PSUSA/00001333/202302 - periodic safety update report single assessment

etoposide

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:
  etoposide
• Procedure number:
  PSUSA/00001333/202302

Documents

Etoposide : List of nationally authorised medicinal products - PSUSA/00001333/202302

Reference Number: EMA/535777/2023

Etoposide : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001333/202302