欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称COVID-19 Vaccine (inactivated, adjuvanted) Valneva
适用类别Human
治疗领域COVID-19 virus infection
通用名/非专利名称COVID-19 vaccine (inactivated, adjuvanted, adsorbed)
活性成分COVID-19 vaccine (inactivated, adjuvanted, adsorbed)
产品号EMEA/H/C/006019
患者安全信息no
授权状态Withdrawn
ATC编码J07BX03
是否额外监管no
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no
是否加速审评no
是否罕用药no
批准上市日期2022/06/24
上市许可持有人/公司名称Valneva Austria GmbH
人用药物治疗分组Vaccines
审评意见发布日期2022/06/23
决定日期2023/10/12
修订号6
适应症COVID-19 Vaccine (inactivated, adjuvanted) Valneva is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 to 50 years of age. The use of this vaccine should be in accordance with official recommendations.
首次发布日期2022/06/27
修订日期2023/12/01
产品信息https://www.ema.europa.eu/en/documents/product-information/covid-19-vaccine-inactivated-adjuvanted-valneva-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-inactivated-adjuvanted-valneva
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