PSUSA/00000426/201812 - periodic safety update report single assessment

Botulinum toxin a

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:
  Botulinum toxin a
• Procedure number:
  PSUSA/00000426/201812
• Regulatory outcome:
  Variation

Documents

Botulinum toxin a: List of nationally authorised medicinal products - PSUSA/00000426/201812

Reference Number: EMA/58116/2019

Botulinum toxin a: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000426/201812