Busilvex

Withdrawn

This medicine's authorisation has been withdrawn

busulfan

Overview

On 9 January 2023, the European Commission withdrew the marketing authorisation for Busilvex (busulfan) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Pierre Fabre Medicament, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Busilvex was granted marketing authorisation in the EU on 9 July 2003 for use as a conditioning treatment prior to haematopoietic progenitor cell transplantation. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2008. 

There are generic medicinal products of Busilvex authorised and marketed in the EU. 

The European Public Assessment Report (EPAR) for Busilvex is updated to indicate that the marketing authorisation is no longer valid.

Busilvex : EPAR - Summary for the public

Reference Number: EMA/500878/2014

Product information

Busilvex : EPAR - Product Information

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 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.

Authorisation details

• EMA product number:
  EMEA/H/C/000472
• Marketing authorisation holder:
  Pierre Fabre Medicament

  Les Cauquillous; 81500 - Lavaur; France

• Opinion adopted:
  19/03/2003
• Marketing authorisation issued:
  09/07/2003
• Revision:
  19

Assessment history

Changes since initial authorisation of medicine

Busilvex : EPAR - Procedural steps taken and scientific information after authorisation

Busilvex-H-C-PSUSA-00000464-201607 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/566488/2017

Busilvex-H-C-472-II-019 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/550530/2014

CHMP post-authorisation summary of positive opinion for Busilvex

AdoptedReference Number: EMA/CHMP/450097/2014

Busilvex-H-C-PSUSA-0464 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Busilvex-H-C-472-A20-13 : EPAR - Assessment Report - Article 20

AdoptedReference Number: EMA/303399/2012

Busilvex-H-C-472-II-04 : EPAR - Scientific Discussion - Variation

Adopted

Initial marketing authorisation documents

Busilvex : EPAR - Scientific Discussion

Busilvex : EPAR - Procedural steps taken before authorisation