欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/3287/001
药品名称
Paroxetin Teva
活性成分
Paroxetine 10.0 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
Belgium (BE)
Paroxetine Teva 10 mg filmomhulde tabletten
Netherlands (NL)
Spain (ES)
Portugal (PT)
Sweden (SE)
Romania (RO)
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_smpc_v0003_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase