PSUSA/00001370/202304 - periodic safety update report single assessment

fentanyl (transdermal patches, solution for injection - nationally authorised product only)

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:
  fentanyl (transdermal patches, solution for injection - nationally authorised product only)
• Procedure number:
  PSUSA/00001370/202304

Documents

Fentanyl (transdermal patches, solution for injection - nationally authorised product only) : List of nationally authorised medicinal products - PSUSA/00001370/202304

Reference Number: EMA/51342/2024

Fentanyl (transdermal patches, solution for injection - nationally authorised product only) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001370/202304