Busulfan Fresenius Kabi
busulfan
Table of contents
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.
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Busulfan Fresenius Kabi : EPAR - Summary for the public (PDF/88.57 KB)
First published: 15/10/2014
Last updated: 21/04/2015 -
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Busulfan Fresenius Kabi : EPAR - Risk-management-plan summary (PDF/158.6 KB)
First published: 15/10/2014
Last updated: 09/10/2019
Authorisation details
Product details | |
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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 and hybrid medicines. |
Publication details | |
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Marketing-authorisation holder |
Fresenius Kabi Deutschland GmbH
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Revision |
6
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Date of issue of marketing authorisation valid throughout the European Union |
22/09/2014
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Contact address |
Product information
20/06/2019 Busulfan Fresenius Kabi - EMEA/H/C/002806 - R/0010
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
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.