法规知识库 · EMA 集中审评
Tivicay
dolutegravir · EMEA/H/C/002753 · 已授权
获批上市许可
2014-01-16
欧委会决定日
2025-10-16
持有人 / 申请人
ViiV Healthcare BV
终止日期字段
无
从产品到官方文件
文件记录
13
官方索引 13
EPAR / 审评
11
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：J05AX12
治疗领域：HIV Infections
药理分类：Antivirals for systemic use
修订号：37 · 最新影响 PI 的程序：VR/0000249653
适应症（原文）：Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 6 years of age or older and weighing at least 14 kg. Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 4 weeks of age or older and weighing at least 3 kg.
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。
2025-10-16 · 欧委会决定
2014-01-16 · 获批上市许可
2013-11-21 · 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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Tivicay : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-11-14
- 打开官方文件 ↗
Tivicay : EPAR - Risk management plan
rmp · 2025-11-14
- 打开官方文件 ↗
Tivicay : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-11-14
- 打开官方文件 ↗
Tivicay-PAM-0000279558 : EPAR - Assessment report
variation-report · 2025-09-10 · EMADOC-1700519818-2216398
- 打开官方文件 ↗
Tivicay : EPAR - Paediatric investigation plan compliance statement
pip-compliance · 2023-03-07 · EMA/CHMP/106165/2023
- 打开官方文件 ↗
Tivicay-H-C-002753-P46-014 : EPAR - Assessment report
variation-report · 2021-06-30 · EMA/260697/2021
- 打开官方文件 ↗
Tivicay-H-C-2753-X-0058-G: EPAR - Assessment report - Variation
variation-report · 2021-02-04 · EMA/CHMP/540603/2020
- 打开官方文件 ↗
Tivicay : EPAR - Medicine overview
overview · 2021-02-04 · EMA/617341/2020
- 打开官方文件 ↗
Tivicay-H-C-PSUSA-00010075-202001 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2020-11-27 · EMA/470525/2020
- 打开官方文件 ↗
Tivicay-H-C-002753-X-0018-G : EPAR - Assessment Report - Extension
variation-report · 2017-10-31 · EMA/601663/20177
- 打开官方文件 ↗
Tivicay : EPAR - Public assessment report
assessment-report · 2014-02-05 · EMA/CHMP/772068/2013
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。