欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
IT/H/0188/001
药品名称
ZOLPREM
活性成分
zolpidem tartrate 10.0 mg/ml
剂型
Oral drops, solution
上市许可持有人
Lifepharma S.p.A. Via dei Lavoratori, 54 20092 Cinisello Balsamo (MI) Italy
参考成员国 - 产品名称
Italy (IT)
互认成员国 - 产品名称
许可日期
2009/11/10
最近更新日期
2022/01/11
药物ATC编码
N05CF02 zolpidem
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Product Information
|
Labelling ZOLPREM_clean
Date of last change:2024/09/06
Final PL
|
Zolprem_EN_PIL_clean
Date of last change:2024/09/06
Final Product Information
|
Zolprem_EN_PIL_clean_2
Date of last change:2024/09/06
Final Product Information
|
Zolprem_SmPC_clean
Date of last change:2024/09/06
Final SPC
|
Zolprem_SmPC_EN_clean
Date of last change:2024/09/06
市场状态
Positive
©2006-2025
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase