欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
IT/H/0187/001
药品名称
SONIREM
活性成分
zolpidem tartrate 10.0 mg/ml
剂型
Oral drops, solution
上市许可持有人
Italfarmaco S.p.A. Viale Fulvio Testi, 330 20126 Milano Italy
参考成员国 - 产品名称
Italy (IT)
互认成员国 - 产品名称
Greece (GR)
许可日期
2009/11/10
最近更新日期
2024/04/10
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
|
common_sonirem PIL_EN_clean_day 20
Date of last change:2024/09/06
Final Labelling
|
common_sonirem_labeling_EN_clean_day 20
Date of last change:2024/09/06
Final SPC
|
common_sonirem_SmPC_EN_clean_day 20
Date of last change:2024/09/06
Final PL
|
Sonirem PIL_EN_clean_RPGCMM_last_version
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase