PSUSA/00000294/202309 - periodic safety update report single assessment

baclofen (oral use, for muscle spasticity indication)

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:
  baclofen (oral use, for muscle spasticity indication)
• Procedure number:
  PSUSA/00000294/202309
• Regulatory outcome:
  Variation

Documents

Baclofen (oral use, for muscle spasticity indication) : List of nationally authorised medicinal products - PSUSA/00000294/202309

Reference Number: EMA/320173/2024

Baclofen (oral use, for muscle spasticity indication) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000294/202309