欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号DK/H/2902/002
药品名称Valsimia HCT
活性成分
    • AMLODIPINE BESILATE 5.0 mg
    • hydrochlorothiazide 25.0 mg
    • valsartan 160.0 mg
剂型Film-coated tablet
上市许可持有人ELPEN Pharmaceutical Co. Inc. 95 Marathonos Ave. Pikermi Attica 19009 Greece
参考成员国 - 产品名称Denmark (DK)
互认成员国 - 产品名称
    • Germany (DE)
      Valsimia HCT 5 mg/160 mg/25 mg Filmtabletten
    • Spain (ES)
    • Greece (GR)
    • Cyprus (CY)
      Valsimia HCT 5mg_160mg _25mg film-coated tablets
许可日期2019/05/14
最近更新日期2019/06/18
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
    市场状态Withdrawn(注:已撤市)
    撤市原因:1.The company decided to withdraw the application. At the time of withdrawal, the MS considered that the data provided did not allow to conclude on a positive benefit-risk balance as major objections were raised.
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