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

Approved name
Antifibrinolytic medicines
International non-proprietary name (INN) or common name
aprotinin, aminocaproic acid, tranexamic acid
Class
B02A, Antihemorrhagics
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.

Status
European Commission final decision
Opinion date
19/06/2012

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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