EMA
safety_alert
· 2026-06-12
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 June 2026
Summary
PRAC evaluated new data on potential risk of neurodevelopmental disorders in children born to men treated with valproate.
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Snippet
PRAC concludes evaluation of new data regarding potential risk of neurodevelopmental disorders in children born to men treated with valproate