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
- Carbamazepine
- Procedure number
- PSUSA/00000539/202012
- Regulatory outcome
- Variation
Documents
Carbamazepine - List of nationally authorised medicinal products - PSUSA-00000539-202012
English (EN) (290.95 KB - PDF)
Carbamazepine - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA-00000539-202012
English (EN) (139.18 KB - PDF)
български (BG) (171.13 KB - PDF)
español (ES) (149.16 KB - PDF)
čeština (CS) (208.45 KB - PDF)
dansk (DA) (156.77 KB - PDF)
Deutsch (DE) (150.52 KB - PDF)
eesti keel (ET) (143.97 KB - PDF)
ελληνικά (EL) (177.71 KB - PDF)
français (FR) (146.04 KB - PDF)
hrvatski (HR) (177.29 KB - PDF)
íslenska (IS) (143.87 KB - PDF)
italiano (IT) (148.67 KB - PDF)
latviešu valoda (LV) (171.85 KB - PDF)
lietuvių kalba (LT) (169.43 KB - PDF)
magyar (HU) (184.04 KB - PDF)
Malti (MT) (188.49 KB - PDF)
Nederlands (NL) (161.09 KB - PDF)
norsk (NO) (139.03 KB - PDF)
polski (PL) (187.26 KB - PDF)
português (PT) (141.88 KB - PDF)
română (RO) (189.7 KB - PDF)
slovenčina (SK) (171.38 KB - PDF)
slovenščina (SL) (160.31 KB - PDF)
Suomi (FI) (134.62 KB - PDF)
svenska (SV) (140.84 KB - PDF)