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
- Dexamethasone (apart from centrally authorised products)
- Procedure number
- PSUSA/00000973/202101
- Regulatory outcome
- Variation
Documents
Dexamethasone - List of nationally authorised medicinal products - PSUSA-00000973-202101
English (EN) (392.14 KB - PDF)
Dexamethasone - Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA-00000973-202101
English (EN) (119.33 KB - PDF)
български (BG) (169.62 KB - PDF)
español (ES) (143.04 KB - PDF)
čeština (CS) (193.22 KB - PDF)
dansk (DA) (156.64 KB - PDF)
Deutsch (DE) (162.11 KB - PDF)
eesti keel (ET) (151.8 KB - PDF)
ελληνικά (EL) (177.73 KB - PDF)
français (FR) (157.17 KB - PDF)
hrvatski (HR) (187.68 KB - PDF)
íslenska (IS) (156.85 KB - PDF)
italiano (IT) (195.14 KB - PDF)
latviešu valoda (LV) (187.49 KB - PDF)
lietuvių kalba (LT) (188.48 KB - PDF)
magyar (HU) (196.21 KB - PDF)
Malti (MT) (195.53 KB - PDF)
Nederlands (NL) (157.11 KB - PDF)
norsk (NO) (137.41 KB - PDF)
polski (PL) (148.73 KB - PDF)
português (PT) (226.72 KB - PDF)
română (RO) (191.68 KB - PDF)
slovenčina (SK) (193.9 KB - PDF)
slovenščina (SL) (185.43 KB - PDF)
Suomi (FI) (150.76 KB - PDF)
svenska (SV) (154.33 KB - PDF)