欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号NL/H/4137/001
药品名称Sildinafil Sandoz 25 mg, tablets
活性成分
    • sildenafil citrate 25.0 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
    • Austria (AT)
    • Belgium (BE)
    • Croatia (HR)
    • Czechia (CZ)
      SEMPAVOX
    • Germany (DE)
      SEMPAVOX 25 mg Tabletten
    • Denmark (DK)
      Sempavox
    • Estonia (EE)
    • Greece (GR)
    • Spain (ES)
    • France (FR)
    • Italy (IT)
    • Latvia (LV)
    • Lithuania (LT)
      Sempavox 25 mg tabletės
    • Portugal (PT)
    • Slovakia (SK)
    • Slovenia (SI)
    • United Kingdom (GB)
许可日期2018/09/24
最近更新日期2018/11/07
药物ATC编码
    • G04BE03 sildenafil
申请类型
  • TypeLevel1:Abridged
  • 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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