European Medicines Agency reiterates PRAC recommendation for Diane 35 and generics

News 17/05/2013

Following the conclusion of the Pharmacovigilance Risk Assessment Committee (PRAC) that the benefits of Diane 35 and its generics outweigh the risks in a specific patient group, the French National Agency for the Safety of Medicine and Health Products (ANSM) unexpectedly announced today the decision to suspend the marketing authorisations of these medicines in France.

The French decision comes at a time when the process is not yet complete as the PRAC recommendation is the first step towards a common European Union (EU) approach.

The European Medicines Agency reiterates the PRAC recommendation that, provided a number of measures are taken to minimise the risk of thromboembolism, Diane 35 and its generics can be used in the treatment of moderate to severe acne related to androgen sensitivity or hirsutism (excessive unwanted growth of hair) in women of reproductive age. Furthermore, Diane 35 should only be used for the treatment of acne when alternative treatments, such as topical therapy and oral antibiotic treatment, have failed.

The PRAC adopted this recommendation with a 31:1 majority, following a thorough review of these medicines in which it sought expert advice and considered feedback from users of these medicines.

The recommendation will now be considered by the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh). If a position by this group is not reached by consensus, it will then be considered by the European Commission, who will adopt a final decision. Once a final decision is adopted, all Member States must follow it.

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