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Busilvex (busulfan)

Region

🇪🇺 EU

Active substance

busulfan

Company

Pierre Fabre Medicament

Status

Withdrawn

Therapeutic area

Hematopoietic Stem Cell Transplantation

CHMP opinion

Wed 19 Mar 2003

EU approval

Wed 09 Jul 2003

Application

EMEA/H/C/000472

ATC

L01AB01

Official record

www.ema.europa.eu

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.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

• 🇪🇺 Busulfan Fresenius Kabi Authorised · Fresenius Kabi Deutschland GmbH

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.