| Product No | EMEA/H/C/002280 |
|---|---|
| Brand Name | Giotrif |
| Nonproprietary Name | afatinib |
| API | afatinib |
| ATC Code | L01XE13 |
| Indications | Giotrif as monotherapy is indicated for the treatment ofEpidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s);locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy. |
| Orphan Drug | no |
| Generics | no |
| Marketing Authorization Holder | Boehringer Ingelheim International GmbH |
| Status | Authorised(授权) |
| Authorization Date | 2013-09-25 |
| Version | 14 |
| 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