欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号SE/H/0390/001
药品名称Gammanorm
活性成分
    • Human Normal Immunoglobulin g 165.0 mg/ml
剂型Solution for injection
上市许可持有人Octapharma AB Sweden
参考成员国 - 产品名称Sweden (SE)
互认成员国 - 产品名称
    • Italy (IT)
    • Latvia (LV)
    • Lithuania (LT)
      gammanorm 165mg/ml injekcinis tirpalas
    • Romania (RO)
      Gammanorm 165 mg/ml solutie injectabila
    • Slovenia (SI)
    • Malta (MT)
    • Germany (DE)
    • Belgium (BE)
    • Netherlands (NL)
    • Luxembourg (LU)
    • Austria (AT)
      Gammanorm 165 mg/ml Injektionslösung
    • France (FR)
    • Portugal (PT)
    • Estonia (EE)
    • Hungary (HU)
      GAMMANORM 165 mg/ml oldatos injekció
    • Czechia (CZ)
    • Slovakia (SK)
      Gammanorm
许可日期2004/05/04
最近更新日期2025/07/22
药物ATC编码
    • J06BA01 immunoglobulins, normal human, for extravascular adm.
申请类型
  • TypeLevel1：Known Active Substance
  • TypeLevel2：Initial Application
  • TypeLevel3：Full Dossier Article 4.8 Di 65/65
  • TypeLevel4：Biological: Blood Product
  • TypeLevel5：Prescription Only
附件文件下载
市场状态Positive
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