| 商品名称 | Celdoxome pegylated liposomal |
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| 适用类别 | Human |
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| 治疗领域 | Breast Neoplasms;Ovarian Neoplasms;Multiple Myeloma;Sarcoma, Kaposi |
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| 通用名/非专利名称 | doxorubicin hydrochloride |
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| 活性成分 | doxorubicin hydrochloride |
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| 产品号 | EMEA/H/C/005330 |
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| 患者安全信息 | No |
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| 许可状态 | Lapsed |
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| ATC编码 | L01DB01 |
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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 | 2022/09/15 |
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| 上市许可开发者/申请人/持有人 | Baxter Holding B.V. |
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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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| 审评意见日期 | 2022/07/21 |
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| 欧盟委员会决定日期 | 2024/03/21 |
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| 修订号 | 3 |
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| 治疗适应症 | Celdoxome pegylated liposomal is indicated in adults: as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk. or treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant. for treatment of AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4 counts (< 200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. Celdoxome pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline). |
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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 | 2022/06/20 |
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| 最后更新日期 | 2025/11/27 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/celdoxome-pegylated-liposomal-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/celdoxome-pegylated-liposomal |
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