Bufexamac

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

Overview

The European Medicines Agency has completed a review of the safety and effectiveness of bufexamac. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of bufexamac do not outweigh its risks, and recommended that the marketing authorisations for medicines containing bufexamac be revoked (withdrawn) throughout the European Union (EU).

Key facts

Approved name
Bufexamac
International non-proprietary name (INN) or common name
bufexamac
Associated names
  • Parfenac
  • Bufal
  • Calmaderm
  • Fansamac
  • Mastu S
  • Parfenoide
  • Proctosan
Reference number
EMEA/H/A-107/001260
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 This procedure has been replaced by Article 107i.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
22/04/2010
EC decision date
27/07/2010

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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