欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号AT/H/0359/001
药品名称Gemsol 40 mg/ml Konzentrat zur Herstellung einer Infusionslösung
活性成分
    • gemcitabine hydrochloride 40.0 mg/ml
剂型Concentrate for solution for infusion
上市许可持有人Ebewe Pharma Ges.m.b.H. Nfg. KG, Mondseestraße 11 A-4866, Unterach am Attersee
参考成员国 - 产品名称Austria (AT)
Gemsol 40 mg/ml Konzentrat zur Herstellung einer Infusionslösung
互认成员国 - 产品名称
    • Denmark (DK)
    • Belgium (BE)
    • Netherlands (NL)
      Gemsol 40 mg/ml concentraat voor oplossing voor infusie
    • France (FR)
    • Italy (IT)
    • Sweden (SE)
      Gemsol
    • Norway (NO)
    • Finland (FI)
    • Poland (PL)
    • Latvia (LV)
      Gemsol 40 mg/ml koncentrāts infūziju šķīduma pagatavošanai
    • Lithuania (LT)
      Gemsol 40 mg/ml koncentratas infuziniam tirpalui
    • Estonia (EE)
      GEMSOL 40MG/ML
    • Bulgaria (BG)
      Gemsol
    • Czechia (CZ)
      Gemliquid Ebewe 40 mg/ml
    • Slovakia (SK)
      Gemliquid 40 mg/ml
    • Slovenia (SI)
      Gemcitabin Ebewe 40 mg/ml koncentrat za raztopino za infundiranje
许可日期2010/08/17
最近更新日期2024/02/29
药物ATC编码
    • L01BC05 gemcitabine
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
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市场状态Positive
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