欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
IS/H/0126/003
药品名称
Almertan
活性成分
Hydrochlorothiazide 25.0 mg
Valsartan 160.0 mg
剂型
Film-coated tablet
上市许可持有人
EGIS Pharmaceuticals PLC Keresztúri út 30-38, H-1106 Budapest Hungary
参考成员国 - 产品名称
Iceland (IS)
互认成员国 - 产品名称
Poland (PL)
Tensart HCT
Hungary (HU)
TENSART HCT 160 mg/25 mg filmtabletta
Bulgaria (BG)
Sarteg HCT
Czechia (CZ)
BLESSIN PLUS H 160/25mg
许可日期
2008/10/30
最近更新日期
2025/04/08
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 Product Information
|
IS_H_0126_001_003_IA_041_PI_clean_Almertan_8_4_2025
Date of last change:2025/04/08
PubAR
|
IS_H_0125_0126_ 0128_ 0132_0134_0137_MR_PAR_ValsartanHCT_Actavis
Date of last change:2024/09/06
Final Labelling
|
IS_H_0126_001_003_P_001_PI_Clean_Almertan_EGIS Pharmaceuticals PLC_11_12_2018
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase