| Product No | EMEA/H/C/000558 |
|---|---|
| Brand Name | Erbitux |
| Nonproprietary Name | cetuximab |
| API | cetuximab |
| ATC Code | L01FE01 |
| Indications | 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. |
| Orphan Drug | no |
| Generics | no |
| Marketing Authorization Holder | Merck Europe B.V.? |
| Status | Authorised(授权) |
| Authorization Date | 2004-06-29 |
| Version | 29 |
| Condition Approval | no |
| Exceptions | no |
| Biosimilar | no |
| Details | 查看 (公众评估报告、授权细节、产品规格/剂型、标签、历史评估信息) |
Extended Information