Annex II
Scientific conclusions and grounds for the variation of the marketing
authorisations
3
Scientific conclusions
Overall summary of the scientific evaluation of methysergide contai
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PD
20 February 2014
EMA/276466/2014
Committee for Medicinal Products for Human Use (CHMP)
Assessment report
Pursuant to Article 31 of Directive 2001/83/EC
Methysergide containing medicinal produ
18.12.2017
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PD
28 April 2014
EMA/276477/2014
Restrictions on the use of methysergide-containing
medicines
On 20 February 2014, the European Medicines Agency recommended restricting the use of
methysergide d
18.12.2017
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PD
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Annex II
Scientific conclusions and grounds for revocation / variation to the terms of
the Marketing Authorisations
37
Scientific conclusions
Overall summary of the scientific evaluatio
18.12.2017
Datei
PD
20 December 2013
EMA/753989/2013
Assessment report
Metoclopramide only containing medicinal products
International Non-proprietary Name: metoclopramide
Procedure number: EMEA/H/A-31/1321
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20 December 2013
EMA/13239/2014 Corr. 1
European Medicines Agency recommends changes to the
use of metoclopramide
Changes aim mainly to reduce the risk of neurological side effects
On 24 Octo
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Auf der eSubmission Webseite der EMA wurden mit Datum vom 15. Dezember 2017 die neuen Versionen (Version 1.22) der elektronischen Antragsformulare (eAF) veröffentlicht. Diese Antragsformulare können s
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Meldung
PD
Annex III
Amendments to relevant sections of the summary of product characteristics
and package leaflet
Note:
The relevant sections of the Summary of Product Characteristics and package leaf
18.12.2017
Datei
PD
