欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号SE/H/1721/002
药品名称Amlodipine Valsartan Adamed
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Adamed Sp. z.o.o. Poland
参考成员国 - 产品名称Sweden (SE)
互认成员国 - 产品名称
    许可日期2020/06/23
    最近更新日期2020/06/24
    药物ATC编码
      • C09DB01 valsartan and amlodipine
    申请类型
    • TypeLevel1:Abridged
    • 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
      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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