| Product No | EMEA/H/C/004826 |
|---|---|
| Brand Name | Gefitinib Mylan |
| Nonproprietary Name | gefitinib |
| API | gefitinib |
| ATC Code | L01XE02 |
| Indications | Gefitinib Mylan is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non‑small cell lung cancer (NSCLC) with activating mutations of EGFR‑TK. |
| Orphan Drug | no |
| Generics | yes |
| Marketing Authorization Holder | Mylan Pharmaceuticals Limited |
| Status | Authorised(授权) |
| Authorization Date | 2018-09-27 |
| Version | 5 |
| 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