- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
The European Medicines Agency (EMEA) has completed a review of the safety and effectiveness of veralipride. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that veralipride's benefits do not outweigh its risks, and that all marketing authorisations for medicines containing veralipride should be withdrawn throughout Europe. The review was carried out under an 'Article 31' referral1.
The final opinion was converted into a Decision by the European Commission on 1 October 2007.
1 Article 31 of Directive 2001/83/EC as amended, referral under Community interest.
|International non-proprietary name (INN) or common name||
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.
European Commission final decision
|EC decision date||
Questions and answers on the recommendation to withdraw the marketing authorisation of Veralipride (PDF/44.71 KB)Adopted
First published: 23/07/2007
Last updated: 23/07/2007
Opinion following an Article 31 referral for Agreal and associated names (see annex I) International Non-Proprietary Name (INN): Veralipride: Background information (PDF/18.97 KB)Adopted
First published: 01/10/2007
Last updated: 01/10/2007
Agreal - Article 31 referral - Annex I, II (PDF/26.8 KB)Adopted
First published: 07/01/2008
Last updated: 07/01/2008
- 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