欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号SI/H/0320/002
药品名称Sakubitril/valsartan HCS 49 mg/51 mg Film-coated tablets
活性成分
    • Sacubitril sodium 51.21 mg
    • Valsartan 51.4 mg
剂型Film-coated tablet
上市许可持有人Hcs Hendrik Kennisstraat 53 Edegem 2650 Belgium
参考成员国 - 产品名称Slovenia (SI)
Sakubitril/valsartan HCS 49 mg/51 mg filmsko obložene tablete
互认成员国 - 产品名称
    • Sweden (SE)
    • Norway (NO)
    • Germany (DE)
      Sacubitril/Valsartan-TAD 24 mg/26 mg Filmtabletten
    • Finland (FI)
    • Denmark (DK)
      Sakubitril/Valsartan "Krka"
    • Cyprus (CY)
      Sacubitril/Valsartan TAD 49 mg/51 mg επικαλυμμένα με λεπτό υμένιο δισκία
    • Belgium (BE)
      Sacubitril/Valsartan HCS 49 mg/51 mg filmomhulde tabletten
    • Iceland (IS)
    • Ireland (IE)
    • Austria (AT)
    • France (FR)
    • Spain (ES)
    • Portugal (PT)
    • Italy (IT)
许可日期2025/07/23
最近更新日期2025/07/23
药物ATC编码
    • C09DX04 valsartan and sacubitril
申请类型
  • TypeLevel1:Abridged
  • TypeLevel2:Multiple (Copy) Application
  • TypeLevel3:Generic Art 10.1 and 10.2 Dir 2001/83/EC
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Prescription Only
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    市场状态Positive
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