欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号UK/H/5914/001
药品名称Finasteride 1 mg film-coated tablets
活性成分
    • finasteride 1.0 mg
剂型Film-coated tablet
上市许可持有人Ascend Laboratories (UK) Limited, 51 h Floor, 89,' New Bond Street, Londop., W1S1DA, United Kingdonj
参考成员国 - 产品名称United Kingdom (GB)
Finasteride 1 mg film-coated tablets
互认成员国 - 产品名称
    • Poland (PL)
      Finasteride Ascend
    • Spain (ES)
    • Romania (RO)
    • France (FR)
    • Germany (DE)
      Finasteride 1 mg Filmtabletten
许可日期2016/04/04
最近更新日期2016/04/27
药物ATC编码
    • D11AX10 finasteride
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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