Antifibrinolytic medicines

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

Overview

On 14 February 2012, the European Medicines Agency completed a review of the antifibrinolytic medicines aprotinin, aminocaproic acid and tranexamic acid. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of these medicines outweigh their risks and recommended that the EU-wide suspension of the marketing authorisation for aprotinin-containing medicines that has been in place since 2008 be lifted. The CHMP set out conditions for the reintroduction of aprotinin medicines onto the market and also made recommendations on the use of aminocaproic acid and tranexamic acid.

On 19 June 2012, following a re-examination, the CHMP confirmed its initial conclusions but decided to remove a requirement for a pharmacokinetic study with tranexamic acid. The CHMP was informed of ongoing pharmacokinetic studies which are to be finalised and assessed by national authorities.

Key facts

About this medicine
Approved name
Antifibrinolytic medicines
International non-proprietary name (INN) or common name
  • aprotinin
  • aminocaproic acid
  • tranexamic acid
Class
B02A, Antihemorrhagics
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-31/1267
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
19/06/2012

All documents

Opinion provided by Committee for Medicinal Products for Human Use

European Commission final decision

  • List item

    Questions and answers on the review of antifibrinolytic medicines (aprotinin, aminocaproic acid and tranexamic acid) (PDF/121.14 KB)

    Adopted

    First published: 17/02/2012
    Last updated: 06/11/2013
    EMA/CHMP/116572/2012

  • List item

    Antifibrinolytic medicines - Article-31 referral - Annex I (aprotinin) (PDF/85.82 KB)


    First published: 06/11/2013
    Last updated: 06/11/2013

  • List item

    Antifibrinolytic medicines - Article-31 referral - Annex II (aprotinin) (PDF/46.8 KB)


    First published: 06/11/2013
    Last updated: 06/11/2013

  • List item

    Antifibrinolytic medicines - Article-31 referral - Annex IV (aprotinin) (PDF/13.87 KB)


    First published: 06/11/2013
    Last updated: 06/11/2013

  • List item

    Antifibrinolytic medicines - Article-31 referral - Annex I (aminocaproic acid) (PDF/63.84 KB)


    First published: 06/11/2013
    Last updated: 06/11/2013

  • List item

    Antifibrinolytic medicines - Article-31 referral - Annex II (aminocaproic acid) (PDF/83.81 KB)


    First published: 06/11/2013
    Last updated: 06/11/2013

  • List item

    Antifibrinolytic medicines - Article-31 referral - Annex I (tranexamic acid) (PDF/138.95 KB)


    First published: 06/11/2013
    Last updated: 06/11/2013

  • List item

    Antifibrinolytic medicines - Article-31 referral - Annex II (tranexamic acid) (PDF/69.37 KB)


    First published: 06/11/2013
    Last updated: 06/11/2013

  • List item

    Antifibrinolytic medicines - Article-31 referral - Annex III (tranexamic acid) (PDF/219.48 KB)


    First published: 17/02/2012
    Last updated: 06/11/2013

  • List item

    Antifibrinolytic medicines - Article 31 referral - Annex III (aprotinin) (PDF/143.43 KB)


    First published: 17/02/2012
    Last updated: 06/11/2013

  • List item

    Antifibrinolytic medicines - Article 31 referral - Annex III (aminocaproic acid) (PDF/303.51 KB)


    First published: 17/02/2012
    Last updated: 06/11/2013

  • 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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