| 商品名称 | Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva) |
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| 适用类别 | Human |
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| 治疗领域 | Hyperphosphatemia;Renal Dialysis |
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| 通用名/非专利名称 | sevelamer carbonate |
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| 活性成分 | sevelamer carbonate |
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| 产品号 | EMEA/H/C/003971 |
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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 | V03AE02 |
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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 | 2015/01/15 |
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| 上市许可开发者/申请人/持有人 | Sanofi Winthrop Industrie |
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| 人用药物治疗学分组 | All other therapeutic products |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2014/11/20 |
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| 欧盟委员会决定日期 | 2024/12/12 |
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| 修订号 | 23 |
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| 治疗适应症 | Sevelamer carbonate Winthrop is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Sevelamer carbonate Winthrop is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus > 1.78 mmol/L. Sevelamer carbonate Winthrop should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease. |
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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 | 2018/07/25 |
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| 最后更新日期 | 2024/12/18 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/sevelamer-carbonate-winthrop-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/sevelamer-carbonate-winthrop |
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