In view of renewed discussions and assessments on a European level as well as current findings and discussions with scientific societies, the BfArM also considers it necessary to introduce a patient alert card as a further measure in addition to previous risk minimisation measures. The following notice in this regard was prepared after the hearing of 1 March 2017.

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