Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 - 12 February 2026

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Source: EMA News

Original: https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-asse...

Published: Fri, 13 Feb 2026 12:30:00 +0100

The Pharmacovigilance Risk Assessment Committee (PRAC) met on 9-12 February 2026. The PRAC recommends the withdrawal of marketing authorizations for medicinal products containing levamisole. Leukoencephalopathy has been confirmed as a serious side effect of levamisole. The EMA Safety Committee has assessed this safety signal. A safety signal is information indicating a new potentially causal connection or a new aspect of a known association. The meeting included an assessment of the safety signals of levamisole drugs. The related PRAC statistics for February 2026 have been published.