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
- Amoxicillin/clavulanate
- Procedure number
- PSUSA/00000188/202203
- Regulatory outcome
- Variation
Documents
Amoxicillin/clavulanate : List of nationally authorised medicinal products - PSUSA/00000188/202203
English (EN) (474.71 KB - PDF)
Amoxicillin/clavulanate : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000188/202203
English (EN) (205.19 KB - PDF)
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čeština (CS) (206.76 KB - PDF)
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Deutsch (DE) (184.69 KB - PDF)
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italiano (IT) (209.54 KB - PDF)
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polski (PL) (248.44 KB - PDF)
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