PSUSA/00010593/201903 - periodic safety update report single assessment
Sulfametrole / trimethoprim, sulfadiazine / trimethoprim, sulfamethoxazole / trimethoprim (co-trimoxazole)
PSUSAHuman
Slovak is available via eTranslation, the European Commission's machine translation service.
Translate to Slovak | Important information about machine translation
Informácie o
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
- Sulfametrole / trimethoprim, sulfadiazine / trimethoprim, sulfamethoxazole / trimethoprim (co-trimoxazole)
- Procedure number
- PSUSA/00010593/201903
- Regulatory outcome
- Variation