欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号FI/H/0104/004
药品名称Singulair 4 mg granules
活性成分
    • montelukast 4.0 mg
剂型Granules
上市许可持有人Merck Sharp & Dohme B.V. Waarderweg 39 2031 BN HAARLEM The Netherlands
参考成员国 - 产品名称Finland (FI)
互认成员国 - 产品名称
    • Lithuania (LT)
    • Spain (ES)
    • Sweden (SE)
    • Greece (GR)
    • Italy (IT)
    • Portugal (PT)
    • Ireland (IE)
    • Luxembourg (LU)
    • Germany (DE)
    • Croatia (HR)
    • Denmark (DK)
    • Slovenia (SI)
    • Romania (RO)
      Singulair 4 mg granule
    • Malta (MT)
    • Latvia (LV)
      Singulair mini 4 mg granulas
    • Cyprus (CY)
    • Bulgaria (BG)
      Singulair
    • Norway (NO)
    • Slovakia (SK)
    • Czechia (CZ)
    • Hungary (HU)
      SINGULAIR 4 mg granulátum
    • Poland (PL)
      Singulair Mini
    • France (FR)
    • Netherlands (NL)
    • Belgium (BE)
许可日期2002/12/10
最近更新日期2024/04/25
药物ATC编码
    • R03DC03 montelukast
申请类型
  • TypeLevel1:Line Extension
  • TypeLevel2:Additional Strength/Form
  • TypeLevel3:Full Dossier Article 4.8 Di 65/65
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Prescription Only
附件文件下载
    市场状态Positive
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