PSUSA/00001509/202304 - periodic safety update report single assessment
gadoxetic acid disodium
PSUSAHuman
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
- gadoxetic acid disodium
- Procedure number
- PSUSA/00001509/202304
- Regulatory outcome
- Variation
Documents
Gadoxetic acid disodium : List of nationally authorised medicinal products - PSUSA/00001509/202304
Reference Number: EMA/49699/2024
English (EN) (419.01 KB - PDF)
First published:
Gadoxetic acid disodium : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001509/202304
English (EN) (26.16 KB - PDF)
First published:
български (BG) (161.65 KB - PDF)
First published: 29/02/2024
español (ES) (26.39 KB - PDF)
First published: 29/02/2024
čeština (CS) (165.01 KB - PDF)
First published: 29/02/2024
dansk (DA) (86.48 KB - PDF)
First published: 29/02/2024
Deutsch (DE) (27.06 KB - PDF)
First published: 29/02/2024
eesti keel (ET) (126.01 KB - PDF)
First published: 29/02/2024
ελληνικά (EL) (161.11 KB - PDF)
First published: 29/02/2024
français (FR) (133.65 KB - PDF)
First published: 29/02/2024
hrvatski (HR) (158.61 KB - PDF)
First published: 29/02/2024
íslenska (IS) (26.01 KB - PDF)
First published: 29/02/2024
Gaeilge (GA) (27.15 KB - PDF)
First published: 29/02/2024
italiano (IT) (131.1 KB - PDF)
First published: 29/02/2024
latviešu valoda (LV) (198.94 KB - PDF)
First published: 29/02/2024
lietuvių kalba (LT) (161.61 KB - PDF)
First published: 29/02/2024
magyar (HU) (132.54 KB - PDF)
First published: 29/02/2024
Malti (MT) (141.56 KB - PDF)
First published: 29/02/2024
Nederlands (NL) (86.24 KB - PDF)
First published: 29/02/2024
norsk (NO) (85.97 KB - PDF)
First published: 29/02/2024
polski (PL) (164.89 KB - PDF)
First published: 29/02/2024
português (PT) (27.26 KB - PDF)
First published: 29/02/2024
română (RO) (129.58 KB - PDF)
First published: 29/02/2024
slovenčina (SK) (141.49 KB - PDF)
First published: 29/02/2024
slovenščina (SL) (158.3 KB - PDF)
First published: 29/02/2024
Suomi (FI) (80.83 KB - PDF)
First published: 29/02/2024
svenska (SV) (27.32 KB - PDF)
First published: 29/02/2024