欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号HU/H/0791/003
药品名称Xuvelex XR 1000 mg prolonged-release tablet
活性成分
    • metformin hydrochloride 1000.0 mg
剂型Prolonged-release tablet
上市许可持有人Egis Pharmaceuticals PLC Keresztúri út 30-38 Budapest 1106 Hungary Telephone +36-1-803-2414 E-mail registry@egis.hu
参考成员国 - 产品名称Hungary (HU)
互认成员国 - 产品名称
    • Romania (RO)
    • Poland (PL)
      Xuvelex XR
    • Czechia (CZ)
      Xuvelex XR
许可日期2022/12/06
最近更新日期2022/12/09
药物ATC编码
    • A10BA02 metformin
申请类型
  • TypeLevel1:Known Active Substance
  • 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Positive
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