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法规知识库 · EMA 集中审评

Emtriva

emtricitabine · EMEA/H/C/000533 · 已授权

获批上市许可

2003-10-24

欧委会决定日

2023-04-18

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:J05AF09

治疗领域:HIV Infections

药理分类:Antivirals for systemic use

修订号:33 · 最新影响 PI 的程序:IB/0141

适应症(原文):Emtriva is indicated for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents. This indication is based on studies in treatment-naive patients and treatment-experienced patients with stable virological control. There is no experience of the use of Emtriva in patients who are failing their current regimen or who have failed multiple regimens. When deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the patterns of mutations associated with different medicinal products and the treatment history of the individual patient. Where available, resistance testing may be appropriate.

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。

  1. 2023-04-18 · 欧委会决定

  2. 2003-10-24 · 获批上市许可

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 5产品信息 2其他 0

EPAR / 审评资料

  • Emtriva : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2023-04-18

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  • Emtriva-H-C-533-P46-051 : EPAR - Assessment Report

    variation-report · 2017-12-12 · EMA/815191/2017

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  • Emtriva : EPAR - Summary for the public

    overview · 2016-12-22

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  • Emtriva : EPAR - Scientific Discussion

    scientific-discussion · 2006-08-11

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  • Emtriva : EPAR - Procedural steps taken before authorisation

    procedural-steps-before · 2006-08-11

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产品信息

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。