Epilepsy

• EMA guidance · 2024-01-12
  Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 January 2024

  PRAC highlights potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines and recommends preca…

• EMA guidance · 2018-03-23
  New measures to avoid valproate exposure in pregnancy endorsed

  EU endorses new measures to avoid valproate exposure in pregnancy, reinforcing restrictions due to teratogenic risk.

• EMA guidance · 2017-09-26
  EMA's first public hearing: giving EU citizens a voice to help reduce the risk of valproate

  EMA held its first public hearing to involve EU citizens in reducing the risk associated with valproate use, aiming to give patients a voice…

• CLINICAL_TRIALS guidance · 2013-01-07
  Clinical Trial Update: Policy on Optimal Epilepsy Management [NA]

  This clinical trial update outlines policy guidance for optimal epilepsy management, highlighting recommended practices for clinicians.