| 商品名称 | Paxene |
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| 适用类别 | Human |
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| 治疗领域 | Sarcoma, Kaposi;Carcinoma, Non-Small-Cell Lung;Ovarian Neoplasms;Breast Neoplasms |
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| 通用名/非专利名称 | paclitaxel |
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| 活性成分 | paclitaxel |
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| 产品号 | EMEA/H/C/000216 |
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| 患者安全信息 | No |
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| 许可状态 | Withdrawn |
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| ATC编码 | L01CD01 |
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| 是否额外监管 | No |
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| 是否仿制药或hybrid药物 | No |
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| 是否生物类似药 | No |
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| 是否附条件批准 | No |
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| 是否特殊情形 | No |
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| 是否加速审评 | No |
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| 是否罕用药 | No |
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| 上市许可日期 | 1999/07/19 |
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| 上市许可开发者/申请人/持有人 | Norton Healthcare Ltd. |
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| 人用药物治疗学分组 | Antineoplastic agents |
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| 兽用药物治疗学分组 | |
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| 欧盟委员会决定日期 | 2009/07/14 |
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| 修订号 | 14 |
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| 治疗适应症 | Paxene is indicated for the treatment of patients with: advanced AIDS-related Kaposi's sarcoma (AIDS-KS) who have failed prior liposomal anthracycline therapy; metastatic carcinoma of the breast (MBC) who have failed, or are not candidates for standard anthracycline-containing therapy; advanced carcinoma of the ovary (AOC) or with residual disease (> 1 cm) after initial laparotomy, in combination with cisplatin as first-line treatment; metastatic carcinoma of the ovary (MOC) after failure of platinum-containing combination therapy without taxanes as second-line treatment; non-small cell lung carcinoma (NSCLC) who are not candidates for potentially curative surgery and/or radiation therapy, in combination with cisplatin. Limited efficacy data supports this indication (see section 5.1). |
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| 适用物种 | |
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| 兽用药物ATC编码 | |
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| 首次发布日期 | 2009/07/14 |
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| 最后更新日期 | 2010/03/22 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/paxene-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/paxene |
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