Highlights from EMA pharmacovigilance committee meeting

12 June 2026

The European Medicines Agency’s (EMA) safety committee, PRAC, concluded evaluation of new data regarding potential risk of medicines at its June meeting.

The PRAC has completed its review of a safety signal for valproate and related substances, and concluded that based on the evaluation of new data, the evidence on neurodevelopmental disorders (NDDs) in children born to men treated with valproate is inconsistent and the causal role of valproate is uncertain.

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