Direct Healthcare Professional Communication (DHPC) on cyproterone acetate: restrictions in use due to the risk of meningioma
2020.04.16
Active substance: Cyproteronacetat
The marketing authorisation holders of cyproterone containing medicines in agreement with the European Medicines Agency and the Federal Institute for Drugs and Medical Devices would like to inform you, that the occurrence of meningiomas (single and multiple) has been reported in association with the use of cyproterone acetate, primarily at doses of 25 mg/day and above. The use of cyproterone acetate is contraindicated in patients with a meningioma or a history of meningioma and remains unchanged for the following indications: palliative therapy of metastatic or locally advanced inoperable prostate carcinoma.
To the risk assessment procedure
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