欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DK/H/3202/001
药品名称Vildagliptin/ Metformin HCl Bluepharma
活性成分
    • metformin hydrochloride 500.0 mg
    • vildagliptin 50.0 mg
剂型Film-coated tablet
上市许可持有人Bluepharma Industria Farmaceutica S.A. Rua Da Bayer Coimbra 3045-016 Portugal
参考成员国 - 产品名称Denmark (DK)
Vildagliptin/ Metformin HCl Bluepharma
互认成员国 - 产品名称
    • Portugal (PT)
许可日期2020/12/09
最近更新日期2020/12/15
药物ATC编码
    • A10BD08 metformin and vildagliptin
申请类型
  • TypeLevel1：Abridged
  • TypeLevel2：Multiple (Copy) 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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