法规知识库 · EMA 集中审评
Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva)
sevelamer carbonate · EMEA/H/C/003971 · 已授权
获批上市许可
2015-01-15
欧委会决定日
2024-12-12
持有人 / 申请人
Sanofi Winthrop Industrie
终止日期字段
无
从产品到官方文件
文件记录
8
官方索引 8
EPAR / 审评
6
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：V03AE02
治疗领域：Hyperphosphatemia;Renal Dialysis
药理分类：All other therapeutic products
修订号：23 · 最新影响 PI 的程序：T/0038
适应症（原文）：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.
关键日期时间轴
来自 EMA medicines JSON 日期字段；缺失字段不展示，不补推结论。
2024-12-12 · 欧委会决定
2015-01-15 · 获批上市许可
2014-11-20 · CHMP 意见通过
说明书、EPAR 与其他文件
仅展示 EMA 官方 document_url；本站不下载或镜像 PDF。
EPAR / 审评资料
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Sevelamer carbonate Winthrop : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2024-12-18
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Sevelamer carbonate Zentiva-H-C-PSUSA-00002697-201810 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-09-06 · EMA/CHMP/462037/2019
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Sevelamer carbonate Winthrop : EPAR - Medicine overview
overview · 2019-07-22 · EMA/213714/2019
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Sevelamer carbonate Zentiva-H-C-3971-WS-0965 : EPAR - Scientific Discussion - Variation
variation-report · 2017-07-26 · EMA/352101/2017
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Sevelamer carbonate Zentiva-H-C-PSUSA-00002697-201510 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2016-08-25 · EMA/CHMP/571186/2016
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Sevelamer carbonate Zentiva : EPAR - Public assessment report
assessment-report · 2015-03-13 · EMA/CHMP/473530/2014
数据来自 EMA 官方 JSON；最终以 EMA / 欧委会文件为准。本页不自动给出安全或非安全结论。