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
- Amikacin (except for centrally authorised products)
- Procedure number
- PSUSA/00000143/202206
- Regulatory outcome
- Variation
Documents
Amikacin (except for centrally authorised products) : List of nationally authorised medicinal products - PSUSA/00000143/202206
English (EN) (227.29 KB - PDF)
Amikacin (except for centrally authorised products) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000143/202206
English (EN) (111.79 KB - PDF)
български (BG) (137.79 KB - PDF)
español (ES) (121.61 KB - PDF)
čeština (CS) (136.43 KB - PDF)
dansk (DA) (113.2 KB - PDF)
Deutsch (DE) (116.13 KB - PDF)
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italiano (IT) (125.18 KB - PDF)
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polski (PL) (142.17 KB - PDF)
português (PT) (122.18 KB - PDF)
română (RO) (141.36 KB - PDF)
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