Research and analysis

Valproate: review of safety data and expert advice on management of risks

Public Assessment Report of review of valproate safety data and expert advice on management of risks.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 28 November 2023

Documents

Valproate: review of safety data and expert advice on management of risks

PDF, 941 KB, 89 pages

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Details

This report presents the MHRA’s review of safety data for valproate in 2022 and expert advice on management of risks recommended by the CHM over multiple meetings. This report also presents the advice from the CHM’s implementation Expert Working Group, which met several times in 2022 and 2023 and the changes their advice made to the introduction of these regulatory safety measures.

For more information see valproate document collection.

Published 28 November 2023