欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0233/002
药品名称
Paroxetin "HEXAL"
活性成分
Paroxetine hydrochloride 40.0 mg
剂型
Film-coated tablet
上市许可持有人
HEXAL A/S Edvard Thomsens Vej 14 2300 København S Denmark
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Germany (DE)
Austria (AT)
Paroxat Hexal 40 mg - Filmtabletten
许可日期
2001/05/28
最近更新日期
2024/12/09
药物ATC编码
N06AB05 paroxetine
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Other Article 4.8(a)(iii), second paragraph
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Product Information
|
1 3 1 spc_label_pl _ common_spc _ 4916
Date of last change:2024/09/06
Final Product Information
|
1 3 1 spc_label_pl _ common_spc _ 4916_NHL
Date of last change:2024/09/06
Final Product Information
|
1_3_1 spc_label_pl _ common_pl _ 4_734_1__NHL
Date of last change:2024/09/06
Final Product Information
|
1_3_1 spc_label_pl _ common_pl _ 4_734_1__NHL_2
Date of last change:2024/09/06
Final Labelling
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1_3_1_spc_label_pl_common_outer_4_2C789_final_clean
Date of last change:2024/09/06
Final PL
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DK_H_0233_1_2_3_4_WS_1537_Paroxetine_FINAL_PIL_cv
Date of last change:2024/09/06
Final SPC
|
DK_H_0233_1_2_3_4_WS_1537_Paroxetine_FINAL_SPC_cv
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase