欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/0344/004
药品名称
Cirantan 5 mg
活性成分
rosuvastatin 5.0 mg
剂型
Film-coated tablet
上市许可持有人
Astra Zeneca Louis Pasteurlaan 5 2719 EE Zoetermeer
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
许可日期
2004/11/02
最近更新日期
2014/12/22
药物ATC编码
C10AA07 rosuvastatin
申请类型
TypeLevel1:
Line Extension
TypeLevel2:
Multiple (Copy) Application
TypeLevel3:
Full Dossier Article 4.8 Di 65/65
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Labelling
|
Annex 1Label QRD _Crestor 10 mg_
Date of last change:2024/09/06
Final SPC
|
Cirantan common_combined_proposed_clean
Date of last change:2024/09/06
Final PL
|
common_pl_cirantantabletnonannotatedpending 02 July 2012
Date of last change:2024/09/06
Final Product Information
|
nlh_343_6 common_combined_crestor_proposedday59annotated_RMS assessment
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Withdrawn(注:已撤市)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