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
- lomustine
- Procedure number
- PSUSA/00001902/202301
- Regulatory outcome
- Variation
Documents
Lomustine : List of nationally authorised medicinal products - PSUSA/00001902/202301
English (EN) (114.23 KB - PDF)
Lomustine : CMDh Scientific conclusions and grounds for variation, amendments to the ProductInformation and timetable for the implementation - PSUSA/00001902/202301
English (EN) (72.49 KB - PDF)
български (BG) (134.32 KB - PDF)
español (ES) (43.36 KB - PDF)
čeština (CS) (139.93 KB - PDF)
dansk (DA) (45.7 KB - PDF)
Deutsch (DE) (39.9 KB - PDF)
eesti keel (ET) (45.03 KB - PDF)
ελληνικά (EL) (131.11 KB - PDF)
français (FR) (44.77 KB - PDF)
hrvatski (HR) (124.21 KB - PDF)
Gaeilge (GA) (44.75 KB - PDF)
italiano (IT) (59.77 KB - PDF)
latviešu valoda (LV) (135.07 KB - PDF)
lietuvių kalba (LT) (130.25 KB - PDF)
magyar (HU) (128.93 KB - PDF)
Malti (MT) (138.97 KB - PDF)
Nederlands (NL) (45.67 KB - PDF)
polski (PL) (133.97 KB - PDF)
português (PT) (44.52 KB - PDF)
română (RO) (133.27 KB - PDF)
slovenčina (SK) (139.76 KB - PDF)
slovenščina (SL) (131.64 KB - PDF)
Suomi (FI) (43.2 KB - PDF)
svenska (SV) (35.91 KB - PDF)