欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/1364/001
药品名称
Anaquetan XR
活性成分
quetiapine fumarate 50.0 mg
剂型
Prolonged-release tablet
上市许可持有人
Anabiosis PC
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Greece (GR)
ANAUETAN XR
许可日期
2016/03/02
最近更新日期
2024/09/03
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 Product Information
|
common_interpack_rev01_clean
Date of last change:2024/09/06
Final Product Information
|
common_outerpack_rev01_clean
Date of last change:2024/09/06
Final PL
|
common_pil_clean_1_
Date of last change:2024/09/06
Final Product Information
|
common_pl_rev01_clean
Date of last change:2024/09/06
Final SPC
|
common_spc_clean_3_
Date of last change:2024/09/06
Final Product Information
|
common_spc_rev01_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase