Antifibrinolytic medicines
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
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 |
|
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
Assessment report for Antifibrinolytic medicines (aprotinin) (PDF/256.45 KB)
First published: 06/11/2013
Last updated: 06/11/2013
Assessment report for Antifibrinolytic medicines (aminocaproic acid) (PDF/193.51 KB)
First published: 06/11/2013
Last updated: 06/11/2013
Assessment report for Antifibrinolytic medicines (tranexamic acid) (PDF/195.92 KB)
First published: 06/11/2013
Last updated: 06/11/2013
European Commission final decision
Antifibrinolytic medicines - Article-31 referral - Annex I (aprotinin) (PDF/85.82 KB)
First published: 06/11/2013
Last updated: 06/11/2013
Antifibrinolytic medicines - Article-31 referral - Annex II (aprotinin) (PDF/46.8 KB)
First published: 06/11/2013
Last updated: 06/11/2013
Antifibrinolytic medicines - Article-31 referral - Annex IV (aprotinin) (PDF/13.87 KB)
First published: 06/11/2013
Last updated: 06/11/2013
Antifibrinolytic medicines - Article-31 referral - Annex I (aminocaproic acid) (PDF/63.84 KB)
First published: 06/11/2013
Last updated: 06/11/2013
Antifibrinolytic medicines - Article-31 referral - Annex II (aminocaproic acid) (PDF/83.81 KB)
First published: 06/11/2013
Last updated: 06/11/2013
Antifibrinolytic medicines - Article-31 referral - Annex I (tranexamic acid) (PDF/138.95 KB)
First published: 06/11/2013
Last updated: 06/11/2013
Antifibrinolytic medicines - Article-31 referral - Annex II (tranexamic acid) (PDF/69.37 KB)
First published: 06/11/2013
Last updated: 06/11/2013
Antifibrinolytic medicines - Article-31 referral - Annex III (tranexamic acid) (PDF/219.48 KB)
First published: 17/02/2012
Last updated: 06/11/2013
Antifibrinolytic medicines - Article 31 referral - Annex III (aprotinin) (PDF/143.43 KB)
First published: 17/02/2012
Last updated: 06/11/2013
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.