Merisone and associated names

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
Opinion provided by Committee for Medicinal Products for Human Use

Overview

On 23 April 2015, the European Medicines Agency completed two arbitration procedures following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicines Merisone and Myoson (tolperisone). The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Merisone and Myoson outweigh their risks, and the marketing authorisation granted in Hungary can be recognised in other Member States of the EU.

Key facts

Approved name
Merisone and associated names
International non-proprietary name (INN) or common name
tolperisone
Class
-
Reference number
EMEA/H/A-29/1411
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
23/04/2015
EC decision date
25/06/2015

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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