欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号HU/H/0371/002
药品名称RESTIGULIN 15 mg filmtabletta
活性成分
    • aripiprazole 15.0 mg
剂型Film-coated tablet
上市许可持有人Gedeon Richter Plc. Gyömrői street 19-21., Budapest H-1103 Hungary Telephone: + 36 1 431 4040 Telefax: + 36 1 431 5415
参考成员国 - 产品名称Hungary (HU)
RESTIGULIN 15 mg tabletta
互认成员国 - 产品名称
    • Czechia (CZ)
      Amdoal 15 mg
    • Poland (PL)
    • Bulgaria (BG)
    • Romania (RO)
许可日期2015/04/28
最近更新日期2023/04/27
药物ATC编码
    • N05AX12 aripiprazole
申请类型
  • TypeLevel1:Known Active Substance
  • TypeLevel2:Initial Application
  • TypeLevel3:Generic Art 10.1 and 10.2 Dir 2001/83/EC
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Prescription Only
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市场状态Positive
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