Clobutinol

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

Overview

The European Medicines Agency (EMEA) has completed a review of the safety of clobutinol. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of medicines containing clobutinol no longer outweigh their risks, and that all marketing authorisations for these products should be withdrawn throughout Europe.

Key facts

Approved name
Clobutinol
International non-proprietary name (INN) or common name
clobutinol
Associated names
Silomat
Reference number
CHMP/471052/07
Type
Article 107 procedures (prior to July 2012)

This type of procedure was triggered when a Member State varied, suspended or revoked the marketing authorisation for a medicine in its territory because of a safety issue. This procedure has been replaced by Article 107i.

Status
European Commission final decision
Opinion date
18/10/2007
EC decision date
30/11/2007

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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