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Direct Healthcare Professional Communication (DHPC) on medroxyprogesterone acetate: Risk of meningioma and measures to minimise this risk

Active substance: medroxyprogesterone acetate

The marketing authorisation holder of medroxyprogesterone acetate-containing medicines in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you about the increased risk of developing meningioma with high doses of medroxyprogesterone acetate (all injectable and ≥100 mg oral formulations), primarily after prolonged use (several years). Patients treated with high doses medroxyprogesterone acetate should be monitored for signs and symptoms of meningioma in accordance with clinical practice.

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