20.05.2015 - CMDh decision

The Co-ordination group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has unanimously decided further measures to minimise the risk of arrhythmias.

13.02.2015 PRAC recommendation

The BfArM issues information on the PRAC's recommendation within a European safety review according to Article 31 of Directive 2001/83/EC.

09.05.2014 - Procedure started

The BfArM issues information on the initiation of a European safety review according to Article 31 of Directive 2001/83/EC. This procedure was initiated at the request of the Hungarian National Institute of Pharmacy.

Further information

For details regarding the procedure please click on the following link to the European Medicines Agency (EMA):

To the risk assessment procedure (available in German only)