欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号CZ/H/0170/002
药品名称Septanazal for children
活性成分
    • dexpanthenol 50.0 mg
    • xylometazoline hydrochloride 0.5 mg
剂型Nasal spray*
上市许可持有人Krka, d.d., Novo mesto, Novo mesto
参考成员国 - 产品名称Czechia (CZ)
SEPTANAZAL PRO DĚTI 0,5 MG/50 MG V 1 ML
互认成员国 - 产品名称
    • Poland (PL)
      Septanazal dla dzieci
    • Latvia (LV)
    • Lithuania (LT)
      Septanazal 0,5 mg/50 mg/ml nosies purškalas (tirpalas), vaikams
    • Estonia (EE)
      SEPTANAZAL
    • Hungary (HU)
      SEPTANAZAL 1 mg/1 ml + 50 mg/1 ml oldatos orrspray felnőtteknek
    • Bulgaria (BG)
      Septanazal
    • Romania (RO)
      Septanazal pentru copii 0,5 mg/50 mg in 1 ml spray nazal, solutie
    • Slovakia (SK)
      Septanazal sprej pre deti
    • Slovenia (SI)
许可日期2013/07/29
最近更新日期2023/11/14
药物ATC编码
    • R01AB06 xylometazoline
申请类型
  • TypeLevel1:Abridged
  • TypeLevel2:Initial Application
  • TypeLevel3:Other Generic application Art 10.3 Dir 2001/83/EC
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Non Prescription (including OTC)
附件文件下载
市场状态Positive
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