欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号IS/H/0545/001
药品名称Nintedanib STADA
活性成分
    • nintedanib esilate 100.0 mg
剂型Capsule, soft
上市许可持有人STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany
参考成员国 - 产品名称Iceland (IS)
Nintedanib STADA
互认成员国 - 产品名称
    • Romania (RO)
      NIDOTEN 100 mg capsule moi
    • Austria (AT)
    • Ireland (IE)
    • Croatia (HR)
    • France (FR)
    • Portugal (PT)
    • Spain (ES)
    • Slovakia (SK)
    • Greece (GR)
    • Slovenia (SI)
    • Sweden (SE)
    • Malta (MT)
      Nintedanib IPF 100mg Soft Capsules
    • Norway (NO)
    • Finland (FI)
    • Germany (DE)
      NIDOTEN 100 mg Weichkapseln
    • Poland (PL)
    • Denmark (DK)
    • Latvia (LV)
    • Belgium (BE)
      Nintedanib EG 100 mg zachte capsules
    • Lithuania (LT)
    • Netherlands (NL)
    • Estonia (EE)
    • Luxembourg (LU)
许可日期2023/12/21
最近更新日期2025/09/26
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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