PSUSA/00002192/202303 - periodic safety update report single assessment

nortriptyline

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:
  nortriptyline
• Procedure number:
  PSUSA/00002192/202303
• Regulatory outcome:
  Variation

Documents

Nortriptyline : List of nationally authorised medicinal products - PSUSA/00002192/202303

Reference Number: EMA/555754/2023

Nortriptyline : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002192/202303