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

MR编号	HR/H/0161/001
药品名称	Vainas Combi 5 mg/160 mg/12.5 mg film-coated tablets
活性成分	amlodipine 5.0 mg hydrochlorothiazide 12.5 mg valsartan 160.0 mg
剂型	Film-coated tablet
上市许可持有人	Belupo lijekovi i kozmetika d.d Ulica Danica 5, 48000 Koprivnica Croatia
参考成员国 - 产品名称	Croatia (HR) Vainas HCT 5 mg/160 mg/12,5 mg filmom obložene tablete
互认成员国 - 产品名称	Slovenia (SI)
许可日期	2020/05/05
最近更新日期	2024/01/30
药物ATC编码	C09DX01 valsartan, amlodipine and hydrochlorothiazide
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	PAR Summary \| Vainas HCT_PAR SummaryDate of last change:2023/06/02 PAR \| Vainas HCT_PARDate of last change:2023/06/02 Final SPC \| Vainas_HCT_common_SPC_cleanDate of last change:2023/02/27 Final PL \| Vainas_HCT_common_PL_cleanDate of last change:2023/02/27 Final Product Information \| common-LAB 10_320_25 mgDate of last change:2020/07/23 Final Product Information \| common-LAB 5_160_12,5 mgDate of last change:2020/07/23 Final Product Information \| common-PLDate of last change:2020/07/23 Final Product Information \| common-SmPCDate of last change:2020/07/23 Final Product Information \| common-LAB 10_160_12,5 mgDate of last change:2020/07/23 Final Product Information \| common-LAB 10_160_25 mgDate of last change:2020/07/23 Final Product Information \| common-LAB 5_160_25 mgDate of last change:2020/07/23
市场状态	Positive