欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号EE/H/0252/001
药品名称Midazolam Kalceks
活性成分
    • Midazolam 5.0 mg/ml
剂型Solution for injection/infusion
上市许可持有人AS KALCEKS Krustpils iela 53, Rīga, Latvia
参考成员国 - 产品名称Estonia (EE)
互认成员国 - 产品名称
    • Germany (DE)
      Midazolam Kalceks 5 mg/ml Injektions-/Infusionslösung
    • Poland (PL)
      Midazolam Kalceks
    • Latvia (LV)
      Midazolam Kalceks 5 mg/ml šķīdums injekcijām/infūzijām
    • Lithuania (LT)
      Midazolam Kalceks 5 mg/ml injekcinis ar infuzinis tirpalas
    • Hungary (HU)
      MIDAZOLAM KALCEKS 5 mg/ml oldatos injekció vagy infúzió
    • Czechia (CZ)
      Midazolam Kalceks
    • Slovakia (SK)
      Midazolam Kalceks 5 mg/ml injekčný/infúzny roztok
    • Croatia (HR)
    • Austria (AT)
    • Belgium (BE)
    • Bulgaria (BG)
      Midazolam Kalceks
    • France (FR)
    • Ireland (IE)
    • Italy (IT)
    • Netherlands (NL)
    • Sweden (SE)
许可日期2018/06/10
最近更新日期2024/10/24
药物ATC编码
    • N05CD08 midazolam
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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