欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0245/002
药品名称
Esomeprazole Ratiopharm
活性成分
esomeprazole magnesium salt 40.0 mg
剂型
Gastro-resistant capsule*
上市许可持有人
Ratiopharm Lda. Portugal
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Spain (ES)
许可日期
2010/08/20
最近更新日期
2024/06/24
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_form_form
Date of last change:2024/09/06
Final Labelling
|
Esomeprazole_gastro_resistant capsules____Labeling006088_2
Date of last change:2024/09/06
Final PL
|
Esomeprazole_gastro_resistant capsules____PT_PIL_osnutek_SmPCPIL006544_2
Date of last change:2024/09/06
市场状态
Positive
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