Tolperisone

  • 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 tolperisone. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of tolperisone-containing medicines given orally (by mouth) continue to outweigh their risks, but that their use should be restricted to the treatment of adults with post-stroke spasticity (stiffness). The Committee also recommended that the marketing authorisations for tolperisone-containing medicines given by injection should be revoked throughout the European Union (EU).

After re-examination, the Committee confirmed these recommendations on 18 October 2012.

Key facts

Approved name
Tolperisone
International non-proprietary name (INN) or common name
Tolperisone
Class
-
Reference number
EMEA/H/A-31/1311
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
18/10/2012
EC decision date
21/01/2013

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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