欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/1762/004
药品名称
Quetiapin Orion
活性成分
QUETIAPINE FUMARATE 300.0 mg
剂型
Film-coated tablet
上市许可持有人
Orion Corporation Finland
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Denmark (DK)
Norway (NO)
Finland (FI)
Poland (PL)
Quetiapine Orion
许可日期
2018/12/20
最近更新日期
2024/08/29
药物ATC编码
N05AH04 quetiapine
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Multiple (Copy) Application
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 PL
|
SE_H_1762_004_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_1762_004_Final SPC
Date of last change:2024/09/06
PubAR
|
SE_H_1762_004_PAR
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase