| 商品名称 | Erbitux |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Head and Neck Neoplasms;Colorectal Neoplasms |
| 通用名/非专利名称 | cetuximab |
| 活性成分 | cetuximab |
| 产品号 | EMEA/H/C/000558 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L01FE01 |
| 是否额外监管 | No |
| 是否仿制药或hybrid药物 | No |
| 是否生物类似药 | No |
| 是否附条件批准 | No |
| 是否特殊情形 | No |
| 是否加速审评 | No |
| 是否罕用药 | No |
| 上市许可日期 | 2004/06/29 |
| 上市许可开发者/申请人/持有人 | Merck Europe B.V. |
| 人用药物治疗学分组 | Antineoplastic agents |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2025/01/16 |
| 修订号 | 33 |
| 治疗适应症 | 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 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. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2017/06/02 |
| 最后更新日期 | 2025/02/19 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/erbitux-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/erbitux |