On 24–27 November 2025, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) held its monthly meeting. The committee carried out its routine duties, covering the entire spectrum of medicine risk management, including assessment of safety signals, risk management plans, periodic safety update reports (PSURs) and post‑authorisation safety studies (PASSs). No new referral procedures were initiated or concluded during the session. The committee’s ongoing referral list, which is updated in the accompanying table, currently includes levamisole‑containing medicinal products. All agenda items and detailed discussion points are documented in the meeting agenda PDF (reference EMA/PRAC/354765/2025). PRAC statistics for December 2025 are also available in a separate report.
© European Medicines Agency (1995‑).
Summary adapted from EMA materials available at https://www.ema.europa.eu
https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-24-27-november-2025
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