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

MR编号	DE/H/5192/001
药品名称	AMOXICLAV IBISQUS 500 mg/100 mg Pulver zur Herstellung einer Injektions-/Infusionslösung
活性成分	amoxicillin 500.0 mg clavulanic acid 100.0 mg
剂型	Powder for solution for injection/infusion
上市许可持有人	Istituto Biochimico Italiano G. Lorenzini SpA Via Fossignano 2 04011 Aprilia Italy
参考成员国 - 产品名称	Germany (DE) Amoxicillin/Clavulan-säure Ivowen 500 mg/100 mg Pulver zur Herstellung einer Injektions-/ Infusionslösung
互认成员国 - 产品名称	Belgium (BE) Malta (MT) Netherlands (NL) Ireland (IE) Austria (AT)
许可日期	2019/05/02
最近更新日期	2023/10/19
药物ATC编码	J01CR02 amoxicillin and beta-lactamase inhibitor
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 PL \| final_common_pl_5192_003__006Date of last change:2023/05/17 Final SPC \| final_common_spc_5192_003__006Date of last change:2023/05/17 Final Product Information \| common-final-label-5192(001-002)-V004Date of last change:2021/11/19 Final Product Information \| common-final-label-5192(003)-V004Date of last change:2021/11/19 Final Product Information \| common-final-spc-5192(001-002)-V004Date of last change:2021/11/19 Final Product Information \| common-final-pl-5192(001-002)-V004Date of last change:2021/11/19 Final Product Information \| common-final-pl-5192(003)-V004Date of last change:2021/11/19 Final Product Information \| common-final-spc-5192(003)-V004Date of last change:2021/11/19 PAR \| 2199627-29_PAREN_DE 5192_Amoxiclav IvowenDate of last change:2019/10/28
市场状态	Positive