欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号IT/H/0168/001
药品名称Gemcitin
活性成分
    • gemcitabine 200.0 mg
剂型Powder for solution for infusion
上市许可持有人ICN Polfa Rzeszów S.A. 2 Przemyslowa street 35-959 Rzeszów Poland
参考成员国 - 产品名称Italy (IT)
互认成员国 - 产品名称
    • Hungary (HU)
      Gemdex 200 mg por oldatos infúzióhoz
    • Romania (RO)
      Gemcitin 200 mg pulbere pentru solutie perfuzabila
许可日期2009/10/08
最近更新日期2012/07/18
药物ATC编码
    • L01BC05 gemcitabine
申请类型
  • TypeLevel1:Abridged
  • TypeLevel2:Initial Application
  • TypeLevel3:Generic Art 10.1 and 10.2 Dir 2001/83/EC
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Prescription Only
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    市场状态Positive
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