欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/1912/005
药品名称
Vigicord
活性成分
rosuvastatin 40.0 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)
Vigicord
互认成员国 - 产品名称
许可日期
2012/01/18
最近更新日期
2015/01/21
药物ATC编码
C10AA HMG CoA reductase inhibitors
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 SPC
|
common_combined_m13101runcaltab00105core
Date of last change:2024/09/06
Final PL
|
common_combined_m13103runcaltab00105core
Date of last change:2024/09/06
PubAR
|
Module 2 SmPC DK_H_1912_001_005_DC
Date of last change:2024/09/06
PubAR
|
Module 3 and 4 PIL and Labelling DK_H_1912_001_005_DC
Date of last change:2024/09/06
PubAR
|
PAR DK_H_1912_001_005_DC
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Withdrawn(注:已撤市)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