欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/1729/001
药品名称
Paroxetina Oara
活性成分
paroxetine hydrochloride 22.22 mg
剂型
Film-coated tablet
上市许可持有人
Bluepharma - Indústria Farmacêutica, S.A.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Italy (IT)
France (FR)
许可日期
2017/04/27
最近更新日期
2024/02/06
药物ATC编码
N06AB05 paroxetine
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_proposed_clean
Date of last change:2024/02/06
Final SPC
|
common_spc_proposed_clean
Date of last change:2024/02/06
Final Product Information
|
common-pl-clean
Date of last change:2017/08/10
PAR
|
609882_20170516_PAR_VMB
Date of last change:2017/08/10
Final Product Information
|
common-outer-clean
Date of last change:2017/08/10
Final Product Information
|
common-spc-clean
Date of last change:2017/08/10
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase