Aprotinin

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

Overview

The European Medicines Agency (EMEA) has looked at the safety of medicines containing aprotinin. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of 'systemic' formulations of these medicines no longer outweigh their risks, and has recommended that all marketing authorisations for these medicines should be suspended throughout Europe. 'Systemic' formulations are those that affect the whole body, such as infusions (drips).

Key facts

Approved name
Aprotinin
International non-proprietary name (INN) or common name
aprotinin
Associated names
Trasylol
Reference number
EMEA/533599/07
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 This procedure has been replaced by Article 107i.

Status
European Commission final decision
Opinion date
15/11/2007
EC decision date
15/02/2008

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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