欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号SE/H/1661/001
药品名称VALSIMIA PLUS
活性成分
    • AMLODIPINE BESILATE 5.0 mg
    • hydrochlorothiazide 12.5 mg
    • valsartan 160.0 mg
剂型Film-coated tablet
上市许可持有人ELPEN Pharmaceutical Co. Inc. Greece
参考成员国 - 产品名称Sweden (SE)
VALSIMIA PLUS
互认成员国 - 产品名称
    • Cyprus (CY)
      VALSIMIA PLUS 5MG/160MG/12.5MG FC TABS
    • Greece (GR)
      VALSIMIA PLUS®
    • Germany (DE)
      VALSIMIA PLUS 5 mg/160 mg/12,5 mg Filmtabletten
许可日期2018/02/07
最近更新日期2018/02/08
药物ATC编码
    • C09DX01 valsartan, amlodipine and hydrochlorothiazide
申请类型
  • TypeLevel1：Known Active Substance
  • TypeLevel2：Initial Application
  • TypeLevel3：Full Dossier Art 8.3(i) 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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