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/00002254/202304
- Regulatory outcome
- Variation
Documents
Oxycodone : List of nationally authorised medicinal products - PSUSA/00002254/202304
English (EN) (472.21 KB - PDF)
Oxycodone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information - PSUSA/00002254/202304and timetable for the implementation
English (EN) (26.33 KB - PDF)
български (BG) (159.34 KB - PDF)
español (ES) (29.66 KB - PDF)
čeština (CS) (150.24 KB - PDF)
dansk (DA) (29.97 KB - PDF)
Deutsch (DE) (30.71 KB - PDF)
eesti keel (ET) (30.41 KB - PDF)
ελληνικά (EL) (149.81 KB - PDF)
français (FR) (29.74 KB - PDF)
hrvatski (HR) (144.52 KB - PDF)
íslenska (IS) (31.05 KB - PDF)
italiano (IT) (31.03 KB - PDF)
latviešu valoda (LV) (143.6 KB - PDF)
lietuvių kalba (LT) (147.98 KB - PDF)
magyar (HU) (150.26 KB - PDF)
Malti (MT) (158.24 KB - PDF)
Nederlands (NL) (31.93 KB - PDF)
norsk (NO) (175.3 KB - PDF)
polski (PL) (153.29 KB - PDF)
português (PT) (29.37 KB - PDF)
română (RO) (146.04 KB - PDF)
slovenčina (SK) (149.47 KB - PDF)
slovenščina (SL) (145.41 KB - PDF)
Suomi (FI) (29.51 KB - PDF)
svenska (SV) (30.21 KB - PDF)