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
- Dexketoprofen / tramadol
- Procedure number
- PSUSA/00010468/202201
- Regulatory outcome
- Variation
Documents
Dexketoprofen / tramadol - List of nationally authorised medicinal products - PSUSA/00010468/202201
English (EN) (325.71 KB - PDF)
Dexketoprofen / tramadol - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) - PSUSA/00010468/202201
English (EN) (139.71 KB - PDF)
български (BG) (216.34 KB - PDF)
español (ES) (141.65 KB - PDF)
čeština (CS) (246.22 KB - PDF)
dansk (DA) (137.38 KB - PDF)
Deutsch (DE) (145.38 KB - PDF)
eesti keel (ET) (134.01 KB - PDF)
ελληνικά (EL) (215.74 KB - PDF)
français (FR) (168.31 KB - PDF)
Gaeilge (IE) (140.2 KB - PDF)
hrvatski (HR) (258.86 KB - PDF)
italiano (IT) (159.9 KB - PDF)
latviešu valoda (LV) (279.82 KB - PDF)
lietuvių kalba (LT) (284.42 KB - PDF)
magyar (HU) (219.26 KB - PDF)
Malti (MT) (241.9 KB - PDF)
Nederlands (NL) (139.83 KB - PDF)
polski (PL) (227.98 KB - PDF)
português (PT) (142.78 KB - PDF)
română (RO) (225.22 KB - PDF)
slovenčina (SK) (250.38 KB - PDF)
slovenščina (SL) (206.44 KB - PDF)
Suomi (FI) (138.76 KB - PDF)
svenska (SV) (138.46 KB - PDF)