欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号DK/H/3022/001
药品名称Dronedarone Medical Valley
活性成分
    • dronedarone hydrochloride 400.0 mg
剂型Film-coated tablet
上市许可持有人Medical Valley Invest AB Brädgårdsvägen 28 236 32 - Höllviken Sweden
参考成员国 - 产品名称Denmark (DK)
Dronedarone Medical Valley
互认成员国 - 产品名称
    • Germany (DE)
      Dronedarone AXiromed 400 mg
    • Sweden (SE)
    • Norway (NO)
    • Iceland (IS)
许可日期2021/03/31
最近更新日期2021/04/07
药物ATC编码
    • C01 CARDIAC THERAPY
    • C01B ANTIARRHYTHMICS, CLASS I AND III
    • C01BD Antiarrhythmics, class III
    • C01BD07 dronedarone
申请类型
  • TypeLevel1:Abridged
  • 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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