| 商品名称 | Tarceva |
|---|
| 适用类别 | Human |
|---|
| 治疗领域 | Carcinoma, Non-Small-Cell Lung;Pancreatic Neoplasms |
|---|
| 通用名/非专利名称 | erlotinib |
|---|
| 活性成分 | erlotinib |
|---|
| 产品号 | EMEA/H/C/000618 |
|---|
| 患者安全信息 | No |
|---|
| 许可状态 | Authorised |
|---|
| ATC编码 | L01EB02 |
|---|
| 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 | 2005/09/19 |
|---|
| 上市许可开发者/申请人/持有人 | Cheplapharm Registration GmbH |
|---|
| 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 | 2025/03/04 |
|---|
| 修订号 | 34 |
|---|
| 治疗适应症 | Non-small cell lung cancer (NSCLC) Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations and stable disease after first-line chemotherapy. Tarceva is also indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. In patients with tumours without EGFR activating mutations, Tarceva is indicated when other treatment options are not considered suitable. When prescribing Tarceva, factors associated with prolonged survival should be taken into account. No survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with Epidermal Growth Factor Receptor (EGFR)-IHC - negative tumours. Pancreatic cancer Tarceva in combination with gemcitabine is indicated for the treatment of patients with metastatic pancreatic cancer. When prescribing Tarceva, factors associated with prolonged survival should be taken into account. |
|---|
| 适用物种 | |
|---|
| 兽用药物ATC编码 | |
|---|
| 首次发布日期 | 2018/08/09 |
|---|
| 最后更新日期 | 2025/03/05 |
|---|
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/tarceva-epar-product-information_en.pdf |
|---|
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/tarceva |
|---|