法规知识库 · EMA 集中审评
Erbitux
cetuximab · EMEA/H/C/000558 · 已授权
获批上市许可
2004-06-29
欧委会决定日
2026-06-25
持有人 / 申请人
Merck Europe B.V.
终止日期字段
无
从产品到官方文件
文件记录
16
官方索引 16
EPAR / 审评
14
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L01FE01
治疗领域：Head and Neck Neoplasms;Colorectal Neoplasms
药理分类：Antineoplastic agents
修订号：36 · 最新影响 PI 的程序：VR/0000326978, VR/0000327014
适应症（原文）：Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer: in combination with irinotecan-based chemotherapy; in first-line in combination with FOLFOX; as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan. For details, see section 5.1. Erbitux is indicated for the treatment of adult patients with BRAF V600E mutant metastatic colorectal cancer: in combination with encorafenib and FOLFOX for the first line treatment; in combination with encorafenib in patients who have received prior systemic therapy. For details, see section 5.1, for biomarker-based patient selection, see section 4.2. Erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck: in combination with radiation therapy for locally advanced disease; in combination with platinum-based chemotherapy for recurrent and/or metastatic disease.
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。
2026-06-25 · 欧委会决定
2004-06-29 · 获批上市许可
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 ↗
Erbitux-VR-0000327014 : EPAR - Assessment report - Variation
variation-report · 2026-07-15 · EMADOC-1700519818-2963495
- 打开官方文件 ↗
Erbitux : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-07-15
- 打开官方文件 ↗
Erbitux : EPAR - Risk management plan
rmp · 2026-07-15
- 打开官方文件 ↗
Erbitux : EPAR - Medicine overview
overview · 2026-07-15 · EMA/35341/2023
- 打开官方文件 ↗
Erbitux : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-01-26
- 打开官方文件 ↗
Erbitux-H-C-558-II-0062 : EPAR - Assessment report - Variation
variation-report · 2014-01-27 · EMA/CHMP/701107/2013
- 打开官方文件 ↗
Erbitux-H-C-558-II-0047 : EPAR - Assessment report - Variation
variation-report · 2012-02-20 · EMA/CHMP/873904/2011
- 打开官方文件 ↗
Erbitux-H-C-558-II-0042: EPAR - Assessment report - Variation
variation-report · 2011-07-21 · EMA/466184/2011
- 打开官方文件 ↗
Erbitux-H-C-558-II-0029 : EPAR - Assessment report - Variation
variation-report · 2010-03-12 · EMA/49762/2010
- 打开官方文件 ↗
Erbitux-H-C-558-II-0026 : EPAR - Assessment report - Variation
variation-report · 2008-12-18 · EMEA/590803/2008
- 打开官方文件 ↗
Erbitux-H-C-558-II-0020 : EPAR - Assessment report - Variation
variation-report · 2008-09-10
- 打开官方文件 ↗
Erbitux : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2006-10-30
- 打开官方文件 ↗
Erbitux : EPAR - Scientific Discussion
scientific-discussion · 2006-10-30
- 打开官方文件 ↗
Erbitux-H-C-558-II-0005 : EPAR - Scientific Discussion
scientific-discussion-variation · 2006-10-30
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。