欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号PT/H/1557/001
药品名称Ondansetrom Aurovitas
活性成分
    • ondansetron hydrochloride 2.49 mg
剂型Solution for injection/infusion
上市许可持有人Aurovitas Unipessoal, Lda.
参考成员国 - 产品名称Portugal (PT)
互认成员国 - 产品名称
    • Germany (DE)
      Ondansetron Aurobindo 2 mg/ml Injektions-/Infusionslösung
    • Belgium (BE)
      Ondansetron AB 2 mg/ml oplossing voor injectie of infusie
    • Luxembourg (LU)
    • Spain (ES)
    • Italy (IT)
许可日期2017/01/11
最近更新日期2024/03/27
药物ATC编码
    • A04AA01 ondansetron
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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