PSUSA/00009174/202402 - periodic safety update report single assessment
human coagulation factor VIII (inhibitor bypassing fraction)
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
- human coagulation factor VIII (inhibitor bypassing fraction)
- Procedure number
- PSUSA/00009174/202402
- Regulatory outcome
- Maintenance