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法规知识库 · EMA 集中审评

Fuzeon

enfuvirtide · EMEA/H/C/000514 · 已授权

获批上市许可

2003-05-27

欧委会决定日

2023-10-16

持有人 / 申请人

Roche Registration GmbH

终止日期字段

无

从产品到官方文件

文件记录

8

官方索引 8

EPAR / 审评

6

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:J05AX07

治疗领域:HIV Infections

药理分类:Antivirals for systemic use

修订号:25 · 最新影响 PI 的程序:IB/0065

适应症(原文):Fuzeon is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following antiretroviral classes: protease inhibitors, non-nucleoside reverse-transcriptase inhibitors and nucleoside reverse-transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens. In deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different medicinal products. 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. 2023-10-16 · 欧委会决定

  2. 2003-05-27 · 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 6产品信息 2其他 0

EPAR / 审评资料

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

    procedural-steps-after · 2024-02-23

    打开官方文件 ↗
  • Fuzeon-H-C-PSUSA-00001217-201503 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

    scientific-conclusion · 2016-01-18 · EMA/816421/2015

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

    overview · 2008-10-24

    打开官方文件 ↗
  • Fuzeon : EPAR - Steps taken after authorisation when a cutoff date has been used

    steps-after-cutoff · 2006-08-11

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

    procedural-steps-before · 2006-08-11

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

    scientific-discussion · 2006-08-11

    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。