欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号NL/H/5433/001
药品名称Kisilea 30 mg Solution for injection in pre-filled syringe
活性成分
    • Icatibant acetate 10.0 mg/ml
剂型Solution for injection in pre-filled syringe
上市许可持有人Viatris Limited Damastown Industrial Park Dublin 15 Ireland
参考成员国 - 产品名称Netherlands (NL)
Kisilea
互认成员国 - 产品名称
    • Germany (DE)
    • Denmark (DK)
    • France (FR)
    • Italy (IT)
    • Sweden (SE)
    • Norway (NO)
      Kisilea
    • Finland (FI)
许可日期2021/12/20
最近更新日期2025/01/08
药物ATC编码
    • B06AC02 icatibant
申请类型
  • TypeLevel1：Known Active Substance
  • TypeLevel2：Multiple (Copy) 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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