Pholcodine
- 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 pholcodine, following concerns that its use may put people at risk of developing anaphylactic (severe allergic) reactions to neuromuscular blocking agents used during surgery. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the existing evidence of the risk is weak, and that the benefits of pholcodine continue to outweigh its risks. Therefore, it recommended that all marketing authorisations for medicines containing pholcodine should be maintained throughout the European Union (EU).
Key facts
Approved name |
Pholcodine
|
International non-proprietary name (INN) or common name |
Pholcodine |
Reference number |
EMEA/H/A-31/1292
|
Type |
Article 31 referrals
This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines. |
Status |
European Commission final decision
|
Opinion date |
15/12/2011
|
EC decision date |
17/02/2012
|
All documents
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Questions and answers on the review of the marketing authorisations for medicines containing pholcodine (PDF/63.84 KB)
Adopted
First published: 18/11/2011
Last updated: 18/11/2011
EMA/890819/2011 -
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Pholcodine - Article 31 referral - Assessment report (PDF/229.94 KB)
First published: 28/03/2012
Last updated: 28/03/2012 -
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Pholcodine - Article 31 referral - Annex I (PDF/485.54 KB)
First published: 28/03/2012
Last updated: 28/03/2012 -
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Pholcodine - Article 31 referral - Annex II (PDF/103.25 KB)
First published: 28/03/2012
Last updated: 28/03/2012 -
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Pholcodine - Article 31 referral - Annex III (PDF/24.16 KB)
First published: 28/03/2012
Last updated: 28/03/2012 -
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