欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DK/H/2948/001
药品名称Macacillin
活性成分
    • benzathine benzylpenicillin 1.2 million IU
剂型Powder and solvent for suspension for injection
上市许可持有人Macure Pharma ApS Hejrevej 39 2400 Copenhagen NV Denmark
参考成员国 - 产品名称Denmark (DK)
Macacillin
互认成员国 - 产品名称
    • Finland (FI)
      Macacillin 1.2 MIU, 2.4 MIU
    • Norway (NO)
      Midomil
    • Sweden (SE)
    • Estonia (EE)
    • Lithuania (LT)
    • Latvia (LV)
许可日期2021/10/14
最近更新日期2021/11/04
药物ATC编码
    • J01CE08 benzathine benzylpenicillin
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Withdrawn（注：已撤市）
    撤市原因：1.The company decided to withdraw the application. At the time of withdrawal, the MS considered that the data provided did not allow to conclude on a positive benefit-risk balance as major objections were raised.
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