Buflomedil

  • 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 buflomedil-containing medicines, both oral and injectable, due to serious side effects seen with buflomedil. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of buflomedil do not outweigh its risks, and has recommended that all marketing authorisations for medicines containing buflomedil should be suspended throughout the European Union (EU).

Key facts

About this medicine
Approved name
Buflomedil
International non-proprietary name (INN) or common name
buflomedil
Class
vasoactive agent
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-107/1293
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 This procedure has been replaced by Article 107i.

Key dates and outcomes
CHMP opinion date
17/11/2011
EC decision date
13/02/2012

All documents

  • List item

    Questions and answers on the suspension of buflomedil-containing medicines (PDF/55.95 KB)

    Adopted

    First published: 17/11/2011
    Last updated: 13/06/2012
    EMEA/H/A-107/1293

  • List item

    Buflomedil - Article 107 referral - Assessment report (PDF/239.63 KB)


    First published: 13/06/2012
    Last updated: 13/06/2012
    EMA/CHMP/83070/2012

  • List item

    Buflomedil - Article 107 referral - Annex I (PDF/342.71 KB)


    First published: 13/06/2012
    Last updated: 13/06/2012

  • List item

    Buflomedil - Article 107 referral - Annex II (PDF/87.24 KB)


    First published: 13/06/2012
    Last updated: 13/06/2012

  • List item

    Buflomedil - Article 107 referral - Annex III (PDF/39.81 KB)


    First published: 13/06/2012
    Last updated: 13/06/2012

  • List item

    Questions and answers on the suspension of oral buflomedil-containing medicines (PDF/56.56 KB)

    Adopted

    First published: 20/05/2011
    Last updated: 20/05/2011
    EMA/CHMP/377431/2011

  • 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.

    How useful was this page?

    Add your rating