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
- Indapamide
- Procedure number
- PSUSA/00001731/202011
- Regulatory outcome
- Variation
Documents
Indapamide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001731/202011
English (EN) (164.04 KB - PDF)
български (BG) (191.56 KB - PDF)
español (ES) (106.22 KB - PDF)
čeština (CS) (114.23 KB - PDF)
dansk (DA) (163.08 KB - PDF)
Deutsch (DE) (160.28 KB - PDF)
eesti keel (ET) (160.66 KB - PDF)
ελληνικά (EL) (154.12 KB - PDF)
français (FR) (191.01 KB - PDF)
hrvatski (HR) (227.03 KB - PDF)
íslenska (IS) (40.59 KB - PDF)
italiano (IT) (673.94 KB - PDF)
latviešu valoda (LV) (131.63 KB - PDF)
lietuvių kalba (LT) (122.34 KB - PDF)
magyar (HU) (230.34 KB - PDF)
Malti (MT) (209.97 KB - PDF)
Nederlands (NL) (25.94 KB - PDF)
norsk (NO) (144.13 KB - PDF)
polski (PL) (212.27 KB - PDF)
português (PT) (164.84 KB - PDF)
română (RO) (226.63 KB - PDF)
slovenčina (SK) (147.83 KB - PDF)
slovenščina (SL) (194.76 KB - PDF)
Suomi (FI) (137.49 KB - PDF)
svenska (SV) (25.75 KB - PDF)
Indapamide: List of nationally authorised medicinal products - PSUSA/00001731/202011
English (EN) (220.89 KB - PDF)