欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号HU/H/0648/001
药品名称Mikafungin Rompharm 50 mg powder for solution for infusion
活性成分
    • Micafungin 50.0 mg
剂型Powder for solution for infusion
上市许可持有人SC Rompharm Company SRL 1A Eroilor Street Otopeni Ilfov 075100 Romania tel.: +4 021 350 46 40 e-mail: office@rompharm.ro
参考成员国 - 产品名称Hungary (HU)
互认成员国 - 产品名称
    • Bulgaria (BG)
      Micafungin Rompharm
    • Romania (RO)
      Micafungin Rompharm 50 mg pulbere pentru soluție perfuzabilă
许可日期2020/09/03
最近更新日期2025/01/06
药物ATC编码
    • J02AX05 micafungin
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
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    市场状态Positive
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