法规知识库 · EMA 集中审评
Tamiflu
oseltamivir · EMEA/H/C/000402 · 已授权
获批上市许可
2002-06-20
欧委会决定日
2025-04-15
持有人 / 申请人
Roche Registration GmbH
终止日期字段
无
从产品到官方文件
文件记录
20
官方索引 20
EPAR / 审评
18
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
修订号：43 · 最新影响 PI 的程序：N/0000247267
适应症（原文）：Treatment of influenza Tamiflu is indicated in adults and children including full term neonates who present with symptoms typical of influenza, when influenza virus is circulating in the community. Efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms.Prevention of influenza Post-exposure prevention in individuals one 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 Tamiflu 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. Tamiflu is indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic-influenza outbreak. Tamiflu is not a substitute for influenza vaccination. The use of antivirals for the treatment and prevention of influenza should be determined on the basis of official recommendations. Decisions regarding the use of oseltamivir for treatment and prophylaxis should take into consideration what is known about the characteristics of the circulating influenza viruses, available information on influenza drug susceptibility patterns for each season and the impact of the disease in different geographical areas and patient populations.
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。
2025-04-15 · 欧委会决定
2002-06-20 · 获批上市许可
2002-03-21 · 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
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Tamiflu : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-04-15
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Tamiflu : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2023-03-24
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Tamiflu-H-C-402-II-0142: EPAR - Assessment Report - Variation
variation-report · 2020-04-23 · EMA/114965/2020
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Tamiflu : EPAR - Risk-management-plan summary
rmp-summary · 2020-04-23
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Tamiflu H-C-402-P46-106 : EPAR - Assessment Report
variation-report · 2019-08-12 · EMA/451755/2019
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Tamiflu : EPAR - Medicine overview
overview · 2019-02-07 · EMA/506592/2012
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Tamiflu-H-C-402-P46-105 : EPAR - Assessment Report
variation-report · 2018-05-25 · EMA/229024/2018
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Tamiflu-H-C-402-II-0110-G: EPAR - Assessment Report - Variation
variation-report · 2015-07-31 · EMA/CHMP/186699/2015
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Tamiflu-H-C-402-A20-93 : EPAR - Assessment Report - Article 20
variation-report · 2012-11-21 · EMA/568029/2012
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Tamiflu-H-C-402-R-89 : EPAR - Assessment Report - Renewal
variation-report · 2012-10-04 · EMA/CHMP/104274/2012
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Tamiflu : EPAR - Conditions imposed on member states for safe and effective use
conditions-member-states · 2012-06-14
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Tamiflu H-C-402-II-70 : EPAR - Assessment Report - Variation
variation-report · 2009-12-01
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Tamiflu H-C-402-II-68 : EPAR - Assessment Report - Variation
variation-report · 2009-09-21
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Tamiflu-H-C-402-X-45 : EPAR - Scientific Discussion - Extension
scientific-discussion-variation · 2008-11-10
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Tamiflu-H-C-402-X-44 : EPAR - Scientific Discussion - Extension
scientific-discussion-variation · 2008-11-10
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Tamiflu-H-C-402-II-20 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2006-04-12
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Tamiflu : EPAR - Scientific Discussion
scientific-discussion · 2005-10-21
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Tamiflu : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2005-10-21
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。