Annex I
List of the names, pharmaceutical forms, strengths of the medicinal
products, route of administration, marketing authorisation holders in the
Member States
1
Member State
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An agency of the European Union
Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7129
E-mail info@ema.europa.eu Webs
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07 March 2013
EMA/147828/2013
Patient Health Protection
Annex I
List of the names, pharmaceutical forms, strengths of the medicinal
products, routes of administration, marketing authorisation
26.11.2014
Datei
PD
Annex I
List of the names, pharmaceutical forms, strengths of the medicinal
products, route of administration, marketing authorisation holders in the
Member States
1
Member State
(
26.11.2014
Datei
PD
3. How to take < product name >
[the wording below should be inserted in the relevant sections]
[…]
[100 mg IR pharmaceutical form, suppositories]
Flupirtine should be used at the lowest effect
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Annex III
Amendments to relevant sections of the summary of product characteristics
and package leaflet
Note:
The summary of product characteristics and package leaflet may need to be su
26.11.2014
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PD
07 March 2013
EMA/PRAC/137417/2013
PRAC List of questions
To be addressed by the marketing authorisation holder(s) for flupirtine
containing medicinal products
Article 107i of Directive 2001/83
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Annex II
Scientific conclusions and grounds for variation to the terms of the
marketing authorisations subject to conditions and detailed explanation for
the differences from the PRAC recommen
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Appendix to CMDh position
Divergent positions to CMDh position
Article 107i of Directive 2001/83/EC
Procedure No: EMEA/H/A-107i/1363 for Flupiritine containing medicinal products
The
26.11.2014
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PD
