法规知识库 · EMA 集中审评
Atripla
efavirenz;emtricitabine;tenofovir disoproxil fumarate · EMEA/H/C/000797 · 已撤市
获批上市许可
2007-12-13
欧委会决定日
2021-08-17
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
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:J05AR06
治疗领域:HIV Infections
药理分类:Antivirals for systemic use
修订号:36 · 最新影响 PI 的程序:IB/0150
适应症(原文):Atripla is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil fumarate. It is indicated for the treatment of human-immunodeficiency-virus-1 (HIV-1) infection in adults with virologic suppression to HIV-1 RNA levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in Atripla prior to initiation of their first antiretroviral treatment regimen. The demonstration of the benefit of Atripla is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to Atripla. No data are currently available from clinical studies with Atripla in treatment-naive or in heavily pretreated patients. No data are available to support the combination of Atripla and other antiretroviral agents.
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。
2021-08-17 · 欧委会决定
2007-12-13 · 获批上市许可
说明书、EPAR 与其他文件
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EPAR / 审评资料
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Atripla : EPAR - Risk-management-plan summary
rmp-summary · 2022-01-21
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Atripla : EPAR - Medicine overview
overview · 2022-01-21
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Atripla : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2022-01-21
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Atripla : EPAR - Scientific Discussion
scientific-discussion · 2022-01-21
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Atripla : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2022-01-21
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。