欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2306/001
药品名称
Mogilarta
活性成分
hydrochlorothiazide 12.5 mg
telmisartan 40.0 mg
剂型
Tablet
上市许可持有人
Teva Denmark A/S Parallelvej 10-12 2800 Kongens Lyngby Denmark
参考成员国 - 产品名称
Denmark (DK)
Mogilarta
互认成员国 - 产品名称
Germany (DE)
Femisar 40 mg/12,5 mg Tabletten
Italy (IT)
Hungary (HU)
TELMISARTAN/HCT-TEVA 40 mg/12,5 mg tabletta
许可日期
2014/01/24
最近更新日期
2024/07/11
药物ATC编码
C09DA07 telmisartan and diuretics
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Multiple (Copy) 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 SPC
|
Telmisartan_HCT_DK_H_2306_001_003_SmPC
Date of last change:2024/01/04
Final PL
|
Telmisartan _ HCT_DK_H_2306_001_003 _ PIL common clean
Date of last change:2022/10/28
Final Product Information
|
Telmisartan_HCT_DK_H_2306_001_003_SmPC_26_08_21
Date of last change:2022/06/02
PAR Summary
|
sPAR Telmisartan+HCT DK_H_2306
Date of last change:2015/05/05
PAR
|
Final PAR Scientific discussion Mogilarta DKH2306_001-003_DC
Date of last change:2014/11/18
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase