法规知识库 · EMA 集中审评
Truvada
emtricitabine;tenofovir disoproxil fumarate · EMEA/H/C/000594 · 已授权
获批上市许可
2005-02-20
欧委会决定日
2024-02-16
持有人 / 申请人
Gilead Sciences Ireland UC
终止日期字段
无
从产品到官方文件
文件记录
14
官方索引 14
EPAR / 审评
12
assessment / overview 等
产品信息
2
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：49 · 最新影响 PI 的程序：PSUSA/1210/202304
适应症（原文）：Treatment of HIV-1 infection: Truvada is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults. Truvada is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years. Pre-exposure prophylaxis (PrEP): Truvada is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.
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。
2024-02-16 · 欧委会决定
2005-02-20 · 获批上市许可
2004-11-18 · 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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Truvada : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-11-18
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Truvada : EPAR - Risk management plan
rmp · 2025-11-18
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Truvada : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-11-18
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Truvada-H-C-PSUSA-00001210-202304 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2024-02-29 · EMA/91628/2024
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Truvada : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2021-03-31 · EMA/190145/2021
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Truvada-H-C-594-II-0135 : EPAR - Assessment Report - Variation
variation-report · 2018-03-14 · EMA/10650/2018
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Truvada : EPAR - Paediatric investigation plan compliance statement
pip-compliance · 2018-03-14 · EMA/801777/2017
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Truvada : EPAR - Medicine overview
overview · 2018-03-14
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Truvada-H-C-594-II-0131 : EPAR - Assessment Report - Variation
variation-report · 2017-04-24 · EMA/169793/2017
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Truvada-H-C-594-II-0126 : EPAR - Assessment Report - Variation
variation-report · 2016-09-14
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Truvada : EPAR - Scientific Discussion
scientific-discussion · 2005-11-23
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Truvada : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2005-11-23
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。