药品名称VPRIV
申请号022575产品号001
活性成分VELAGLUCERASE ALFA市场状态处方药
剂型或给药途径INJECTABLE;IV (INFUSION)规格400 UNITS/VIAL
治疗等效代码参比药物
批准日期2010/02/26申请机构SHIRE HUMAN GENETIC THERAPIES INC
化学类型New molecular entity (NME)审评分类Priority review drug
罕用药/孤儿药
与本品相关的专利信息(来自橙皮书Orange Book)
专利号专利过期日是否化合物专利是否产品专利专利用途代码专利下载
历史专利信息
与本品相关的市场独占权保护信息
独占权代码失效日期
M-1302016/11/21
历史市场独占权保护信息
NCE2015/02/26
与药品注册相关的信息
申请号修订号审批结论公开文档类型文档创建时间获取文档
022575017APLabel2015/05/06下载
022575017APLetter2015/05/11下载
022575013APLetter2013/10/04下载
022575013APLabel2013/10/08下载
022575012APLabel2013/11/22下载
022575012APLetter2013/11/25下载
022575009APLabel2013/04/01下载
022575007APLetter2013/03/28下载
022575007APLabel2013/04/01下载
022575000APLabel2010/03/02下载
022575000APLetter2010/03/04下载
022575000APReview2010/08/04下载
药品注册审批历史信息
申请号修订号审批结论审批日期审批内容
022575018AP2016/01/11Manufacturing Change or Addition
022575017AP2015/05/05Labeling Revision
022575016AP2015/02/03Manufacturing Change or Addition
022575015AP2014/12/02Manufacturing Change or Addition
022575014AP2014/06/18Manufacturing Change or Addition
022575013AP2013/10/02Labeling Revision
022575012AP2013/11/21Efficacy Supplement with Clinical Data to Support
022575011AP2013/06/03Manufacturing Change or Addition
022575010AP2014/07/11Manufacturing Change or Addition
022575009AP2013/03/26Labeling Revision
022575008AP2014/02/11Manufacturing Change or Addition
022575007AP2013/03/26Labeling Revision
022575000AP2010/02/26Approval