欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
RO/H/0200/002
药品名称
Oseltamivir Phosphate Accord 45 mg Capsule
活性成分
oseltamivir phosphate 45.0 mg
剂型
Capsule, hard
上市许可持有人
Accord Healthcare Polska Sp. z o.o. Poland
参考成员国 - 产品名称
Romania (RO)
互认成员国 - 产品名称
Spain (ES)
许可日期
2023/02/14
最近更新日期
2024/03/08
药物ATC编码
J05AH02 oseltamivir
申请类型
TypeLevel1:
Known Active Substance
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
|
common final interpack_Oseltamivir Accord
Date of last change:2024/09/06
Final PL
|
common final package leaflet Oseltamivir Accord
Date of last change:2024/09/06
Final SPC
|
common final SPC Oseltamivir Accord
Date of last change:2024/09/06
PubAR
|
Oseltamivir Accord RO H 0200 001_003 DC PAR
Date of last change:2024/09/06
PubAR Summary
|
Oseltamivir Accord RO H 0200 001_003 DC Summary PAR
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase