欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/1240/002
药品名称
Imasemamed
活性成分
fluvastatin 40.0 mg
剂型
Capsule, hard
上市许可持有人
Medis ehf, Reykjavikurvegur 78, IS-220 Hafnarfjördur, Iceland
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
许可日期
2009/02/19
最近更新日期
2018/08/16
药物ATC编码
C10AA04 fluvastatin
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
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
|
D210_Labelling_Fluvastatin caps_UK_Clean_2009_10_30
Date of last change:2024/09/06
Final PL
|
D210_PIL_Fluvastatin caps_UK_CLEAN_2009_10_30
Date of last change:2024/09/06
PubAR
|
Final PAR Imasemamed DKH1240_001_002_DC
Date of last change:2024/09/06
Final SPC
|
SPC_Fluvastatin DK_clean_final_021109
Date of last change:2024/09/06
市场状态
Withdrawn(注:已撤市)
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European Union HMA Authorisation of Medicines DataBase