欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号DE/H/2300/005
药品名称Bilaxten 6 mg/ml Augentropfen, Lösung
活性成分
    • bilastine 6.0 mg/ml
剂型Eye drops, solution
上市许可持有人Menarini International Operations Luxembourg S.A. 1 Avenue De La Gare 1611 Luxemburg, Luxembourg
参考成员国 - 产品名称Germany (DE)
Bilaxten 6 mg/ml Augentropfen, Lösung
互认成员国 - 产品名称
    • Austria (AT)
    • Czechia (CZ)
      Xados
    • France (FR)
    • Romania (RO)
      Borenar 6 mg/mL picături oftalmice, soluţie
    • Spain (ES)
    • Slovakia (SK)
    • Portugal (PT)
    • Slovenia (SI)
    • Italy (IT)
    • Malta (MT)
    • Greece (GR)
    • Croatia (HR)
    • Poland (PL)
      Clatra
    • Latvia (LV)
    • Lithuania (LT)
      Opexa 6 mg/ml akių lašai (tirpalas)
    • Belgium (BE)
    • Estonia (EE)
    • Luxembourg (LU)
    • Hungary (HU)
      Lendin 6 mg/ml szemcsepp
    • Ireland (IE)
    • Cyprus (CY)
      Bilaz 6mg/mL οφθαλμικές σταγόνες
许可日期2022/06/29
最近更新日期2025/07/21
药物ATC编码
    • S01GX13 bilastine
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
附件文件下载
市场状态Positive
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