Medicinal products containing valproate: PRAC recommends new measures to avoid exposure to valproate during pregnancy
Active substance valproate
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) is recommending new restrictions to avoid exposure of babies to valproate in the womb; babies exposed to valproate are at risk of congenital malformations and developmental problems.
To the risk assessment procedure (available in German only)
For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):