欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0240/002
药品名称
Euplix
活性成分
paroxetine mesilate 33.1 mg/ml
剂型
Oral drops, solution
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)
Euplix
互认成员国 - 产品名称
Italy (IT)
许可日期
2007/12/18
最近更新日期
2024/01/19
药物ATC编码
N06AB05 paroxetine
申请类型
TypeLevel1:
Line Extension
TypeLevel2:
Initial Application
TypeLevel3:
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
PubAR
|
Final Module 5 Scientific discussion Euplix oral drops_ solution DKH_0240_002_MR
Date of last change:2024/09/06
Final Labelling
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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
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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