欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Porcilis Porcoli Diluvac Forte (previously Porcilis Porcoli)
适用类别Veterinary
治疗领域
通用名/非专利名称vaccine to provide passive immunity to the progeny against E. coli in pigs
活性成分F4ab (K88ab) fimbrial adhesin;F4ac (K88ac) fimbrial adhesin;F5 (K99) fimbrial adhesin;F6 (987P) fimbrial adhesin;LT toxoid
产品号EMEA/V/C/000024
患者安全信息No
许可状态Authorised
ATC编码QI09AB02
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1996/02/29
上市许可开发者/申请人/持有人Intervet International BV
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2014/04/04
修订号7
治疗适应症For the passive immunisation of piglets by active immunisation of sows / gilts to reduce mortality and clinical signs such as diarrhoea due to neonatal enterotoxicosis during the first days of life, caused by those E.coli strains which express the fimbrial adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P).
适用物种Pigs (gilts and sows)
兽用药物ATC编码QI09AB02
首次发布日期2014/04/04
最后更新日期2014/04/14
产品说明书https://www.ema.europa.eu/en/documents/product-information/porcilis-porcoli-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/veterinary/EPAR/porcilis-porcoli-diluvac-forte
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