法规知识库 · EMA 集中审评
Plerixafor Accord
Plerixafor · EMEA/H/C/005943 · 已授权
获批上市许可
2022-12-16
欧委会决定日
2026-07-22
持有人 / 申请人
Accord Healthcare S.L.U.
终止日期字段
无
从产品到官方文件
文件记录
7
官方索引 7
EPAR / 审评
5
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC:L03AX16
治疗领域:Multiple Myeloma;Hematopoietic Stem Cell Transplantation
药理分类:Immunostimulants
修订号:3 · 最新影响 PI 的程序:VR/0000362277
适应症(原文):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).
关键日期时间轴
来自 EMA medicines JSON 日期字段;缺失字段不展示,不补推结论。
2026-07-22 · 欧委会决定
2022-12-16 · 获批上市许可
2022-10-13 · CHMP 意见通过
说明书、EPAR 与其他文件
仅展示 EMA 官方 document_url;本站不下载或镜像 PDF。
EPAR / 审评资料
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Plerixafor Accord : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-07-22
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Plerixafor Accord : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-07-22
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Plerixafor Accord : EPAR - Medicine overview
overview · 2023-02-06 · EMA/851603/2022
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Plerixafor Accord : EPAR - Public assessment report
assessment-report · 2023-02-06 · EMA/889120/2022
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Plerixafor Accord : EPAR - Risk-management-plan summary
rmp-summary · 2023-02-06
数据来自 EMA 官方 JSON;最终以 EMA / 欧委会文件为准。本页不自动给出安全或非安全结论。