmaceutica, S.A.
Nalfino 18 mg Filmtabletten 7017505.00.00 22.08.2025 axunio Pharma GmbH
Nebido
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7019206.00.00 14.08.2025 2CARE4 ApS
Bekanntmachung
Veröffentlicht am Mittwoch, 1. Juli 2026
BAnz AT 01.07.2026 B9
Seite 4 von 12
Bezeichnung des Arzneimittels Zul.-Nr.
Datum der
Zulassung Zulassungsinhaber
Nebido 1 000 mg Injektionslösung
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7021955.00.00 01.08.2025 EurimPharm Arzneimittel GmbH
Nebido 1 000 mg Injektionslösung
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7023275.00.00 01.08.2025 ACA Müller ADAG Pharma
Aktiengesellschaft
Nebido 1 000 mg Injektionslösung
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7023300.00.00 02.08.2025 B2B Medical GmbH
Neurontin 300 mg Hartkapseln
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7019934.00.00 15.08.2025 B2B Medical GmbH
Nevolat 7012086.00.00 07.08.2025 Zentiva Pharma GmbH
Oxygesic 10 mg Retardtabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7020113.00.00 27.08.2025 B2B Medical GmbH
Oxygesic 40 mg Retardtabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7020115.00.00 27.08.2025 B2B Medical GmbH
Oxygesic 80 mg Retardtabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7020116.00.00 27.08.2025 B2B Medical GmbH
Pomalidomid Abdi 1 mg Hartkapseln 7015036.00.00 08.08.2025 Abdi Farma GmbH
Pomalidomid Abdi 2 mg Hartkapseln 7015037.00.00 08.08.2025 Abdi Farma GmbH
Pomalidomid Abdi 3 mg Hartkapseln 7015038.00.00 08.08.2025 Abdi Farma GmbH
Pomalidomid Abdi 4 mg Hartkapseln 7015039.00.00 08.08.2025 Abdi Farma GmbH
Pomalidomid Welding 1 mg Hartkapseln 7014531.00.00 11.08.2025 Stragen Pharma GmbH
Pomalidomid Welding 2 mg Hartkapseln 7014532.00.00 11.08.2025 Stragen Pharma GmbH
Pomalidomid Welding 3 mg Hartkapseln 7014533.00.00 11.08.2025 Stragen Pharma GmbH
Pomalidomid Welding 4 mg Hartkapseln 7014534.00.00 11.08.2025 Stragen Pharma GmbH
Posaconazol Zentiva 100 mg
magensaftresistente Tabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7020261.00.00 27.08.2025 B2B Medical GmbH
Pred Forte 10 mg/ml Augentropfensuspension
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7019904.00.00 19.08.2025 Abacus Medicine A/S
Prijidin 10 mg Retardtabletten 7019301.00.00 18.08.2025 Vale Pharmaceuticals Limited
Progebel 200 mg Weichkapseln
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7020086.00.00 27.08.2025 Orifarm GmbH
Rayaldee 30 Mikrogramm
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7019757.00.00 18.08.2025 kohlpharma GmbH
Sildenafil AL 100 mg Kautabletten 7009631.00.00 29.08.2025 ALIUD PHARMA GmbH
Sildenafil AL 25 mg Kautabletten 7009629.00.00 29.08.2025 ALIUD PHARMA GmbH
Sildenafil AL 50 mg Kautabletten 7009630.00.00 29.08.2025 ALIUD PHARMA GmbH
Sildenafil STADA 100 mg Kautabletten 7009628.00.00 30.08.2025 STADA Consumer Health
Deutschland GmbH
Sildenafil STADA 25 mg Kautabletten 7009626.00.00 30.08.2025 STADA Consumer Health
Deutschland GmbH
Sildenafil STADA 50 mg Kautabletten 7009627.00.00 30.08.2025 STADA Consumer Health
Deutschland GmbH
Bekanntmachung
Veröffentlicht am Mittwoch, 1. Juli 2026
BAnz AT 01.07.2026 B9
Seite 5 von 12
Bezeichnung des Arzneimittels Zul.-Nr.
Datum der
Zulassung Zulassungsinhaber
Sirolimus Panacea Biotec 1 mg/ml Lösung
zum Einnehmen
7008395.00.00 19.08.2025 Panacea Biotec Germany GmbH
Sitagliptin GeneriNobel 100 mg Filmtabletten 7006993.00.00 02.08.2025 GeneriNobel GmbH
Sitagliptin GeneriNobel 25 mg Filmtabletten 7006991.00.00 02.08.2025 GeneriNobel GmbH
Sitagliptin GeneriNobel 50 mg Filmtabletten 7006992.00.00 02.08.2025 GeneriNobel GmbH
Tacrolimus CF 0,5 mg Hartkapseln
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7019551.00.00 22.08.2025 BB Farma s.r.l.
Tadalafil AbZ 20 mg Filmtabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7020806.00.00 20.08.2025 BB Farma s.r.l.
Tadalafil AL 20 mg Filmtabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7019905.00.00 20.08.2025 BB Farma s.r.l.
Tadalafil PUREN 20 mg Filmtabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7019756.00.00 20.08.2025 BB Farma s.r.l.
Tadalafil STADA 20 mg Filmtabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7019906.00.00 20.08.2025 BB Farma s.r.l.
Testosteron-ratiopharm 1 000 mg/4 ml
Injektionslösung
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7019944.00.00 27.08.2025 EurimPharm Arzneimittel GmbH
Ticagrelor Ascend 60 mg Filmtabletten 7006210.00.00 11.08.2025 Ascend GmbH
Ticagrelor Ascend 90 mg Filmtabletten 7006247.00.00 11.08.2025 Ascend GmbH
Ticagrelor Bluefish 60 mg Filmtabletten 7016233.00.00 02.08.2025 Bluefish Pharmaceuticals AB
(publ)
Ticagrelor Bluefish 90 mg Filmtabletten 7016234.00.00 02.08.2025 Bluefish Pharmaceuticals AB
(publ)
Tigecyclin Cipla 50 mg Pulver zur Herstellung
einer Infusionslösung
7015636.00.00 12.08.2025 Cipla Europe
Rechtsform: NV
Togal IbuPlus Paracetamol 7017094.00.00 19.08.2025 Kyberg Pharma Vertriebs-GmbH
Tolvaptan – 1 A Pharma 15 mg + 45 mg Tabletten 7018383.00.00 17.08.2025 1 A Pharma GmbH
Tolvaptan – 1 A Pharma 15 mg Tabletten 7018381.00.00 17.08.2025 1 A Pharma GmbH
Tolvaptan – 1 A Pharma 30 mg + 60 mg Tabletten 7018384.00.00 17.08.2025 1 A Pharma GmbH
Tolvaptan – 1 A Pharma 30 mg + 90 mg Tabletten 7018385.00.00 17.08.2025 1 A Pharma GmbH
Tolvaptan – 1 A Pharma 30 mg Tabletten 7018382.00.00 17.08.2025 1 A Pharma GmbH
Tolvaptan beta 15 mg + 45 mg Tabletten 7018513.00.00 18.08.2025 betapharm Arzneimittel GmbH
Tolvaptan beta 15 mg Tabletten 7018511.00.00 18.08.2025 betapharm Arzneimittel GmbH
Tolvaptan beta 30 mg + 60 mg Tabletten 7018514.00.00 18.08.2025 betapharm Arzneimittel GmbH
Tolvaptan beta 30 mg + 90 mg Tabletten 7018515.00.00 18.08.2025 betapharm Arzneimittel GmbH
Tolvaptan beta 30 mg Tabletten 7018512.00.00 18.08.2025 betapharm Arzneimittel GmbH
Tolvaptan beta SIADH 15 mg Tabletten 7018509.00.00 18.08.2025 betapharm Arzneimittel GmbH
Tolvaptan beta SIADH 30 mg Tabletten 7018510.00.00 18.08.2025 betapharm Arzneimittel GmbH
Tolvaptan beta SIADH 7,5 mg Tabletten 7018508.00.00 18.08.2025 betapharm Arzneimittel GmbH
Vancomycin Dr. Eberth 125 mg
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7020719.00.00 28.08.2025 kohlpharma GmbH
Vepesid K 50 mg
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7020092.00.00 21.08.2025 B2B Medical GmbH
Vestolvo 15 mg Tabletten 7018379.00.00 17.08.2025 1 A Pharma GmbH
Vestolvo 30 mg Tabletten 7018380.00.00 17.08.2025 1 A Pharma GmbH
Bekanntmachung
Veröffentlicht am Mittwoch, 1. Juli 2026
BAnz AT 01.07.2026 B9
Seite 6 von 12
Bezeichnung des Arzneimittels Zul.-Nr.
Datum der
Zulassung Zulassungsinhaber
Vestolvo 7,5 mg Tabletten 7018378.00.00 17.08.2025 1 A Pharma GmbH
Voriconazol – 1 A Pharma 200 mg Filmtabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7020413.00.00 15.08.2025 B2B Medical GmbH
Voriconazol Amarox 200 mg Pulver
zur Herstellung einer Infusionslösung
7013737.00.00 19.08.2025 AMAROX PHARMA GmbH
Voriconazol Heumann 200 mg Pulver
zur Herstellung einer Infusionslösung
7012218.00.00 28.08.2025 Heumann Pharma GmbH
& Co. Generica KG
Voriconazol PUREN 200 mg Filmtabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7020709.00.00 22.08.2025 BB Farma s.r.l.
Voriconazol PUREN 200 mg Filmtabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7022309.00.00 15.08.2025 B2B Medical GmbH
Zenon 10 mg/10 mg Filmtabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7020980.00.00 05.08.2025 Orifarm GmbH
Zenon 10 mg/10 mg Filmtabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7023172.00.00 22.08.2025 BB Farma s.r.l.
Zenon 20 mg/10 mg Filmtabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7020981.00.00 05.08.2025 Orifarm GmbH
Zenon 20 mg/10 mg Filmtabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7022269.00.00 22.08.2025 BB Farma s.r.l.
ZENON 20 mg/10 mg Filmtabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7021458.00.00 04.08.2025 EMRA-MED Arzneimittel GmbH
Zenon 40 mg/10 mg Filmtabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7020982.00.00 05.08.2025 Orifarm GmbH
Zenon 40 mg/10 mg Filmtabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7023173.00.00 22.08.2025 BB Farma s.r.l.
ZENON 40 mg/10 mg Filmtabletten
(Es handelt sich um ein parallel importiertes
Arzneimittel)
7021532.00.00 04.08.2025 EMRA-MED Arzneimittel GmbH
II.
Verlängerung einer Zulassung gemäß § 31 Absatz 3 AMG
Bezeichnung des Arzneimittels Zul.-Nr.
Datum der
Zulassung Zulassungsinhaber
Arzneimittel zur Anwendung am Menschen
XEOMIN 200 Einheiten Pulver zur Herstellung
einer Injektionslösung
2205635.00.00 04.06.2021 Abacus Medicine A/S
Solifenacin Uropharm 5 mg Filmtabletten 99936.00.00 21.03.2018 Abanta Pharma GmbH
Solifenacin Uropharm 10 mg Filmtabletten 99937.00.00 21.03.2018 Abanta Pharma GmbH
Tadalafil PAH AL 20 mg Filmtabletten 2203444.00.00 04.09.2020 ALIUD PHARMA GmbH
Candesartan AL 8 mg Tabletten 2204543.00.00 27.04.2020 ALIUD PHARMA GmbH
Candesartan AL 16 mg Tabletten 2204544.00.00 27.04.2020 ALIUD PHARMA GmbH
Candesartan AL 32 mg Tabletten 2204545.00.00 27.04.2020 ALIUD PHARMA GmbH
Levonorgestrel/Ethinylestradiol AL
150 Mikrogramm/30 Mikrogramm Filmtablette
2205540.00.00 22.07.2021 ALIUD PHARMA GmbH
Levetiracetam Amarox 250 mg Filmtabletten 2205385.00.00 30.06.2021 AMAROX PHARMA GmbH
Bekanntmachung
Veröffentlicht am Mittwoch, 1. Juli 2026
BAnz AT 01.07.2026 B9
Seite 7 von 12
Bezeichnung des Arzneimittels Zul.-Nr.
Datum der
Zulassung Zulassungsinhaber
Levetiracetam Amarox 500 mg Filmtabletten 2205386.00.00 30.06.2021 AMAROX PHARMA GmbH
Levetiracetam Amarox 750 mg Filmtabletten 2205387.00.00 30.06.2021 AMAROX PHARMA GmbH
Levetiracetam Amarox 1000 mg Filmtabletten 2205388.00.00 30.06.2021 AMAROX PHARMA GmbH
Levetiracetam Amarox 100 mg/ml Lösung
zum Einnehmen
2205389.00.00 27.06.2021 AMAROX PHARMA GmbH
Tadalafil NIO 5 mg Filmtabletten 2204216.00.00 12.12.2019 axunio Pharma GmbH
Tadalafil NIO 10 mg Filmtabletten 2204217.00.00 12.12.2019 axunio Pharma GmbH
Tadalafil NIO 20 mg Filmtabletten 2204218.00.00 12.12.2019 axunio Pharma GmbH
Ciclopirox beta 80 mg/g wirkstoffhaltiger
Nagellack
7000015.00.00 30.11.2020 betapharm Arzneimittel GmbH
SmofKabiven zentral Emulsion zur Infusion 2203788.00.00 29.05.2020 CC - Pharma GmbH
Almogran 12,5 mg Filmtablette 7000062.00.00 31.05.2021 CC - Pharma GmbH
Abstral 100 Mikrogramm Sublingualtabletten 7000344.00.00 23.03.2021 CC - Pharma GmbH
Abstral 200 Mikrogramm Sublingualtabletten 7000345.00.00 23.03.2021 CC - Pharma GmbH
Nilafustin 100 mg Pulver für ein Konzentrat
zur Herstellung einer Infusionslösung
2205390.00.00 10.05.2022 DEMO ABEE
Fingolimod Denk 0,5 mg Hartkapseln 2204980.00.00 04.05.2021 Denk Pharma GmbH & Co. KG
Abibam 500 mg Filmtabletten 2204713.00.00 18.11.2021 Dr. Pfleger Arzneimittel GmbH
Leuprostin 3-Monats-Depot 2202562.00.00 15.06.2020 EMRA-MED Arzneimittel GmbH
SmofKabiven zentral Emulsion zur Infusion 2202661.00.00 11.08.2020 EurimPharm Arzneimittel GmbH
Solaraze 3% Gel 2204027.00.00 12.04.2021 EurimPharm Arzneimittel GmbH
Almogran 12,5 mg Filmtablette 2204029.00.00 31.05.2021 EurimPharm Arzneimittel GmbH
Zocor 20 mg Filmtabletten 2204187.00.00 12.04.2021 EurimPharm Arzneimittel GmbH
Visanne 2 mg Tabletten 2205039.00.00 16.04.2021 EurimPharm Arzneimittel GmbH
Paricalcitol Sciecure 2 Mikrogramm/ml
Injektionslösung
97822.00.00 24.03.2019 GENMED Pharma GmbH
Paricalcitol Sciecure 5 Mikrogramm/ml
Injektionslösung
97823.00.00 24.03.2019 GENMED Pharma GmbH
Olmesartan/Amlodipin Heumann 20 mg/5 mg
Filmtabletten
2202849.00.00 23.04.2020 Heumann Pharma GmbH
& Co. Generica KG
Olmesartan/Amlodipin Heumann 40 mg/5 mg
Filmtabletten
2202850.00.00 23.04.2020 Heumann Pharma GmbH
& Co. Generica KG
Olmesartan/Amlodipin Heumann 40 mg/10 mg
Filmtabletten
2202851.00.00 23.04.2020 Heumann Pharma GmbH
& Co. Generica KG
Pemetrexed NeoCorp 25 mg/ml Konzentrat
zur Herstellung einer Infusionslösung
2204513.00.00 20.11.2020 Hexal Aktiengesellschaft
Deferasirox HEXAL 90 mg Filmtabletten 2205478.00.00 06.07.2021 Hexal Aktiengesellschaft
Deferasirox HEXAL 180 mg Filmtabletten 2205479.00.00 06.07.2021 Hexal Aktiengesellschaft
Deferasirox HEXAL 360 mg Filmtabletten 2205480.00.00 06.07.2021 Hexal Aktiengesellschaft
Abirateron Holsten 500 mg Filmtabletten 2204711.00.00 04.10.2021 Holsten Pharma GmbH
Regaine Frauen Schaum 90282.00.00 22.10.2014 Kenvue Germany GmbH
Fingolimod Koanaa 0,5 mg Hartkapseln 2205218.00.00 05.05.2021 Koanaa Healthcare Spain S.L.
XEOMIN 200 Einheiten 2204041.00.00 31.05.2021 kohlpharma GmbH
Duokopt 2204396.00.00 25.06.2021 kohlpharma GmbH
Rivaroxaban Micro Labs 10 mg Filmtabletten 2205045.00.00 08.11.2021 Micro Labs GmbH
Rivaroxaban Micro Labs 15 mg Filmtabletten 2205046.00.00 08.11.2021 Micro Labs GmbH
Rivaroxaban Micro Labs 20 mg Filmtabletten 2205047.00.00 08.11.2021 Micro Labs GmbH
Dorzolamid Micro Labs 20 mg/ml Augentropfen,
Lösung im Einzeldosisbehältnis
2205614.00.00 08.02.2021 Micro Labs GmbH
Bekanntmachung
Veröffentlicht am Mittwoch, 1. Juli 2026
BAnz AT 01.07.2026 B9
Seite 8 von 12
Bezeichnung des Arzneimittels Zul.-Nr.
Datum der
Zulassung Zulassungsinhaber
Ofloxa-Vision Kombi-Packung 2204526.00.00 23.04.2021 OmniVision GmbH
Duokopt 20 mg/ml + 5 mg/ml Augentropfen,
Lösung
2203692.00.00 26.01.2021 Orifarm GmbH
Abstral 300 Mikrogramm Sublingualtabletten 2204146.00.00 23.03.2021 Orifarm GmbH
Abstral 400 Mikrogramm Sublingualtabletten 2204147.00.00 23.03.2021 Orifarm GmbH
XEOMIN 200 Einheiten Pulver zur Herstellung
einer Injektionslösung
2205565.00.00 29.05.2021 Orifarm GmbH
XEOMIN 50 Einheiten Pulver zur Herstellung
einer Injektionslösung
2205569.00.00 29.05.2021 Orifarm GmbH
Adrenalin 1:1 000 Pädia 2205834.00.00 05.08.2020 Pädia GmbH
Docetaxel PhaRes 20 mg/ml Konzentrat
zur Herstellung einer Infusionslösung
2201329.00.00 07.12.2018 Pharma Resources GmbH
Docetaxel PhaRes 20 mg/ml Konzentrat
zur Herstellung einer Infusionslösung
2201331.00.00 07.12.2018 Pharma Resources GmbH
Docetaxel PhaRes 20 mg/ml Konzentrat
zur Herstellung einer Infusionslösung
2202476.00.00 07.12.2018 Pharma Resources GmbH
Azacitidin Pharmascience 25 mg/ml Pulver
zur Herstellung einer Injektionssuspension
7000445.00.00 20.06.2021 PHARMASCIENCE
INTERNATIONAL LIMITED
desderman 78,2 g/100 g Lösung zur Anwendung
auf der Haut
7001747.00.00 13.04.2021 Schülke & Mayr GmbH
desderman 78,2 g/100 g Lösung zur Anwendung
auf der Haut
7001748.00.00 13.04.2021 Schülke & Mayr GmbH
desderman 78,2 g/100 g Lösung zur Anwendung
auf der Haut
7001749.00.00 13.04.2021 Schülke & Mayr GmbH
Vinblastin STADA 10 mg Pulver zur Herstellung
einer Injektionslösung
2201771.00.00 20.12.2019 STADAPHARM GmbH
Sorafenib STADA 200 mg Filmtabletten 2204214.00.00 17.09.2020 STADAPHARM GmbH
Aprepitant STADA 80 mg Hartkapseln 2205251.00.00 23.12.2020 STADAPHARM GmbH
Aprepitant STADA 125 mg und 80 mg
Hartkapseln
2205252.00.00 23.12.2020 STADAPHARM GmbH
Aprepitant STADA 125 mg Hartkapseln 2205366.00.00 23.12.2020 STADAPHARM GmbH
Sorafenib STADA 400 mg Filmtabletten 7000080.00.00 04.06.2021 STADAPHARM GmbH
Abirateron Synthon 250 mg Tabletten 2204710.00.00 04.10.2021 Synthon B.V.
Tranexamsäure Tillomed 100 mg/ml
Injektionslösung
2202025.00.00 31.05.2019 TILLOMED PHARMA GmbH
Milrinon Tillomed 1 mg/ml
Injektions-/Infusionslösung
2203340.00.00 25.11.2021 TILLOMED PHARMA GmbH
Erlotinib Tillomed 25 mg Filmtabletten 2204558.00.00 27.11.2021 TILLOMED PHARMA GmbH
Erlotinib Tillomed 100 mg Filmtabletten 2204559.00.00 27.11.2021 TILLOMED PHARMA GmbH
Erlotinib Tillomed 150 mg Filmtabletten 2204560.00.00 27.11.2021 TILLOMED PHARMA GmbH
Fingolimod Tillomed 0,5 mg Hartkapseln 2205168.00.00 26.08.2021 TILLOMED PHARMA GmbH
Melatonin Unimedic Pharma 1 mg/ml Lösung
zum Einnehmen
7017293.00.00 30.06.2025 Unimedic Pharma AB
Eplerenon Vivanta 25 mg Filmtabletten 2202011.00.00 22.10.2020 Vivanta Generics s.r.o.
Eplerenon Vivanta 50 mg Filmtabletten 2202012.00.00 22.10.2020 Vivanta Generics s.r.o.
Conaret 1,25 mg Tabletten 2204676.00.00 15.10.2021 Zentiva Pharma GmbH
Conaret 2,5 mg Tabletten 2204677.00.00 15.10.2021 Zentiva Pharma GmbH
Conaret 3,75 mg Tabletten 2204678.00.00 15.10.2021 Zentiva Pharma GmbH
Conaret 5 mg Tabletten 2204679.00.00 15.10.2021 Zentiva Pharma GmbH
Conaret 7,5 mg Tabletten 2204680.00.00 15.10.2021 Zentiva Pharma GmbH
Conaret 10 mg Tabletten 2204681.00.00 15.10.2021 Zentiva Pharma GmbH
Bekanntmachung
Veröffentlicht am Mittwoch, 1. Juli 2026
BAnz AT 01.07.2026 B9
Seite 9 von 12
III.
Verlängerung einer Registrierung gemäß § 39 Absatz 2c AMG
Bezeichnung des homöopathischen Arzneimittels Reg.-Nr.
Datum
der Reg. Zulassungsinhaber
Arzneimittel zur Anwendung am Menschen
Hekla lava e lava C6 7002819.00.00 08.02.2021 Spagyra GmbH & Co KG
Hekla lava e lava D6 7003958.00.00 08.02.2021 Spagyra GmbH & Co KG
IV.
Nachstehend genannte Arzneimittel sind laut Feststellung gemäß § 31 Absatz 4 Satz 2 AMG
nicht mehr verkehrsfähig
Bezeichnung des Arzneimittels Zul.-Nr. Zulassungsinhaber
Arzneimittel zur Anwendung am Menschen
Andriol Testocaps 61078.00.00 AxiCorp Pharma GmbH
Ciqorin 10 mg Weichkapseln 2202449.00.00 BB Farma s.r.l.
Levetiracetam Aurobindo 500 mg Filmtabletten 2202038.00.00 BB Farma s.r.l.
Bisobeta comp 5 mg/12,5 mg 46829.00.00 betapharm Arzneimittel GmbH
Bisobeta comp 10 mg/25 mg 46829.01.00 betapharm Arzneimittel GmbH
levetiracetam-biomo 500 mg Filmtabletten 2202769.00.00 biomo pharma GmbH
levetiracetam-biomo 750 mg Filmtabletten 2202770.00.00 biomo pharma GmbH
levetiracetam-biomo 1000 mg Filmtabletten 2202771.00.00 biomo pharma GmbH
Andriol Testocaps 64447.00.00 Docpharm GmbH
Sandimmun 25 mg 32420.00.00 Docpharm GmbH
Sandimmun 100 mg 32420.01.00 Docpharm GmbH
Testosteron-Depot Jenapharm 3000306.00.00 Jenapharm GmbH & Co. KG
Andriol Testocaps 59.01.00 MSD Sharp & Dohme
Gesellschaft mit
beschränkter Haftung
Levetiracetam Mylan 250 mg Filmtabletten 78556.00.00 Mylan Germany GmbH
Levetiracetam Mylan 500 mg Filmtabletten 78557.00.00 Mylan Germany GmbH
Levetiracetam Mylan 750 mg Filmtabletten 78558.00.00 Mylan Germany GmbH
Levetiracetam Mylan 1000 mg Filmtabletten 78559.00.00 Mylan Germany GmbH
Levetiragamma 250 mg Filmtabletten 83385.00.00 Wörwag Pharma GmbH & Co. KG
Levetiragamma 500 mg Filmtabletten 83386.00.00 Wörwag Pharma GmbH & Co. KG
Levetiragamma 750 mg Filmtabletten 83387.00.00 Wörwag Pharma GmbH & Co. KG
Levetiragamma 1000 mg Filmtabletten 83388.00.00 Wörwag Pharma GmbH & Co. KG
V.
Änderung einer Bezeichnung gemäß § 29 Absatz 2 AMG
Eine Beurteilung der Zulässigkeit der angezeigten Änderung und eine Entscheidung über die Verkehrsfähigkeit des
betreffenden Arzneimittels ist mit dieser Veröffentlichung nicht verbunden.
Bisherige Bezeichnung des Arzneimittels Neue Bezeichnung des Arzneimittels Zul.-/Reg.-Nr.
Arsenicum album C3 Arsenicum album C6 2502546.00.00
Budo-San Rektalschaum Budenofalk Rektalschaum 86959.00.00
Budo-San 3 mg Budenofalk 3 mg magensaftresistente
Hartkapseln
60356.00.00
Cinacalcet Hetero 30 mg Filmtabletten Cinacalcet Amarox Pharma 30 mg Filmtabletten 2202074.00.00
Cinacalcet Hetero 60 mg Filmtabletten Cinacalcet Amarox Pharma 60 mg Filmtabletten 2202075.00.00
Cinacalcet Hetero 90 mg Filmtabletten Cinacalcet Amarox Pharma 90 mg Filmtabletten 2202076.00.00
Dapagliflozin Day Zero 10 mg Filmtabletten Zinodap 10 mg Filmtabletten 7002569.00.00
Dapagliflozin Day Zero 5 mg Filmtabletten Zinodap 5 mg Filmtabletten 7002568.00.00
Bekanntmachung
Veröffentlicht am Mittwoch, 1. Juli 2026
BAnz AT 01.07.2026 B9
Seite 10 von 12
Bisherige Bezeichnung des Arzneimittels Neue Bezeichnung des Arzneimittels Zul.-/Reg.-Nr.
Dexmedetomidin YRPG 100 Mikrogramm/ml
Konzentrat zur Herstellung einer Infusionslösung
Dexmedetomidin Seacross 100 Mikrogramm/ml
Konzentrat zur Herstellung einer Infusionslösung
7003491.00.00
Epirubicin-HCl Bhardwaj 2 mg/ml
Injektionslösung
Epirubicin Entomus 2 mg/ml Injektionslösung 98161.00.00
Fludrocortisonacetat GALEN 50 Mikrogramm
Tabletten
Fludrocortisonacetat GALEN 0,05 mg Tabletten 7015484.00.00
ITRAISDIN 50 mg Hartkapseln ITRACONAZOL Ebb 50 mg Hartkapseln 7020972.00.00
Lenalidomid Ethypharm 10 mg Hartkapseln Lenalidomid Grindeks 10 mg Hartkapseln 7002614.00.00
Lenalidomid Ethypharm 15 mg Hartkapseln Lenalidomid Grindeks 15 mg Hartkapseln 7002615.00.00
Lenalidomid Ethypharm 20 mg Hartkapseln Lenalidomid Grindeks 20 mg Hartkapseln 7002616.00.00
Lenalidomid Ethypharm 2,5 mg Hartkapseln Lenalidomid Grindeks 2,5 mg Hartkapseln 7002611.00.00
Lenalidomid Ethypharm 25 mg Hartkapseln Lenalidomid Grindeks 25 mg Hartkapseln 7002617.00.00
Lenalidomid Ethypharm 5 mg Hartkapseln Lenalidomid Grindeks 5 mg Hartkapseln 7002612.00.00
Lenalidomid Ethypharm 7,5 mg Hartkapseln Lenalidomid Grindeks 7,5 mg Hartkapseln 7002613.00.00
Magnesiocard i.v. Magnesiocard i.v. 0,3 mmol/ml Injektionslösung 6182768.00.00
meridol med CHX 0,2 % meridol med Chlorhexidin 0.2 % 34721.00.00
Metfogamma 500 Metformin AAA-Pharma 500 mg Filmtabletten 40163.00.00
Metfogamma 850 Metformin AAA-Pharma 850 mg Filmtabletten 44175.00.00
Paliperidon kohlpharma 75 mg Palmeux 75 mg 7021011.00.00
Panthenol-Creme LAW Panthenol Abanta 50 mg/g Creme 3000780.00.00
Salofalk 1 g Suppositorien Salofalk 1000 mg Zäpfchen 88774.00.00
Sapropterin Day Zero 100 mg Tabletten
zur Herstellung einer Lösung zum Einnehmen
Arpetran 100 mg Tabletten zur Herstellung
einer Lösung zum Einnehmen
7003252.00.00
Sildenafil Vale 25 mg Filmtabletten SildeViatris 25 mg Filmtabletten 7018443.00.00
Sildenafil Vale 50 mg Filmtabletten SildeViatris 50 mg Filmtabletten 7018444.00.00
Strophanthus C2 Strophanthus C6 2516075.00.00
Unasyn PD oral 375 mg Filmtabletten Unasyn PD oral 85931.00.00
Veratrum e radice D3 (Zulassung gilt auch
für die Verdünnungsgrade: D4, D6)
Veratrum e radice D3 (Zulassung gilt auch
für den Verdünnungsgrad: D6)
6694103.00.00
Vitamin-A-saar Vitachin-A 6136372.00.00
VI.
Berichtigungen
Die 552. Bekanntmachung über die Zulassung von Arzneimitteln sowie andere Amtshandlungen vom 22. August 2025
(BAnz AT 29.12.2025 B10) wird im Abschnitt I – Erteilung einer Zulassung wie folgt berichtigt:
Bezeichnung des Arzneimittels Zul.-Nr.
Datum der
Zulassung Antragsteller
Lanreotid Viatris 60 mg Injektionslösung
in einer Fertigspritze
7014926.00.00 04.03.2025 Mylan Germany GmbH
Lanreotid Viatris 90 mg Injektionslösung
in einer Fertigspritze
7014927.00.00 04.03.2025 Mylan Germany GmbH
Die korrigierten Angaben wurden durch Fettdruck kenntlich gemacht.
Bekanntmachung
Veröffentlicht am Mittwoch, 1. Juli 2026
BAnz AT 01.07.2026 B9
Seite 11 von 12
Die 546. Bekanntmachung über die Zulassung von Arzneimitteln sowie andere Amtshandlungen vom 21. März 2025
(BAnz AT 20.06.2025 B4) wird im Abschnitt III – Erlöschen einer Zulassung gemäß § 31 Absatz 1 Nummer 1 AMG wie
folgt berichtigt:
Bezeichnung des Arzneimittels Zul.-Nr. Antragsteller
Treprostinil Ferrer 1 mg/ml Infusionslösung 7003800.00.00 Ferrer Internacional S.A.
Treprostinil Ferrer 2,5 mg/ml Infusionslösung 7003801.00.00 Ferrer Internacional S.A.
Treprostinil Ferrer 5 mg/ml Infusionslösung 7003802.00.00 Ferrer Internacional S.A.
Meno Albin Mischung 6082446.00.00 Homviora Arzneimittel
Dr. Hagedorn GmbH & Co. KG
Die Bekanntgabe des Erlöschens für die vorbezeichneten Arzneimittel wird hiermit zurückgenommen.
Weitere Informationen zu den Arzneimitteln erhalten Sie unter:
www.dimdi.de
Bonn, den 21. Januar 2026
13.21-3533-00
Bundesinstitut
für Arzneimittel und Medizinprodukte
Im Auftrag
Dr. M. Horn
Bekanntmachung
Veröffentlicht am Mittwoch, 1. Juli 2026
BAnz AT 01.07.2026 B9
Seite 12 von 12
Bundesanzeiger Verlag GmbH
2026-07-01T09:54:47+0200
Bundesanzeiger Verlag GmbH
02.07.2026
Datei
PD
Gemäß § 34 AMG enthält die Bekanntmachung über die Zulassung von Arzneimitteln sowie anderer Amtshandlungen Informationen über die Erteilung und Verlängerung von Zulassungen bzw. Registrierungen, die Rücknahme, den Widerruf, das Ruhen, das Erlöschen von Zulassungen, Registrierungen und Bezeichnungsänderungen sowie Berichtigungen. Die 557. Zulassungsbekanntmachung vom 21. Januar 2026 wurde im Bundesanzeiger vom 1. Juli 2026 (BAnz AT 01.07.2026 B9) veröffentlicht. Sie ist im amtlichen Teil der Internetseite des Bundesanzeiger-Verlags unter dem Datum 1. Juli 2026 abrufbar. Die Bekanntmachung enthält alle im August 2025 erteilten Zulassungen und Registrierungen sowie weitere amtliche Entscheidungen.
02.07.2026
Beitrag
PD
1
Overview of CABs/NBs at each stage of the designation process
(30 June 2026)
67 65 62
57 57
52 52 52 52 52
25
22 21
19 19
19 19 19 19 19
0
10
20
30
40
50
60
70
80
90
100
Application to SANTE
F
PAR On-site JAT
assessment
completed
Final CAPA`received JAT CAPA Review DA Final Report JAT Final Opinion MDCG
Recommendation
Designation NANDO
IVDR MDR
2
Initial Stages
APPLICATIONS
PRELIMINARY ASSESSMENT REPORTS (PARs)
Received: 65 Received: 22
APPLICATIONS
Received: 67* Received: 25*
MDR IVDR
* - UK, CH & withdrawn applications
3
Final Stages
57
JAT CAPA Plan
Reviews
52
DA Final Reports
52
JAT Final Opinions
52
MDCG
Recommendations
52
NANDO
19
JAT CAPA Plan
Reviews
19
DA Final Reports
19
JAT Final Opinions
19
MDCG
Recommendations
19
NANDO
MDR:
IVDR:
02.07.2026
Datei
PD
Wie in der Meldung „ Übersicht aus Dezember 2025 über die Anträge auf Benennung als Benannte Stelle “ vom 3. Dezember 2025 berichtet, wurde am 2. Dezember 2025 eine Übersicht über die Anträge auf Benennung als benannte Stelle gemäß der Medizinprodukteverordnung (MDR) und In-vitro-Diagnostika (IVDR) veröffentlicht. Am 1. Juli 2026 wurde eine aktualisierte Version dieser Übersicht veröffentlicht. Im Vergleich zur Version vom Dezember 2025 wurden zwei weitere Anträge auf Benennung als benannte Stelle nach der MDR eingereicht. Zudem haben die zuständigen Behörden drei weitere vorläufige Bewertungsberichte erstellt, und eine weitere Benennung wurde im NANDO-Informationssystem veröffentlicht. Der Übersicht zufolge liegen inzwischen 67 Anträge auf Benennung als benannte Stelle nach der MDR vor. Insgesamt wurden bislang 52 Konformitätsbewertungsstellen nach der MDR benannt. Darüber hinaus zeigt die Präsentation, dass die Anzahl der von der Koordinierungsgruppe Medizinprodukte (MDCG) ausgesprochenen Empfehlungen der Anzahl der benannten Stellen entspricht.
02.07.2026
Beitrag
PD
BERLIN
Friedrichstraße 134
10117 Berlin
BONN
Ubierstraße 71–73
53173 Bonn
Pharma Deutschland e. V.
info@pharmadeutschland.de
www.pharmadeutschland.de
BRÜSSEL
Rue Marie de Bourgogne 58
1000 Brüssel
Ihre Ansprechpartner in der
Pharma Deutschland-Pressestelle:
Hannes Hönemann
Leiter Abteilung Presse- und
Öffentlichkeitsarbeit
M: +49-171-5618203
hoenemann@pharmadeutschland.de
Anna Frederike Gutzeit
CvD Presse- und
Öffentlichkeitsarbeit
M: +49-170-4548014
gutzeit@pharmadeutschland.de
Pressemitteilung
Pharma Deutschland gratuliert Dr. Sonja Optendrenk
zur Berufung an die Spitze des G-BA
Größter Pharmaverband Deutschlands betont zentrale
Rolle des G-BA und dankt Prof. Josef Hecken für seine
langjährige Arbeit
Berlin (1. Juli 2026) – Pharma Deutschland gratuliert Dr. Sonja
Optendrenk zu ihrer Berufung als unparteiische Vorsitzende des
Gemeinsamen Bundesausschusses (G-BA) und wünscht ihr eine
glückliche Hand bei ihren Entscheidungen. Mit dem Vorsitz des G-
BA übernimmt sie eine zentrale Rolle im deutschen
Gesundheitswesen, in dem das Gremium die medizinische
Versorgung in der gesetzlichen Krankenversicherung entscheidend
ausgestaltet und den Zugang zu innovativen Therapien prägt.
Dorothee Brakmann, Hauptgeschäftsführerin von Pharma
Deutschland, erklärt: „Mit Dr. Sonja Optendrenk übernimmt eine
erfahrene und profilierte Persönlichkeit den G-BA in einer Zeit, in
der das Gesundheitswesen vor zahlreichen Herausforderungen
steht. Der G-BA wird bei der Sicherung der Versorgung, dem
Zugang der Patientinnen und Patienten zu Innovationen und
insgesamt der Weiterentwicklung einer leistungsfähigen und
bezahlbaren Versorgung eine zentrale Rolle spielen. Ich wünsche
Frau Optendrenk für ihre Aufgabe viel Erfolg, eine glückliche Hand
und einen guten Start.”
Zugleich dankt Pharma Deutschland Prof. Dr. Josef Hecken für sein
langjähriges Engagement als unparteiischer Vorsitzender des G-
BA. In dem Schreiben des Verbands heißt es, Hecken habe die
Gesundheitsversorgung in Deutschland „maßgeblich mitgestaltet
und entscheidend geprägt“, der Dialog sei „jederzeit von
gegenseitigem Respekt und Offenheit geprägt“ gewesen.
mailto:hoenemann@pharmadeutschland.de
2
_______________
Der Pharma Deutschland e.V. ist der mitgliederstärkste Branchenverband der
Pharmaindustrie in Deutschland. Er vertritt die Interessen von rund 400
Mitgliedsunternehmen, die in Deutschland ca. 80.000 Mitarbeiterinnen und
Mitarbeiter beschäftigen. Die in Pharma Deutschland e.V. organisierten
Unternehmen tragen maßgeblich dazu bei, die Arzneimittelversorgung in
Deutschland zu sichern. So stellen sie fast 80 Prozent der in Apotheken
verkauften rezeptfreien und fast zwei Drittel der rezeptpflichtigen
Arzneimittel sowie einen Großteil der stofflichen und dentalen
Medizinprodukte für die Patientinnen und Patienten bereit. Unter
www.pharmadeutschland.de gibt es mehr Informationen zu Pharma
Deutschland.
http://www.pharmadeutschland.de/
01.07.2026
Datei
