欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2236/001
药品名称
Agomelatine Mylan
活性成分
agomelatine 25.0 mg
剂型
Film-coated tablet
上市许可持有人
Mylan AB
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Germany (DE)
Agomelatin Mylan 25 mg Filmtabletten
Denmark (DK)
Ireland (IE)
France (FR)
Portugal (PT)
Finland (FI)
Latvia (LV)
Agomelatine Mylan 25 mg apvalkotās tabletes
Lithuania (LT)
Agomelatine Mylan 25 mg plėvele dengtos tabletės
Estonia (EE)
AGOMELATINE VIATRIS
Hungary (HU)
AGOMELATIN MYLAN 25 mg filmtabletta
Czechia (CZ)
Agomelatine Mylan
Slovakia (SK)
Agomelatine Mylan 25 mg
许可日期
2018/07/27
最近更新日期
2024/08/30
药物ATC编码
N06AX22 agomelatine
申请类型
TypeLevel1:
[not specified]
TypeLevel2:
[not specified]
TypeLevel3:
[not specified]
TypeLevel4:
[not specified]
TypeLevel5:
[not specified]
附件文件下载
PubAR Summary
|
https___docetp_mpa_se_LMF_Agomelatine_20Mylan_20film_coated_20ENG_20sPAR_09001bee840942f2_pdf
Date of last change:2024/09/06
PubAR
|
https___docetp_mpa_se_LMF_Agomelatine_20Mylan_20film_coated_20tablet_20ENG_20PAR_09001bee840942f8_pdf
Date of last change:2024/09/06
Final Labelling
|
common label text clean version
Date of last change:2024/09/06
Final SPC
|
common_spc
Date of last change:2024/09/06
Final PL
|
PIL _ 001815359 _ Clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase