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
- gadoteridol
- Procedure number
- PSUSA/00001507/202304
- Regulatory outcome
- Variation
Documents
Gadoteridol : List of nationally authorised medicinal products - PSUSA/00001507/202304
English (EN) (133.44 KB - PDF)
Gadoteridol : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001507/202304
English (EN) (103.83 KB - PDF)
български (BG) (117.9 KB - PDF)
español (ES) (104.62 KB - PDF)
čeština (CS) (119.37 KB - PDF)
dansk (DA) (103.02 KB - PDF)
Deutsch (DE) (106.76 KB - PDF)
eesti keel (ET) (98.42 KB - PDF)
ελληνικά (EL) (117.34 KB - PDF)
français (FR) (104.16 KB - PDF)
hrvatski (HR) (116.27 KB - PDF)
italiano (IT) (104.59 KB - PDF)
latviešu valoda (LV) (115.4 KB - PDF)
lietuvių kalba (LT) (116.88 KB - PDF)
magyar (HU) (102.77 KB - PDF)
Malti (MT) (108.87 KB - PDF)
Nederlands (NL) (106.25 KB - PDF)
norsk (NO) (103.15 KB - PDF)
polski (PL) (120.59 KB - PDF)
português (PT) (102.9 KB - PDF)
română (RO) (100.4 KB - PDF)
slovenčina (SK) (106.07 KB - PDF)
slovenščina (SL) (113.98 KB - PDF)
Suomi (FI) (99.09 KB - PDF)
svenska (SV) (103.39 KB - PDF)