Trimetadizine ratiopharm

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

Key facts

Approved name
Trimetadizine ratiopharm
International non-proprietary name (INN) or common name


Reference number
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.

European Commission final decision
Opinion date
EC decision date

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:

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