欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DK/H/3139/001
药品名称Sitagliptin/Metformin HCl Tiefenbacher
活性成分
    • metformin hydrochloride 500.0 mg
    • SITAGLIPTIN hydrochloride 50.0 mg
剂型Film-coated tablet
上市许可持有人Alfred E. Tiefenbacher GmbH & Co. KG Van-Der-Smissen-Straße 1 Altona-Altstadt 22767 Hamburg Germany
参考成员国 - 产品名称Denmark (DK)
互认成员国 - 产品名称
    • Cyprus (CY)
      Simebetes 50/500mg FCT
    • Malta (MT)
许可日期2021/01/08
最近更新日期2022/03/29
药物ATC编码
    • A10BD07 metformin and sitagliptin
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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