欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0334/001
药品名称
Esomeprazol Teva
活性成分
esomeprazole magnesium salt 20.0 mg
剂型
Gastro-resistant tablet
上市许可持有人
Ranbaxy (U.K.) Limited
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Denmark (DK)
Spain (ES)
Greece (GR)
Hungary (HU)
Raciper 20mg
Austria (AT)
Esomeprazol Teva 20 mg magensaftresistente Tabletten
许可日期
2010/07/20
最近更新日期
2012/08/13
药物ATC编码
A02BC05 esomeprazole
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial 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 SPC
|
common-spc-final-334
Date of last change:2012/07/20
Final PL
|
common-pl-334_20mg
Date of last change:2012/07/20
Final PL
|
common-pl-334_40mg
Date of last change:2012/07/20
Final Labelling
|
common-impack-334_20mg
Date of last change:2011/12/08
Final Labelling
|
common-impack-334_40mg
Date of last change:2011/12/08
Final Labelling
|
common-outer-334_20mg
Date of last change:2011/12/08
Final Labelling
|
common-outer-334_40mg
Date of last change:2011/12/08
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase