PSUSA/00001509/202304 - periodic safety update report single assessment

gadoxetic acid disodium

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:
  gadoxetic acid disodium
• Procedure number:
  PSUSA/00001509/202304
• Regulatory outcome:
  Variation

Documents

Gadoxetic acid disodium : List of nationally authorised medicinal products - PSUSA/00001509/202304

Reference Number: EMA/49699/2024

Gadoxetic acid disodium : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001509/202304