PSUSA/00001783/202005 - periodic safety update report single assessment

Irinotecan (except for liposomal formulations)

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:
  Irinotecan (except for liposomal formulations)
• Procedure number:
  PSUSA/00001783/202005
• Regulatory outcome:
  Variation

Documents

Irinotecan (except for liposomal formulations): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001783/202005

Summary:

CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation

Irinotecan (except for liposomal formulations): List of nationally authorised medicinal products - PSUSA/00001783/202005

Reference Number: EMA/150667/2021 Summary:

List of nationally authorised medicinal products