法规知识库 · EMA 集中审评
Renvela
sevelamer carbonate · EMEA/H/C/000993 · 已授权
获批上市许可
2009-06-09
欧委会决定日
2024-12-19
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
11
官方索引 11
EPAR / 审评
9
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：29 · 最新影响 PI 的程序：T/0066
适应症（原文）：Renvela is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Renvela 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. Renvela 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。
2024-12-19 · 欧委会决定
2009-06-09 · 获批上市许可
2009-03-19 · CHMP 意见通过
说明书、EPAR 与其他文件
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EPAR / 审评资料
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Renvela : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-01-08
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Renvela : EPAR - Risk management plan
rmp · 2024-01-10
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Renvela-H-C-PSUSA-00002697-201810 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-09-03 · EMA/CHMP/462037/2019
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Renvela : EPAR - Medicine overview
overview · 2019-07-19 · EMA/357790/2019
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Renvela-H- C-993-WS-0965 : EPAR - Assessment Report - Variation
variation-report · 2017-07-26 · EMA/352101/2017
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Renvela-H-C-PSUSA-00002697-201510 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2016-08-30 · EMA/CHMP/571186/2016
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Renvela-H-C-993-P46-0023 : EPAR - Assessment Report
variation-report · 2016-05-11 · EMA/271022/2016
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Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV
conditions-member-states · 2009-06-23
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Renvela : EPAR - Public assessment report
assessment-report · 2009-06-23
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。