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
- Ondansetron
- Procedure number
- PSUSA/00002217/202102
- Regulatory outcome
- Variation
Documents
Ondansetron: List of nationally authorised medicinal products - PSUSA/00002217/202102
English (EN) (482.82 KB - PDF)
Ondansetron: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002217/202102
English (EN) (153.92 KB - PDF)
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čeština (CS) (175.38 KB - PDF)
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Deutsch (DE) (157.11 KB - PDF)
eesti keel (ET) (151.26 KB - PDF)
ελληνικά (EL) (169.42 KB - PDF)
français (FR) (153.84 KB - PDF)
hrvatski (HR) (169.3 KB - PDF)
íslenska (IS) (155.52 KB - PDF)
italiano (IT) (157.02 KB - PDF)
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magyar (HU) (174.92 KB - PDF)
Malti (MT) (172.59 KB - PDF)
Nederlands (NL) (154.28 KB - PDF)
norsk (NO) (153.85 KB - PDF)
polski (PL) (158.18 KB - PDF)
português (PT) (146.9 KB - PDF)
română (RO) (171.37 KB - PDF)
slovenčina (SK) (179.82 KB - PDF)
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