欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0467/002
药品名称
Valsartan + HCTZ Covartix
活性成分
hydrochlorothiazide 12.5 mg
valsartan 160.0 mg
剂型
Film-coated tablet
上市许可持有人
Pentafarma - Soc. Técnico-Medicinal, S.A.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Italy (IT)
许可日期
2012/08/17
最近更新日期
2020/04/24
药物ATC编码
C09DA03 valsartan and diuretics
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 SPC
|
summary-product-characteristics-160-12-5mg-final
Date of last change:2012/08/17
Final SPC
|
summary-product-characteristics-160-25mg-final
Date of last change:2012/08/17
Final SPC
|
summary-product-characteristics-320-12-5mg-final
Date of last change:2012/08/17
Final SPC
|
summary-product-characteristics-320-25mg-final
Date of last change:2012/08/17
Final SPC
|
summary-product-characteristics-80-12-5mg-final
Date of last change:2012/08/17
Final PL
|
package-leaflet-160-12-5mg-final
Date of last change:2012/08/17
Final PL
|
package-leaflet-160-25mg-final
Date of last change:2012/08/17
Final PL
|
package-leaflet-320-12-5mg-final
Date of last change:2012/08/17
Final PL
|
package-leaflet-320-25mg-final
Date of last change:2012/08/17
Final PL
|
package-leaflet-80-12-5mg-final
Date of last change:2012/08/17
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase