Busulfan Fresenius Kabi

Basic Information

Product Name

Regulatory Information

EMA Product Number

EMEA/H/C/002806

Authorization StatusAuthorised

Authorization Issued

September 22, 2014

Opinion Adopted

July 25, 2014

Authorization Revision

Last Updated

May 18, 2021

Drug Classification

Generic Medicine

Active Substances Detail

busulfan

EMA Resources

Risk Management Plan SummaryView Risk Management Plan

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Detailed Information

Therapeutic Indication

### Therapeutic indication Busulfan Fresenius Kabi 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. Busulfan Fresenius Kabi followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.

Overview Summary

This is a summary of the European public assessment report (EPAR) for Busulfan Fresenius Kabi. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Busulfan Fresenius Kabi. For practical information about using Busulfan Fresenius Kabi, patients should read the package leaflet or contact their doctor or pharmacist.