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
- Iohexol
- Procedure number
- PSUSA/00001768/202006
- Regulatory outcome
- Variation
Documents
Iohexol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001768/202006
English (EN) (156 KB - PDF)
български (BG) (189 KB - PDF)
español (ES) (130.91 KB - PDF)
čeština (CS) (160.22 KB - PDF)
dansk (DA) (112.32 KB - PDF)
Deutsch (DE) (165.86 KB - PDF)
eesti keel (ET) (52.6 KB - PDF)
ελληνικά (EL) (185.25 KB - PDF)
français (FR) (97.91 KB - PDF)
hrvatski (HR) (158.65 KB - PDF)
íslenska (IS) (106.33 KB - PDF)
italiano (IT) (157.22 KB - PDF)
latviešu valoda (LV) (193.92 KB - PDF)
lietuvių kalba (LT) (159.07 KB - PDF)
magyar (HU) (155.87 KB - PDF)
Malti (MT) (251.82 KB - PDF)
Nederlands (NL) (56.84 KB - PDF)
norsk (NO) (113.6 KB - PDF)
polski (PL) (155.24 KB - PDF)
português (PT) (103.74 KB - PDF)
română (RO) (154.76 KB - PDF)
slovenčina (SK) (162.64 KB - PDF)
slovenščina (SL) (153.91 KB - PDF)
Suomi (FI) (49.49 KB - PDF)
svenska (SV) (53.56 KB - PDF)
Iohexol: List of nationally authorised medicinal products - PSUSA/00001768/202006
English (EN) (398.87 KB - PDF)