Trimetazidine

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

Overview

On 21 June 2012, the European Medicines Agency completed a review of the safety and effectiveness of trimetazidine following concerns over its effectiveness and reports of movement disorders such as Parkinsonian symptoms with these medicines. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits continue to outweigh the risks in patients with angina pectoris but that treatment should be restricted to add-on to existing treatments in patients who are not adequately controlled by or who are intolerant to other medicines for angina pectoris. For the symptomatic treatment of tinnitus, vertigo and visual-field disturbances, the CHMP concluded that the benefits no longer outweigh the risks and that these uses should no longer be authorised. In addition, the Committee recommended new contraindications and warnings to reduce and manage the possible risk of movement disorders, associated with the use of this medicine.

Key facts

Approved name
Trimetazidine
International non-proprietary name (INN) or common name
Trimetazidine
Associated names
Vastarel
Reference number
EMEA/H/A-31/1305
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
21/06/2012
EC decision date
03/09/2012

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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