PSUSA/00010000/202601 - periodic safety update report single assessment
5 fluorouracil (topical application)
PSUSAHuman
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
- 5 fluorouracil (topical application)
- Procedure number
- PSUSA/00010000/202601
- Regulatory outcome
- Maintenance