欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号EE/H/0258/001
药品名称Hydromorphone Kalceks
活性成分
    • hydromorphone hydrochloride 2.0 mg/ml
剂型Solution for injection/infusion
上市许可持有人AS KALCEKS Krustpils iela 53 Riga LV-1057 Latvia
参考成员国 - 产品名称Estonia (EE)
Hydromorphone Kalceks
互认成员国 - 产品名称
    • Germany (DE)
      Hydromorphone Ethypharm 2 mg/ml Injektions-/Infusionslösung
    • Denmark (DK)
      Hydromorphonhydrochlorid "Kalceks"
    • Netherlands (NL)
    • Austria (AT)
      Hydromorphon Kalceks 2 mg/ml Injektions-/Infusionslösung
    • Sweden (SE)
    • Norway (NO)
      Hydromorfonhydroklorid Kalceks
    • Finland (FI)
    • Latvia (LV)
      Hydromorphone Kalceks 2 mg/ml šķīdums injekcijām/infūzijām
许可日期2018/11/04
最近更新日期2023/04/27
药物ATC编码
    • N02AA03 hydromorphone
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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