Busulfan Fresenius Kabi



This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 18/05/2021

Authorisation details

Product details
Busulfan Fresenius Kabi
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Hematopoietic Stem Cell Transplantation
Anatomical therapeutic chemical (ATC) code

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Fresenius Kabi Deutschland GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Else-Kröner-Straße 1,
61352 Bad Homburg v.d.Höhe

Product information

26/04/2021 Busulfan Fresenius Kabi - EMEA/H/C/002806 - IB/0020

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Alkyl sulfonates

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.

Assessment history

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