欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
IT/H/0121/001
药品名称
Viroflu
活性成分
A/Moscow/10/99 (H3N2)-like virus 15.0 µg
A/New Caledonia/20/99 (H1N1)-like virus 15.0 µg
B/Hong Kong/330/2001-like virus 15.0 µg
剂型
Suspension for injection
上市许可持有人
Crucell Italia Via Zambeletti 25 20021 Baranzate (MI), Italy
参考成员国 - 产品名称
Italy (IT)
互认成员国 - 产品名称
Germany (DE)
United Kingdom (Northern Ireland) (XI)
许可日期
2005/02/15
最近更新日期
2014/02/22
药物ATC编码
J07BB02 influenza, inactivated, split virus or surface antigen
申请类型
TypeLevel1:
New Active Substance
TypeLevel2:
Multiple (Copy) Application
TypeLevel3:
Full Dossier [Article 8.3(i)]
TypeLevel4:
Biological: Vaccine
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
common-pl-annotated-037
Date of last change:2014/03/13
Final SPC
|
common-spc-annotated-037
Date of last change:2014/03/13
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase