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Valproate: Risk of congenital malformations and developmental problems associated with use during pregnancy

Date 2018.11.09
Active substance valproate

09.11.2018 - Educational material on medicinal products containing valproate

20.06.2018 - European Commission final decision

In its notice of 20 June 2018, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision of the EU Commission C(2018) 3623 final of 31 May 2018.

27.03.2018 - CMDh position

The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has recommended new measures to avoid valproate exposure of unborn babies in the womb.

09.02.2018 - PRAC recommendation

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.

14.03.2017 - procedure startet

The BfArM issues information on the initiation of a safety review by the European Medicines Agency (EMA) to review the use of medicinal products containing valproate in girls and women who are pregnant or of childbearing age.

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):

Valproate and related substances