| 商品名称 | Potactasol |
|---|---|
| 适用类别 | Human |
| 治疗领域 | 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/002282 |
| 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 | Yes |
| 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 | 2011/01/06 |
| 上市许可开发者/申请人/持有人 | Actavis Group PTC ehf |
| 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 | 2010/10/21 |
| 欧盟委员会决定日期 | 2025/01/17 |
| 修订号 | 12 |
| 治疗适应症 | Topotecan monotherapy is indicated for the treatment of:- patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy- patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1). Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.1). |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/03/20 |
| 最后更新日期 | 2025/01/20 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/potactasol-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/potactasol |