- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
The European Medicines Agency (EMEA) has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Trimetazidine-ratiopharm. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the marketing authorisation should be granted in Germany and other concerned Member States of the European Union (Czech Republic, Estonia, Hungary, Lithuania, Latvia, Poland, Portugal, Slovakia and Spain).
The review was carried out under an 'Article 29' referral1.
A European Commission decision on this opinion will be issued in due course.
1 Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health
|International non-proprietary name (INN) or common name||
Article 29(4) referrals
This type of referral is triggered when there is a disagreement between Member States regarding a marketing authorisation application being evaluated in a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.
Opinion provided by Committee for Medicinal Products for Human Use
Questions and answers on the referral for Trimetadizine-ratiopharm trimetazidine 35 mg modified-release tablets (PDF/28.29 KB)Adopted
First published: 23/01/2009
Last updated: 23/01/2009
- 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