| 商品名称 | ChondroCelect |
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| 适用类别 | Human |
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| 治疗领域 | Cartilage Diseases |
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| 通用名/非专利名称 | characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins |
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| 活性成分 | characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins |
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| 产品号 | EMEA/H/C/000878 |
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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| 许可状态 | Withdrawn |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 | M09AX02 |
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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 | 2009/10/05 |
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| 上市许可开发者/申请人/持有人 | TiGenix N.V. |
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| 人用药物治疗学分组 | Other drugs for disorders of the musculo-skeletal system |
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| 兽用药物治疗学分组 | |
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| 欧盟委员会决定日期 | 2016/07/29 |
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| 修订号 | 6 |
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| 治疗适应症 | Repair of single symptomatic cartilage defects of the femoral condyle of the knee (International Cartilage Repair Society [ICRS] grade III or IV) in adults. Concomitant asymptomatic cartilage lesions (ICRS grade I or II) might be present. Demonstration of efficacy is based on a randomised controlled trial evaluating the efficacy of Chondrocelect in patients with lesions between 1 and 5 cm². |
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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 | 2016/07/29 |
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| 最后更新日期 | 2017/01/12 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/chondrocelect-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/chondrocelect |
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