欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号AT/H/1072/001
药品名称Lotemax Augengel
活性成分
    • LOTEPREDNOL ETABONATE 0.5 %
剂型Eye gel
上市许可持有人Bausch Health Ireland Limited 3013 Lake Drive Citywest Business Campus Dublin 24 D24PPT Dublin Ireland
参考成员国 - 产品名称Austria (AT)
互认成员国 - 产品名称
    • Germany (DE)
      Lotemax Augengel
    • Cyprus (CY)
      LOTEMAX G ™ 0.5% eye gel
    • Malta (MT)
      Lotemax 0.5%, eye gel
    • Greece (GR)
    • Italy (IT)
    • Spain (ES)
    • Portugal (PT)
    • Poland (PL)
      Lotemax
许可日期2023/09/12
最近更新日期2023/10/05
药物ATC编码
    • S01BA14 loteprednol
申请类型
  • TypeLevel1:Known Active Substance
  • TypeLevel2:Initial Application
  • TypeLevel3:Full Dossier Art 8.3(i) 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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