法规知识库 · EMA 集中审评
Emtricitabine/Tenofovir disoproxil Krka
emtricitabine;tenofovir disoproxil succinate · EMEA/H/C/004215 · 已授权
获批上市许可
2016-12-09
欧委会决定日
2025-01-31
持有人 / 申请人
KRKA tovarna zdravil d.d. Novo mesto
终止日期字段
无
从产品到官方文件
文件记录
7
官方索引 7
EPAR / 审评
5
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：J05AR03
治疗领域：HIV Infections
药理分类：Antivirals for systemic use
修订号：15 · 最新影响 PI 的程序：N/0000242560
适应症（原文）：Treatment of HIV-1 infection Emtricitabine/tenofovir disoproxil Krka is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults. Emtricitabine/Tenofovir disoproxil Krka is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years (see section 5.1 Pre-exposure prophylaxis (PrEP) Emtricitabine/Tenofovir disoproxil Krka is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.
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。
2025-01-31 · 欧委会决定
2016-12-09 · 获批上市许可
2016-10-13 · 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 ↗
Emtricitabine/Tenofovir disoproxil Krka : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-01-31
- 打开官方文件 ↗
Emtricitabine/Tenofovir disoproxil Krka : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2024-06-20
- 打开官方文件 ↗
Emtricitabine/Tenofovir disoproxil Krka : EPAR - Risk-management plan summary
rmp-summary · 2020-02-13
- 打开官方文件 ↗
Emtricitabine/Tenofovir disoproxil Krka : EPAR - Medicine overview
overview · 2019-02-19 · EMA/693387/2016
- 打开官方文件 ↗
Emtricitabine/Tenofovir disoproxil Krka : EPAR - Public assessment report
assessment-report · 2017-04-04 · EMA/CHMP/522913/2016
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。