欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号CZ/H/0508/001
药品名称Septabene 1.5 mg/ml + 5.0 mg/ml
活性成分
    • benzydamine hydrochloride 1.5 mg
    • cetylpyridinium chloride 5.0 mg
剂型Oromucosal 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)
Septolete Total Spray 1.5 mg /ml + 5.0 mg /ml
互认成员国 - 产品名称
    • Ireland (IE)
    • Portugal (PT)
    • Italy (IT)
    • Poland (PL)
    • Latvia (LV)
      Septabene 1,5 mg/5,0 mg/ml aerosols izsmidzināšanai mutes dobumā, šķīdums
    • Lithuania (LT)
      Septabene 1,5 mg / 5 mg / 1 ml burnos gleivinės purškalas (tirpalas)
    • Estonia (EE)
      SEPTOLETE OMNI
    • Hungary (HU)
      SEPTOLETE EXTRA 1,5 mg/ml + 5 mg/ml szájnyálkahártyán alkalmazott oldatos spray
    • Bulgaria (BG)
      Septolete total
    • Romania (RO)
      Septolete omni 1,5 mg + 5,0 mg/ml spray bucofaringian, soluție
    • Slovakia (SK)
      Septolete extra 1,5 mg/ml + 5 mg/ml
    • Slovenia (SI)
    • Croatia (HR)
      Septolete duo 1,5 mg/5 mg u 1 ml sprej za usnu sluznicu, otopina
许可日期2015/06/15
最近更新日期2024/04/26
药物ATC编码
    • R02AA20 various
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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