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
- Levomethadone
- Procedure number
- PSUSA/00001855/202205
- Regulatory outcome
- Variation
Documents
Levomethadone - List of nationally authorised medicinal products - PSUSA/00001855/202205
English (EN) (234.65 KB - PDF)
Levomethadone - CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001855/202205
English (EN) (171.84 KB - PDF)
български (BG) (154.56 KB - PDF)
español (ES) (132.11 KB - PDF)
čeština (CS) (154.17 KB - PDF)
dansk (DA) (152.64 KB - PDF)
Deutsch (DE) (202.03 KB - PDF)
ελληνικά (EL) (190.6 KB - PDF)
français (FR) (155.9 KB - PDF)
hrvatski (HR) (145.77 KB - PDF)
íslenska (IS) (136.14 KB - PDF)
italiano (IT) (155 KB - PDF)
latviešu valoda (LV) (172.4 KB - PDF)
lietuvių kalba (LT) (227.89 KB - PDF)
magyar (HU) (229.36 KB - PDF)
Malti (MT) (185.5 KB - PDF)
Nederlands (NL) (139.93 KB - PDF)
norsk (NO) (119.21 KB - PDF)
polski (PL) (157.07 KB - PDF)
português (PT) (153.6 KB - PDF)
română (RO) (169.41 KB - PDF)
slovenčina (SK) (219.35 KB - PDF)
slovenščina (SL) (195.39 KB - PDF)
Suomi (FI) (151.83 KB - PDF)
svenska (SV) (136.74 KB - PDF)