PSUSA/00003090/202401 - periodic safety update report single assessment

valproic acid, sodium valproate, valproate pivoxil, valproate semisodium, valpromide, valproate bismuth, calcium valproate, valproate magnesium

About

Periodic safety update report single assessments (PSUSAs) are single assessments of related periodic safety update reports (PSURs) for active substances contained in medicines authorised in the European Union (EU). A PSUR is a pharmacovigilance report submitted regularly by a marketing-authorisation holder at defined time points following a medicine's authorisation.

Key facts

• Active substance(s) in scope of the PSUSA procedure:
  valproic acid, sodium valproate, valproate pivoxil, valproate semisodium, valpromide, valproate bismuth, calcium valproate, valproate magnesium
• Procedure number:
  PSUSA/00003090/202401
• Regulatory outcome:
  Variation

Documents

Valproic acid, sodium valproate, valproate pivoxil, valproate semisodium, valpromide, valproate bismuth, calcium valproate, valproate magnesium : List of nationally authorised medicinal products - PSUSA/00003090/202401

Reference Number: EMA/270645/2015

Valproic acid, sodium valproate, valproate pivoxil.....valproate magnesium : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003090/202401