欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号UK/H/5297/002
药品名称Fluoxetine Hydrochloride
活性成分
    • fluoxetine 10.0 mg
剂型Dispersible tablet
上市许可持有人MERCURY PHARMACEUTICALS LIMITED
参考成员国 - 产品名称United Kingdom (GB)
Fluoxetine Hydrochloride
互认成员国 - 产品名称
    • Ireland (IE)
许可日期2016/10/17
最近更新日期2016/10/18
药物ATC编码
    • N06AB03 fluoxetine
申请类型
  • TypeLevel1：Abridged
  • TypeLevel2：Initial Application
  • TypeLevel3：Other Generic application Art 10.3 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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