欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/1046/001
药品名称
Edluar
活性成分
zolpidem tartrate 5.0 mg
剂型
Sublingual tablet
上市许可持有人
Viatris AB Sweden
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Denmark (DK)
edluar
Belgium (BE)
Netherlands (NL)
Luxembourg (LU)
Iceland (IS)
United Kingdom (Northern Ireland) (XI)
Ireland (IE)
Austria (AT)
Edluar 5 mg Sublingualtabletten
France (FR)
Spain (ES)
Portugal (PT)
Italy (IT)
Finland (FI)
Hungary (HU)
EDLUAR 5 mg nyelvalatti tabletta
Bulgaria (BG)
EDLUAR
Romania (RO)
Edluar 5 mg comprimate sublinguale
Slovenia (SI)
许可日期
2012/06/14
最近更新日期
2023/12/29
药物ATC编码
N05CF02 zolpidem
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
|
SE_H_1046_001_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_1046_001_Final SPC
Date of last change:2024/09/06
PubAR
|
SE_H_1046_001_PAR
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase