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Direct Healthcare Professional Communication (DHPC) on▼Picato® (ingenol mebutate): suspension of the marketing authorisation due to risk of skin malignancy

Active substance: ingenol mebutate

LEO Pharma 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 suspension of the marketing authorisation of Picato (ingenol mebutate) as a precautionary measure due to growing concerns on the possible risk of skin malignancy, while EMA continues to investigate. Healthcare professionals should stop prescribing Picato and consider other treatment options as appropriate. The medicinal product is no longer marketable.

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