欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/3300/001
药品名称
Zopiclone Dune
活性成分
Zopiclone 3.75 mg
剂型
Film-coated tablet
上市许可持有人
Dune Medicare ApS Industriholmen 80, 1. 2650 Hvidovre Denmark
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Sweden (SE)
Norway (NO)
许可日期
2022/10/06
最近更新日期
2024/12/04
药物ATC编码
N05CF01 zopiclone
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
common_pil_duneclean
Date of last change:2024/12/04
Final Labelling
|
Approved EN Labelling cartons Zopiclone 7_5 mg
Date of last change:2024/09/06
Final Labelling
|
Approved EN Labelling Zopiclone 3_75 mg blister
Date of last change:2024/09/06
Final Labelling
|
Approved EN Labelling Zopiclone 7_5 mg blister
Date of last change:2024/09/06
Final SPC
|
Approved SmPC Zopiclone 3_75 and 7_5 mg 06 Oct 2022
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase