Use of valproate (and related substances) during pregnancy: recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) within a European safety review
2014.10.10
Active substance: valproate
The BfArM issues information on the PRAC's recommendation within a European safety review according to Article 31 of Directive 2001/83/EC.
To the risk assessment procedure (available in German only)
Details on the procedure can be found on the website of the European Medicines Agency (EMA):