欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Ixiaro
适用类别Human
治疗领域Encephalitis, Japanese;Immunization
通用名/非专利名称Japanese encephalitis vaccine (inactivated, adsorbed)
活性成分Japanese-encephalitis virus, inactivated (attenuated strain SA14-14-2 grown in vero cells)
产品号EMEA/H/C/000963
患者安全信息No
许可状态Authorised
ATC编码J07BA02
是否额外监管No
是否仿制药或hybrid药物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
上市许可日期2009/03/31
上市许可开发者/申请人/持有人Valneva Austria GmbH
人用药物治疗学分组Vaccines
兽用药物治疗学分组
欧盟委员会决定日期2021/03/19
修订号17
治疗适应症Ixiaro is indicated for active immunisation against Japanese encephalitis in adults, adolescents, children and infants aged two months and older. Ixiaro should be considered for use in individuals at risk of exposure through travel or in the course of their occupation.
适用物种
兽用药物ATC编码
首次发布日期2018/01/08
最后更新日期2023/05/25
产品说明书https://www.ema.europa.eu/en/documents/product-information/ixiaro-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/ixiaro
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