Mozobil

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plerixafor

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

Overview

This is a summary of the European public assessment report (EPAR) for Mozobil. 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 Mozobil.

For practical information about using Mozobil, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 09/08/2019

Authorisation details

Product details
Name
Mozobil
Agency product number
EMEA/H/C/001030
Active substance
Plerixafor
International non-proprietary name (INN) or common name
plerixafor
Therapeutic area (MeSH)
  • Multiple Myeloma
  • Hematopoietic Stem Cell Transplantation
  • Lymphoma
Anatomical therapeutic chemical (ATC) code
L03AX16
OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Genzyme Europe BV
Revision
16
Date of issue of marketing authorisation valid throughout the European Union
30/07/2009
Contact address

Paasheuvelweg 25
1105 BP Amsterdam
The Netherlands

Product information

20/12/2018 Mozobil - EMEA/H/C/001030 - IG/1003

Contents

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

Immunostimulants

Therapeutic indication

Mozobil is indicated in combination with granulocyte-colony-stimulating factor to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma whose cells mobilise poorly.

Assessment history

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