法规知识库 · EMA 集中审评
Reyataz
atazanavir (as sulfate) · EMEA/H/C/000494 · 已授权
获批上市许可
2004-03-01
欧委会决定日
2026-05-07
持有人 / 申请人
Bristol-Myers Squibb Pharma EEIG
终止日期字段
无
从产品到官方文件
文件记录
18
官方索引 18
EPAR / 审评
15
assessment / overview 等
产品信息
2
PI / presentations
其他
1
RMP / PIP 等
ATC：J05AE08
治疗领域：HIV Infections
药理分类：Antivirals for systemic use
修订号：58 · 最新影响 PI 的程序：VR/0000288444
适应症（原文）：Reyataz capsules, co-administered with low dose ritonavir, are 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 (see section 4.2). 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). The choice of Reyataz in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history (see sections 4.4 and 5.1). Reyataz oral powder, co-administered with low dose ritonavir, is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected paediatric patients at least 3 months of age and weighing at least 5 kg (see section 4.2). 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). The choice of Reyataz in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history (see sections 4.4 and 5.1).
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。
2026-05-07 · 欧委会决定
2004-03-01 · 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 ↗
Reyataz : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-06-29
- 打开官方文件 ↗
Reyataz : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-06-29
- 打开官方文件 ↗
Reyataz-H-C-494-P46-086 : EPAR - Assessment Report
variation-report · 2017-11-30 · EMA/779741/2017
- 打开官方文件 ↗
Reyataz : EPAR - Summary for the public
overview · 2016-09-28
- 打开官方文件 ↗
Reyataz-H-C-494-X-0094-G : EPAR - Assessment Report - Extension
variation-report · 2016-07-14 · EMA/340991/2016
- 打开官方文件 ↗
Reyataz-H-C-494-P46-0082 : EPAR - Assessment Report
variation-report · 2015-06-05 · EMA/CHMP/382948/2015
- 打开官方文件 ↗
Reyataz-H-C-494-P46-0074.4 : EPAR - Assessment Report
variation-report · 2015-02-19 · EMA/67730/2015
- 打开官方文件 ↗
Reyataz : EPAR - Assessment Report - Variation
variation-report · 2015-02-03 · EMA/759171/2014
- 打开官方文件 ↗
Reyataz-H-C-494-II-0075 : EPAR - Assessment Report - Variation
variation-report · 2011-05-04 · EMA/CHMP/257566/2011
- 打开官方文件 ↗
Reyataz-H-C-494-II-0057 : EPAR - Assessment Report - Variation
variation-report · 2010-07-19 · EMA/CHMP/356437/2010
- 打开官方文件 ↗
Reyataz-H-C-494-II-0039 : EPAR - Assessment Report - Variation
variation-report · 2009-05-29
- 打开官方文件 ↗
Reyataz-H-C-494-II-0054 : EPAR - Scientific Discussion
scientific-discussion-variation · 2007-07-10
- 打开官方文件 ↗
Reyataz : EPAR - Scientific Discussion
scientific-discussion · 2006-08-08
- 打开官方文件 ↗
Reyataz : EPAR - Steps taken after authorisation when a cutoff date has been used
steps-after-cutoff · 2006-08-08
- 打开官方文件 ↗
Reyataz : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2006-08-08
产品信息
其他
- 打开官方文件 ↗
Reyataz
rmp · 2026-06-29
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。