| 商品名称 | Yervoy |
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| 适用类别 | Human |
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| 治疗领域 | Melanoma;Carcinoma, Renal Cell;Carcinoma, Non-Small-Cell Lung;Mesothelioma, Malignant;Colorectal Neoplasms |
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| 通用名/非专利名称 | ipilimumab |
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| 活性成分 | Ipilimumab |
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| 产品号 | EMEA/H/C/002213 |
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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 | L01FX04 |
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| 是否额外监管 | Nei |
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| 是否仿制药或hybrid药物 | Nei |
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| 是否生物类似药 | Nei |
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| 是否附条件批准 | Nei |
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| 是否特殊情形 | Nei |
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| 是否加速审评 | Nei |
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| 是否罕用药 | Nei |
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| 上市许可日期 | 2011/07/13 |
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| 上市许可开发者/申请人/持有人 | Bristol-Myers Squibb Pharma EEIG |
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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 | 2011/05/19 |
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| 欧盟委员会决定日期 | 2025/11/13 |
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| 修订号 | 59 |
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| 治疗适应症 | MelanomaYervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.4). Yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression (see sections 4.4 and 5.1). Renal cell carcinoma (RCC) Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1). Non-small cell lung cancer (NSCLC) Yervoy in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation. Malignant pleural mesothelioma (MPM) Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. Mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) Yervoy in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability high colorectal cancer in the following settings:- first-line treatment of unresectable or metastatic colorectal cancer;- treatment of metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy (see section 5.1). Oesophageal squamous cell carcinoma (OSCC) Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.Hepatocellular carcinoma (HCC)Yervoy in combination with nivolumab is indicated for the first line treatment of adult patients with unresectable or advanced hepatocellular carcinoma. |
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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 | 2018/06/14 |
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| 最后更新日期 | 2025/11/21 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/yervoy-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/yervoy |
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