Trimetadizine-ratiopharm

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CHMP opinion
European Commission final decision

Overview
Key facts
All documents

Current status:

Opinion provided by Committee for Medicinal Products for Human Use

Overview

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

: Trimetadizine-ratiopharm is used in patients with ischaemic heart disease, with other medicines, to prevent angina attacks. Ischaemic heart disease is a condition where the heart is receiving less oxygen than usual, often because of a narrowing of the blood vessels that supply the heart (coronary arteries). Angina attacks are sudden pains to the chest, jaw, back, brought on by physical effort and due to problems with the blood flow to the heart.
The active substance in Trimetadizine-ratiopharm, trimetazidine, is a medicine that acts on the heart. Its exact mechanism of action in ischaemic heart disease is not known.
Trimetazidine Ratiopharm is a generic medicine based on a reference medicine product authorised in France (Vastarel 35 mg modified-release tablets).

: ratiopharm GmbH submitted Trimetazidine-ratiopharm for a decentralised procedure to the German medicines regulatory agency with a view of obtaining a marketing authorisation in this country as well as the Czech Republic, Estonia, Hungary, Lithuania, Latvia, Poland, Portugal, Slovakia and Spain (the concerned Member States). These Member States were not able to reach an agreement. On 23 December 2008, the German medicines regulatory agency referred the matter to the CHMP for arbitration.
The grounds for the referral were that the effectiveness of the reference medicine was not established and that the successful bioequivalence studies carried out with Trimetazidine-ratiopharm, showing that it produces the same levels of active substance in the body as Vastarel, were not sufficient to show that it was effective.

: Based on the currently available data and the scientific discussion within the Committee, the CHMP concluded that Trimetazidine-ratiopharm had shown that it is bioequivalent to the reference medicine, and its benefit and risk are taken as being the same as those of the reference medicine. Therefore the marketing authorisation for Trimetazidine-ratioPharm should be granted in all concerned Member States.
The Committee also noted that it was not able in the context of this referral to conclude on the benefitrisk balance of the reference medicine.

List item

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
EMEA/45404/2009

Key facts

Approved name	Trimetadizine-ratiopharm
International non-proprietary name (INN) or common name	trimetazidine
Reference number	CHMP/45404/2009
Type	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.
Status	Opinion provided by Committee for Medicinal Products for Human Use
Opinion date	22/01/2009

All documents

List item

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
EMEA/45404/2009

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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