欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号AT/H/1331/001
药品名称Brimogen Sine 2 mg/ml eye drops, solution
活性成分
    • Brimonidine tartrate 2.0 mg/ml
剂型Eye drops, solution
上市许可持有人Pharmaselect International Beteiligungs GmbH Ernst-Melchior-Gasse 20 1020 Wien Austria
参考成员国 - 产品名称Austria (AT)
Brimogen Sine 2 mg/ml Augentropfen, Lösung
互认成员国 - 产品名称
    • Belgium (BE)
    • Bulgaria (BG)
    • Czech Republic (CZ)
      Brimogen Sine
    • Germany (DE)
      Brimogen Sine 2 mg/ml Augentropfen, Lösung
    • Spain (ES)
    • Croatia (HR)
    • Hungary (HU)
    • Italy (IT)
    • Poland (PL)
      Brimogen Sine
    • Portugal (PT)
    • Slovak Republic (SK)
许可日期2025/10/28
最近更新日期2025/11/20
药物ATC编码
    • S01EA05 brimonidine
申请类型
  • TypeLevel1:Abridged
  • TypeLevel2:Initial Application
  • TypeLevel3:Other
  • 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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