Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 September – 2 October 2025 – www.ema.europa.eu

3 Ott, 2025

www.ema.europa.eu

At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines: assessment of safety signals, risk management plans, periodic safety update reports and post-authorisation safety studies.

The Committee did not start or conclude any referral procedures.

Information on all topics discussed by the PRAC is available in the agenda.

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