欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/1259/001
药品名称
Rosuvastatina 1APharma
活性成分
Rosuvastatin calcium 5.0 mg
剂型
Film-coated tablet
上市许可持有人
Sandoz Farmacêutica, Lda.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Sweden (SE)
Germany (DE)
Belgium (BE)
Rosuvastatin Sandoz 5 mg filmomhulde tabletten
Netherlands (NL)
Rosuvastatine Sandoz 5 mg, filmomhulde tabletten
United Kingdom (Northern Ireland) (XI)
Austria (AT)
Rosuvastatin Sandoz 5 mg – Filmtabletten
France (FR)
Spain (ES)
Greece (GR)
ROSUVASTATIN/SANDOZ
Norway (NO)
Cyprus (CY)
许可日期
2015/10/28
最近更新日期
2025/06/12
药物ATC编码
C10AA07 rosuvastatin
申请类型
TypeLevel1:
Known Active Substance
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
PubAR
|
1259_Rosuvastatina_1APharma_Summary_PAR_Scientific_PAR_Final_05AGO2016
Date of last change:2024/09/06
Final Product Information
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common_outer
Date of last change:2024/09/06
Final Product Information
|
common_pl
Date of last change:2024/09/06
Final Product Information
|
common_spc
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase