欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/1524/002
药品名称
Tevavaltan Comp.
活性成分
hydrochlorothiazide 25.0 mg
valsartan 160.0 mg
剂型
Film-coated tablet
上市许可持有人
Teva B.V. Swensweg 5 2031 GA Haarlem Netherlands
参考成员国 - 产品名称
Denmark (DK)
Tevavaltan Comp.
互认成员国 - 产品名称
Netherlands (NL)
France (FR)
Italy (IT)
许可日期
2009/03/02
最近更新日期
2024/02/01
药物ATC编码
C09DA03 valsartan and diuretics
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
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
|
Tevavaltan DK_H_1524_001_002_Common SmPC_clean
Date of last change:2022/09/22
PAR
|
spc_dk1524tevaltancomp_pdf
Date of last change:2022/06/02
PAR
|
pllab_dk1524tevaltancomp_pdf
Date of last change:2022/06/02
PAR
|
parmod5_dk1524tevaltancomp_pdf
Date of last change:2022/06/02
Final PL
|
Valsartan_HCT-DK_H_1524_001-002-PIL-03.07.20_clean
Date of last change:2020/07/10
Final Labelling
|
1.3.1 combined-eu clean
Date of last change:2018/05/29
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase