欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/1816/001
药品名称
Aspendos
活性成分
Modafinil 100.0 g
剂型
Tablet
上市许可持有人
Medochemie Ltd. 1-10 Constantinoupoleos Str, 3011 Limassol
参考成员国 - 产品名称
Netherlands (NL)
Aspendos
互认成员国 - 产品名称
Iceland (IS)
Greece (GR)
Bulgaria (BG)
Aspendos
Cyprus (CY)
ASPENDOS 100mg TABS
Czechia (CZ)
ASPENDOS 100 mg
Romania (RO)
Aspendos 100 mg comprimate
Slovakia (SK)
ASPENDOS 100 mg
许可日期
2010/10/12
最近更新日期
2024/11/28
药物ATC编码
N06BA07 modafinil
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial 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 Labelling
|
common_outer
Date of last change:2024/09/06
Final PL
|
Final PIL
Date of last change:2024/09/06
Final SPC
|
Final SPC
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase