欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号PT/H/1800/001
药品名称Xylometazoline Dexpanthenol Farmaprojects Sensitive
活性成分
    • Dexpanthenol 50.0 mg
    • Xylometazoline 1.0 mg
剂型Nasal spray, solution
上市许可持有人Farmaprojects, S.A.U
参考成员国 - 产品名称Portugal (PT)
互认成员国 - 产品名称
    • Germany (DE)
      Xylometazolin Dexpanthenol Farmaprojects Sensitive 1,0 mg/ml, 50,0 mg/ml Nasenspray, Lösung
    • Poland (PL)
      Otrivin Regeneracja
    • Latvia (LV)
      Otrinazil 1mg/50mg/ml deguna aerosols, šķīdums
    • Lithuania (LT)
      Xylometazoline/Dexpanthenol GSK 1 mg/50 mg/ml nosies purškalas (tirpalas)
    • Estonia (EE)
      Otrinazil
    • Hungary (HU)
      OTRIVIN EXTRA 1 mg/ml+50 mg/ml adagoló oldatos orrspray
    • Bulgaria (BG)
      Xylomethazoline Dexpanthenol Farmprojects Sensitive
    • Slovakia (SK)
许可日期2018/05/02
最近更新日期2025/09/25
药物ATC编码
    • D03AX03 dexpanthenol
    • 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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