PSUSA/00001493/202303 - periodic safety update report single assessment
PSUSAHuman
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/00001493/202303
- Regulatory outcome
- Variation
Documents
Furosemide-spironolactone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001493/202303
Adopted
English (EN) (93.51 KB - PDF)
First published:
български (BG) (219.47 KB - PDF)
First published: 22/12/2023
español (ES) (185.4 KB - PDF)
First published: 22/12/2023
čeština (CS) (132.45 KB - PDF)
First published: 22/12/2023
dansk (DA) (156.67 KB - PDF)
First published: 22/12/2023
Deutsch (DE) (146.77 KB - PDF)
First published: 22/12/2023
eesti keel (ET) (43.81 KB - PDF)
First published: 22/12/2023
ελληνικά (EL) (112.92 KB - PDF)
First published: 22/12/2023
français (FR) (145.39 KB - PDF)
First published: 22/12/2023
hrvatski (HR) (162.37 KB - PDF)
First published: 22/12/2023
íslenska (IS) (152.35 KB - PDF)
First published: 22/12/2023
italiano (IT) (170.94 KB - PDF)
First published: 22/12/2023
latviešu valoda (LV) (108.85 KB - PDF)
First published: 22/12/2023
lietuvių kalba (LT) (110.47 KB - PDF)
First published: 22/12/2023
magyar (HU) (146.65 KB - PDF)
First published: 22/12/2023
Malti (MT) (182.78 KB - PDF)
First published: 22/12/2023
Nederlands (NL) (83.86 KB - PDF)
First published: 22/12/2023
norsk (NO) (83 KB - PDF)
First published: 22/12/2023
polski (PL) (78.75 KB - PDF)
First published: 22/12/2023
português (PT) (155.68 KB - PDF)
First published: 22/12/2023
română (RO) (216.83 KB - PDF)
First published: 22/12/2023
slovenčina (SK) (85 KB - PDF)
First published: 22/12/2023
slovenščina (SL) (78.79 KB - PDF)
First published: 22/12/2023
Suomi (FI) (91.63 KB - PDF)
First published: 22/12/2023
svenska (SV) (155.79 KB - PDF)
First published: 22/12/2023
Furosemide-spironolactone : List of nationally authorised medicinal products - PSUSA/00001493/202303
Reference Number: EMA/PRAC/464397/2023
English (EN) (179.78 KB - PDF)
First published: