欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号DK/H/3367/001
药品名称Folsyre Sandoz
活性成分
    • folic acid hydrate 1.0 mg
剂型Tablet
上市许可持有人Sandoz A/S Edvard Thomsens Vej 14 2300 Copenhagen S Denmark
参考成员国 - 产品名称Denmark (DK)
Folsyre Sandoz
互认成员国 - 产品名称
    • Sweden (SE)
    • Norway (NO)
许可日期2023/05/24
最近更新日期2023/06/01
药物ATC编码
    • B03BB01 folic acid
申请类型
  • TypeLevel1:Known Active Substance
  • TypeLevel2:Initial Application
  • TypeLevel3:Bibliographic Art 10 a 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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