法规知识库 · EMA 集中审评
Telzir
fosamprenavir calcium · EMEA/H/C/000534 · 已撤市
获批上市许可
2004-07-12
欧委会决定日
2022-08-19
持有人 / 申请人
ViiV Healthcare BV
终止日期字段
2025-11-21
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：J05AE07
治疗领域：HIV Infections
药理分类：Antivirals for systemic use
修订号：48 · 最新影响 PI 的程序：IG1531
适应症（原文）：Telzir in combination with low-dose ritonavir is indicated for the treatment of human-immunodeficiency-virus-type-1-infected adults, adolescents and children of six years and above in combination with other antiretroviral medicinal products. In moderately antiretroviral-experienced adults, Telzir in combination with low-dose ritonavir has not been shown to be as effective as lopinavir / ritonavir. No comparative studies have been undertaken in children or adolescents. In heavily pretreated patients, the use of Telzir in combination with low-dose ritonavir has not been sufficiently studied. In protease-inhibitor-experienced patients, the choice of Telzir should be based on individual viral resistance testing and treatment history.
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。
2025-11-21 · 上市许可终止（撤市/失效/撤销等）
Withdrawn
2022-08-19 · 欧委会决定
2004-07-12 · 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 ↗
Telzir-H-C-534-P46-0075 : EPAR - Assessment Report
variation-report · 2026-01-05 · EMA/642265/2014
- 打开官方文件 ↗
Telzir-H-C-534-II-0074 : EPAR - Assessment Report - Variation
variation-report · 2026-01-05 · EMA/339053/2014
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Telzir-H-C-534-P46-0060 : EPAR - Assessment Report
variation-report · 2026-01-05 · EMA/131182/2013
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Telzir-H-C-534-II-0058 : EPAR - Assessment Report - Variation
variation-report · 2026-01-05
- 打开官方文件 ↗
Telzir : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-01-05
- 打开官方文件 ↗
Telzir : EPAR - Medicine overview
overview · 2026-01-05
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Telzir-H-C-534-II-0041 : EPAR - Assessment Report - Variation
variation-report · 2026-01-05 · EMEA/CHMP/182021/2009
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Telzir-H-C-534-II-0018 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2026-01-05
- 打开官方文件 ↗
Telzir : EPAR - Scientific Discussion
scientific-discussion · 2026-01-05
- 打开官方文件 ↗
Telzir : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2026-01-05
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。