欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）

MR编号	AT/H/0351/002
药品名称	Azelastin-POS nasal spray
活性成分	azelastine hydrochloride 1.0 mg/ml
剂型	Nasal spray, solution
上市许可持有人	Ursapharm Arzneimittel GmbH Industristrasse 35 66129 Saarbrücken Germany
参考成员国 - 产品名称	Austria (AT) Azelastin POS 1 mg/ml Nasenspray, Lösung
互认成员国 - 产品名称	Germany (DE) Azelastin-POS 1 mg/ml Nasenspray, Lösung Belgium (BE) Pollival 1 mg/ml solution pour pulvérisation nasale Netherlands (NL) Luxembourg (LU) Poland (PL) Azelastin POS
许可日期	2014/11/06
最近更新日期	2023/03/10
药物ATC编码	R01AC03 azelastine
申请类型	TypeLevel1：Line Extension TypeLevel2：Additional Strength/Form TypeLevel3：Other Generic application Art 10.3 Dir 2001/83/EC TypeLevel4：Chemical Substance TypeLevel5：Prescription Only
附件文件下载	Final SPC \| FRAR_AT_H_0351_002_R_002_final_SmPCDate of last change:2021/06/18 Final PL \| AT_H_0351_002_R_002_PL_trackedDate of last change:2021/06/18 Final SPC \| AT_H_0351_002_R_002_SmPC_trackedDate of last change:2021/06/18 Final Labelling \| FRAR_AT_H_0351_002_R_002_final_LABDate of last change:2021/06/18 Final PL \| FRAR_AT_H_0351_002_R_002_final_PLDate of last change:2021/06/18 Final Labelling \| AT_H_0351_002_R_002_LAB_trackedDate of last change:2021/06/18 PAR \| PAR_AT_H_0351_002_Azelastin POS NasensprayDate of last change:2017/01/04 Final Product Information \| Day_210_final LAB_AT_H_0351_002_DCDate of last change:2015/01/12 Final Product Information \| Day_210_final_PIL_AT_0351_002_DCDate of last change:2015/01/12 Final Product Information \| Day_210_final_SmPC_AT_H_0351_002_DCDate of last change:2015/01/12
市场状态	Positive