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
- Sotalol
- Procedure number
- PSUSA/00002774/201908
- Regulatory outcome
- Variation
Documents
Sotalol: List of nationally authorised medicinal products - PSUSA/00002774/201908
English (EN) (155.09 KB - PDF)
Sotalol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002774/201908
English (EN) (94.65 KB - PDF)
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čeština (CS) (184.13 KB - PDF)
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Deutsch (DE) (140.38 KB - PDF)
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hrvatski (HR) (189.9 KB - PDF)
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italiano (IT) (170.9 KB - PDF)
latviešu valoda (LV) (190.23 KB - PDF)
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Malti (MT) (195.7 KB - PDF)
Nederlands (NL) (133.8 KB - PDF)
norsk (NO) (132.66 KB - PDF)
polski (PL) (197.35 KB - PDF)
português (PT) (141.15 KB - PDF)
română (RO) (196.12 KB - PDF)
slovenčina (SK) (180.52 KB - PDF)
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