欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DK/H/0245/001
药品名称
Paroxegen
活性成分
Paroxetine hydrochloride anhydrate 20.0 mg
剂型
Film-coated tablet
上市许可持有人
Ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Portugal (PT)
Italy (IT)
许可日期
2001/09/10
最近更新日期
2024/01/19
药物ATC编码
N06AB05 paroxetine
申请类型
TypeLevel1：
Abridged
TypeLevel2：
Multiple (Copy) Application
TypeLevel3：
Generic Article 4.8(a)(iii), first paragraph
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
Final SPC
|
paroxetine_dk_h_0245_001_smpc_12_10_23_clean
Date of last change:2024/01/19
Final PL
|
Paroxetine-DK_H_0245_001-PIL
Date of last change:2021/05/20
Final PL
|
Paroxetine-DK_H_0245_002-PIL
Date of last change:2021/05/20
Final Labelling
|
Paroxetine-DK_H_0245_001-OuP+ImP(Label+Blister)
Date of last change:2021/05/20
Final Labelling
|
Paroxetine-DK_H_0245_002-OuP+ImP(Label)
Date of last change:2021/05/20
Final Product Information
|
Paroxetine-DK_H_245_002-PIL-25.06.19_tracked
Date of last change:2019/09/25
Final Product Information
|
Paroxetine-DK_H_245_001-PIL-25.06.19_tracked
Date of last change:2019/09/25
Final Product Information
|
Paroxetine-DK_H_245_001-SmPC-25.06.19_tracked
Date of last change:2019/09/25
Final Product Information
|
Paroxetine-DK_H_245_002-SmPC-25.06.19_tracked
Date of last change:2019/09/25
市场状态
Positive
©2006-2024
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase