欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0403/003
药品名称
Escitalopram Parke-Davis
活性成分
escitalopram oxalate 15.0 mg
剂型
Film-coated tablet
上市许可持有人
Parke-Davis Produtos Farmacêuticos Lda
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
许可日期
2011/05/05
最近更新日期
2023/03/01
药物ATC编码
N06AB10 escitalopram
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 SPC
|
3_2_P_3_3 _ MANUFACTURING PROCESS AND PROCESS CONTROLS
Date of last change:2024/09/06
Final SPC
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Clean_Labelling__Approved day 210_
Date of last change:2024/09/06
Final SPC
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Clean_PIL_Including all CMSs
Date of last change:2024/09/06
Final SPC
|
Clean_SPC_Escitalopram _Approved day 210_
Date of last change:2024/09/06
Final SPC
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commitment May 02
Date of last change:2024/09/06
Final SPC
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FAR_Q_corr
Date of last change:2024/09/06
Final SPC
|
PT403_escitalopram parke_davis_D90_EoP
Date of last change:2024/09/06
Final SPC
|
PT403_EscitalopramParkeDavis_FAR_O
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase