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EMA Product

Plerixafor Accord

Product approved by European Medicines Agency (EU)

Basic Information

Plerixafor Accord

Regulatory Information

EMEA/H/C/005943

Authorised

December 16, 2022

October 13, 2022

2

May 13, 2024

Company Information

Spain

Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona

ACCORD HEALTHCARE SL

Drug Classification

Generic Medicine

Active Substances Detail

Detailed Information

Therapeutic Indication

### 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).

Overview Summary

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](https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-generic-medicines_en.pdf). Plerixafor Accord contains the active substance plerixafor.

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