欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DK/H/2891/001
药品名称Dexmedetomidine Kalceks
活性成分
    • Dexmedetomidine 100.0 mcg/ml
剂型Concentrate for solution for infusion
上市许可持有人AS Kalceks Krustpils iela 53, Rīga, LV1057 Latvia
参考成员国 - 产品名称Denmark (DK)
Dexmedetomidine Kalceks
互认成员国 - 产品名称
    • Finland (FI)
    • Latvia (LV)
    • Netherlands (NL)
    • Austria (AT)
    • Germany (DE)
      Dexmedetomidin Ethypharm 100 microgarms/ml Konzentrat zur Herstellung einer Infusionslösung
    • France (FR)
    • Hungary (HU)
      DEXMEDETOMIDINE KALCEKS 100 mikrogramm/ml koncentrátum oldatos infúzióhoz
    • Sweden (SE)
    • Norway (NO)
    • Belgium (BE)
    • Spain (ES)
    • Ireland (IE)
    • Romania (RO)
    • Portugal (PT)
    • Slovenia (SI)
    • Poland (PL)
      Dexmedetomidine Kalceks
    • Bulgaria (BG)
      Dexmedetomidine Kalceks
    • Lithuania (LT)
      Dexmedetomidine Kalceks 100 mikrogramų/ml koncentratas infuziniam tirpalui
    • Croatia (HR)
    • Estonia (EE)
      DEXMEDETOMIDINE KALCEKS
    • Italy (IT)
    • Czechia (CZ)
      Dexmedetomidine Kalceks
    • Slovakia (SK)
      Dexmedetomidine Kalceks 100 mikrogramov/ml infúzny koncentrát
许可日期2019/01/17
最近更新日期2025/09/28
药物ATC编码
    • N05CM18 dexmedetomidine
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
附件文件下载
市场状态Positive
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