欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
CZ/H/0799/004
药品名称
VALTRICOM
活性成分
amlodipine besilate 10.0 mg
hydrochlorothiazide 25.0 mg
valsartan 160.0 mg
剂型
Film-coated tablet
上市许可持有人
Krka d.d. Novo mesto Šmarješka cesta 6 Novo mesto 8501 Slovenia
参考成员国 - 产品名称
Czechia (CZ)
VALTRICOM
互认成员国 - 产品名称
Poland (PL)
Valtricom
Latvia (LV)
Valtricom 10 mg/160 mg/25 mg apvalkotās tabletes
Lithuania (LT)
Valtricom 10 mg/160 mg/25 mg plėvele dengtos tabletės
Estonia (EE)
VALTRICOM
Hungary (HU)
Bulgaria (BG)
Co-Walmox
Romania (RO)
Slovakia (SK)
Slovenia (SI)
Valtricom 10 mg/160 mg/25 mg filmsko obložene tablete
Croatia (HR)
Valtricom 10 mg/160 mg/25 mg filmom obložene tablete
许可日期
2019/01/21
最近更新日期
2023/08/28
药物ATC编码
C09DX01 valsartan, amlodipine and hydrochlorothiazide
申请类型
TypeLevel1:
Known Active Substance
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_combined_clean
Date of last change:2023/08/17
Final SPC
|
final_common_SPC_AT_H_1042_001_005_IA_015_clean
Date of last change:2022/07/13
Final PL
|
final_common_PIL_AT_H_1042_001_005_IA_015_clean
Date of last change:2022/07/13
PAR
|
PAR cz -H-799-823-824-829-DC
Date of last change:2019/10/22
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase