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Oral bromocriptine-containing medicines: indicated in the prevention or suppression of physiological lactation post-partum

2014.11.28

Active substance: bromocriptine

28.11.2014 - Notice within the graduated plan procedure ("Stufenplanverfahren")

In its notice of 27 November 2014, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision of the EU Commission of 30 October 2014 regarding medicinal products containing bromocriptine. This implementing decision includes changes to the summary of product characteristics and package leaflet.

21.08.2014 - CMDh position

The BfArM issues information on the fact that the PRAC's recommendation has been confirmed by the Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) within the European safety review according to Article 31 of Directive 2001/83/EC--European Community.

14.07.2014 - PRAC recommendation

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

11.09.2013 - Procedure started

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

Further information

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

Bromocriptine-containing medicines indicated in the prevention or suppression of physiological lactation post-partum

To the risk assessment procedure (available in German only)