欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号NL/H/2447/002
药品名称Gemcitabine 38 mg/ml Concentrate for Solution for Infusion
活性成分
    • gemcitabine hydrobromide 38.0 mg/ml
剂型Concentrate for solution for infusion
上市许可持有人Fresenius Kabi Nederland BV Amersfoortseweg 10E 3712BC Huis ter Heide The Netherlands
参考成员国 - 产品名称Netherlands (NL)
Gemcitabine Fresenius Kabi 38 mg/ml concentraat voor oplossing voor infusie
互认成员国 - 产品名称
    • Slovakia (SK)
    • Denmark (DK)
    • Belgium (BE)
      Gemcitabine Fresenius Kabi 38 mg/ml concentraat voor oplossing voor infusie (xx mg/xx ml)
    • Luxembourg (LU)
    • Iceland (IS)
      Gemkabi 38 mg/ml Innrennslisþykkni, lausn
    • United Kingdom (Northern Ireland) (XI)
    • Ireland (IE)
    • Austria (AT)
      Gemcitabin Kabi 38 mg/ml Konzentrat zur Herstellung einer Infusionslösung
    • France (FR)
    • Portugal (PT)
    • Sweden (SE)
    • Norway (NO)
      Gemkabi
    • Finland (FI)
    • Poland (PL)
    • Latvia (LV)
      Gemcitabine Kabi 38 mg/ml koncentrāts infūziju šķīduma pagatavošanai
    • Lithuania (LT)
      Gemcitabine Kabi 38 mg/ml koncentratas infuziniam tirpalui
    • Estonia (EE)
      GEMCITABINE KABI 38 MG/ML
    • Hungary (HU)
      GEMCITABIN KABI 38 mg/ml koncentrátum oldatos infúzióhoz
    • Czechia (CZ)
      GEMCITABINE KABI 38 MG/ML KONCENTRÁT PRO INFUZNÍ ROZTOK
    • Romania (RO)
      Gemcitabina Kabi 38 mg/ml concentrat pentru soluţie perfuzabilă
    • Slovenia (SI)
    • Malta (MT)
      Gemcitabine 38 mg/ml concentrate for
许可日期2014/10/15
最近更新日期2024/02/13
药物ATC编码
    • L01BC05 gemcitabine
申请类型
  • TypeLevel1:Line Extension
  • TypeLevel2:Additional Strength/Form
  • 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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