欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号FR/H/0390/001
药品名称Gemcitabine Mylan
活性成分
    • gemcitabine hydrochloride 38.0 mg/ml
剂型Powder for solution for infusion
上市许可持有人Mylan SAS 117 Allée des Parcs 69800 Saint Priest France
参考成员国 - 产品名称France (FR)
互认成员国 - 产品名称
    • Denmark (DK)
    • Belgium (BE)
    • Netherlands (NL)
    • United Kingdom (Northern Ireland) (XI)
    • Ireland (IE)
    • Austria (AT)
    • Spain (ES)
    • Portugal (PT)
    • Italy (IT)
    • Greece (GR)
    • Poland (PL)
    • Hungary (HU)
    • Bulgaria (BG)
    • Cyprus (CY)
    • Romania (RO)
    • Slovakia (SK)
    • Slovenia (SI)
许可日期2009/03/19
最近更新日期2020/02/16
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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