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
- Procedure number
- PSUSA/00001404/202303
- Regulatory outcome
- Variation
Documents
Fluconazole : List of nationally authorised medicinal products - PSUSA/00001404/202303
English (EN) (528.95 KB - PDF)
Fluconazole : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001404/202303
English (EN) (145.02 KB - PDF)
български (BG) (130.06 KB - PDF)
español (ES) (121.67 KB - PDF)
čeština (CS) (139.77 KB - PDF)
dansk (DA) (119.13 KB - PDF)
Deutsch (DE) (124.38 KB - PDF)
eesti keel (ET) (114.51 KB - PDF)
ελληνικά (EL) (129.86 KB - PDF)
français (FR) (118.46 KB - PDF)
hrvatski (HR) (200.15 KB - PDF)
íslenska (IS) (116.47 KB - PDF)
italiano (IT) (131.56 KB - PDF)
latviešu valoda (LV) (127.96 KB - PDF)
lietuvių kalba (LT) (127.44 KB - PDF)
magyar (HU) (154.62 KB - PDF)
Malti (MT) (128.39 KB - PDF)
Nederlands (NL) (122.91 KB - PDF)
norsk (NO) (107.67 KB - PDF)
polski (PL) (117.68 KB - PDF)
português (PT) (119.05 KB - PDF)
română (RO) (128.23 KB - PDF)
slovenčina (SK) (131.23 KB - PDF)
slovenščina (SL) (123.9 KB - PDF)
Suomi (FI) (141.23 KB - PDF)
svenska (SV) (118.11 KB - PDF)