法规知识库 · EMA 集中审评
Sustiva
efavirenz · EMEA/H/C/000249 · 已撤市
获批上市许可
1999-05-28
欧委会决定日
2023-05-23
持有人 / 申请人
Bristol-Myers Squibb Pharma EEIG
终止日期字段
2024-02-01
从产品到官方文件
文件记录
10
官方索引 10
EPAR / 审评
8
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：J05AG03
治疗领域：HIV Infections
药理分类：Antivirals for systemic use
修订号：48 · 最新影响 PI 的程序：N/0161
适应症（原文）：Sustiva is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children three years of age and older. Sustiva has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease-inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing Sustiva.
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。
2024-02-01 · 上市许可终止（撤市/失效/撤销等）
Withdrawn
2023-05-23 · 欧委会决定
1999-05-28 · 获批上市许可
1999-02-24 · 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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Sustiva-H-C-PSUSA-00001200-201804 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2024-03-14 · EMA/132484/2019
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Sustiva-H-C-249-II-0126-G : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2024-03-14 · EMA/260283/2015
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Sustiva-H-C-249-P45-0056: EPAR - Assessment Report
variation-report · 2024-03-14 · EMA/815692/2012
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Sustiva : EPAR - Summary for the public
overview · 2024-03-14
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Sustiva : EPAR - Steps taken after authorisation when a cutoff date has been used
steps-after-cutoff · 2024-03-14
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Sustiva : EPAR - Scientific Discussion
scientific-discussion · 2024-03-14
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Sustiva : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2024-03-14
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Sustiva : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2024-03-14
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。