EU/3/00/011: Orphan designation for the conditioning treatment prior to haematopoietic-progenitor-cell transplantation


Table of contents


Please note that this product was withdrawn from the Community register of designated orphan medicinal products in July 2013 at the end of the period of market exclusivity.

On 29 December 2001, orphan designation (EU/3/00/011) was granted by the European Commission to Pierre Fabre Médicament, France, for busulfan (intravenous use) for the conditioning treatment prior to haematopoietic-progenitor-cell transplantation.

Busulfan (intravenous use) has been authorised in the EU as Busilvex since 9 July 2003.

For a list of the administrative updates to this public summary of opinion, please refer to the PDF document below.

Key facts

Active substance
Medicine name
Intended use
Conditioning treatment prior to haematopoietic-progenitor-cell transplantation
Orphan designation status
EU designation number
Date of designation
Pierre Fabre Médicament
45 place Abel Gance
92654 Boulogne Cedex
Tel. +33 1 49 10 80 00
Fax + 33 1 49 10 96 93

Documents related to this orphan designation evaluation

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

EU register of orphan medicines

The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

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