欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2307/001
药品名称
Sanluper
活性成分
Hydrochlorothiazide 12.5 mg
Telmisartan 40.0 mg
剂型
Tablet
上市许可持有人
Teva B.V Swensweg 5 2031 GA Haarlem - Noord-Holland Denmark
参考成员国 - 产品名称
Denmark (DK)
Sanluper
互认成员国 - 产品名称
Germany (DE)
Sanluper 40 mg/12,5 mg Tabletten
Netherlands (NL)
许可日期
2014/01/24
最近更新日期
2025/01/06
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 PL
|
common_pl
Date of last change:2024/09/06
PubAR
|
Final PAR Scientific discussion Sanluper DKH2307_001_003_DC
Date of last change:2024/09/06
PubAR Summary
|
sPAR Telmisartan_HCT DK_H_2307
Date of last change:2024/09/06
Final SPC
|
Telmisartan_HCT_DK_H_2307_001_003_SmPC
Date of last change:2024/09/06
Final Product Information
|
Telmisartan_HCT_DK_H_2307_001_003_SmPC_26_08_21
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase