Pharmaceuticals - Community Register

  

Community list of not active orphan medicinal products


EXPIRED  

Product information

Busulfan (Intravenous use)

EU orphan designation number: EU/3/00/011
Active ingredient: Busulfan (Intravenous use)
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 followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.
Sponsor: Pierre Fabre Médicament
45 place Abel Gance, F-92654 Boulogne-Billancourt CEDEX, France
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Busilvex on 09/07/2003 with the number EU/1/03/254

   Public summary of scientific opinion     EPAR

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
29/12/2000 Centralised Orphan - Designation EMEA/OD/024/00 (2000)4259 of 29/12/2000
11/07/2013 Centralised Orphan - Removal of orphan designation from Community Register