PSUSA/00002655/202306 - periodic safety update report single assessment
PSUSAHuman
German is available via eTranslation, the European Commission's machine translation service.
Translate to German | Important information about machine translation
Über
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/00002655/202306
- Regulatory outcome
- Variation