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EMA to review Bayer's Diane 35

This article was originally published in Scrip

Executive Summary

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee has begun a safety review of Bayer's Diane 35 (cyproterone acetate plus ethinylestradiol) and generic versions. The move comes after the French regulator, the ANSM, suspended the drug in France and asked the EMA to review the product (, 31 January 2013). The committee will make a decision on any action that needs to be taken at its meeting in May. The products are widely authorised in Europe for different uses, for example as oral contraceptives. In France they are approved as an acne treatment, but are widely used off-label as a contraceptive, according to the French regulator.



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