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
- Famotidine
- Procedure number
- PSUSA/00001350/202209
- Regulatory outcome
- Variation
Documents
Famotidine : List of nationally authorised medicinal products - PSUSA/00001350/202209
English (EN) (163.67 KB - PDF)
Famotidine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001350/202209
English (EN) (96.96 KB - PDF)
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čeština (CS) (118.61 KB - PDF)
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Deutsch (DE) (100.32 KB - PDF)
eesti keel (ET) (93.67 KB - PDF)
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français (FR) (98.34 KB - PDF)
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Nederlands (NL) (98.42 KB - PDF)
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polski (PL) (132.77 KB - PDF)
português (PT) (97.7 KB - PDF)
română (RO) (117.21 KB - PDF)
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