欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0689/004
药品名称
Rosuvastatina Aurobindo
活性成分
Rosuvastatin calcium 40.0 mg
剂型
Film-coated tablet
上市许可持有人
Aurobindo Pharma (Portugal), Unip. Lda.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Finland (FI)
Romania (RO)
Rosuvastatina Aurobindo 40 mg comprimate filmate
Malta (MT)
Rosuvastatin Aurobindo 40mg Film coated tablets
Belgium (BE)
Rosuvastatin AB 40mg filmomhulde tabletten
Netherlands (NL)
Luxembourg (LU)
Cyprus (CY)
ROSUVASTATIN AUROBINDO 40MG FC TABS
许可日期
2012/06/27
最近更新日期
2024/10/28
药物ATC编码
C10AA07 rosuvastatin
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 PL
|
common_pl_clean
Date of last change:2024/10/28
Final Product Information
|
56412_56413_20130902_PAR_GBB
Date of last change:2024/09/06
Final Product Information
|
56414_56415_20130902_PAR_GBB
Date of last change:2024/09/06
Final Labelling
|
common_outer_clean
Date of last change:2024/09/06
Final SPC
|
common_spc_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase