Diane 35 cyproterone/ethinylestradiol regulatory update

EMA's Pharmacovigilance Risk Assessment Committee (PRAC) concluded that the benefits of Bayer's Diane 35 cyproterone/ethinylestradiol and its generic versions outweigh the risks, provided that measures are taken to minimize the risk of thromboembolism. PRAC said the medicines should only be used to treat moderate to severe acne related to androgen-sensitivity and/or hirsutism in women of reproductive age. Additionally, the committee said Diane 35 should only be used to treat acne when alternative treatments, such as topical therapy and oral antibiotic treatments have failed. EMA's Co-ordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh) will now consider the PRAC recommendation. ...