欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Imvanex
适用类别Human
治疗领域Smallpox Vaccine; Monkeypox virus
通用名/非专利名称smallpox vaccine (smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara))
活性成分modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus
产品号EMEA/H/C/002596
患者安全信息no
授权状态Authorised
ATC编码J07BX
是否额外监管yes
是否仿制药no
是否生物类似药no
是否附条件批准no
是否特殊情形yes
是否加速审评no
是否罕用药no
批准上市日期2013/07/31
上市许可持有人/公司名称Bavarian Nordic A/S
人用药物治疗分组Other viral vaccines,
审评意见发布日期2013/05/30
决定日期2022/07/22
修订号21
适应症Active immunisation against smallpox, monkeypox and disease caused by vaccinia virus in adults (see sections 4.4 and 5.1).The use of this vaccine should be in accordance with official recommendations.
首次发布日期2018/04/23
修订日期2022/07/25
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/imvanex
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