23.08.2013 - Notice within the graduated plan procedure ("Stufenplanverfahren")

In a notice dated 8 August 2013, the Federal Institute for Drugs and Medical Devices has ruled the realisation of the European Commission's implementing decision on medicinal products containing the combination cyproterone acetate/ethinylestradiol (2 mg/0.035 MG).

31.05.2013 - PRAC recommendation

At its May meeting, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has now concluded that the benefits of taking the medicinal product Diane® 35 and its generics outweigh the risks, provided these medicinal products are used to treat moderate to severe acne based on an increased androgen sensitivity and/or for treatment of hirsutism in women of reproductive age.

14.02.2013 - Procedure started

In its February meeting (4 - 7 February 2013) the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee has started a safety review of the medicinal product Diane® 35 (which contains 2 mg cyproterone acetate and 35 µg ethinylestradiol) and its associated generics.

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)