欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DE/H/4904/001
药品名称
BioThrax
活性成分
bacillus anthracis antigenic fraction 50.0 µg
剂型
Suspension for injection
上市许可持有人
Emergent Sales and Marketing Germany GmbH
参考成员国 - 产品名称
Germany (DE)
BioThrax
互认成员国 - 产品名称
United Kingdom (Northern Ireland) (XI)
France (FR)
Italy (IT)
Poland (PL)
BioThrax
许可日期
2018/04/08
最近更新日期
2024/04/10
药物ATC编码
J07AC01 anthrax antigen
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Full Dossier Art 8.3(i) Dir 2001/83/EC
TypeLevel4:
Biological: Vaccine
TypeLevel5:
Prescription Only
附件文件下载
Final Labelling
|
BioThrax_common_interpack_clean
Date of last change:2024/09/06
Final PL
|
BioThrax_common_pil_clean
Date of last change:2024/09/06
Final SPC
|
BioThrax_common_spc_clean
Date of last change:2024/09/06
Final Product Information
|
de_combined_1
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase