PSUSA/00002602/202303 - periodic safety update report single assessment

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

• Procedure number:
  PSUSA/00002602/202303
• Regulatory outcome:
  Variation

Documents

Racecadotril : List of nationally authorised medicinal products - PSUSA/00002602/202303

Racecadotril : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002602/202303