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PRAC Recommendations on Safety Signals

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed between September 29 and October 2, 2025. These recommendations are directly actionable by marketing authorisation holders (MAHs) for both Centrally Authorised Products (CAPs) and Nationally Authorised Products (NAPs).

Priority review Notice Healthcare

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