欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2527/003
药品名称
Quetiapin "Zentiva"
活性成分
quetiapine 200.0 mg
剂型
Prolonged-release tablet
上市许可持有人
Zentiva k.s., Czech Republic
参考成员国 - 产品名称
Denmark (DK)
Quetiapin "Zentiva"
互认成员国 - 产品名称
Portugal (PT)
Romania (RO)
Slovakia (SK)
Quetiapin Zentiva SR 200 mg
许可日期
2016/04/28
最近更新日期
2023/12/13
药物ATC编码
N05AH04 quetiapine
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Product Information
|
Common combined Quetiapin Zentiva _ clean
Date of last change:2023/12/13
Final SPC
|
Common- spc_clean
Date of last change:2021/11/24
PAR Summary
|
Final sPAR Quetiapin Zentiva prolonged-release tablets DKH2527_001-005_DC
Date of last change:2018/07/03
PAR
|
Final PAR Quetiapin Zentiva prolonged-release tablets DKH2527_001-005_DC
Date of last change:2018/07/03
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase