欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/0343/004
药品名称
Crestor 5 mg
活性成分
Rosuvastatin 5.0 mg
剂型
Film-coated tablet
上市许可持有人
Grünenthal B.V. De Corridor 21K 3621 ZA Breukelen The Netherlands
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Denmark (DK)
Belgium (BE)
Luxembourg (LU)
Ireland (IE)
Austria (AT)
Crestor 5 mg - Filmtabletten
France (FR)
Portugal (PT)
Italy (IT)
Greece (GR)
Sweden (SE)
Finland (FI)
Germany (DE)
Spain (ES)
Norway (NO)
许可日期
2005/08/19
最近更新日期
2024/12/23
药物ATC编码
C10AA07 rosuvastatin
申请类型
TypeLevel1:
Line Extension
TypeLevel2:
Initial Application
TypeLevel3:
Full Dossier Article 4.8 Di 65/65
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final SPC
|
common SmPC
Date of last change:2025/02/18
Final PL
|
common_pil_crestor_fct_clean
Date of last change:2024/12/03
Final Labelling
|
Annex 1Label QRD _Crestor 10 mg_
Date of last change:2024/09/06
Final Product Information
|
common_comb_crestor_annot_Avara_to_AZReims_Brecon_delet
Date of last change:2024/09/06
Final Product Information
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common_comb_crestor_clean_Avara_to_AZReims_Brecon_delet
Date of last change:2024/09/06
Final Product Information
|
common_comb_provisacor_annot_Avara_to_AZReims_Brecon_delet
Date of last change:2024/09/06
Final Product Information
|
common_comb_provisacor_clean_Avara_to_AZReims_Brecon_delet
Date of last change:2024/09/06
Final Product Information
|
common_comb_rosuvastatin_annot_Avara_to_AZReims_Brecon_delet
Date of last change:2024/09/06
PubAR
|
EPAR_CRESTOR_343_3 feb 2012_clean
Date of last change:2024/09/06
市场状态
Positive
©2006-2025
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European Union HMA Authorisation of Medicines DataBase