欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/6240/002
药品名称
Sacubitril/Valsartan Synthon 49 mg/51 mg
活性成分
Sacubitril sodium 48.6 mg
Valsartan 51.4 mg
剂型
Film-coated tablet
上市许可持有人
Gideon Richter plc, HU
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Lithuania (LT)
Sacubitril/Valsartan Gedeon Richter 49 mg/51 mg plėvele dengtos tabletės
Estonia (EE)
Hungary (HU)
Bulgaria (BG)
Sacubitril Valsartan Gedeon Richter
Czechia (CZ)
Sacubitril/Valsartan Gedeon Richter
Romania (RO)
Slovakia (SK)
Poland (PL)
Sacubitril/Valsartan Gedeon Richter
Latvia (LV)
许可日期
2025/06/20
最近更新日期
2025/06/21
药物ATC编码
C09DX04 valsartan and sacubitril
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Additional Strength/Form
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 PL
|
M1_3_1_03_S_V_tab_001_08_core
Date of last change:2025/06/21
Final SPC
|
M1_3_1_01_S_V_tab_001_07_core
Date of last change:2025/06/21
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase