Plerixafor Accord (plerixafor)
- Region
- 🇪🇺 EU
- Active substance
- plerixafor
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Multiple Myeloma; Hematopoietic Stem Cell Transplantation
- CHMP opinion
- Thu 13 Oct 2022
- EU approval
- Fri 16 Dec 2022
- Designations
- Generic
- Application
- EMEA/H/C/005943
- ATC
- L03AX16
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Mozobil Authorised · Sanofi B.V.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.