欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号MT/H/0520/002
药品名称Meldopharm 500 mg/5 ml solution for injection
活性成分
    • meldonium dihydrate 500.0 mg /5ml
剂型Solution for injection
上市许可持有人Pharmexon Consulting s.r.o Pitterova 2855/7 Prague, 13000 Czechia
参考成员国 - 产品名称Malta (MT)
Meldopharm 500 mg/5 ml solution for injection
互认成员国 - 产品名称
    • Bulgaria (BG)
    • Cyprus (CY)
      Mildronate 500 mg/5 ml ενέσιμο διάλυμα
    • Romania (RO)
      Mildronate 500 mg/5 ml soluție injectabilă
    • Slovakia (SK)
许可日期2025/03/05
最近更新日期2025/03/05
药物ATC编码
    • C01EB22 meldonium
申请类型
  • TypeLevel1:Known Active Substance
  • TypeLevel2:Additional Strength/Form
  • 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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