法规知识库 · EMA 集中审评
Emend
aprepitant · EMEA/H/C/000527 · 已授权
获批上市许可
2003-11-11
欧委会决定日
2025-10-24
持有人 / 申请人
Merck Sharp & Dohme B.V.
终止日期字段
无
从产品到官方文件
文件记录
15
官方索引 15
EPAR / 审评
13
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：A04AD12
治疗领域：Vomiting;Postoperative Nausea and Vomiting;Cancer
药理分类：Antiemetics and antinauseants
修订号：33 · 最新影响 PI 的程序：N/0000308121
适应症（原文）：Emend 40 mg hard capsules is indicated for the prevention of postoperative nausea and vomiting (PONV) in adults. Emend is also available as 80 mg and 125 mg hard capsules for the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and adolescents from the age of 12 (see separate Summary of Product Characteristics). Emend is also available as 165 mg hard capsules for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy in adults and the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults. Emend is also available as powder for oral suspension for the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in children, toddlers and infants from the age of 6 months to less than 12 years. Emend 80 mg, 125 mg, 165 mg hard capsules and Emend powder for oral suspension are given as part of combination therapy.
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。
2025-10-24 · 欧委会决定
2003-11-11 · 获批上市许可
2003-07-24 · 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
- 打开官方文件 ↗
Emend : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-10-24
- 打开官方文件 ↗
Emend : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-04-23
- 打开官方文件 ↗
Emend : EPAR - Risk Management Plan
rmp · 2023-04-28
- 打开官方文件 ↗
Emend : EPAR - Medicine overview
overview · 2021-03-17 · EMA/313469/2020
- 打开官方文件 ↗
Emend-H-C-527-P46-041 : EPAR - Assessment Report
variation-report · 2017-08-22 · EMA/CHMP/356710/2017
- 打开官方文件 ↗
Emend-H-C-527-X-0049/G : EPAR - Assessment Report - Extension
variation-report · 2016-02-01 · EMA/787667/2015
- 打开官方文件 ↗
Emend-H-C-527-P46-0040.1 : EPAR - Assessment Report
variation-report · 2015-05-11 · EMA/294881/2015
- 打开官方文件 ↗
Emend-H-C-527-PSUV-0042 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2014-01-13 · EMA/11649/2014
- 打开官方文件 ↗
Emend-H-C-527-P46-0035 : EPAR - Assessment Report
variation-report · 2013-02-28 · EMA/110996/2013
- 打开官方文件 ↗
Emend-H-C-527-II-0014 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2007-02-14
- 打开官方文件 ↗
Emend : EPAR - Scientific Discussion
scientific-discussion · 2006-09-05
- 打开官方文件 ↗
Emend : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2006-09-05
- 打开官方文件 ↗
Emend-H-C-527-II-0009 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2006-09-05
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。