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Medicinal products containing ponatinib (Iclusig®): risk of blood vessel blockage

2015.01.15

Active substance: Ponatinib

15.01.2015 - European Commission final decision

With the publication of the decision of the European Commission on 15 January 2015, the risk assessment procedure in accordance with Article 20 of Regulation (EC) No 726/2004 on Iclusig® was completed.

24.10.2014 - CHMP opinion

The BfArM issues information on the fact that the PRAC's recommendation has been confirmed by the European Committee for Medicinal Products (CHMP) within a European safety review in accordance with Article 20 of Regulation (EC) No. 726/2004.

10.10.2014 - PRAC recommendation

The BfArM issues information on the PRAC's recommendation within a European safety review in accordance with Article 20 of Regulation (EC) No. 726/2004.

Further information

Details on the procedure can be found on the website of the European Medicines Agency (EMA):

Iclusig

To the risk assessment procedure (available in German only)