欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DK/H/1136/003
药品名称Montelukast Krka
活性成分
    • montelukast 10.0 mg
剂型Film-coated tablet
上市许可持有人KRKA Sverige AB Göta Ark 175 Medborgarplatsen 25 11872 Stockholm Sweden
参考成员国 - 产品名称Denmark (DK)
互认成员国 - 产品名称
    • Germany (DE)
      Montelukast TAD 10 mg Fillmtabletten
    • Belgium (BE)
    • Netherlands (NL)
    • United Kingdom (Northern Ireland) (XI)
    • Ireland (IE)
    • Austria (AT)
      Montelukast Krka 10 mg Filmtabletten
    • France (FR)
    • Spain (ES)
    • Portugal (PT)
    • Italy (IT)
    • Sweden (SE)
    • Latvia (LV)
    • Hungary (HU)
      MONALUX 10 mg filmtabletta
    • Cyprus (CY)
      MONTELUKAST KRKA 10mg FC TABS
    • Czechia (CZ)
      Monkasta 10mg Film-coated tablets
    • Romania (RO)
      Monkasta 10 mg comprimate filmate
    • Slovakia (SK)
      Monkasta 10 mg
    • Norway (NO)
    • Finland (FI)
    • Poland (PL)
      Monkasta
    • Lithuania (LT)
      Monkasta 10 mg plėvele dengtos tabletės
    • Estonia (EE)
    • Bulgaria (BG)
      Monkasta
    • Malta (MT)
      Monkasta 10 mg Film-coated Tablets
许可日期2008/07/31
最近更新日期2024/04/12
药物ATC编码
    • R03DC03 montelukast
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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