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
- iron
- Procedure number
- PSUSA/00010236/202001
- Regulatory outcome
- Variation
Documents
Iron (parenteral preparations, except for iron dextran): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010236/202001
English (EN) (27.64 KB - PDF)
български (BG) (76.13 KB - PDF)
español (ES) (28.52 KB - PDF)
čeština (CS) (59.24 KB - PDF)
dansk (DA) (27.87 KB - PDF)
Deutsch (DE) (29.5 KB - PDF)
eesti keel (ET) (27.8 KB - PDF)
ελληνικά (EL) (132.29 KB - PDF)
français (FR) (28.65 KB - PDF)
hrvatski (HR) (65.09 KB - PDF)
íslenska (IS) (27.78 KB - PDF)
italiano (IT) (28.84 KB - PDF)
latviešu valoda (LV) (81.43 KB - PDF)
lietuvių kalba (LT) (74.33 KB - PDF)
magyar (HU) (57.1 KB - PDF)
Malti (MT) (70.47 KB - PDF)
Nederlands (NL) (28.21 KB - PDF)
norsk (NO) (28.4 KB - PDF)
polski (PL) (61.32 KB - PDF)
português (PT) (28.01 KB - PDF)
română (RO) (66.42 KB - PDF)
slovenčina (SK) (58.98 KB - PDF)
slovenščina (SL) (65.5 KB - PDF)
Suomi (FI) (26.7 KB - PDF)
svenska (SV) (27.31 KB - PDF)
Iron (parenteral preparations, except for iron dextran): List of nationally authorised medicinal products - PSUSA/00010236/202001
English (EN) (328.79 KB - PDF)