欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/1457/001
药品名称
Esomeprazol Sandoz
活性成分
Esomeprazole magnesium salt 20.0 mg
剂型
Gastro-resistant tablet
上市许可持有人
Sandoz A/S Edvard Thomsens Vej 14 2300 Copenhagen S Denmark
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Austria (AT)
Esomeprazol Sandoz 20 mg - magensaftresistente Tabletten
Spain (ES)
Finland (FI)
Poland (PL)
Stomezul
Latvia (LV)
Lithuania (LT)
Nexmezol 20 mg skrandyje neirios tabletės
Estonia (EE)
NEXMEZOL 20 MG
Hungary (HU)
Esomeprazol Sandoz 20 mg gyomornedv-ellenálló tabletta
Slovenia (SI)
许可日期
2009/02/18
最近更新日期
2024/12/02
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 Labelling
|
common_labelling_final
Date of last change:2024/09/06
Final PL
|
common_pil_clean_final_esomeprazole
Date of last change:2024/09/06
Final SPC
|
common_spc_clean_final
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase