法规知识库 · EMA 集中审评
Deltyba
Delamanid · EMEA/H/C/002552 · 已授权
获批上市许可
2014-04-27
欧委会决定日
2026-02-20
持有人 / 申请人
Otsuka Novel Products GmbH
终止日期字段
无
从产品到官方文件
文件记录
14
官方索引 14
EPAR / 审评
12
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：J04AK06
治疗领域：Tuberculosis, Multidrug-Resistant
药理分类：Antimycobacterials
修订号：28 · 最新影响 PI 的程序：R/0000293774
适应症（原文）：Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults, adolescents, children and infants with a body weight of at least 10 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4.2, 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
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。
2026-02-20 · 欧委会决定
2014-04-27 · 获批上市许可
2013-11-21 · CHMP 意见通过
2013-07-25 · 拒绝上市许可
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 ↗
Deltyba : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-03-18
- 打开官方文件 ↗
Deltyba-R-0000293774 : EPAR - Assessment report
variation-report · 2026-03-18 · EMADOC-1700519818-2416995
- 打开官方文件 ↗
Deltyba : EPAR - Risk management plan
rmp · 2026-03-18
- 打开官方文件 ↗
Deltyba : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-03-18
- 打开官方文件 ↗
Deltyba : EPAR - Medicine overview
overview · 2026-03-18
- 打开官方文件 ↗
Deltyba-H-C-PSUSA-00010213-202304: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2024-02-29 · EMA/540391/2023
- 打开官方文件 ↗
Deltyba-H-C-PSUSA-00010213-202104 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2022-02-22 · EMA/723817/2021
- 打开官方文件 ↗
Deltyba-H-C-002552-X-0046-G : EPAR - Assessment report - Variation
variation-report · 2021-10-28 · EMA/543612/2021
- 打开官方文件 ↗
Deltyba-H-C-2552-II-0040 : EPAR - Assessment report - Variation
variation-report · 2020-12-17 · EMA/526836/2020
- 打开官方文件 ↗
Deltyba-PSUSA-00010213-201810 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2019-08-08 · EMA/444492/2019
- 打开官方文件 ↗
Deltyba-H-C-2552-P46-007 : EPAR - Assessment report
variation-report · 2018-11-13 · EMEA/H/C/002552/P46
- 打开官方文件 ↗
Deltyba : EPAR - Public assessment report
assessment-report · 2014-05-08 · EMA/55567/2014
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。