欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DK/H/2131/002
药品名称Esomeprazol "Actavis"
活性成分
    • esomeprazole 40.0 mg
剂型Gastro-resistant tablet
上市许可持有人Actavis Group PTC ehf Iceland Pilot: Splitting. CMS (BE,DE,FR and NL) splitted into PT/H/1701/002, IE and UK into IE/H/0589/001-002/DC and BG into BG/H/0122/001-002/DC
参考成员国 - 产品名称Denmark (DK)
Esomeprazol "Actavis"
互认成员国 - 产品名称
    • Iceland (IS)
    • Austria (AT)
      Esomeprazol Actavis 40 mg magensaftresistente Tabletten
    • Sweden (SE)
    • Norway (NO)
      Esomeprazol Actavis
    • Finland (FI)
    • Latvia (LV)
      Esomeprazole Actavis 40 mg zarnās šķīstošās tabletes
    • Lithuania (LT)
      Esomeprazole Actavis 40 mg skrandyje neirios tabletės
    • Estonia (EE)
      ESOMEPRAZOLE ACTAVIS
    • Hungary (HU)
      ESOMEPRAZOL ACTAVIS 40 mg gyomornedv-ellenálló tabletta
许可日期2012/12/12
最近更新日期2023/12/08
药物ATC编码
    • A02BC05 esomeprazole
申请类型
  • TypeLevel1：Abridged
  • TypeLevel2：Additional Strength/Form
  • 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Positive
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