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News|Articles|September 6, 2019
EMA Initiates Review into Picato
Author(s)Pharmaceutical Technology Editors
EMA has started a data review of Picato (ingenol mebutate) to investigate the potential for skin cancer risk.
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The European Medicines Agency (EMA)
The agency’s Pharmacovigilance Risk Assessment Committee (PRAC) will review all available data and assess the impact of the data on the benefits versus risk of Picato. After review, PRAC will recommend any necessary amendments to the marketing authorization.
EMA is advising healthcare professionals to caution patients with a past history of skin cancer about the potential risk.
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