欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/3287/002
药品名称
Paroxetin Teva
活性成分
Paroxetine 20.0 mg
剂型
Film-coated tablet
上市许可持有人
Teva B.V. Swensweg 5 2031GA Haarlem Netherlands
参考成员国 - 产品名称
Denmark (DK)
Paroxetin Teva
互认成员国 - 产品名称
Latvia (LV)
Lithuania (LT)
Paroxetine Teva 20 mg plėvele dengtos tabletės
Estonia (EE)
Germany (DE)
Paroxetin-ratiopharm 20 mg Filmtabletten
Bulgaria (BG)
Xetanor
Belgium (BE)
Paroxetine Teva 20 mg filmomhulde tabletten
Romania (RO)
Netherlands (NL)
Iceland (IS)
France (FR)
Spain (ES)
Portugal (PT)
Italy (IT)
Sweden (SE)
许可日期
2024/02/08
最近更新日期
2024/09/23
药物ATC编码
N06AB05 paroxetine
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 PL
|
paroxetine_dk_h_3287_pil_p001_clean
Date of last change:2024/09/23
Final Labelling
|
paroxetine_dk_h_3287_oup_p001_clean
Date of last change:2024/09/23
PubAR Summary
|
Sumary PAR_DK_H_3287_01_03_DC
Date of last change:2024/09/20
PubAR
|
PAR module 5_Scientific discussion_DK_H_3287_01_03_DC_final
Date of last change:2024/09/20
Final SPC
|
paroxetine_dk_h_3287_3360_3486_3487_3488_smpc
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase