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

MR编号	DE/H/2807/002
药品名称	Ulcerex 40 mg magensaftresistente Hartkapseln
活性成分	esomeprazole 40.0 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) Ulcerex 40 mg magensaftresistente Hartkapseln
互认成员国 - 产品名称	Denmark (DK) Belgium (BE) Netherlands (NL) United Kingdom (Northern Ireland) (XI) Ireland (IE) Austria (AT) Esomeprazol Regiomedica 40 mg magensaftresistente Hartkapseln Spain (ES) Italy (IT) Sweden (SE) Finland (FI)
许可日期	2012/06/06
最近更新日期	2023/10/10
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 Labelling \| final_common_labob_FO_40 mg_2807_035_GDate of last change:2023/04/05 Final SPC \| final_common_spc_2807_035_GDate of last change:2023/04/05 Final PL \| final_common_pl_2807_035_GDate of last change:2023/04/05 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)-2807(001)-V029Date of last change:2021/07/21 Final Product Information \| common-final-labip(bo)-2807(001)-V029Date of last change:2021/07/21 Final Product Information \| common-final-labip(bl)-2807(002)-V029Date of last change:2021/07/21 Final Product Information \| common-final-labip(bo)-2807(002)-V029Date of last change:2021/07/21 Final Product Information \| common-final-labop(bl)-2807(001)-V029Date of last change:2021/07/21 Final Product Information \| common-final-labop(bo)-2807(001)-V029Date of last change:2021/07/21 Final Product Information \| common-final-labop(bl)-2807(002)-V029Date of last change:2021/07/21 Final Product Information \| common-final-pl-2807-V029Date of last change:2021/07/21 Final Product Information \| common-final-labop(bo)-2807(002)-V029Date of last change:2021/07/21 Final Product Information \| common-final-spc-2807-V029Date of last change:2021/07/21
市场状态	Positive