Plerixafor Accord
plerixafor
Table of contents
Overview
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.
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List item
Plerixafor Accord : EPAR - Medicine overview (PDF/167.1 KB)
First published: 06/02/2023
EMA/851603/2022 -
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Plerixafor Accord : EPAR - Risk-management-plan summary (PDF/102.56 KB)
First published: 06/02/2023
Authorisation details
Product details | |
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Name |
Plerixafor Accord
|
Agency product number |
EMEA/H/C/005943
|
Active substance |
Plerixafor
|
International non-proprietary name (INN) or common name |
plerixafor
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L03AX16
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Additional 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. |
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 |
Accord Healthcare S.L.U.
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Revision |
1
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Date of issue of marketing authorisation valid throughout the European Union |
16/12/2022
|
Contact address |
Accord Healthcare S.L.U. |
Product information
07/08/2023 Plerixafor Accord - EMEA/H/C/005943 - IB/0001
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
Immunostimulants
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).