| 商品名称 | Nintedanib Accord |
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| 适用类别 | Human |
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| 治疗领域 | Idiopathic Pulmonary Fibrosis;Lung Diseases, Interstitial;Scleroderma, Systemic;Pulmonary Fibrosis |
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| 通用名/非专利名称 | nintedanib |
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| 活性成分 | nintedanib |
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| 产品号 | EMEA/H/C/006179 |
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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 | L01EX09 |
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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 | 2024/04/19 |
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| 上市许可开发者/申请人/持有人 | Accord Healthcare S.L.U. |
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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 | 2024/02/22 |
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| 欧盟委员会决定日期 | 2025/08/29 |
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| 修订号 | 4 |
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| 治疗适应症 | Nintedanib Accord is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib Accord is also indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype (see section 5.1). Nintedanib Accord is indicated in adults for the treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD). Nintedanib Accord is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib Accord is also indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. Nintedanib Accord is indicated in children and adolescents from 6 to 17 years old for the treatment of clinically significant, progressive fibrosing interstitial lung diseases (ILDs). Nintedanib Accord is indicated in adults, adolescents and children aged 6 years and older for the treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD). |
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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 | 2024/02/23 |
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| 最后更新日期 | 2025/08/29 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/nintedanib-accord-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/nintedanib-accord |
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