Dextropropoxyphene

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

Overview

On 25 June 2009, the European Medicines Agency completed a review of the safety and effectiveness of dextropropoxyphene-containing medicines. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of dextropropoxyphene do not outweigh its risks, and recommended that all marketing authorisations for dextropropoxyphene-containing medicines should be withdrawn throughout the European Union (EU).

At the request of the marketing authorisation holders, the CHMP re-examined its opinion. On 21 October 2009, the Committee confirmed its original recommendation that the marketing authorisations for the non-parenteral (tablets, capsules and suppositories) forms of dextropropoxyphene-containing medicines should be withdrawn. However, for the parenteral form (solution for injection), the CHMP recommended that the marketing authorisations be suspended until further data are available.

The Committee recommended that the withdrawals and suspensions should be gradual in line with national recommendations.
The review was carried out under an 'Article 31' referral.

Key facts

Approved name
Dextropropoxyphene
International non-proprietary name (INN) or common name
dextropropoxyphene
Reference number
CHMP/681374/2009
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
22/10/2009
EC decision date
14/06/2010

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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