欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/0310/001
药品名称
Zolpidem Viatris
活性成分
Zolpidem tartrate 10.0 mg
剂型
Film-coated tablet
上市许可持有人
Viatris Limited
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Germany (DE)
Denmark (DK)
Belgium (BE)
Zolpidem Viatris 10 mg filmcoated tablet
Netherlands (NL)
Luxembourg (LU)
United Kingdom (Northern Ireland) (XI)
Iceland (IS)
许可日期
2003/03/03
最近更新日期
2024/09/09
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 PL
|
SE_H_0310_001_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_0310_001_Final SPC
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase