欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Plerixafor Accord
适用类别Human
治疗领域Multiple Myeloma; Hematopoietic Stem Cell Transplantation
通用名/非专利名称plerixafor
活性成分Plerixafor
产品号EMEA/H/C/005943
患者安全信息no
授权状态Authorised
ATC编码L03AX16
是否额外监管yes
是否仿制药yes
是否生物类似药no
是否附条件批准no
是否特殊情形no
是否加速审评no
是否罕用药no
批准上市日期2022/12/16
上市许可持有人/公司名称Accord Healthcare S.L.U.
人用药物治疗分组Immunostimulants,
审评意见发布日期2022/10/13
决定日期2023/08/07
修订号1
适应症Adult patientsPlerixafor 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).
首次发布日期2023/02/06
修订日期2023/08/07
产品信息https://www.ema.europa.eu/en/documents/product-information/plerixafor-accord-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/plerixafor-accord
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