欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/2470/002
药品名称
Prasugrel Vivanta
活性成分
Prasugrel 10.0 mg
剂型
Film-coated tablet
上市许可持有人
Vivanta Generics s.r.o.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Netherlands (NL)
Spain (ES)
Germany (DE)
Prasugrel Vivanta 10 mg Filmtabletten
许可日期
2021/02/17
最近更新日期
2023/12/11
药物ATC编码
B01AC22 prasugrel
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 PL
|
650584_650585_20231020_FI_JPC
Date of last change:2024/09/06
Final SPC
|
650584_650585_20231020_RCM_JPC
Date of last change:2024/09/06
Final Labelling
|
650584_650585_20231020_ROT_JPC
Date of last change:2024/09/06
PubAR
|
PT_2470_PAR_draft_final
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase