Plerixafor Accord



This medicine is authorised for use in the European Union.


Plerixafor Accord 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.

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

The patients who are given Plerixafor Accord are:

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

Plerixafor Accord is a ‘generic medicine’. This means that Plerixafor Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Plerixafor Accord is Mozobil. For more information on generic medicines, see the question-and-answer document here.

Plerixafor Accord contains the active substance plerixafor.

This EPAR was last updated on 07/08/2023

Authorisation details

Product details
Plerixafor Accord
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Multiple Myeloma
  • Hematopoietic Stem Cell Transplantation
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.


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
Marketing-authorisation holder
Accord Healthcare S.L.U.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Accord Healthcare S.L.U.
Edificio Este Planta 6a
World Trade Center
Moll De Barcelona S/n
08039 Barcelona

Product information

07/08/2023 Plerixafor Accord - EMEA/H/C/005943 - IB/0001

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group


Therapeutic indication

Adult patients

Plerixafor Accord 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)

Plerixafor Accord 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).

Assessment history

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