欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DK/H/3110/001
药品名称Vildagliptin/Metformin HCl 50 mg/500 mg film-coated tablets
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Merck Healthcare KGaA Frankfurter Strasse 250 Darmstadt, 64293 Hesse Germany
参考成员国 - 产品名称Denmark (DK)
Gluaddo Duo
互认成员国 - 产品名称
    • Hungary (HU)
    • Malta (MT)
    • Poland (PL)
      GluaddaMet
    • Portugal (PT)
    • Romania (RO)
      Gluaddo Duo 50 mg/500 mg comprimate filmate
许可日期2020/12/09
最近更新日期2021/02/23
药物ATC编码
    • A10BD08 metformin and vildagliptin
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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