欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号PT/H/0120/002
药品名称Ondansetron Hikma 8mg/4ml Solution for Injection
活性成分
    • ondansetron hydrochloride 8.0 mg/4ml
剂型Solution for injection
上市许可持有人Hikma Farmacêutica (Portugal), Lda Estrada do Rio da Mó No.8, 8A e 8B - Fervença 2705-906 Terrugem SNT Portugal
参考成员国 - 产品名称Portugal (PT)
互认成员国 - 产品名称
    • France (FR)
    • Spain (ES)
    • Belgium (BE)
      Ondansetron Hikma 2 mg/ml solution injectable (4 ml)
    • Germany (DE)
      Ondansetron Hikma 8 mg /4 ml Infusionslösung
    • Netherlands (NL)
    • Austria (AT)
      Ondansetron Hikma 8 mg/4 ml Injektionslösung
    • Italy (IT)
许可日期2006/05/16
最近更新日期2024/06/25
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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