欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号SE/H/2064/001
药品名称Icatibant Teva
活性成分
    • Icatibant acetate 30.0 mg
剂型Solution for injection in pre-filled syringe
上市许可持有人Teva B.V: Swensweg 5 Haarlem 2031GA Netherlands
参考成员国 - 产品名称Sweden (SE)
互认成员国 - 产品名称
    • Netherlands (NL)
      Icatibant Teva 30 mg oplossing voor injectie, in voorgevulde spuit
    • Austria (AT)
      Icatibant ratiopharm 30 mg Injektionslösung in einer Fertigspritze
    • Italy (IT)
    • Norway (NO)
    • Finland (FI)
    • Lithuania (LT)
      Icatibant Teva 30 mg injekcinis tirpalas užpildytame švirkšte
    • Estonia (EE)
      ICATIBANT TEVA
    • Hungary (HU)
      Icatibant Teva 30 mg oldatos injekció előretöltött fecskendőben
    • Denmark (DK)
      Icatibant Teva
    • Croatia (HR)
      Ikatibant Teva 30 mg otopina za injekciju u napunjenoj štrcaljki
    • Belgium (BE)
      Icatibant Teva 30 mg oplossing voor injectie in een voorgevulde spuit
    • United Kingdom (Northern Ireland) (XI)
许可日期2021/06/02
最近更新日期2025/02/07
药物ATC编码
    • B06AC02 icatibant
申请类型
  • TypeLevel1：Abridged
  • 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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