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

MR编号	DK/H/2188/001
药品名称	Solifenacinsuccinat "Teva"
活性成分	solifenacin succinate 5.0 mg
剂型	Film-coated tablet
上市许可持有人	Teva Denmark A/S Parallelvej 10-12 2800 Kgs. Lyngby Denmark
参考成员国 - 产品名称	Denmark (DK) Solifenacinsuccinat "Teva"
互认成员国 - 产品名称	Belgium (BE) France (FR) Netherlands (NL) United Kingdom (Northern Ireland) (XI) Croatia (HR) Solifenacin Pliva 5 mg filmom obložene tablete Czechia (CZ) Solifenacin Teva 5 mg Spain (ES) Italy (IT) Finland (FI)
许可日期	2013/11/07
最近更新日期	2023/03/22
药物ATC编码	G04BD08 solifenacin
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 Labelling \| 1.3.1 combined-5mg_10mg-eu cleanDate of last change:2019/04/11 Final SPC \| 1.3.1 spc-eu-5mg_10mg cleanDate of last change:2019/04/11 Final PL \| 1.3.1 pil-eu-5mg_10mg cleanDate of last change:2019/04/11 PAR \| PAR_DK_H_2188_001_DC_PARDate of last change:2018/01/24 PAR \| PAR Update_DK_H_2188_001_002_DC_repeat use II_Module 6Date of last change:2018/01/24 PAR Summary \| Final sPAR Solifenacinsuccinat Teva 5 mg 10 mg film-coated tablets DKH2188_001_002_DCDate of last change:2016/08/22 Final Product Information \| 1.3.1-spc-5mg-10mg-eu-cleanDate of last change:2014/02/12 Final Product Information \| 1.3.1 label-outer-5mg-cleanDate of last change:2014/02/12 Final Product Information \| 1.3.1 label-outer-10mg-cleanDate of last change:2014/02/12 Final Product Information \| 1.3.1 PIL-5mg-10mg-cleanDate of last change:2014/02/12
市场状态	Positive