欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0244/001
药品名称
Paroxetin Mylan
活性成分
Paroxetine hydrochloride anhydrate 20.0 mg
剂型
Film-coated tablet
上市许可持有人
Mylan AB Box 230333, 2a 10435 Stockholm Sweden
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Germany (DE)
Belgium (BE)
Paroxetine Viatris 20 mg FC tablets
Luxembourg (LU)
United Kingdom (Northern Ireland) (XI)
Spain (ES)
Portugal (PT)
Italy (IT)
许可日期
2001/09/10
最近更新日期
2024/12/06
药物ATC编码
N06AB05 paroxetine
申请类型
TypeLevel1:
Abridged
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 Labelling
|
Other Product Information _ 001824329 _ DK0244 _ V092 _ Clean
Date of last change:2024/12/06
Final PL
|
Patient Information Leaflet _ clean _ V072
Date of last change:2024/12/06
Final SPC
|
Summary of Product Characteristics _clean_V072
Date of last change:2024/12/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase