Aprotinin
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
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 This procedure has been replaced by Article 107i.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