跳到正文

法规知识库 · EMA 集中审评

Aptivus

tipranavir · EMEA/H/C/000631 · 已授权

获批上市许可

2005-10-25

欧委会决定日

2026-04-23

持有人 / 申请人

Boehringer Ingelheim International GmbH

终止日期字段

无

从产品到官方文件

文件记录

11

官方索引 11

EPAR / 审评

9

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:J05AE09

治疗领域:HIV Infections

药理分类:Antivirals for systemic use

修订号:44 · 最新影响 PI 的程序:N/0000342540

适应症(原文):Aptivus, co-administered with low-dose ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infection in highly pretreated adults and adolescents 12 years of age or older with virus resistant to multiple protease inhibitors. Aptivus should only be used as part of an active combination antiretroviral regimen in patients with no other therapeutic options. This indication is based on the results of two phase-III studies, performed in highly pretreated adult patients (median number of 12 prior antiretroviral agents) with virus resistant to protease inhibitors and of one phase-II study investigating pharmacokinetics, safety and efficacy of Aptivus in mostly treatment-experienced adolescent patients aged 12 to 18 years. In deciding to initiate treatment with Aptivus, co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of Aptivus. Initiation of treatment should take into account the combinations of mutations which may negatively impact the virological response to Aptivus, co-administered with low-dose ritonavir.

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. 2026-04-23 · 欧委会决定

  2. 2005-10-25 · 获批上市许可

  3. 2005-07-27 · 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 9产品信息 2其他 0

EPAR / 审评资料

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

    procedural-steps-after · 2026-04-23

    打开官方文件 ↗
  • Aptivus : EPAR - Procedural steps taken and scientific information after authorisation (archive)

    procedural-steps-after · 2026-04-23

    打开官方文件 ↗
  • Aptivus : EPAR - Summary for the public

    overview · 2014-08-27

    打开官方文件 ↗
  • Aptivus-H-C-631-II-60 : EPAR - Assessment Report - Variation

    variation-report · 2014-02-04 · EMA/CHMP/40711/2014

    打开官方文件 ↗
  • Aptivus-H-C-631-II-49-G : EPAR - Assessment Report - Variation

    variation-report · 2011-08-02 · EMA/567400/2011

    打开官方文件 ↗
  • Aptivus-H-C-631-II-29 : EPAR - Assessment Report - Variation

    variation-report · 2009-07-16

    打开官方文件 ↗
  • Aptivus-H-C-631-X-30 : EPAR - Assessment Report - Extension

    variation-report · 2009-07-16

    打开官方文件 ↗
  • Aptivus : EPAR - Scientific Discussion

    scientific-discussion · 2005-11-04

    打开官方文件 ↗
  • Aptivus : EPAR - Procedural steps taken before authorisation

    procedural-steps-before · 2005-11-04

    打开官方文件 ↗

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。