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/00003002/202306
- Regulatory outcome
- Variation
Documents
Tramadol : List of nationally authorised medicinal products - PSUSA/00003002/202306
English (EN) (912.74 KB - PDF)
Tramadol : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - - PSUSA/00003002/202306
English (EN) (322.8 KB - PDF)
español (ES) (375.27 KB - PDF)
čeština (CS) (322.81 KB - PDF)
Deutsch (DE) (257.02 KB - PDF)
ελληνικά (EL) (302.07 KB - PDF)
français (FR) (254.61 KB - PDF)
hrvatski (HR) (316.51 KB - PDF)
íslenska (IS) (293.41 KB - PDF)
italiano (IT) (423.63 KB - PDF)
latviešu valoda (LV) (321.21 KB - PDF)
lietuvių kalba (LT) (912.74 KB - PDF)
magyar (HU) (294.68 KB - PDF)
Malti (MT) (297.21 KB - PDF)
Nederlands (NL) (324.83 KB - PDF)
norsk (NO) (290.07 KB - PDF)
polski (PL) (296.14 KB - PDF)
português (PT) (295.22 KB - PDF)
română (RO) (292.94 KB - PDF)
slovenčina (SK) (323.21 KB - PDF)
Suomi (FI) (241.17 KB - PDF)
svenska (SV) (446.41 KB - PDF)