On 19 November 2014, the Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) decided unanimously based on the recommendations of the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) that valproate and related substances should only be used for treatment of manic episodes in bipolar disorders and of epilepsy in girls and women of childbearing potential if other medicinal products are ineffective or not tolerated.

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