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
- Deoxycholic acid
- Procedure number
- PSUSA/00010525/202004
- Regulatory outcome
- Variation
Documents
Deoxycholic acid: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010525/202004
English (EN) (80.32 KB - PDF)
български (BG) (183.85 KB - PDF)
español (ES) (82.34 KB - PDF)
čeština (CS) (159.38 KB - PDF)
dansk (DA) (80.18 KB - PDF)
Deutsch (DE) (83.22 KB - PDF)
eesti keel (ET) (83.96 KB - PDF)
ελληνικά (EL) (184.37 KB - PDF)
français (FR) (82.46 KB - PDF)
hrvatski (HR) (180.89 KB - PDF)
íslenska (IS) (78.98 KB - PDF)
italiano (IT) (83.23 KB - PDF)
latviešu valoda (LV) (177.4 KB - PDF)
lietuvių kalba (LT) (177.24 KB - PDF)
magyar (HU) (154.09 KB - PDF)
Malti (MT) (183.81 KB - PDF)
Nederlands (NL) (82.96 KB - PDF)
norsk (NO) (80.63 KB - PDF)
polski (PL) (181.13 KB - PDF)
português (PT) (81.07 KB - PDF)
română (RO) (174.96 KB - PDF)
slovenčina (SK) (157.58 KB - PDF)
slovenščina (SL) (124.25 KB - PDF)
Suomi (FI) (81.72 KB - PDF)
svenska (SV) (81.75 KB - PDF)
Deoxycholic acid: List of nationally authorised medicinal products - PSUSA/00010525/202004
English (EN) (173.45 KB - PDF)