EMA's PRAC Meeting Highlights: 29th September – 2nd October 2025

10th October 2025

EMA's PRAC Meeting Highlights: 29th September – 2nd October 2025

Summary:

• Safety Signal Assessments: PRAC evaluated new safety signals, including:

  • Tirzepatide (Mounjaro): Investigating potential interactions with warfarin and other coumarin derivatives leading to decreased international normalised ratio.

  • Pancreatin: Assessing risks of infection due to viral transmission.

• Risk Management Plans (RMPs): The committee reviewed and adopted RMPs for several medicines, ensuring updated safety information and risk minimisation strategies.

• Periodic Safety Update Reports (PSURs): PRAC evaluated PSURs to monitor the benefit-risk balance of authorised medicines, contributing to ongoing safety assessments.

• Post-Authorisation Safety Studies (PASS): The committee discussed protocols and results of PASS to gather further information on the safety and effectiveness of medicines post-authorisation.

No new referral procedures were initiated or concluded during this meeting. For detailed information on all topics discussed, refer to the PRAC agenda.

Link: Meeting Highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 September - 2 October 2025

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