欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2232/002
药品名称
Rovasyn
活性成分
rosuvastatin calcium 10.0 mg
剂型
Film-coated tablet
上市许可持有人
Codal Synto Ltd. 21 Konstantinoupoleos Street 3011 Limassol Cyprus
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Cyprus (CY)
ROVASYN 10mg FC TABS
许可日期
2013/09/04
最近更新日期
2024/09/02
药物ATC编码
C10AA07 rosuvastatin
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_2232_pl_Mar 2023 _ clean
Date of last change:2024/09/06
Final SPC
|
common_2232_spc_Mar 2023 _ clean
Date of last change:2024/09/06
Final Labelling
|
common_combined_labellingenv11clean2232
Date of last change:2024/09/06
Final Product Information
|
common_combined_spcenv1_5_clean_2232
Date of last change:2024/09/06
Final Product Information
|
common_combined_spcenv15_clean_2231
Date of last change:2024/09/06
PubAR
|
Final PAR Scientific discussion Rovasyn DKH2232_001_004_DC
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase