| 商品名称 | Eperzan |
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| 适用类别 | Human |
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| 治疗领域 | Diabetes Mellitus, Type 2 |
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| 通用名/非专利名称 | albiglutide |
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| 活性成分 | albiglutide |
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| 产品号 | EMEA/H/C/002735 |
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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| 许可状态 | Withdrawn |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 | A10BJ04 |
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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 | 2014/03/20 |
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| 上市许可开发者/申请人/持有人 | GlaxoSmithKline Trading Services Limited |
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| 人用药物治疗学分组 | Drugs used in diabetes |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2014/01/22 |
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| 欧盟委员会决定日期 | 2017/09/14 |
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| 修订号 | 8 |
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| 治疗适应症 | Eperzan is indicated for the treatment of type 2 diabetes mellitus in adults to improve glycaemic control as: Monotherapy When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to contraindications or intolerance. Add-on combination therapy In combination with other glucose-lowering medicinal products including basal insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see section 4.4 and 5.1 for available data on different combinations). |
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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 | 2017/09/14 |
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| 最后更新日期 | 2019/02/20 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/eperzan-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/eperzan |
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