Busilvex

Withdrawn

This medicine's authorisation has been withdrawn

busulfan

Overview

The marketing authorisation for Busilvex has been withdrawn at the request of the marketing-authorisation holder.

Busilvex : EPAR - Summary for the public

Reference Number: EMA/500878/2014

Product information

Busilvex : EPAR - Product Information

Latest procedure affecting product information: IAIN/0035/G

01/02/2022

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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).

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