PSUSA/00001832/202104 - periodic safety update report single assessment

Latanoprost (except for products with paediatric indication)

Apie

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:
  Latanoprost (except for products with paediatric indication)
• Procedure number:
  PSUSA/00001832/202104
• Regulatory outcome:
  Variation

Dokumentai

Latanoprost (except for products with paediatric indication) : List of nationally authorised medicinal products - PSUSA/00001832/202104

Reference Number: EMA/53162/2022

Latanoprost (except for products with paediatric indication) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001832/202104