27.07.2015 - Notice within the graduated plan procedure ("Stufenplanverfahren")

In its notice of 22 July 2015, the BfArM has ruled the realisation of the decision of the Co-ordination group for Mutual Recognition and Decentralised Procedures - Human (CMDh) of 20 May 2015 regarding medicinal products containing ibuprofen/dexibuprofen. This decision includes changes of summary of product characteristics and package leaflet.

26.05.2015 - CMDh confirmation of the recommendation

The BfArM issues information that the Co-ordination group for Mutual Recognition and Decentralised Procedures - Human (CMDH) has confirmed the PRAC's recommendation within the European safety review according to Article 31 of Directive 2001/83/EC

13.04.2015 - 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

17.06.2014 - Procedure started

The BfArM issues information on the initiation of a European safety review according to Article 31 of Directive 2001/83/EC

Further information

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

To the risk assessment procedure (available in German only)