欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号SI/H/0116/001
药品名称Sempra control 20 mg gastro-resistant capsules, hard
活性成分
    • esomeprazole magnesium salt 20.0 mg
剂型Gastro-resistant capsule, hard
上市许可持有人Krka d.d., Slovenia
参考成员国 - 产品名称Slovenia (SI)
Sempra 20 mg trde gastrorezistentne kapsule
互认成员国 - 产品名称
    • Estonia (EE)
    • Bulgaria (BG)
    • Germany (DE)
      Sempra 20 mg magensaftresistente Hartkapseln
    • Spain (ES)
    • Slovakia (SK)
      Esozoll 20 mg tvrdé gastrorezistentné kapsuly
许可日期2010/06/29
最近更新日期2023/10/19
药物ATC编码
    • A02BC05 esomeprazole
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
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市场状态Positive
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