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
2024/01/19
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 PL
|
M1_3_1_03_POT_sol20_011_29_core_clean
Date of last change:2024/01/19
Final SPC
|
M1_3_1_01_POT_sol20_011_26_core_clean
Date of last change:2024/01/19
Final Labelling
|
SmPC oral drops_M1.3.1_01.POT.sol20.011.24.core.clean_ALL CHANGES
Date of last change:2021/04/16
Final Labelling
|
SmPC tablets_M1.3.1_01.POT.tab20.002.11.core.clean_ALL CHANGES
Date of last change:2021/04/16
Final Labelling
|
PIL oral drops_M1.3.1_03.POT.sol20.011.27.core.clean_ALL CHANGES
Date of last change:2021/04/16
Final Labelling
|
PIL tablets_M1.3.1_03.POT.tab20.006.11.core.clean_ALL CHANGES
Date of last change:2021/04/16
Final Labelling
|
LAB oral drops_M1.3.1_02.POT.sol20.011.11.core.clean_ALL CHANGES
Date of last change:2021/04/16
Final Labelling
|
LAB tablets_M1.3.1_02.POT.tab20.001.09.core.clean_ALL CHANGES
Date of last change:2021/04/16
Final Product Information
|
M1.3.1_03.POT.tab20.006.03.core.WD_corrected_JAN2019
Date of last change:2019/01/10
市场状态
Positive
©2006-2024
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase