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法规知识库 · EMA 集中审评

Zefylti

filgrastim · EMEA/H/C/006400 · 已授权

生物类似药额外监测

获批上市许可

2025-02-12

欧委会决定日

2026-06-12

持有人 / 申请人

CuraTeQ Biologics (Malta) Limited

终止日期字段

无

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assessment / overview 等

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PI / presentations

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RMP / PIP 等

ATC:L03AA02

治疗领域:Neutropenia;Hematopoietic Stem Cell Transplantation;Cancer

药理分类:Immunostimulants

修订号:3 · 最新影响 PI 的程序:T/0000344196

适应症(原文):Zefylti is indicated for the 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 for the 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 Zefylti are similar in adults and children receiving cytotoxic chemotherapy. Zefylti is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs). In patients, children or 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 Zefylti is indicated to increase neutrophil counts and to reduce the incidence and duration of infection related events. Zefylti is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1 x 109/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

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。

  1. 2026-06-12 · 欧委会决定

  2. 2025-02-12 · 获批上市许可

  3. 2024-12-12 · CHMP 意见通过

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