欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）

MR编号	DE/H/2808/001
药品名称	Esogasec 20 mg magensaftresistente Hartkapseln
活性成分	esomeprazole dihydrate 21.69 mg
剂型	Gastro-resistant capsule, hard
上市许可持有人	Aristo Pharma GmbH Wallenroder Str. 8-10 13435 Berlin Germany
参考成员国 - 产品名称	Germany (DE) Esogasec 20 mg magensaftresistente Kapsel
互认成员国 - 产品名称	Poland (PL) France (FR) Sweden (SE) Spain (ES) Portugal (PT)
许可日期	2012/06/06
最近更新日期	2023/10/11
药物ATC编码	A02BC05 esomeprazole
申请类型	TypeLevel1：Abridged TypeLevel2：Additional Strength/Form 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_final_spc_DE2808_V028GDate of last change:2023/10/11 Final PL \| common_final_pl_DE2808_V028GDate of last change:2023/10/11 PAR \| 04_DE_H_2806_2808_001_002_DC_Esomeprazol_final PARDate of last change:2022/11/29 Final Product Information \| common-final-labip(bl)-2808(002)-V021Date of last change:2021/09/22 Final Product Information \| common-final-labip(bl)-2808(001)-V021Date of last change:2021/09/22 Final Product Information \| common-final-labip(bo)-2808(001)-V021Date of last change:2021/09/22 Final Product Information \| common-final-labop(bl)-2808(001)-V021Date of last change:2021/09/22 Final Product Information \| common-final-labip(bo)-2808(002)-V021Date of last change:2021/09/22 Final Product Information \| common-final-labop(bo)-2808(001)-V021Date of last change:2021/09/22 Final Product Information \| common-final-labop(bl)-2808(002)-V021Date of last change:2021/09/22 Final Product Information \| common-final-labop(bo)-2808(002)-V021Date of last change:2021/09/22 Final Product Information \| common-final-pl-2808-V021Date of last change:2021/09/22 Final Product Information \| common-final-spc-2808-V021Date of last change:2021/09/22
市场状态	Positive