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EMA safety_alert · 2026-06-12

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 June 2026

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Summary

PRAC evaluated new data on potential risk of neurodevelopmental disorders in children born to men treated with valproate.

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Diseases / indications

Drugs mentioned

  • Valproate (valproate)

Snippet

PRAC concludes evaluation of new data regarding potential risk of neurodevelopmental disorders in children born to men treated with valproate