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
- Quetiapine
- Procedure number
- PSUSA/00002589/202006
- Regulatory outcome
- Variation
Documents
Quetiapine: List of nationally authorised medicinal products - PSUSA/00002589/202006
English (EN) (852.12 KB - PDF)
Quetiapine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002589/202006
English (EN) (159.49 KB - PDF)
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hrvatski (HR) (265.29 KB - PDF)
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italiano (IT) (129.17 KB - PDF)
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polski (PL) (170.56 KB - PDF)
português (PT) (192.61 KB - PDF)
română (RO) (257.51 KB - PDF)
slovenčina (SK) (154.09 KB - PDF)
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