05/09/2024 | Press release | Distributed by Public on 05/09/2024 13:44
Public Assessment Report of review of results of a post-authorisation safety study on paternal exposure to valproate.
PDF, 782 KB, 64 pages
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Request an accessible format.This report presents the review of the results of a study on the potential risk to children born to men who took valproate in the 3 months before conception, and the steps that the MHRA are taking to implement new safety measures in consultation with the clinical community and other stakeholders.