欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0225/001
药品名称
Clopidogrel Premium Pharma
活性成分
clopidogrel 75.0 mg
剂型
Film-coated tablet
上市许可持有人
Pentafarma - Sociedade Técnico-Medicinal, S. A
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Italy (IT)
许可日期
2010/03/18
最近更新日期
2023/06/19
药物ATC编码
B01AC04 clopidogrel
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 Labelling
|
Labelling_PT_0225_proposed_clean_R001
Date of last change:2024/09/06
Final PL
|
Leaflet_PT_0225_proposed_clean_R001
Date of last change:2024/09/06
Final SPC
|
SmPC_PT_0225_proposed_clean_R001
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase