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

MR编号	DK/H/2327/001
药品名称	Pivmecillinamhydrochlorid "Karo Pharma"
活性成分	pivmecillinam hydrochloride 400.0 mg
剂型	Film-coated tablet
上市许可持有人	Karo Pharma AB Box 16184 103 24 Stockholm Sweden
参考成员国 - 产品名称	Denmark (DK) Pivmecillam "Leo"
互认成员国 - 产品名称	Ireland (IE) Germany (DE) Selexid 400 Belgium (BE) Selexid 400mg filmomhulde tabletten Netherlands (NL) Luxembourg (LU) Selexid 400 mg Comprimé pelliculé Spain (ES) Italy (IT) Poland (PL)
许可日期	2014/09/10
最近更新日期	2024/02/16
药物ATC编码	J01CA08 pivmecillinam
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 \| PL 20200723 Pivmecillinamhydrochlorid Karo Pharma tab_proposed_II_010_cleanDate of last change:2023/09/29 Final SPC \| SmPC 20200723 Pivmecillinamhydrochlorid Karo Pharma tab_proposed II_010_cleanDate of last change:2023/09/29 Final Labelling \| 1.0 Label - Selexid DCP - 400 mg - Common_Karo Pharma - cleanDate of last change:2019/09/10 PAR \| Updated PAR Pivmecillinamhydrochlorid LEO DKH2327_001_DCDate of last change:2017/05/22 Final Product Information \| common-impackDate of last change:2015/12/29 Final Product Information \| common-outerDate of last change:2015/12/29 Final Product Information \| common-plDate of last change:2015/12/29 Final Product Information \| common-spcDate of last change:2015/12/29 PAR Summary \| Final sPAR Pivmecillinamhydrochlorid LEO DKH2327_001_DCDate of last change:2015/09/18
市场状态	Positive