Busulfan Fresenius Kabi (busulfan)
- Region
- 🇪🇺 EU
- Active substance
- busulfan
- Company
- Fresenius Kabi Deutschland GmbH
- Status
- Authorised
- Therapeutic area
- Hematopoietic Stem Cell Transplantation
- CHMP opinion
- Fri 25 Jul 2014
- EU approval
- Mon 22 Sep 2014
- Designations
- Generic
- Application
- EMEA/H/C/002806
- ATC
- L01AB01
- Official record
- www.ema.europa.eu
Indication
Busulfan Fresenius Kabi followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the combination is considered the best available option. Busulfan Fresenius Kabi followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Busilvex Withdrawn · Pierre Fabre Medicament
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.