欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DK/H/3194/001
药品名称Icatibant Zentiva
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Zentiva, k.s., U kabelovny 130, Dolní Měcholupy, Prague 10, 102 37 Czechia
参考成员国 - 产品名称Denmark (DK)
Icatibant Zentiva
互认成员国 - 产品名称
    • Romania (RO)
      Icatibant Zentiva 30 mg/3 ml soluţie injectabilă în seringă preumplută
    • Slovakia (SK)
      Icatibant Zentiva
    • Germany (DE)
      Icatibant Zentiva 30 mg/3 ml Injektionslösung in einer Fertigspritze
    • France (FR)
    • Italy (IT)
    • Sweden (SE)
    • Norway (NO)
      Icatibant Zentiva
    • Finland (FI)
    • Poland (PL)
      Icatibant Zentiva
    • Czechia (CZ)
      ICATIBANT ZENTIVA
许可日期2021/09/08
最近更新日期2024/06/27
药物ATC编码
    • B06AC02 icatibant
申请类型
  • TypeLevel1：Known Active Substance
  • 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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