欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DE/H/7346/001
药品名称Duloxetine Aristo 20 mg hard gastro-resistant capsules
活性成分
    • DULOXETINE HYDROCHLORIDE 20.0 mg
剂型Gastro-resistant capsule, hard
上市许可持有人Aristo Pharma GmbH Wallenroder Strasse 8-10 13435 Berlin Germany
参考成员国 - 产品名称Germany (DE)
Duloxetin Aristo 20 mg magensaftresistente Hartkapsel
互认成员国 - 产品名称
    • Poland (PL)
      Duloxetine Aristo
许可日期2023/02/17
最近更新日期2023/02/24
药物ATC编码
    • N06AX21 duloxetine
申请类型
  • TypeLevel1：Known Active Substance
  • TypeLevel2：Initial Application
  • 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Withdrawn（注：已撤市）
    撤市原因：2.The company decided to withdraw the application. At the time of withdrawal, the MS considered that the data provided could allow to conclude on a positive benefit-risk balance if the points for clarification identified were solved.
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