欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称ProQuad
适用类别Human
治疗领域Chickenpox;Rubella;Measles;Mumps;Immunization
通用名/非专利名称measles, mumps, rubella and varicella vaccine (live)
活性成分virus, live attenuated, measles, virus, live attenuated, mumps, virus, live attenuated, rubella, virus, live attenuated, varicella
产品号EMEA/H/C/000622
患者安全信息No
许可状态Authorised
ATC编码J07BD54
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2006/04/05
上市许可开发者/申请人/持有人Merck Sharp & Dohme B.V.
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2025/09/24
修订号36
治疗适应症ProQuad is indicated for simultaneous vaccination against measles, mumps, rubella and varicella in individuals from 12 months of age. ProQuad can be administered to individuals from 9 months of age under special circumstances (e.g., to conform with national vaccination schedules, outbreak situations, or travel to a region with high prevalence of measles.
适用物种
兽用药物ATC编码
首次发布日期2017/05/18
最后更新日期2025/09/25
产品说明书https://www.ema.europa.eu/en/documents/product-information/proquad-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/proquad
©2006-2025 DrugFuture->European Medicines Agency Authorisation of Medicines DataBase