Chlormezanone

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

Overview

On 25 September 1996, Germany presented a referral for chlormezanone under Article 12 of Council Directive 75/319/EEC as amended. Germany requested the CPMP “to give an opinion on whether there is an unfavourable benefit/risk relation for chlormezanone in the indication where it is most widely used in the EU, that is lower back pain with muscle contracture”.

According to the CPMP opinion given on 22 January 1997, the risk/benefit balance of chlormezanone-containing compounds was considered to be unfavourable, and the Committee recommended the withdrawal of the marketing authorisations of all chlormezanone-containing medicinal products.

Some of the Marketing Authorisation Holders of chlormezanone appealed against the opinion and grounds for appeal were submitted on 21 March 1997.

On 14 May 1997, the CPMP having considered the grounds for appeal adopted a final opinion maintaining the conclusions of the opinion dated 22 January 1997.

A copy of the final opinion for chlormezanone is provided on the Internet, together with Annex C which provides the scientific conclusions. Translations of the opinion and Annex C, are also provided on the Internet in French, German, and Spanish.

The final opinion was converted into a Decision by the European Commission on 27 August 1997.

Key facts

Approved name
Chlormezanone
International non-proprietary name (INN) or common name
chlormezanone
Reference number
CPMP/375/97
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
23/01/1997
EC decision date
27/08/1997

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:

  • 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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