欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号NL/H/5386/001
药品名称Tranylcypromine Aurobindo 20 mg Film-Coated tablets
活性成分
    • Tranylcypromine sulfate 20.0 mg
剂型Film-coated tablet
上市许可持有人Aurobindo Pharma B.V. Baarnsche Dijk 1 3741 LN Baarn The Netherlands
参考成员国 - 产品名称Netherlands (NL)
Tranylcypromine Aurobindo 20 mg, filmomhulde tabletten
互认成员国 - 产品名称
    • Malta (MT)
      Tranylcypromine Aurobindo 20 mg film coated tablets
许可日期2024/09/23
最近更新日期2024/09/25
药物ATC编码
    • N06AF04 tranylcypromine
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：1.The company decided to withdraw the application. At the time of withdrawal, the MS considered that the data provided did not allow to conclude on a positive benefit-risk balance as major objections were raised.
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