欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号NL/H/4731/001
药品名称Omexir 10 mg gastro-resistant capsules, hard
活性成分
    • omeprazole 10.0 mg
剂型-
上市许可持有人Laboratorios Liconsa S.A. De Carles III 98, Planta 7 08028 Barcelona Spain
参考成员国 - 产品名称Netherlands (NL)
Omexir 10 mg harde maagsapresistente capsules
互认成员国 - 产品名称
    • Germany (DE)
      Omexiv 10 mg magensaftresistente Hartkapseln
    • Denmark (DK)
    • Finland (FI)
    • Norway (NO)
    • Poland (PL)
    • Sweden (SE)
许可日期2020/03/19
最近更新日期2020/03/19
药物ATC编码
    • A02BC01 omeprazole
申请类型
  • TypeLevel1:Abridged
  • TypeLevel2:Multiple (Copy) 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)
    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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