法规知识库 · EMA 集中审评
Efavirenz Teva
efavirenz · EMEA/H/C/002352 · 已授权
获批上市许可
2012-01-09
欧委会决定日
2023-02-27
持有人 / 申请人
Teva B.V.
终止日期字段
无
从产品到官方文件
文件记录
5
官方索引 5
EPAR / 审评
3
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：12 · 最新影响 PI 的程序：IB/0027/G
适应症（原文）：Efavirenz is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children 3 years of age and older. Efavirenz 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 protease inhibitors (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 efavirenz.
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。
2023-02-27 · 欧委会决定
2012-01-09 · 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 ↗
Efavirenz Teva : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2023-03-03
- 打开官方文件 ↗
Efavirenz Teva : EPAR - Public assessment report
assessment-report · 2012-01-27 · EMA/916997/2011
- 打开官方文件 ↗
Efavirenz Teva : EPAR - Summary for the public
overview · 2012-01-27 · EMA/883956/2011
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。