| 商品名称 | Pemetrexed medac |
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| 适用类别 | Human |
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| 治疗领域 | Carcinoma, Non-Small-Cell Lung;Mesothelioma |
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| 通用名/非专利名称 | pemetrexed |
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| 活性成分 | pemetrexed |
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| 产品号 | EMEA/H/C/003905 |
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| 患者安全信息 | No |
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| 许可状态 | Authorised |
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| ATC编码 | L01BA04 |
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| 是否额外监管 | No |
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| 是否仿制药或hybrid药物 | Yes |
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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 | 2015/11/26 |
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| 上市许可开发者/申请人/持有人 | medac Gesellschaft für klinische Spezialpräparate mbH |
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| 人用药物治疗学分组 | Folic acid analogues;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 | 2015/09/23 |
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| 欧盟委员会决定日期 | 2025/05/28 |
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| 修订号 | 9 |
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| 治疗适应症 | Malignant pleural mesothelioma Pemetrexed medac in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed medac in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Pemetrexed medac is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed medac is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. |
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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 | 2018/05/18 |
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| 最后更新日期 | 2025/05/28 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/pemetrexed-medac-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/pemetrexed-medac |
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