欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/1616/001
药品名称
Quetiapine PharOS Generics 25 mg, film coated tablets
活性成分
quetiapine fumarate 25.0 mg
剂型
Film-coated tablet
上市许可持有人
PharOS Generics, Greece
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Germany (DE)
Quetiapine PharOS Generics 25 mg Filmtabletten
许可日期
2009/12/09
最近更新日期
2022/09/22
药物ATC编码
N05AH04 quetiapine
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial 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
|
common-pl-quetiapin-cv-202006
Date of last change:2020/08/17
Final SPC
|
common-spc-quetiapin-fct-hv-201811
Date of last change:2019/01/10
Final Labelling
|
common-outer-hv-201811
Date of last change:2019/01/10
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase