欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DE/H/7086/001
药品名称Ipratropium Bromide/Fenoterol Hydrobromide Glenmark
活性成分
    • Fenoterol hydrobromide 0.5 mg/ml
    • Ipratropium bromide monohydrate 0.25 mg/ml
剂型Nebuliser 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)
Ipratropium bromide/Fenoterol hydrobromide Glenmark 0,25 mg/0,5 mg Lösung für einen Vernebler
互认成员国 - 产品名称
    • Czechia (CZ)
      Releta
    • Austria (AT)
许可日期2025/05/05
最近更新日期2025/05/30
药物ATC编码
    • R03AL01 fenoterol and ipratropium bromide
申请类型
  • TypeLevel1：Known Active Substance
  • TypeLevel2：Initial Application
  • TypeLevel3：Hybrid 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.
    ©2006-2025 Drugfuture->European Union HMA Authorisation of Medicines DataBase