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

MR编号	DE/H/0113/001
药品名称	Bioclavid 500/125 mg Filmtabletten
活性成分	amoxicillin trihydrate 574.0 mg clavulanic acid potassium salt 149.0 mg
剂型	Film-coated tablet
上市许可持有人	Sandoz GmbH Biochemiestr. 10 6250 Kundl / Tirol Austria
参考成员国 - 产品名称	Germany (DE)
互认成员国 - 产品名称	Denmark (DK) Netherlands (NL) Amoxicilline Clavulaanzuur Sandoz Suspensie 125/31.25 (RVG 21691) Austria (AT) Curam 625 mg - Filmtabletten Portugal (PT) Greece (GR) Finland (FI) Belgium (BE)
许可日期	1997/09/04
最近更新日期	2024/04/29
药物ATC编码	J01CR02 amoxicillin and beta-lactamase inhibitor
申请类型	TypeLevel1：Known Active Substance TypeLevel2：Initial Application TypeLevel3：Full Dossier Article 4.8 Di 65/65 TypeLevel4：Chemical Substance TypeLevel5：Prescription Only
附件文件下载	Final SPC \| common_final_spc_0113_001__V109GDate of last change:2023/04/19 Final PL \| common_final_pl_0113_001__V109GDate of last change:2023/04/19 Final Labelling \| common_final_labop_0113_001__V109GDate of last change:2023/04/19 Final Product Information \| common-final-labop-0113(002-003)-V094Date of last change:2019/08/02 Final Product Information \| common-final-labop-0113(001)-V094Date of last change:2019/08/02 Final Product Information \| common-final-spc-0113(002-003)-V094Date of last change:2019/08/02 Final Product Information \| common-final-pl-0113(002-003)-V094Date of last change:2019/08/02 Final Product Information \| common-final-spc-0113(001)-V094Date of last change:2019/08/02
市场状态	Positive