欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/1046/002
药品名称
Edluar
活性成分
zolpidem tartrate 10.0 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)
France (FR)
Spain (ES)
Portugal (PT)
Italy (IT)
Finland (FI)
Hungary (HU)
Edular 10 mg szublingvális tabletta
Bulgaria (BG)
EDLUAR
Romania (RO)
Edluar 10 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:
Additional Strength/Form
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_002_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_1046_002_Final SPC
Date of last change:2024/09/06
PubAR
|
SE_H_1046_002_PAR
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase