法规知识库 · EMA 集中审评
Kadcyla
trastuzumab emtansine · EMEA/H/C/002389 · 已授权
获批上市许可
2013-11-15
欧委会决定日
2026-06-16
持有人 / 申请人
Roche Registration GmbH
终止日期字段
无
从产品到官方文件
文件记录
10
官方索引 10
EPAR / 审评
7
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：L01FD03
治疗领域：Breast Neoplasms
药理分类：Antineoplastic agents
修订号：18 · 最新影响 PI 的程序：VR/0000348702
适应症（原文）：Early Breast Cancer (EBC) Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy. Metastatic Breast Cancer (MBC) Kadcyla, as a single agent, is indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: Received prior therapy for locally advanced or metastatic disease, or Developed disease recurrence during or within six months of completing adjuvant 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。
2026-06-16 · 欧委会决定
2013-11-15 · 获批上市许可
2013-09-19 · 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 ↗
Kadcyla : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-06-16
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Kadcyla : EPAR - Risk management plan
rmp · 2026-06-16
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Kadcyla : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-03-24
- 打开官方文件 ↗
Kadcyla : EPAR - Risk management plan summary
rmp-summary · 2023-03-22
- 打开官方文件 ↗
Kadcyla : EPAR -H-C-2389-II-0045 : EPAR - Assessment Report - Variation
variation-report · 2020-01-20 · EMA/652550/2019
- 打开官方文件 ↗
Kadcyla : EPAR - Summary for the public
overview · 2016-04-26 · EMA/748315/2013
- 打开官方文件 ↗
Kadcyla : EPAR - Public assessment report
assessment-report · 2013-12-19 · EMA/CHMP/641539/2013
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。