欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号ES/H/0166/002
药品名称Cetraxal Plus Ear drops, solution IN SINGLE-DOSE CONTAINER
活性成分
    • Ciprofloxacin hydrochloride 3.0 mg
    • Fluocinolone acetonide 0.25 mg
剂型Ear drops, solution
上市许可持有人Laboratorios SALVAT, S.A. Gall, 30-36 Esplugues de Llobregat 08950-Barcelona (Spain)
参考成员国 - 产品名称Spain (ES)
互认成员国 - 产品名称
    • Germany (DE)
      InfectoCiproCort 3 mg/ml + 0,25 mg/ml Ohrentropfen, Lösung im Einzeldosisbehältnis
    • Denmark (DK)
    • Iceland (IS)
      Cetraxal Comp 3 mg/ml + 0,25 mg/ml eyrnadropar, lausn í stakskammtaíláti
    • France (FR)
    • Sweden (SE)
    • Norway (NO)
      Cetraxal Comp
    • Finland (FI)
    • Poland (PL)
      Cetraxal Plus
    • Czechia (CZ)
      Infalin duo 3 mg/ml + 0,25 mg/ml ušní kapky, roztok v jednodávkovém obalu
    • Romania (RO)
    • Slovakia (SK)
      Infalin duo 3 mg/ml + 0,25 mg/ml ušná roztoková instilácia v jednodávkovom obale
    • Latvia (LV)
    • Lithuania (LT)
    • Estonia (EE)
    • Portugal (PT)
    • United Kingdom (GB)
许可日期2018/01/31
最近更新日期2024/11/04
药物ATC编码
    • S02CA05 fluocinolone acetonide and antiinfectives
申请类型
  • TypeLevel1:Known Active Substance
  • TypeLevel2:Initial Application
  • TypeLevel3:Full Dossier Art 8.3(i) Dir 2001/83/EC
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Prescription Only
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    市场状态Positive
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