Buflomedil
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Overview
The European Medicines Agency has completed a review of the safety and effectiveness of buflomedil-containing medicines, both oral and injectable, due to serious side effects seen with buflomedil. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of buflomedil do not outweigh its risks, and has recommended that all marketing authorisations for medicines containing buflomedil should be suspended throughout the European Union (EU).
Key facts
Approved name |
Buflomedil
|
International non-proprietary name (INN) or common name |
buflomedil |
Class |
vasoactive agent
|
Reference number |
EMEA/H/A-107/1293
|
Type |
Article 107 procedures (prior to July 2012)
This type of procedure was triggered when a Member State varied, suspended or revoked the marketing authorisation for a medicine in its territory because of a safety issue. This procedure has been replaced by Article 107i. |
Status |
European Commission final decision
|
Opinion date |
17/11/2011
|
EC decision date |
13/02/2012
|
All documents
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List item
Questions and answers on the suspension of buflomedil-containing medicines (PDF/55.95 KB)
Adopted
First published: 17/11/2011
Last updated: 13/06/2012
EMEA/H/A-107/1293 -
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List item
Buflomedil - Article 107 referral - Assessment report (PDF/239.63 KB)
First published: 13/06/2012
Last updated: 13/06/2012
EMA/CHMP/83070/2012 -
List item
Buflomedil - Article 107 referral - Annex I (PDF/342.71 KB)
First published: 13/06/2012
Last updated: 13/06/2012 -
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Buflomedil - Article 107 referral - Annex II (PDF/87.24 KB)
First published: 13/06/2012
Last updated: 13/06/2012 -
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Buflomedil - Article 107 referral - Annex III (PDF/39.81 KB)
First published: 13/06/2012
Last updated: 13/06/2012 -
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List item
Questions and answers on the suspension of oral buflomedil-containing medicines (PDF/56.56 KB)
Adopted
First published: 20/05/2011
Last updated: 20/05/2011
EMA/CHMP/377431/2011
Document description
- Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
- Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
- List of the medicines affected by the referral (Annex I)
- Scientific conclusions of the Committee (Annex II)
The following two documents are sometimes available:
- Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes havebeen recommended by the Committee
- Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies