欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0240/001
药品名称
Euplix
活性成分
Paroxetine mesylate 20.0 mg
剂型
Film-coated tablet
上市许可持有人
Synthon BV Microweg 22 6545 CM Nijmegen The Netherlands
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Germany (DE)
Belgium (BE)
Netherlands (NL)
Luxembourg (LU)
Austria (AT)
Ennos 20 mg - Filmtabletten
Italy (IT)
许可日期
2001/05/13
最近更新日期
2024/05/06
药物ATC编码
N06AB05 paroxetine
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Other Article 4.8(a)(iii), second paragraph
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Labelling
|
LAB oral drops_M1_3_1_02_POT_sol20_011_11_core_clean_ALL CHANGES
Date of last change:2024/09/06
Final Labelling
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LAB tablets_M1_3_1_02_POT_tab20_001_09_core_clean_ALL CHANGES
Date of last change:2024/09/06
Final SPC
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M1_3_1_01_POT_sol20_011_26_core_clean
Date of last change:2024/09/06
Final PL
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M1_3_1_03_POT_sol20_011_29_core_clean
Date of last change:2024/09/06
Final Product Information
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M1_3_1_03_POT_tab20_006_03_core_WD_corrected_JAN2019
Date of last change:2024/09/06
Final Labelling
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PIL oral drops_M1_3_1_03_POT_sol20_011_27_core_clean_ALL CHANGES
Date of last change:2024/09/06
Final Labelling
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PIL tablets_M1_3_1_03_POT_tab20_006_11_core_clean_ALL CHANGES
Date of last change:2024/09/06
Final Labelling
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SmPC oral drops_M1_3_1_01_POT_sol20_011_24_core_clean_ALL CHANGES
Date of last change:2024/09/06
Final Labelling
|
SmPC tablets_M1_3_1_01_POT_tab20_002_11_core_clean_ALL CHANGES
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase