法规知识库 · EMA 集中审评
Stocrin
efavirenz · EMEA/H/C/000250 · 已撤市
获批上市许可
1999-05-28
欧委会决定日
2023-04-14
持有人 / 申请人
Merck Sharp & Dohme B.V.
终止日期字段
2025-09-30
从产品到官方文件
文件记录
9
官方索引 9
EPAR / 审评
7
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：49 · 最新影响 PI 的程序：II/130
适应症（原文）：Stocrin is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children three years of age and older. Stocrin 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 Stocrin.
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。
2025-09-30 · 上市许可终止（撤市/失效/撤销等）
Withdrawn
2023-04-14 · 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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Stocrin : EPAR - Risk management plan summary
rmp-summary · 2026-07-01
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Stocrin-H-C-250-P45-56: EPAR - Assessment Report
variation-report · 2026-07-01 · EMA/807379/2012
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Stocrin : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-07-01
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Stocrin : EPAR - Summary for the public
overview · 2026-07-01
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Stocrin : EPAR - Scientific Discussion
scientific-discussion · 2026-07-01
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Stocrin : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2026-07-01
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Stocrin : EPAR - Steps taken after authorisation when a cutoff date has been used
steps-after-cutoff · 2026-07-01
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。