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
- Carbetocin
- Procedure number
- PSUSA/00000546/202206
Documents
Carbetocin - List of nationally authorised medicinal products - PSUSA/00000546/202206
English (EN) (155.61 KB - PDF)
Carbetocin - CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000546/202206
English (EN) (42.06 KB - PDF)
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čeština (CS) (167.15 KB - PDF)
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Deutsch (DE) (50.42 KB - PDF)
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polski (PL) (165.17 KB - PDF)
português (PT) (48.57 KB - PDF)
română (RO) (152.94 KB - PDF)
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