法规知识库 · EMA 集中审评
Emtricitabine/Tenofovir disoproxil Mylan
emtricitabine;tenofovir disoproxil maleate · EMEA/H/C/004050 · 已授权
获批上市许可
2016-12-16
欧委会决定日
2026-08-25
持有人 / 申请人
Mylan Pharmaceuticals Limited
终止日期字段
无
从产品到官方文件
文件记录
9
官方索引 9
EPAR / 审评
6
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：J05AR03
治疗领域：HIV Infections
药理分类：Antivirals for systemic use
修订号：19 · 最新影响 PI 的程序：VR/0000357199
适应症（原文）：Treatment of HIV-1 infection: Emtricitabine/Tenofovir disoproxil Mylan is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults (see section 5.1). Emtricitabine/Tenofovir disoproxil Mylan is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, (see sections 4.2, 4.4 and 5.1). Pre-exposure prophylaxis (PrEP): Emtricitabine/Tenofovir disoproxil Mylan is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents at high risk (see sections 4.2, 4.4 and 5.1).
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。
2026-08-25 · 欧委会决定
2016-12-16 · 获批上市许可
2016-10-13 · 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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Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-09-03
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Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Risk Management Plan
rmp-summary · 2026-09-03
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Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2023-12-05
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Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Risk-management-plan summary
rmp-summary · 2023-07-27
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Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Summary for the public
overview · 2019-07-12 · EMA/693101/2016
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Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Public assessment report
assessment-report · 2017-02-03 · EMA/CHMP/636453/2016
产品信息
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Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Product information
product-information · 2026-09-03
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Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Product information - tracked changes
product-information-tracked-changes · 2026-06-12
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Emtricitabine / Tenofovir disoproxil Mylan : EPAR - All Authorised presentations
all-authorised-presentations · 2023-12-05
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。