PSUSA/00010649/202302 - periodic safety update report single assessment

ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus), ibuprofen / caffeine

À propos

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:
  ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus), ibuprofen / caffeine
• Procedure number:
  PSUSA/00010649/202302
• Regulatory outcome:
  Variation

Documents

Ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus), ibuprofen / caffeine : List of nationally authorised medicinal products - PSUSA/00010649/202302

Reference Number: EMA/485899/2023

Ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus), ibuprofen / caffeine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010649/202302