欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0239/001
药品名称
Paroxetin"Genthon"
活性成分
Paroxetine mesylate 20.0 mg
剂型
Film-coated tablet
上市许可持有人
Genthon BV Microweg 22 6545 CM Nijmegen The Netherlands
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Ireland (IE)
许可日期
2001/05/23
最近更新日期
2015/10/12
药物ATC编码
N06AB05 paroxetine
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Other Article 4.8(a)(iii), second paragraph
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Labelling
|
Labelling oral drops Final
Date of last change:2024/09/06
Final Labelling
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Labelling tablets Final
Date of last change:2024/09/06
Final PL
|
PIL oral drops Final
Date of last change:2024/09/06
Final PL
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PIL tablets DK_H_239 Final
Date of last change:2024/09/06
Final PL
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PIL tablets DK_H_240 Final
Date of last change:2024/09/06
Final SPC
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SmPC oral drops Final
Date of last change:2024/09/06
Final SPC
|
SmPC tablets Final
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase