欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号NL/H/3383/001
药品名称Gemcitabine Actavis PTC, 40 mg/ml Concentrate for solution for infusion
活性成分
    • gemcitabine hydrochloride 40.0 mg/ml
剂型Concentrate for solution for infusion
上市许可持有人Actavis Group PTC ehf. Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland Splitting procedure: New splitted procedure number is UK/H/6765/001
参考成员国 - 产品名称Netherlands (NL)
Gemcitabine Actavis PTC 40 mg/ml, concentraat voor oplossing voor infusie
互认成员国 - 产品名称
    • Iceland (IS)
      Gitrabin 40 mg/ml Innrennslisþykkni, lausn
    • Ireland (IE)
    • Slovenia (SI)
许可日期2016/01/11
最近更新日期2023/12/05
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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