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

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

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:
  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