欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
IT/H/0104/001
药品名称
FLUAD
活性成分
Influenza virus, surface antigen, inactivated 15.0 µg
剂型
Suspension for injection
上市许可持有人
Seqirus Srl Via Fiorentina 1 53100 Siena, Italy
参考成员国 - 产品名称
Italy (IT)
互认成员国 - 产品名称
许可日期
2000/04/23
最近更新日期
2024/04/18
药物ATC编码
J07BB02 influenza, inactivated, split virus or surface antigen
申请类型
TypeLevel1:
New Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Full Dossier Article 4.8 Di 65/65
TypeLevel4:
Biological: Vaccine
TypeLevel5:
Prescription Only
附件文件下载
PubAR
|
Assessment SPC_PIL
Date of last change:2024/09/06
Final SPC
|
common_combined_annotated FLUAD
Date of last change:2024/09/06
Final Product Information
|
Fluad IB_110 final EN texts
Date of last change:2024/09/06
Final Labelling
|
track
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase