欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号NL/H/3275/003
药品名称Arpilif 15 mg
活性成分
    • aripiprazole 15.0 mg
剂型Tablet
上市许可持有人Elpen Pharmaceutical Co. Inc. 95 Marathonos Ave., 19009, Pikermi, Attica, Greece
参考成员国 - 产品名称Netherlands (NL)
Arpilif 15 mg, Tabletten
互认成员国 - 产品名称
    • Germany (DE)
      Arpilif 15 mg Tabletten
    • Cyprus (CY)
      APRILIF 15MG TABS
    • Greece (GR)
      ARPILIF
    • Hungary (HU)
    • Italy (IT)
许可日期2015/04/03
最近更新日期2015/08/08
药物ATC编码
    • N05AX12 aripiprazole
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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