法规知识库 · EMA 集中审评
Trizivir
abacavir (as sulfate);lamivudine;zidovudine · EMEA/H/C/000338 · 已撤市
获批上市许可
2000-12-27
欧委会决定日
2026-01-15
持有人 / 申请人
ViiV Healthcare BV
终止日期字段
2026-10-23
从产品到官方文件
文件记录
10
官方索引 10
EPAR / 审评
7
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC:J05AR04
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:VR/0000296309
适应症(原文):Trizivir is indicated for the treatment of human-immunodeficiency-virus (HIV) infection in adults. This fixed combination replaces the three components (abacavir, lamivudine and zidovudine) used separately in similar dosages. It is recommended that treatment is started with abacavir, lamivudine,and zidovudine separately for the first six to eight weeks. The choice of this fixed combination should be based not only on potential adherence criteria, but mainly on expected efficacy and risk related to the three nucleoside analogues. The demonstration of the benefit of Trizivir is mainly based on results of studies performed in treatment naive patients or moderately antiretroviral experienced patients with non-advanced disease. In patients with high viral load (>100,000 copies/ml) choice of therapy needs special consideration. Overall, the virologic suppression with this triple nucleoside regimen could be inferior to that obtained with other multitherapies notably including boosted protease inhibitors or non-nucleoside reverse-transcriptase inhibitors, therefore the use of Trizivir should only be considered under special circumstances (e.g. co-infection with tuberculosis). Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin. Screening is also recommended prior to re-initiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir (see 'management after an interruption of Trizivir therapy'). Abacavir should not be used in patients known to carry the HLA-B*5701 allele, unless no other therapeutic option is available in these patients, based on the treatment history and resistance testing.
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。
2026-10-23 · 上市许可终止(撤市/失效/撤销等)
Withdrawn
2026-01-15 · 欧委会决定
2000-12-27 · 获批上市许可
2000-09-21 · 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
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Trizivir : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-11-09
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Trizivir-H-C-PSUSA-00003144-202212 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2026-11-09 · EMA/395778/2023
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Trizivir : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-11-09
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Trizivir : EPAR - Summary for the public
overview · 2026-11-09 · EMA/197378/2020
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Trizivir : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2026-11-09
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Trizivir : EPAR - Scientific Discussion
scientific-discussion · 2026-11-09
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Trizivir : EPAR - Steps taken after authorisation when a cutoff date has been used
steps-after-cutoff · 2026-11-09
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。