Busilvex : EPAR - Summary for the public (PDF/632.03 KB)
First published: 19/09/2008
Last updated: 04/08/2023
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Hematopoietic Stem Cell Transplantation
|Anatomical therapeutic chemical (ATC) code||
Pierre Fabre Medicament
|Date of issue of marketing authorisation valid throughout the European Union||
Pierre Fabre Medicament
01/02/2022 Busilvex - EMEA/H/C/000472 - IAIN/0035/G
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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).
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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.
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