This is a summary of the European public assessment report (EPAR) for Busilvex. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Busilvex.
Busilvex : EPAR - Summary for the public (PDF/76.9 KB)
First published: 19/09/2008
Last updated: 29/09/2014
|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 Médicament
|Date of issue of marketing authorisation valid throughout the European Union||
45, place Abel Gance
92654 Boulogne Billancourt Cedex
22/12/2020 Busilvex - EMEA/H/C/000472 - IAIN/0033
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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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