| 商品名称 | Pemetrexed Pfizer (previously Pemetrexed Hospira UK Limited) |
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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 ditromethamine |
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| 产品号 | EMEA/H/C/004488 |
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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| 许可状态 | Withdrawn |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 | 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 | 2017/04/24 |
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| 上市许可开发者/申请人/持有人 | Pfizer Europe MA EEIG |
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| 人用药物治疗学分组 | ANTIMETABOLITES;Folic acid analogues |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2017/02/23 |
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| 欧盟委员会决定日期 | 2020/10/21 |
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| 修订号 | 7 |
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| 治疗适应症 | Malignant pleural mesothelioma Pemetrexed Hospira UK Limited in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Hospira UK Limited 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 (see SmPC section 5.1). Pemetrexed Hospira UK Limited 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 (see SmPC section 5.1). Pemetrexed Hospira UK Limited 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 (see SmPC 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 | 2018/04/24 |
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| 最后更新日期 | 2021/07/29 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/pemetrexed-pfizer-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-pfizer-previously-pemetrexed-hospira-uk-limited |
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