欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/2543/001
药品名称
Azacitidina Eugia
活性成分
Azacitidine 100.0 mg
剂型
Powder for solution for injection
上市许可持有人
Eugia Pharma Limited
参考成员国 - 产品名称
Portugal (PT)
Azacitidina Eugia
互认成员国 - 产品名称
Netherlands (NL)
France (FR)
Spain (ES)
Italy (IT)
Poland (PL)
Azacitidine Aurovitas
Czechia (CZ)
Azacitidin Aurovitas
Romania (RO)
Azacitidină Aurobindo 25 mg/ml pulbere
Germany (DE)
Azacitidin PUREN 25 mg/ml Pulver zur Herstellung einer Injektionssuspension
Belgium (BE)
许可日期
2022/12/06
最近更新日期
2025/01/29
药物ATC编码
L01BC07 azacitidine
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
PubAR
|
679364_20221220_PAR_ACM
Date of last change:2024/09/06
Final Labelling
|
Azacitidine Common ENG_Labelling_Clean
Date of last change:2024/09/06
Final PL
|
common_pl
Date of last change:2024/09/06
Final SPC
|
common_spc
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase