EMA update on Diane 35 (cyproterone acetate 2mg, ethinylestradiol 35mcg) and generics for treatment of acne following French decision to suspend marketing authorisation

Source: Eur Meds Agency (EMA), Reuters Health News Area: News The French medicines agency (ANSM) has announced its plan to suspend the marketing authorisation for Diane 35 (cyproterone acetate 2mg, ethinylestradiol 35mcg) and its generics for acne treatment (its only licensed indiction in that country) within three months. In other countries, these medicines are also licensed for the treatment of acne in women who wish to receive oral contraception, as well as for the treatment of other skin conditions. This announcement follows a review by ANSM of known data which led it to conclude 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.   The European Medicines Agency has issued an update which notes that although Member States can take unilateral action to suspend the marketing authorisation of ...
Source: NeLM - Cardiovascular Medicine - Category: Cardiology Source Type: news