Expired marketing authorisations of medicinal products containing valproate do not or not entirely conform with the implementation of the agreement of the co-ordination Group EMA/CMDh/654826/2014 of 19 November 2014. Thus, the risk-benefit ratio of the medicinal products is no longer positive.

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

Risikoinfo_Downloadtitel_Risikobewertungsverfahren , Download_VeroeffentlichtAm_EN 2017.03.21 PDF, 103KB, File is accessible