PSUSA/00003186/202511 - periodic safety update report single assessment

a-tocopheril, a-tocopherol, vitamin E

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:
  a-tocopheril, a-tocopherol, vitamin E
• Procedure number:
  PSUSA/00003186/202511
• Regulatory outcome:
  Variation

Documents

PSUSA/00003186/202511 - List of nationally authorised medicinal products

PSUSA/00003186/202511 - CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation