Busulfan Fresenius Kabi

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busulfan

Authorised
This medicine is authorised for use in the European Union.

Overview

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 12/06/2018

Authorisation details

Product details
Name
Busulfan Fresenius Kabi
Agency product number
EMEA/H/C/002806
Active substance
busulfan
International non-proprietary name (INN) or common name
busulfan
Therapeutic area (MeSH)
Hematopoietic Stem Cell Transplantation
Anatomical therapeutic chemical (ATC) code
L01AB01
Generic

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 medicines.

Publication details
Marketing-authorisation holder
Fresenius Kabi Deutschland GmbH
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
22/09/2014
Contact address
Else-Kröner-Straße 1,
61352 Bad Homburg v.d.Höhe
Germany

Product information

08/05/2018 Busulfan Fresenius Kabi - EMEA/H/C/002806 - T/0008

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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