PSUSA/00003162/202001 - periodic safety update report single assessment

Bendamustine hydrochloride

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:
  Bendamustine hydrochloride
• Procedure number:
  PSUSA/00003162/202001
• Regulatory outcome:
  Variation

Documents

Bendamustine hydrochloride: List of nationally authorised medicinal products - PSUSA/00003162/202001

Reference Number: EMA/599638/2020 Summary:

List of nationally authorised medicinal products

Bendamustine hydrochloride: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003162/202001

Summary:

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