Agreal

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision

Overview

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do not outweigh its risks, and that all marketing authorisations for medicines containing veralipride should be withdrawn throughout Europe.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.

Key facts

Approved name
Agreal
International non-proprietary name (INN) or common name
veralipride
Reference number
CHMP/432352/07
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
19/07/2007
EC decision date
01/10/2007

All documents

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

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