法规知识库 · EMA 集中审评
Grastofil
filgrastim · EMEA/H/C/002150 · 已撤市
获批上市许可
2013-10-18
欧委会决定日
2021-12-22
持有人 / 申请人
Accord Healthcare S.L.U.
终止日期字段
2025-01-13
从产品到官方文件
文件记录
6
官方索引 6
EPAR / 审评
4
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC:L03AA02
治疗领域:—
药理分类:Immunostimulants
修订号:14 · 最新影响 PI 的程序:N/0039
适应症(原文):Grastofil 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 Grastofil are similar in adults and children receiving cytotoxic chemotherapy. Grastofil 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 Grastofil is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Grastofil is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 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。
2025-01-13 · 上市许可终止(撤市/失效/撤销等)
Withdrawn
2021-12-22 · 欧委会决定
2013-10-18 · 获批上市许可
2003-07-25 · 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
- 打开官方文件 ↗
Grastofil : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2023-08-31
- 打开官方文件 ↗
Grastofil : EPAR - Risk-management-plan summary
rmp-summary · 2020-06-29
- 打开官方文件 ↗
Grastofil : EPAR - Medicine overview
overview · 2018-11-12 · EMA/569200/2018
- 打开官方文件 ↗
Grastofil : EPAR - Public assessment report
assessment-report · 2013-11-11 · EMEA/CHMP/303037/2013
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。