欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号NL/H/3305/004
药品名称Onelar 60 mg
活性成分
    • Duloxetine hydrochloride 67.35 mg
剂型Gastro-resistant capsule, hard
上市许可持有人Medochemie Ltd. 1-10 Constantinoupoleos Street 3011 Limassol
参考成员国 - 产品名称Netherlands (NL)
互认成员国 - 产品名称
    • Greece (GR)
      ONELAR
    • Estonia (EE)
      ONELAR
    • Bulgaria (BG)
      Onelar
    • Cyprus (CY)
    • Czechia (CZ)
      Onelar 60 mg
    • Romania (RO)
      Onelar 60 mg capsule gastrorezistente
    • Slovakia (SK)
      ONELAR 60 mg tvrdé gastrorezistentné kapsuly
    • Malta (MT)
    • Croatia (HR)
      Onelar 60 mg tvrde želučanootporne kapsule
    • Slovenia (SI)
许可日期2016/02/08
最近更新日期2025/02/06
药物ATC编码
    • N06AX21 duloxetine
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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