Mozobil

plerixafor

Opinion

On 28 March 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Mozobil. The marketing authorisation holder for this medicinal product is Genzyme Europe BV.

The CHMP adopted an extension to the existing indication as follows:1

Adult patients

Mozobil is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly (see section 4.2).

Paediatric patients (1 to less than 18 years)

Mozobil is indicated in combination with G-CSF to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either:

  • pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with G-CSF (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or
  • who previously failed to collect sufficient haematopoietic stem cells (see section 4.2).

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1 New text in bold

Key facts

Name
Mozobil
Agency product number
EMEA/H/C/001030
International non-proprietary name (INN) or common name
  • plerixafor
Active substance
  • Plerixafor
Therapeutic area
Multiple Myeloma
Hematopoietic Stem Cell Transplantation
Lymphoma
Orphan

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.

Date opinion adopted
28/03/2019
Company name
Genzyme Europe B.V.
Status
Positive
Application type
Post-authorisation

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