欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
HR/H/0316/002
药品名称
Dipperam, 5 mg/160 mg
活性成分
Amlodipine besilate 5.0 mg
Valsartan 160.0 mg
剂型
Film-coated tablet
上市许可持有人
Sandoz B.V. Veluwezoom 22 1327 AH Almere the Netherlands
参考成员国 - 产品名称
Croatia (HR)
互认成员国 - 产品名称
Italy (IT)
Poland (PL)
Dipperam
Lithuania (LT)
Dipperam 5 mg/160 mg plėvele dengtos tabletės
Bulgaria (BG)
Dipperam
Romania (RO)
许可日期
2017/07/13
最近更新日期
2025/06/27
药物ATC编码
C09DB01 valsartan and amlodipine
申请类型
TypeLevel1:
[not specified]
TypeLevel2:
[not specified]
TypeLevel3:
[not specified]
TypeLevel4:
[not specified]
TypeLevel5:
[not specified]
附件文件下载
Final PL
|
hr_h_0316_common_pl_clean
Date of last change:2025/05/30
Final SPC
|
hr_h_0316_common_spc_clean
Date of last change:2025/05/30
Final Labelling
|
1_3_1 spc_label_pl _ common_outer _ 6_049
Date of last change:2024/09/06
PubAR
|
171221 NL_H_3800_001_003_DC Dipperam PAR
Date of last change:2024/09/06
PubAR Summary
|
171221 NL_H_3800_001_003_DC Dipperam summary EN
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase