Overview
The marketing authorisation for Busilvex has been withdrawn at the request of the marketing-authorisation holder.
Product information
Latest procedure affecting product information: IAIN/0035/G
01/02/2022
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Busilvex
- Active substance
- busulfan
- International non-proprietary name (INN) or common name
- busulfan
- Therapeutic area (MeSH)
- Hematopoietic Stem Cell Transplantation
- Anatomical therapeutic chemical (ATC) code
- L01AB01
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Busilvex 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.
Busilvex following fludarabine (FB) is indicated as conditioning treatment prior to haematopoietic progenitor cell transplantation (HPCT) in adult patients who are candidates for a reduced-intensity conditioning (RIC) regimen.
Busilvex followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.