Diane-35 OK - EMA | Pharmacy Daily

Diane-35 OK – EMA

May 20, 2013

THE European Medicines Agency’s Pharmacovigilance Risk Assessment Committee has concluded that the benefits of Diane 35 (cypoterone acetate 2mg, ethinylestradiol 35ug) and its generics outweigh the risks, as long as measures are taken to minimise the risks of thromboembolism. The move follows a review initiated when French authorities suspended the marketing authorisation of the contraceptive (PD 31 Jan) over concerns about a number of adverse events, which highlighted “extensive offlabel use of these medicines as a contraceptive only”. The EMA said the medicines should be used “solely in the treatment of moderate to severe acne related to androgen-sensitivity and/or hirsutism in women of reproductive age.”

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Pharmacy Daily | Diane-35 OK – EMA

Diane-35 OK – EMA

Other recent headlines

PD breaking news – Top Western Australian talent honoured

Legal action for Montu

Call to unblock wait times

SEARCH PHARMACY DAILY

Featured video

Recent issues

INDUSTRY JOB VACANCIES