欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号DE/H/7183/001
药品名称Formoterol Glenmark 12 micrograms per actuation pressurised inhalation solution
活性成分
    • formoterol 12.0 µg/dose
剂型Pressurised inhalation, solution
上市许可持有人Glenmark Arzneimittel GmbH Industriestrasse 31 82194 Groebenzell Germany
参考成员国 - 产品名称Germany (DE)
Formoterol Glenmark 12 Mikrogramm, Sprühstoß Druckgasinhalation, Lösung
互认成员国 - 产品名称
    • Czechia (CZ)
      Formoterol Glenmark
    • Netherlands (NL)
    • Spain (ES)
    • Poland (PL)
许可日期2023/09/13
最近更新日期2023/10/13
药物ATC编码
    • R03AC13 formoterol
申请类型
  • TypeLevel1:Known Active Substance
  • TypeLevel2:Initial Application
  • TypeLevel3:Other Generic application Art 10.3 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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