欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号IS/H/0548/002
药品名称NINTEDANIB ZENTIVA
活性成分
    • nintedanib esilate 150.0 mg
剂型Capsule, soft
上市许可持有人Zentiva, k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10 Czech republic
参考成员国 - 产品名称Iceland (IS)
NINTEDANIB ZENTIVA
互认成员国 - 产品名称
    • Spain (ES)
    • Portugal (PT)
    • Sweden (SE)
    • Norway (NO)
    • Finland (FI)
    • Poland (PL)
    • Latvia (LV)
    • Lithuania (LT)
      NINTEDANIB ZENTIVA 150 mg minkštosios kapsulės
    • Estonia (EE)
    • Germany (DE)
      NINTEDANIB ZENTIVA 150 mg Weichkapseln
    • Denmark (DK)
    • France (FR)
许可日期2023/12/21
最近更新日期2024/01/30
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
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市场状态Positive
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