Busilvex
busulfan
Table of contents
Overview
The marketing authorisation for Busilvex has been withdrawn at the request of the marketing-authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Busilvex
|
| Agency product number |
EMEA/H/C/000472
|
| 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
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Pierre Fabre Medicament
|
| Revision |
19
|
| Date of issue of marketing authorisation valid throughout the European Union |
09/07/2003
|
| Contact address |
Pierre Fabre Medicament |
Product information
01/02/2022 Busilvex - EMEA/H/C/000472 - IAIN/0035/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic 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.