欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号IS/H/0228/001
药品名称Esomeprazole Elpen
活性成分
    • esomeprazole sodium salt 40.0 mg
剂型Powder for solution for injection/infusion
上市许可持有人Win Medica Ltd, Greece ELPEN Pharmaceutical Co, Inc., 95 Marathonos Ave., 190 09, Pikermi Attica, Greece
参考成员国 - 产品名称Iceland (IS)
Esomeprazole Win Medica 40 mg/ml Stungulyfs-/innrennslisstofn, lausn
互认成员国 - 产品名称
    许可日期2014/12/09
    最近更新日期2022/06/02
    药物ATC编码
      • A02BC05 esomeprazole
    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)
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