法规知识库 · EMA 集中审评
Ebilfumin
oseltamivir · EMEA/H/C/003717 · 已授权
获批上市许可
2014-05-22
欧委会决定日
2025-09-01
持有人 / 申请人
Actavis Group PTC ehf
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:J05AH02
治疗领域:Influenza, Human
药理分类:Antivirals for systemic use;Neuraminidase inhibitors
修订号:16 · 最新影响 PI 的程序:VR/0000292533
适应症(原文):Treatment of influenzaIn patients one year of age and older who present with symptoms typical of influenza, when influenza virus is circulating in the community. Ebilfumin is indicated for the treatment of infants less than 1 year of age during a pandemic influenza outbreak (see section 5.2 of the SmPC). The treating physician should take into account the pathogenicity of the circulating strain and the underlying condition of the patient to ensure there is a potential benefit to the child. Prevention of influenzaPost-exposure prevention in individuals 1 year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community. The appropriate use of Ebilfumin for prevention of influenza should be determined on a case by case basis by the circumstances and the population requiring protection. In exceptional situations (e.g. in case of a mismatch between the circulating and vaccine virus strains, and a pandemic situation) seasonal prevention could be considered in individuals one year of age or older. Ebilfumin is indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic influenza outbreak (see section 5.2 of the SmPC). Ebilfumin is not a substitute for influenza vaccination.
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。
2025-09-01 · 欧委会决定
2014-05-22 · 获批上市许可
2014-03-20 · 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 ↗
Ebilfumin : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-09-02
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Ebilfumin : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-09-02
- 打开官方文件 ↗
Ebilfumin : EPAR - Risk-management-plan summary
rmp-summary · 2021-12-08 · EMA/186637/2014
- 打开官方文件 ↗
Ebilfumin : EPAR - Summary for the public
overview · 2019-05-27 · EMA/205963/2019
- 打开官方文件 ↗
Ebilfumin : EPAR - Public assessment report
assessment-report · 2014-06-06 · EMA/260303/2014
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。