欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2231/003
药品名称
Celmantin
活性成分
rosuvastatin calcium 20.0 mg
剂型
Film-coated tablet
上市许可持有人
Medochemie Ltd. 1-10 Constantinoupoleos street 3011 Limassol Cyprus
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Greece (GR)
CELMANTIN
Latvia (LV)
Rovasyn 20 mg apvalkotās tabletes
Estonia (EE)
ROVASYN
Bulgaria (BG)
Rovasta
Cyprus (CY)
CELMANTIN 20mg FC TABS
Czechia (CZ)
ROVASYN 20 mg
Romania (RO)
ROVASTAMED 20 mg comprimate filmate
Malta (MT)
许可日期
2013/09/04
最近更新日期
2024/08/16
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_2231_pl_Mar 2023_clean
Date of last change:2024/09/06
Final SPC
|
common_2231_spc_Mar 2023_clean
Date of last change:2024/09/06
Final Labelling
|
common_combined_labellingenv11clean2231
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 Celmantin DKH2231_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