欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/1430/002
药品名称
Quetiapin Sandoz
活性成分
quetiapine fumarate 50.0 mg
剂型
Film-coated tablet
上市许可持有人
Sandoz A/S Edvard Thomsens Vej 14 2300 København S Denmark
参考成员国 - 产品名称
Denmark (DK)
42919
互认成员国 - 产品名称
Austria (AT)
Quetados 50 mg - Filmtabletten
Slovenia (SI)
许可日期
2009/03/19
最近更新日期
2024/02/15
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 SPC
|
1_3_1_common_spc_003047173
Date of last change:2023/11/09
Final PL
|
common_pl_clean
Date of last change:2023/07/06
Final Labelling
|
1_3_1_common_outer_002923948_clean
Date of last change:2023/07/06
PAR
|
parmod5_dk1430quetiapinesandoz_pdf
Date of last change:2022/06/02
Final Product Information
|
1.3.1 spc-label-pl - common-outer - 3,100 clean
Date of last change:2016/07/15
Final Product Information
|
1.3.1 spc-label-pl - common-pl - 7,427 clean
Date of last change:2016/07/15
Final Product Information
|
1.3.1 spc-label-pl - common-spc - 6,534 clean
Date of last change:2016/07/15
市场状态
Positive
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