Busilvex

RSS

busulfan

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 09/02/2022

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
Les Cauquillous
81500 - Lavaur
France

Product information

01/02/2022 Busilvex - EMEA/H/C/000472 - IAIN/0035/G

Product information documents contain:

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.

Assessment history

Changes since initial authorisation of medicine

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