法规知识库 · EMA 集中审评
Intelence
Etravirine · EMEA/H/C/000900 · 已授权
获批上市许可
2008-08-28
欧委会决定日
2024-08-08
持有人 / 申请人
Janssen-Cilag International NV
终止日期字段
无
从产品到官方文件
文件记录
12
官方索引 12
EPAR / 审评
10
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：J05AG04
治疗领域：HIV Infections
药理分类：Non-nucleoside reverse transcriptase inhibitors;Antivirals for systemic use
修订号：31 · 最新影响 PI 的程序：N/0070
适应症（原文）：Intelence, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human-immunodeficiency-virus-type-1 (HIV-1) infection in antiretroviral-treatment-experienced adult patients and in antiretroviral-treatment-experienced paediatric patients from six years of age. This indication is based on week-48 analyses from two phase-III trials in highly pretreated patients where Intelence was investigated in combination with an optimised background regimen (OBR) which included darunavir/ritonavir. The indication in paediatric patients is based on 48-week analyses of a single-arm, phase-II trial in antiretroviral-treatment-experienced paediatric patients.
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。
2024-08-08 · 欧委会决定
2008-08-28 · 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
- 打开官方文件 ↗
Intelence: EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2024-08-13
- 打开官方文件 ↗
Intelence : EPAR - Risk-management-plan summary
rmp-summary · 2022-09-16
- 打开官方文件 ↗
Intelence-H-C-900-P46-0054 : EPAR - Assessment Report
variation-report · 2021-08-30 · EMA/475740/2021
- 打开官方文件 ↗
Intelence-H-C-900-P46-053.1 : EPAR - Assessment Report
variation-report · 2021-07-05 · EMA/CHMP/298507/2021
- 打开官方文件 ↗
Intelence-H-C-900-II-0058 : EPAR - Assessment report - Variation
variation-report · 2020-05-15 · EMA/175628/2020
- 打开官方文件 ↗
Intelence : EPAR - Summary for the public
overview · 2020-05-15
- 打开官方文件 ↗
Intelence-H-C-900-PSUV-0033 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2014-02-27 · EMA/88224/2014
- 打开官方文件 ↗
Intelence-H-C-900-P46-0029 : EPAR - Assessment Report
variation-report · 2013-04-10 · EMA/150112/2013
- 打开官方文件 ↗
Intelence-H-C-900-X-0018-G : EPAR - Assessment Report - Extension
variation-report · 2013-04-10 · EMA/CHMP/546580/2012
- 打开官方文件 ↗
Intelence: EPAR - Public assessment report
assessment-report · 2008-09-04
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。