PSUSA/00002737/202501 - periodic safety update report single assessment

disodium hydrogen phosphate / sodium dihydrogen phosphate, phosphate sodium

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:
  disodium hydrogen phosphate / sodium dihydrogen phosphate, phosphate sodium
• Procedure number:
  PSUSA/00002737/202501
• Regulatory outcome:
  Variation

Documents

disodium hydrogen phosphate / sodium dihydrogen phosphate, phosphate sodium : List of nationally authorised medicinal products - PSUSA/00002737/202501

disodium hydrogen phosphate / sodium dihydrogen phosphate, phosphate sodium : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002737/202501