PSUSA/00000294/202009 - periodic safety update report single assessment

Baclofen (oral)

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)
• Procedure number:
  PSUSA/00000294/202009
• Regulatory outcome:
  Variation

Documents

Baclofen (oral) - List of nationally authorised medicinal products - PSUSA/00000294/202009

Reference Number: EMA/CMDh/422905/2021

Baclofen (oral) - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation - PSUSA/00000294/202009

Summary:

Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s)