欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DE/H/1938/001
药品名称
Afluria
活性成分
A/California/7/2009 (H1N1)pdm09-like virus 15.0 µg
A/Singapore/INFIMH-16-0019/2016 (H3N2)-like Virus 15.0 µg
B/Colorado/06/2017-like virus 15.0 µg
剂型
Suspension for injection
上市许可持有人
Seqirus Germany
参考成员国 - 产品名称
Germany (DE)
互认成员国 - 产品名称
Netherlands (NL)
Luxembourg (LU)
United Kingdom (Northern Ireland) (XI)
Italy (IT)
Greece (GR)
AFLURIA
Romania (RO)
Alfuria
许可日期
2008/04/05
最近更新日期
2021/11/08
药物ATC编码
J07BB02 influenza, inactivated, split virus or surface antigen
申请类型
TypeLevel1:
[not specified]
TypeLevel2:
[not specified]
TypeLevel3:
[not specified]
TypeLevel4:
[not specified]
TypeLevel5:
[not specified]
附件文件下载
PAR
|
01_PAR scientific discussion Afluria_Enzira Nov 2014
Date of last change:2014/12/10
PAR
|
02_Summary PAR for Afluria_Enzira Nov 2014
Date of last change:2014/12/10
Final SPC
|
Afluria_EU_Expert_Data_Sheet__blank_e6614b
Date of last change:2012/05/30
Final PL
|
120420_Afluria_EU-PIL_blank_ff90aa
Date of last change:2012/05/30
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase