欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/2149/002
药品名称
Amlodipina + Valsartan + Hidroclorotiazida Macleods
活性成分
amlodipine besilate 13.87 mg
hydrochlorothiazide 12.5 mg
valsartan 160.0 mg
剂型
Film-coated tablet
上市许可持有人
Macleods Pharma España, SLU
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Germany (DE)
Amlodipine / Valsartan/ Hydrochlorothiazid Macleods 5 mg/160 mg/ 25 mg Filmtabletten
Spain (ES)
Poland (PL)
许可日期
2019/08/28
最近更新日期
2024/02/27
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
Final Product Information
|
common-outer-final
Date of last change:2019/10/01
Final Product Information
|
common-pl-avh-final
Date of last change:2019/10/01
Final Product Information
|
common-spc-avh-final
Date of last change:2019/10/01
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase