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
- 5 fluorouracil (i.v. application)
- Procedure number
- PSUSA/00000007/202012
- Regulatory outcome
- Variation
Documents
5 fluorouracil (i.v. application) - List of nationally authorised medicinal products - PSUSA-00000007-202012
English (EN) (308.13 KB - PDF)
5 fluorouracil (i.v. application) - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA-00000007-202012
English (EN) (106.71 KB - PDF)
български (BG) (124.58 KB - PDF)
español (ES) (97.98 KB - PDF)
čeština (CS) (126.3 KB - PDF)
dansk (DA) (97.34 KB - PDF)
Deutsch (DE) (101.67 KB - PDF)
eesti keel (ET) (107.32 KB - PDF)
ελληνικά (EL) (120.7 KB - PDF)
français (FR) (98.93 KB - PDF)
hrvatski (HR) (142.97 KB - PDF)
íslenska (IS) (99.69 KB - PDF)
italiano (IT) (96.93 KB - PDF)
latviešu valoda (LV) (119.09 KB - PDF)
lietuvių kalba (LT) (131.29 KB - PDF)
magyar (HU) (129.78 KB - PDF)
Malti (MT) (120.76 KB - PDF)
Nederlands (NL) (98.38 KB - PDF)
norsk (NO) (97.11 KB - PDF)
polski (PL) (137.17 KB - PDF)
português (PT) (99.23 KB - PDF)
română (RO) (120.16 KB - PDF)
slovenčina (SK) (119.72 KB - PDF)
slovenščina (SL) (114.34 KB - PDF)
Suomi (FI) (97.32 KB - PDF)
svenska (SV) (96.64 KB - PDF)