Myoson and associated names
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
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 |
Myoson and associated names
|
International non-proprietary name (INN) or common name |
tolperisone |
Class |
-
|
Reference number |
EMEA/H/A-29/1411 EMEA/H/A-29/1412
|
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 |
European Commission final decision
|
Opinion date |
23/04/2015
|
All documents
-
List item
Questions and answers on Merisone and Myoson (tolperisone, 50 and 150 mg tablets) (PDF/75.54 KB)
First published: 28/07/2015
Last updated: 28/07/2015
EMA/252261/2015 Rev. 1 -
-
List item
Myoson Article-29(4) referral - Annex I (PDF/40.71 KB)
First published: 28/07/2015
Last updated: 28/07/2015 -
-
List item
Myoson Article-29(4) referral - Annex II (PDF/43.49 KB)
First published: 28/07/2015
Last updated: 28/07/2015 -
-
List item
Myoson Article-29(4) referral - Annex III (PDF/15.54 KB)
First published: 28/07/2015
Last updated: 28/07/2015 -
-
List item
Myoson and associated names Article-29(4) referral - Assessment report (PDF/165.86 KB)
Adopted
First published: 28/07/2015
Last updated: 28/07/2015
EMA/445101/2015
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