欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号AT/H/0741/001
药品名称Bendamustine Hikma 2.5 mg/ml Powder for concentrate for solution for infusion
活性成分
    • bendamustine hydrochloride 2.5 mg/ml
剂型Powder for concentrate for solution for infusion
上市许可持有人Hikma Farmacêutica (Portugal) S.A. Estrada Rio Da Mo 8, 8-A e 8-B Fervença, 2705-906 Terrugem Snt, Lisbon, Portugal
参考成员国 - 产品名称Austria (AT)
Bendamustin Hikma 2.5 mg/ml Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
互认成员国 - 产品名称
    • Germany (DE)
      Bendamustin Hikma 2.5 mg/ml Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
    • United Kingdom (Northern Ireland) (XI)
    • France (FR)
    • Spain (ES)
    • Portugal (PT)
    • Italy (IT)
许可日期2019/08/14
最近更新日期2024/01/17
药物ATC编码
    • L01AA09 bendamustine
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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