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
- Busulfan
- Procedure number
- PSUSA/0464/201907
- Regulatory outcome
- Variation
Documents
Busulfan: List of nationally authorised medicinal products - PSUSA/0464/201907
English (EN) (136.27 KB - PDF)
Busulfan: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/0464/201907
English (EN) (107.9 KB - PDF)
български (BG) (122.54 KB - PDF)
español (ES) (96.96 KB - PDF)
čeština (CS) (221.85 KB - PDF)
dansk (DA) (109.73 KB - PDF)
Deutsch (DE) (99.6 KB - PDF)
eesti keel (ET) (105.2 KB - PDF)
ελληνικά (EL) (124.45 KB - PDF)
français (FR) (104.25 KB - PDF)
hrvatski (HR) (223.11 KB - PDF)
íslenska (IS) (144.25 KB - PDF)
italiano (IT) (96.76 KB - PDF)
latviešu valoda (LV) (119.89 KB - PDF)
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magyar (HU) (113.66 KB - PDF)
Malti (MT) (113.95 KB - PDF)
Nederlands (NL) (96.17 KB - PDF)
norsk (NO) (94.42 KB - PDF)
polski (PL) (118.16 KB - PDF)
português (PT) (96.5 KB - PDF)
română (RO) (114.04 KB - PDF)
slovenčina (SK) (188.95 KB - PDF)
slovenščina (SL) (110.45 KB - PDF)
Suomi (FI) (109.72 KB - PDF)
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