欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号MT/H/0235/001
药品名称Azelastine Zentiva 1mg/ml nasal spray, solution
活性成分
    • azelastine hydrochloride 1.0 mg/ml
剂型Nasal spray, solution
上市许可持有人Zentiva, k.s. U kabelovny 130, Dolni Mecholupy, 102 37 Praha 10 Czech Republic previous MA holder: Galenicum Health, S.L. Avda. diagonal 123, Planta 11, 08005 Barcelona, Spain
参考成员国 - 产品名称Malta (MT)
Azelastine Galenicum 1mg/ml nasal spray, solution
互认成员国 - 产品名称
    • Spain (ES)
许可日期2017/09/22
最近更新日期2023/07/13
药物ATC编码
    • R01AC03 azelastine
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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