欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号NL/H/4139/003
药品名称Sildenafil Sandoz 75 mg, tablets
活性成分
    • sildenafil citrate 75.0 mg
剂型Tablet
上市许可持有人Sandoz B.V. Veluwezoom 22 Almere, The Netherlands
参考成员国 - 产品名称Netherlands (NL)
互认成员国 - 产品名称
    • Germany (DE)
      Silde - 1A Pharma 75 mg Tabletten
    • Austria (AT)
许可日期2018/09/24
最近更新日期2018/10/25
药物ATC编码
    • G04BE03 sildenafil
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.
    ©2006-2024 Drugfuture->European Union HMA Authorisation of Medicines DataBase