欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号DK/H/2729/002
药品名称Eplerenon Krka
活性成分
    • eplerenone 50.0 mg
剂型Film-coated tablet
上市许可持有人KRKA, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto, Slovenia
参考成员国 - 产品名称Denmark (DK)
Eplerenon Krka
互认成员国 - 产品名称
    • Netherlands (NL)
    • Iceland (IS)
      Eplerenon Krka 50 mg Filmuhúðuð tafla
    • United Kingdom (Northern Ireland) (XI)
    • Ireland (IE)
    • Austria (AT)
      Eplerenon HCS 50 mg Filmtabletten
    • France (FR)
    • Spain (ES)
    • Italy (IT)
    • Greece (GR)
    • Sweden (SE)
    • Norway (NO)
      Eplerenon Krka
    • Poland (PL)
      Enplerasa
    • Latvia (LV)
      Enplerasa 50 mg apvalkotās tabletes
    • Lithuania (LT)
      Apleria 50 mg plėvele dengtos tabletės
    • Estonia (EE)
      APLERIA
    • Hungary (HU)
    • Bulgaria (BG)
      Apleria 50 mg
    • Cyprus (CY)
      ALPERIA 50MG FC TABS
    • Czechia (CZ)
      Apleria 50 mg potahované tablety
    • Romania (RO)
    • Slovakia (SK)
      Apleria 50 mg filmom obalené tablety
    • Slovenia (SI)
    • Croatia (HR)
      Apleria 50 mg filmom obložene tablete
许可日期2018/06/14
最近更新日期2023/08/28
药物ATC编码
    • C03DA04 eplerenone
申请类型
  • TypeLevel1:Known Active Substance
  • 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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