欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号PT/H/2583/001
药品名称Nintedanib
活性成分
    • nintedanib 100.0 mg
剂型Capsule, soft
上市许可持有人Eugia Pharma (Malta) Limited
参考成员国 - 产品名称Portugal (PT)
互认成员国 - 产品名称
    • Italy (IT)
    • Poland (PL)
      Nintedanib Eugia
    • Germany (DE)
      Nintedanib PUREN 100 mg Weichkapseln
    • Belgium (BE)
      Nintedanib Eugia 100 mg zachte capsules
    • Netherlands (NL)
      Nintedanib Eugia 100 mg, zachte capsules
    • France (FR)
    • Spain (ES)
许可日期2024/11/12
最近更新日期2024/11/12
药物ATC编码
    • L01EX09 nintedanib
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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