法规知识库 · EMA 集中审评
Atazanavir Viatris (previously Atazanavir Mylan)
atazanavir (as sulfate) · EMEA/H/C/004048 · 已授权
获批上市许可
2016-08-22
欧委会决定日
2026-09-24
持有人 / 申请人
Viatris Limited
终止日期字段
无
从产品到官方文件
文件记录
6
官方索引 6
EPAR / 审评
4
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC:J05AE08
治疗领域:HIV Infections
药理分类:Antivirals for systemic use
修订号:22 · 最新影响 PI 的程序:VR/0000370730
适应症(原文):Atazanavir Viatris, co-administered with low dose ritonavir, is indicated for the treatment of HIV 1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products.Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (≥ 4 PI mutations). There are very limited data available from children aged 6 to less than 18 years. The choice of Atazanavir Viatrisin treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s 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。
2026-09-24 · 欧委会决定
2016-08-22 · 获批上市许可
2016-06-23 · 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
- 打开官方文件 ↗
Atazanavir Viatris : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-09-24
- 打开官方文件 ↗
Atazanavir Mylan : EPAR - Medicine overview
overview · 2025-06-18 · EMA/244864/2024
- 打开官方文件 ↗
Atazanavir Mylan : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2024-02-21
- 打开官方文件 ↗
Atazanavir Mylan : EPAR - Public assessment report
assessment-report · 2017-01-31 · EMA/503216/2016
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。