欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/1527/005
药品名称
Quetiapin Sandoz
活性成分
quetiapine 400.0 mg
剂型
Film-coated tablet
上市许可持有人
Sandoz A/S, Edward Thomsens Vej 14 2300 København S Denmark
参考成员国 - 产品名称
Denmark (DK)
43572
互认成员国 - 产品名称
许可日期
2009/09/25
最近更新日期
2016/11/03
药物ATC编码
N05AH04 quetiapine
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 Product Information
|
Final common_outer DK_H_1527_001_005 clean
Date of last change:2024/09/06
Final Product Information
|
Final common_pl DK_H_1527_001_005 clean
Date of last change:2024/09/06
Final Product Information
|
Final common_spc DK_H_1527_001_005 clean
Date of last change:2024/09/06
Final PL
|
Final_clean_PIL_1527_1_3_1 spc_label_pl _ common_pl _ 6_074
Date of last change:2024/09/06
Final SPC
|
Final_clean_SmPC_1527_1_3_1 spc_label_pl _ common_spc _ 5_616
Date of last change:2024/09/06
PubAR
|
parmod5_dk1527quetiapinesandoz_pdf
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase