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
- Hydrochlorothiazide / spironolactone
- Procedure number
- PSUSA/00001662/202101
- Regulatory outcome
- Variation
Documents
Hydrochlorothiazide / spironolactone : List of nationally authorised medicinal products - PSUSA/00001662/202101
English (EN) (105.37 KB - PDF)
Hydrochlorothiazide / spironolactone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001662/202101
English (EN) (92.92 KB - PDF)
български (BG) (127.93 KB - PDF)
español (ES) (111.92 KB - PDF)
čeština (CS) (135.54 KB - PDF)
dansk (DA) (112.65 KB - PDF)
Deutsch (DE) (114.72 KB - PDF)
eesti keel (ET) (108.7 KB - PDF)
ελληνικά (EL) (127.65 KB - PDF)
français (FR) (112.74 KB - PDF)
hrvatski (HR) (136.28 KB - PDF)
italiano (IT) (135.27 KB - PDF)
latviešu valoda (LV) (138.76 KB - PDF)
lietuvių kalba (LT) (111.54 KB - PDF)
magyar (HU) (138.36 KB - PDF)
Malti (MT) (153 KB - PDF)
Nederlands (NL) (113.24 KB - PDF)
polski (PL) (133.73 KB - PDF)
português (PT) (121.82 KB - PDF)
română (RO) (131.7 KB - PDF)
slovenčina (SK) (132.81 KB - PDF)
slovenščina (SL) (126.6 KB - PDF)
Suomi (FI) (109.89 KB - PDF)
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