Mozobil

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plerixafor

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

Overview

Mozobil is a medicine used to mobilise blood stem cells from a patient’s bone marrow so that they can be collected and used later for transplantation in the same patient.

Mozobil is used together with the hormone granulocyte-colony stimulating factor (G-CSF) and is only for patients in whom collection of stem cells is difficult.

The patients who are given Mozobil are:

  • adults with lymphoma or multiple myeloma (types of blood cancer);
  • children from 1 year of age who have lymphoma or solid tumours. 

Mozobil contains the active substance plerixafor.

The number of patients that need mobilisation and collection of haematopoietic stem cells for transplantation is low and Mozobil was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 20 October 2004. For further information on the orphan designation, see EU/3/04/227.

This EPAR was last updated on 02/09/2019

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
17
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

13/05/2019 Mozobil - EMEA/H/C/001030 - II/0034

Contents

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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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