欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Suvaxyn PCV
适用类别Veterinary
治疗领域
通用名/非专利名称adjuvanted inactivated vaccine against porcine circovirus type 2 in piglets
活性成分porcine circovirus recombinant virus (CPCV) 1-2, inactivated
产品号EMEA/V/C/000149
患者安全信息No
许可状态Withdrawn
ATC编码QI09AA07
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2009/07/24
上市许可开发者/申请人/持有人Zoetis Belgium SA
人用药物治疗学分组
兽用药物治疗学分组Immunologicals
欧盟委员会决定日期2020/04/08
修订号13
治疗适应症Active immunisation of pigs over the age of three weeks against porcine circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues, and the lesions in lymphoid tissues associated with PCV2 infection, as well as to reduce clinical signs - including loss of daily weight gain, and mortality associated with post-weaning multisystemic wasting syndrome.
适用物种Pigs (piglets)
兽用药物ATC编码QI09AA07
首次发布日期2017/03/23
最后更新日期2020/04/15
产品说明书https://www.ema.europa.eu/en/documents/product-information/suvaxyn-pcv-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/veterinary/EPAR/suvaxyn-pcv
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