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
- oxycodone hydrochloride / paracetamol
- Procedure number
- PSUSA/00002256/202307
- Regulatory outcome
- Variation
Documents
Oxycodone hydrochloride / paracetamol : List of nationally authorised medicinal products - PSUSA/00002256/202307
English (EN) (124.61 KB - PDF)
Oxycodone hydrochloride / paracetamol : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002256/202307
English (EN) (122.41 KB - PDF)
български (BG) (145.98 KB - PDF)
español (ES) (108.03 KB - PDF)
čeština (CS) (135.98 KB - PDF)
dansk (DA) (107.32 KB - PDF)
Deutsch (DE) (114.95 KB - PDF)
eesti keel (ET) (103.29 KB - PDF)
ελληνικά (EL) (135.97 KB - PDF)
français (FR) (111.39 KB - PDF)
hrvatski (HR) (139.89 KB - PDF)
italiano (IT) (110.8 KB - PDF)
latviešu valoda (LV) (141.06 KB - PDF)
lietuvių kalba (LT) (150.68 KB - PDF)
magyar (HU) (147.38 KB - PDF)
Malti (MT) (144.25 KB - PDF)
Nederlands (NL) (110.4 KB - PDF)
polski (PL) (144.61 KB - PDF)
português (PT) (109.1 KB - PDF)
română (RO) (142.35 KB - PDF)
slovenščina (SL) (124.66 KB - PDF)
Suomi (FI) (103.9 KB - PDF)