欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号DK/H/2658/001
药品名称Entecavir Orion
活性成分
    • entecavir hydrate 0.5 mg
剂型Film-coated tablet
上市许可持有人Orion Corporation Orionintie 1 Espoo FI-02200 Finland
参考成员国 - 产品名称Denmark (DK)
Entecavir Orion
互认成员国 - 产品名称
    • Norway (NO)
    • Sweden (SE)
许可日期2017/09/06
最近更新日期2017/09/06
药物ATC编码
    • J05AF10 entecavir
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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