欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/1199/002
药品名称
Quetiapina Anfarm
活性成分
quetiapine fumarate 100.0 mg
剂型
Film-coated tablet
上市许可持有人
Anfarm Hellas, S.A.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Greece (GR)
QUAPIANOL
许可日期
2014/12/11
最近更新日期
2023/05/15
药物ATC编码
N05AH04 quetiapine
申请类型
TypeLevel1:
Known Active Substance
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 Product Information
|
ccommon_SPC_v03_tracked
Date of last change:2015/04/09
Final Product Information
|
common_label-blister
Date of last change:2015/04/09
Final Product Information
|
common_label-carton
Date of last change:2015/04/09
Final Product Information
|
common_PIL_v02_tracked
Date of last change:2015/04/09
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase