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
- Fluconazole
- Procedure number
- PSUSA/00001404/202003
- Regulatory outcome
- Variation
Documents
Fluconazole: List of nationally authorised medicinal products - PSUSA/00001404/202003
English (EN) (476.81 KB - PDF)
Fluconazole: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001404/202003
English (EN) (117.21 KB - PDF)
български (BG) (130.16 KB - PDF)
español (ES) (119.67 KB - PDF)
čeština (CS) (119.4 KB - PDF)
dansk (DA) (117.66 KB - PDF)
Deutsch (DE) (125.43 KB - PDF)
eesti keel (ET) (117.61 KB - PDF)
ελληνικά (EL) (133.01 KB - PDF)
français (FR) (123.5 KB - PDF)
hrvatski (HR) (121.13 KB - PDF)
íslenska (IS) (122.57 KB - PDF)
italiano (IT) (122.47 KB - PDF)
latviešu valoda (LV) (128.58 KB - PDF)
lietuvių kalba (LT) (129.16 KB - PDF)
magyar (HU) (120.62 KB - PDF)
Malti (MT) (130.1 KB - PDF)
Nederlands (NL) (123.74 KB - PDF)
norsk (NO) (117.98 KB - PDF)
polski (PL) (127.56 KB - PDF)
português (PT) (122.2 KB - PDF)
română (RO) (117.25 KB - PDF)
slovenčina (SK) (126.34 KB - PDF)
slovenščina (SL) (125.92 KB - PDF)
Suomi (FI) (115.73 KB - PDF)
svenska (SV) (118.59 KB - PDF)