The French medicines agency has announced its plan to suspend the marketing authorisation for Diane 35 ( Cyproterone acetate 2 mg / Ethinylestradiol 35 micrograms ) and its generics for acne treatment in France within three months.
These medicines are widely used across Europe. They have been authorised at the level of individual Member States for many years. In France, they are only authorised for the treatment of acne, but in a number of other Member States they are also authorised for the treatment of acne in women who wish to receive oral contraception, as well as for the treatment of other skin conditions.
The announcement in France follows a review by the French medicines agency ( ANSM ) of known data. ANSM considered that Diane 35 and its generics carry a risk of thromboembolism which has been well known for many years, while their effectiveness in treating acne was only moderate and alternative treatments for acne are available. In addition, it noted that they are widely used off-label as a contraceptive. ( Xagena )
Source: European Medicines Agency, 2013