欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
IT/H/0396/001
药品名称
Esomeprazolo Eurogenerici
活性成分
esomeprazole 20.0 mg
剂型
Gastro-resistant tablet
上市许可持有人
EG SpA Via Pavia 6 20136 - Milano Italy
参考成员国 - 产品名称
Italy (IT)
互认成员国 - 产品名称
许可日期
2012/12/12
最近更新日期
2022/06/06
药物ATC编码
A02BC05 esomeprazole
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 SPC
|
ACKNOWLEDGEMENT OF APPROVAL
Date of last change:2024/09/06
Final Labelling
|
common_lab_clean
Date of last change:2024/09/06
Final PL
|
common_pil_clean
Date of last change:2024/09/06
Final SPC
|
common_smpc_clean
Date of last change:2024/09/06
PubAR
|
Final PAR Scientific discussion Soprisodo gastro_resistant tablets DKH2132_001_002_DC
Date of last change:2024/09/06
Final Product Information
|
PI esomeprazol DK_H_2132_01_02 end of procedure 121212
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase