欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号SE/H/1437/001
药品名称Kolekalciferol D2M
活性成分
    • colecalciferol 50000.0 IU/ml
剂型Oral solution
上市许可持有人D2M SANTE France
参考成员国 - 产品名称Sweden (SE)
互认成员国 - 产品名称
    • Italy (IT)
    • Luxembourg (LU)
    • Netherlands (NL)
      Cholecalciferol D2M 100 000 I.E. drank in ampul
    • Portugal (PT)
    • United Kingdom (GB)
    • Belgium (BE)
    • Germany (DE)
      Cholecalciferol D2M 100000 I.E. Lösung zum Einnehmen in einer Ampulle
许可日期2015/10/28
最近更新日期2015/11/24
药物ATC编码
    • A11CC05 colecalciferol
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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