欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/0257/001
药品名称
Zolpidemtartraat 5 PCH
活性成分
zolpidem tartrate 5.0 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
许可日期
2001/07/26
最近更新日期
2022/11/10
药物ATC编码
N05CF02 zolpidem
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Other Article 4.8(a)(iii), second paragraph
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Labelling
|
Zolpidem 5_10 mg FCT_NL_H_0257_OuP_ImP_08_02_17
Date of last change:2024/09/06
Final PL
|
Zolpidem_NL_H_0257_001_002_PIL_02_05_22
Date of last change:2024/09/06
Final SPC
|
Zolpidem_NL_H_0257_001_002_SmPC_02_05_22
Date of last change:2024/09/06
市场状态
Withdrawn(注:已撤市)
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European Union HMA Authorisation of Medicines DataBase