欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/4018/001
药品名称
Deltamelatin
活性成分
agomelatine 25.0 mg
剂型
Film-coated tablet
上市许可持有人
Helm AG Nordkanalstrasse 28 20097 Hamburg Germany
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Germany (DE)
Agomelatin Mylan 25 mg Filmtabletten
Denmark (DK)
Ireland (IE)
France (FR)
Portugal (PT)
Sweden (SE)
Finland (FI)
Latvia (LV)
Agomelatine Mylan 25 mg apvalkotās tabletes
Lithuania (LT)
Agomelatine Mylan 25 mg plėvele dengtos tabletės
Estonia (EE)
AGOMELATINE MYLAN
Hungary (HU)
AGOMELATIN MYLAN 25 mg filmtabletta
Czechia (CZ)
Agomelatine Mylan
Slovakia (SK)
Agomelatine Mylan 25 mg
许可日期
2018/07/26
最近更新日期
2023/11/10
药物ATC编码
N06AX22 agomelatine
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Multiple (Copy) Application
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
common_PIL_nl4018_clean_v004
Date of last change:2022/09/21
Final SPC
|
common-spc
Date of last change:2021/08/09
Final Labelling
|
common label text clean version
Date of last change:2020/04/15
PAR
|
PAR_4018_Agomelatine Mylan_4 december 2018
Date of last change:2019/07/19
PAR Summary
|
summaryPAR_4018_Agomelatine Mylan_4 december 2018_EN
Date of last change:2019/07/19
市场状态
Positive
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