欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0245/002
药品名称
Paroxegen
活性成分
ANHYDROUS PAROXETINE HYDROCHLORIDE 30.0 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
许可日期
2003/04/25
最近更新日期
2024/11/04
药物ATC编码
N06AB05 paroxetine
申请类型
TypeLevel1:
Line Extension
TypeLevel2:
Initial Application
TypeLevel3:
Generic Article 4.8(a)(iii), first paragraph
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
Paroxetine_DK_H_0245_002_PIL_08_11_23_clean
Date of last change:2024/11/04
Final SPC
|
Paroxetine_DK_H_0245_002_SmPC_08_11_23_clean
Date of last change:2024/11/04
Final Labelling
|
Paroxetine_DK_H_0245_001_OuP_ImP_Label_Blister_
Date of last change:2024/09/06
Final Labelling
|
Paroxetine_DK_H_0245_002_OuP_ImP_Label_
Date of last change:2024/09/06
Final Product Information
|
Paroxetine_DK_H_245_001_PIL_25_06_19_tracked
Date of last change:2024/09/06
Final Product Information
|
Paroxetine_DK_H_245_001_SmPC_25_06_19_tracked
Date of last change:2024/09/06
Final Product Information
|
Paroxetine_DK_H_245_002_PIL_25_06_19_tracked
Date of last change:2024/09/06
Final Product Information
|
Paroxetine_DK_H_245_002_SmPC_25_06_19_tracked
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase