法规知识库 · EMA 集中审评
Filgrastim ratiopharm
filgrastim · EMEA/H/C/000824 · 已撤市
获批上市许可
2008-09-15
欧委会决定日
2011-04-20
持有人 / 申请人
Ratiopharm GmbH
终止日期字段
2011-04-20
从产品到官方文件
文件记录
5
官方索引 5
EPAR / 审评
3
assessment / overview 等
产品信息
2
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:1 · 最新影响 PI 的程序:IB/0001/G
适应症(原文):Filgrastim ratiopharm 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 filgrastim are similar in adults and children receiving cytotoxic chemotherapy. Filgrastim ratiopharm is indicated for the mobilisation of peripheral blood progenitor cells (PBPC). 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 Filgrastim ratiopharm is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Filgrastim ratiopharm 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。
2011-04-20 · 欧委会决定
2011-04-20 · 上市许可终止(撤市/失效/撤销等)
Withdrawn
2008-09-15 · 获批上市许可
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 ↗
Filgrastim ratiopharm : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2011-07-20
- 打开官方文件 ↗
Filgrastim ratiopharm : EPAR - Summary for the public
overview · 2011-07-20
- 打开官方文件 ↗
Filgrastim ratiopharm : EPAR - Public assessment report
assessment-report · 2011-07-20
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。