欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号CZ/H/0643/001
药品名称XYLOMETAZOLIN/DEXPANTHENOL KRKA 0,5MG/ML+50MG/ML
活性成分
    • dexpanthenol 50.0 mg
    • xylometazoline hydrochloride 0.5 mg
剂型Nasal spray, solution
上市许可持有人Krka, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenia
参考成员国 - 产品名称Czechia (CZ)
XYLOMETAZOLIN/DEXPANTHENOL KRKA
互认成员国 - 产品名称
    • Germany (DE)
      Septanasal für Kinder 0,5 mg/ml + 50 mg/ml Nasenspray, Lösung
    • Ireland (IE)
    • Portugal (PT)
    • Malta (MT)
许可日期2016/06/17
最近更新日期2024/05/16
药物ATC编码
    • R01AB06 xylometazoline
申请类型
  • TypeLevel1:Known Active Substance
  • 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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