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its risks, and recommended that all marketing authorisations for dextropropoxyphene-containing medicines should be withdrawn throughout the European Union (EU).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for the non-parenteral (tablets, capsules and suppositories) forms of dextropropoxyphene-containing medicines should be withdrawn.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

About this medicine
Approved name
Dextropropoxyphene
International non-proprietary name (INN) or common name
dextropropoxyphene
About this procedure
Current status
European Commission final decision
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.

Key dates and outcomes
CHMP opinion date
22/10/2009
EC decision date
14/06/2010

All documents

  • List item

    Questions and answers on the withdrawal of the marketing authorisations for medicines containing dextropropoxyphene - re-examination (PDF/50.51 KB)

    Adopted

    First published: 22/10/2009
    Last updated: 07/04/2011
    EMEA/681374/2009

  • List item

    Dextropropoxyphene and Paracetamol - Article 31 referral - Annex I, II (PDF/210.7 KB)

    Adopted

    First published: 19/10/2010
    Last updated: 19/10/2010

  • List item

    Dextropropoxyphene and Paracetamol - Solution for Injection - Article 31 - Annex I, II, III (PDF/48.81 KB)

    Adopted

    First published: 19/10/2010
    Last updated: 19/10/2010

  • List item

    Questions and answers on the withdrawal of the marketing authorisations for medicines containing dextropropoxyphene - Initial (PDF/43.66 KB)

    Adopted

    First published: 25/06/2009
    Last updated: 25/06/2009
    EMEA/401061/2009

  • Description of documents published

    Please note that some of the listed documents apply only to certain procedures.

    • Overview - lay-language summary of the stage of the procedure
    • Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
    • Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
    • List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
    • Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
    • List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
    • List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
    • Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
    • Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
    • Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
    • Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
    • Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
    • Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
    • Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
    • Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

    Note that older documents may have different titles.

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