PSUSA/00000615/202204 - periodic safety update report single assessment

Cefuroxime sodium (except for intracameral use)

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:
  Cefuroxime sodium (except for intracameral use)
• Procedure number:
  PSUSA/00000615/202204
• Regulatory outcome:
  Variation

Documents

Cefuroxime sodium (except for intracameral use) : List of nationally authorised medicinal products - PSUSA/00000615/202204

Reference Number: EMA/794410/2022

Cefuroxime sodium (except for intracameral use) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000615/202204

Reference Number: EMA/794410/2022