欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/0257/002
药品名称
Zolpidemtartraat 10 PCH
活性成分
zolpidem tartrate 10.0 mg
剂型
Film-coated tablet
上市许可持有人
Pharmachemie B.V. Swensweg 5 2003 RN HAARLEM/NL
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Belgium (BE)
United Kingdom (Northern Ireland) (XI)
许可日期
2001/07/26
最近更新日期
2023/11/17
药物ATC编码
N05CF02 zolpidem
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Generic Article 4.8(a)(iii), first paragraph
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Labelling
|
Final Label
Date of last change:2024/09/06
Final PL
|
Zolpidem_NL_H_0257_002_PIL_29_06_23
Date of last change:2024/09/06
Final SPC
|
Zolpidem_NL_H_0257_002_SmPC_29_06_23
Date of last change:2024/09/06
市场状态
Positive
©2006-2025
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase