Meprobamate
- 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 oral meprobamate-containing medicines, due to serious side effects seen with the medicine. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of meprobamate do not outweigh its risks, and that all marketing authorisations for oral medicines containing meprobamate should be suspended throughout the European Union (EU). The Committee recommended that the suspension should be implemented gradually to avoid the risk of severe withdrawal symptoms in patients stopping treatment abruptly.
Key facts
Approved name |
Meprobamate
|
International non-proprietary name (INN) or common name |
meprobamate |
Associated names |
Equanil and other trade names
|
Reference number |
EMEA/H/A-107/1316
|
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 This procedure has been replaced by Article 107i.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 |
19/01/2012
|
EC decision date |
30/03/2012
|
All documents
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List item
Questions and answers on the suspension of the marketing authorisations for oral meprobamate-containing medicines (PDF/77.05 KB)
First published: 20/01/2012
Last updated: 08/06/2012
EMA/42783/2012 -
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Meprobamate - Article 107 referral - Assessment report (PDF/129.82 KB)
Adopted
First published: 08/06/2012
Last updated: 08/06/2012
EMA/212617/2012 -
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Meprobamate - Article 107 referral - Annex I (PDF/86.58 KB)
Adopted
First published: 08/06/2012
Last updated: 08/06/2012 -
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Meprobamate - Article 107 referral - Annex II (PDF/59.51 KB)
Adopted
First published: 08/06/2012
Last updated: 08/06/2012 -
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List item
Meprobamate - Article 107 referral - Annex III (PDF/21.51 KB)
Adopted
First published: 08/06/2012
Last updated: 08/06/2012 -
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