Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Busilvex   
Auth. number : EU/1/03/254
INN : busulfan
Orphan status based on designation EU/3/00/011 added on 11/07/2003
Orphan status based on designation EU/3/00/011 removed or expired on 11/07/2013
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01A - Alkylating agents
Chemical subgroup: L01AB - Alkyl sulphonates
Chemical substance: L01AB01 - Busulfan
(See WHO ATC Index)
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.
Marketing Authorisation Holder: Pierre Fabre Médicament
45 place Abel Gance, F-92654 Boulogne-Billancourt CEDEX, France

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
11/07/2003 Centralised - Authorisation EMEA/H/C/472 (2003)2552 of 09/07/2003
27/10/2003 Centralised - Variation EMEA/H/C/472/I/1
26/07/2004 Centralised - Variation EMEA/H/C/472/IB/3
04/07/2005 Centralised - Variation EMEA/H/C/472/IA/5
31/10/2005 Centralised - Variation EMEA/H/C/472/II/4 (2005)4296 of 27/10/2005
17/04/2007 Centralised - Variation EMEA/H/C/472/IB/7
Updated with Decision(2007)5814 of 22/11/2007
17/04/2007 Centralised - Variation EMEA/H/C/472/IB/6
26/11/2007 Centralised - Variation (2007)5814 of 22/11/2007
06/12/2007 Centralised - Variation EMEA/H/C/472/II/8 (2007)6131 of 04/12/2007
10/07/2008 Centralised - Renewal EMEA/H/C/472/R/9 (2008)3601 of 08/07/2008
08/06/2011 Centralised - Variation EMEA/H/C/472/IB/10
Updated with Decision(2011)5520 of 26/07/2011
28/07/2011 Centralised - Variation EMEA/H/C/472/II/11 (2011)5520 of 26/07/2011
28/11/2011 Referral EMEA/H/C/472/A-20 (2011)8865 of 24/11/2011
31/05/2012 Referral EMEA/H/C/472/A-20/13 (2012)3608 of 25/05/2012
24/07/2012 Centralised - Variation EMEA/H/C/472/II/14, 15 (2012)5275 of 20/07/2012
13/11/2012 Centralised - Variation EMEA/H/C/472/IB/17
Updated with Decision(2013)8700 of 29/11/2013
11/07/2013 Centralised - (orphan status)
03/12/2013 Centralised - Variation (2013)8700 of 29/11/2013
06/12/2013 Centralised - Variation EMEA/H/C/472/IB/20
Updated with Decision(2014)3552 of 22/05/2014
27/05/2014 Centralised - Modification EMEA/H/C/472/PSUSA/464 (2014)3552 of 22/05/2014
28/08/2014 Centralised - Variation EMEA/H/C/472/II/19 (2014)6173 of 26/08/2014