欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/0345/001
药品名称
Provisacor 10 mg
活性成分
Rosuvastatin 10.0 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
Portugal (PT)
Italy (IT)
Spain (ES)
许可日期
2003/03/07
最近更新日期
2024/12/23
药物ATC编码
C10AA07 rosuvastatin
申请类型
TypeLevel1:
New Active Substance
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_2
Date of last change:2025/02/18
Final PL
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common_pil_provisacor_fct__
Date of last change:2024/12/03
Final Labelling
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Annex 1Label QRD _Crestor 10 mg_
Date of last change:2024/09/06
Final Product Information
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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
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common_comb_provisacor_annot_Avara_to_AZReims_Brecon_delet
Date of last change:2024/09/06
Final Product Information
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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
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase