19.05.2020 - Notice within the graduated plan procedure ("Stufenplanverfahren")

The PRAC recommendations were adopted by the Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) by consensus on 25 March 2020. The Federal Institute for Drugs and Medical Devices (BfArM) has implemented the decision at national level by official notice, dated 13 May 2020.

14.02.2020 - PRAC recommendation

The Committee for Pharmacovigilance Risk Assessment (PRAC) recommends restrictions on the use of medicinal products containing cyproterone due to the risk of meningioma.

12.07.2019 - Procedure started

EMA has started a review of medicines containing cyproterone, which are used for treating a range of conditions, including excessive hair growth, prostate cancer and acne, as well as in hormone replacement therapy.

Further information

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

Cyproterone-containing medicinal products

To the risk assessment procedure (available in German only)