| 商品名称 | Hycamtin |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Ovarian Neoplasms;Uterine Cervical Neoplasms;Small Cell Lung Carcinoma |
| 通用名/非专利名称 | topotecan |
| 活性成分 | topotecan |
| 产品号 | EMEA/H/C/000123 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L01CE01 |
| 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 | 1996/11/12 |
| 上市许可开发者/申请人/持有人 | Sandoz Pharmaceuticals d.d. |
| 人用药物治疗学分组 | Antineoplastic agents |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 1996/07/17 |
| 欧盟委员会决定日期 | 2024/09/26 |
| 修订号 | 41 |
| 治疗适应症 | Hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate. Topotecan is indicated for the treatment of patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy. Hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/04/23 |
| 最后更新日期 | 2024/09/27 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/hycamtin-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/hycamtin |