法规知识库 · EMA 集中审评
Zarzio
filgrastim · EMEA/H/C/000917 · 已授权
获批上市许可
2009-02-06
欧委会决定日
2026-10-22
持有人 / 申请人
Sandoz GmbH
终止日期字段
无
从产品到官方文件
文件记录
9
官方索引 9
EPAR / 审评
6
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC:L03AA02
治疗领域:Hematopoietic Stem Cell Transplantation;Cancer
药理分类:Immunostimulants
修订号:29 · 最新影响 PI 的程序:VR/0000368044
适应症(原文):Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. Mobilisation of peripheral blood progenitor cells (PBPC). In children and adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ?0.5 x 109/l, and a history of severe or recurrent infections, long term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Treatment of persistent neutropenia (ANC ? 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate.
关键日期时间轴
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2026-10-22 · 欧委会决定
2009-02-06 · 获批上市许可
说明书、EPAR 与其他文件
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EPAR / 审评资料
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Zarzio : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-10-22
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Zarzio : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-06-05
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Zarzio : EPAR - Risk-management-plan summary
rmp-summary · 2023-01-30
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Zarzio - EMEA/H/C/000917 & 918/P46/022 : EPAR - Assessment report
variation-report · 2021-06-24 · EMA/210565/2021
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Zarzio : EPAR - Summary for the public
overview · 2009-02-17
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Zarzio : EPAR - Public assessment report
assessment-report · 2009-02-16
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。