A post-authorization safety study (PASS) to evaluate the paternal exposure to valproate and the risk of neurodevelopmental disorders including autism spectrum disorders as well as congenital abnormalities in offspring - a population-based retrospective study

30/04/2020
03/09/2025
EU PAS number:
EUPAS34201
Study
Finalised
Documents
Study protocol
Initial protocol
English (4.09 MB - PDF) View document
Study results
Study report
Study report
English (523.07 KB - PDF) View document
Other information