| 商品名称 | Velphoro |
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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 | sucroferric oxyhydroxide |
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| 活性成分 | sucroferric oxyhydroxide |
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| 产品号 | EMEA/H/C/002705 |
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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 | V03AE05 |
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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 | 2014/08/26 |
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| 上市许可开发者/申请人/持有人 | Vifor Fresenius Medical Care Renal Pharma France |
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| 人用药物治疗学分组 | Drugs for treatment of hyperkalemia and hyperphosphatemia |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2014/06/26 |
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| 欧盟委员会决定日期 | 2022/01/11 |
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| 修订号 | 9 |
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| 治疗适应症 | Velphoro is indicated for the control of serum phosphorus levels in adult chronic kidney disease (CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD). Velphoro is indicated for the control of serum phosphorus levels in paediatric patients 2 years of age and older with CKD stages 4-5 (defined by a glomerular filtration rate <30 mL/min/1.73 m²) or with CKD on dialysis. Velphoro 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, or calcimimetics 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 | 2018/02/20 |
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| 最后更新日期 | 2022/12/08 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/velphoro-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/velphoro |
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