欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/1905/001
药品名称
Kataprei
活性成分
rabeprazole sodium salt 10.0 mg
剂型
Gastro-resistant tablet
上市许可持有人
Torrent Pharma GmbH Nürnberg Germany
参考成员国 - 产品名称
Denmark (DK)
Kataprei
互认成员国 - 产品名称
许可日期
2011/03/09
最近更新日期
2014/05/13
药物ATC编码
A02BC04 rabeprazole
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Multiple (Copy) Application
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
Final common_pl_clean Kataprei DK_H_1905_001_002_WS_002
Date of last change:2024/09/06
Final PL
|
Final common_pl_clean Rabeprazolnatrium Torrent Pharma DK_H_1819_001_002_WS_002
Date of last change:2024/09/06
Final SPC
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Final common_SmPC_clean Kataprei DK_H_1905_001_002_WS_002
Date of last change:2024/09/06
Final SPC
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Final common_SmPC_clean Rabeprazolnatrium Torrent Pharma DK_H_1819_001_002_WS_002
Date of last change:2024/09/06
Final Labelling
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Final Labelling Kataprei DKH1905_001_002_DC
Date of last change:2024/09/06
PubAR
|
Final PAR Kataprei DKH1905_001_002_DC
Date of last change:2024/09/06
市场状态
Withdrawn(注:已撤市)
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European Union HMA Authorisation of Medicines DataBase