欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号CZ/H/0979/001
药品名称BENZYDAMIN/CETYLPYRIDINIUM CHLORID KRKA D.D.
活性成分
    • benzydamine hydrochloride 1.5 mg/ml
    • cetylpyridinium chloride 5.0 mg/ml
剂型Oromucosal spray, solution
上市许可持有人KRKA, d.d., Novo mesto Smarjeska Cesta 6 Novo Mesto 8501, Slovenia
参考成员国 - 产品名称Czechia (CZ)
BENZYDAMIN/CETYLPYRIDINIUM CHLORID KRKA D.D.
互认成员国 - 产品名称
    • Germany (DE)
      Septolete 1,5 mg/ml + 5,0 mg/ml Spray zur Anwendung in der Mundhöhle, Lösung
    • Denmark (DK)
    • Iceland (IS)
      Septabene
许可日期2021/05/17
最近更新日期2024/08/22
药物ATC编码
    • R02AX03 benzydamine
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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