欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
ES/H/0793/001
药品名称
Fosquel
活性成分
sevelamer carbonate 2.4 g
剂型
Powder for oral solution
上市许可持有人
Avansor Pharma Oy Tekniikantie 14 02150 Espoo Finland
参考成员国 - 产品名称
Spain (ES)
互认成员国 - 产品名称
Denmark (DK)
Sevelamercarbonat "Avansor"
Luxembourg (LU)
Sevelamercarbonat Avansor, 2,4 g, Poudre pour suspension buvable
许可日期
2016/09/16
最近更新日期
2021/06/18
药物ATC编码
V03 ALL OTHER THERAPEUTIC PRODUCTS
V03AE Drugs for treatment of hyperkalemia and hyperphosphatemia
V VARIOUS
V03AE02 sevelamer
申请类型
TypeLevel1:
[not specified]
TypeLevel2:
[not specified]
TypeLevel3:
[not specified]
TypeLevel4:
[not specified]
TypeLevel5:
[not specified]
附件文件下载
Final PL
|
Package leaflet 2548_7 clean
Date of last change:2019/11/13
Final SPC
|
SmPC 2548_7 clean
Date of last change:2019/11/13
Final Labelling
|
M1.3.1_02.SVL.car.pos.001.05.Core
Date of last change:2019/09/06
PAR
|
Module 5 public summary and scientific discussion_DK_H_2548_001_DC
Date of last change:2018/01/08
PAR
|
PAR_Module 6 Updated scientific discussion_DRAFT
Date of last change:2018/01/08
PAR Summary
|
Summary Public Assessment Report_DK_H_2548_001_DC
Date of last change:2017/03/21
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase