法规知识库 · EMA 集中审评
Triumeq
dolutegravir sodium;lamivudine;abacavir (as sulfate) · EMEA/H/C/002754 · 已授权
获批上市许可
2014-08-31
欧委会决定日
2026-01-23
持有人 / 申请人
ViiV Healthcare B.V.
终止日期字段
无
从产品到官方文件
文件记录
15
官方索引 15
EPAR / 审评
12
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：J05AR13
治疗领域：HIV Infections
药理分类：Antivirals for systemic use
修订号：39 · 最新影响 PI 的程序：N/0000316075
适应症（原文）：Triumeq is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infected children of at least 3 months of age weighing at least 6 kg to less than 25 kg (see sections 4.4 and 5.1). Before initiating treatment with abacavir-containing products, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin (see section 4.4). Abacavir should not be used in patients known to carry the HLA-B*5701 allele. Triumeq is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infected adults, adolescents and children weighing at least 25 kg (see sections 4.4 and 5.1). Before initiating treatment with abacavir-containing products, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin (see section 4.4). Abacavir should not be used in patients known to carry the HLA-B*5701 allele.
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。
2026-01-23 · 欧委会决定
2014-08-31 · 获批上市许可
2014-06-26 · 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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Triumeq : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-01-26
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Triumeq : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-11-14
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Triumeq : EPAR - Risk management plan
rmp · 2025-11-14
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Triumeq-PAM-0000279528 : EPAR - Assessment report
variation-report · 2025-09-04 · EMADOC-1700519818-2216398
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Triumeq-H-C-002754-II-0116 : EPAR - Assessment report - Variation
variation-report · 2024-06-21 · EMA/CHMP/136294/2024
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Triumeq : EPAR - Medicine overview
overview · 2024-06-21 · EMA/258695/2024
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Triumeq-H-C-PSUSA-00010075-202301 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2023-11-27 · EMA/395605/2023
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Triumeq-H-C-002754-X-0101 : EPAR - Assessment Report
variation-report · 2023-04-20 · EMA/CHMP/915669/2022
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Triumeq-H-C-002754-P46-011 : EPAR - Assessment Report
variation-report · 2022-07-14 · EMEA/H/C/002754/P46/011
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Triumeq-H-C-PSUSA-00010075-202101 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2021-11-25 · EMA/508918/2021
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Triumeq-H-C-PSUSA-00010075-202001 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2020-12-16 · EMA/470525/2020
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Triumeq : EPAR - Public assessment report
assessment-report · 2014-10-15 · EMA/580654/2014
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。