欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号PT/H/1745/001
药品名称Accord Healthcare Limited
活性成分
    • miglustat 4.0 mg
剂型Capsule, hard
上市许可持有人Accord Healthcare Limited
参考成员国 - 产品名称Portugal (PT)
互认成员国 - 产品名称
    • Germany (DE)
      Miglustat Accord 100 mg Hartkapseln
    • France (FR)
    • Italy (IT)
    • Finland (FI)
    • Poland (PL)
      Miglustat Accord
    • Czechia (CZ)
      Miglustat Accord 100 mg tvrdé tobolky
    • Romania (RO)
      Miglustat Accord 100 mg capsule
    • Slovakia (SK)
      Miglustat Accord 100 mg tvrdeé kapsuly
许可日期2017/10/29
最近更新日期2024/11/25
药物ATC编码
    • A16AX06 miglustat
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Positive
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