| 商品名称 | Naveruclif |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Breast Neoplasms;Pancreatic Neoplasms;Carcinoma, Non-Small-Cell Lung |
| 通用名/非专利名称 | paclitaxel |
| 活性成分 | paclitaxel |
| 产品号 | EMEA/H/C/006173 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L01CD01 |
| 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 | 2024/01/05 |
| 上市许可开发者/申请人/持有人 | Accord Healthcare S.L.U. |
| 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 | 2023/11/09 |
| 欧盟委员会决定日期 | 2025/08/11 |
| 修订号 | 3 |
| 治疗适应症 | Naveruclif monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated (see section 4.4). Naveruclif in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas. Naveruclif in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2024/02/27 |
| 最后更新日期 | 2025/08/12 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/naveruclif-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/naveruclif |