欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/0449/004
药品名称
Paroxetine 40 mg, tablets
活性成分
paroxetine hydrochloride 40.0 mg
剂型
Tablet
上市许可持有人
I.C.C. B.V. Dijkgraaf 30 6921 RL Duiven
参考成员国 - 产品名称
Netherlands (NL)
Paroxetine 40 mg
互认成员国 - 产品名称
Belgium (BE)
Luxembourg (LU)
Greece (GR)
Lithuania (LT)
ARKETIS 40 mg tabletės
Estonia (EE)
ARKETIS 40 MG
Cyprus (CY)
Malta (MT)
许可日期
2006/10/04
最近更新日期
2024/01/15
药物ATC编码
N06AB05 paroxetine
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
common_combined_plenvs9_9_Dec 2023_cl
Date of last change:2024/01/15
Final SPC
|
common_combined_spcenv7_9_Dec 2023_cl
Date of last change:2024/01/15
Final Product Information
|
common-combined-plenvs81clean
Date of last change:2013/02/26
Final Labelling
|
common-combined-labelling-v2-tracked
Date of last change:2011/10/12
市场状态
Positive
©2006-2024
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase