药品名称GADAVIST
申请号201277产品号004
活性成分GADOBUTROL市场状态处方药
剂型或给药途径SOLUTION;INTRAVENOUS规格18.1416GM/30ML (604.72MG/ML)
治疗等效代码参比药物是
批准日期2011/03/14申请机构BAYER HEALTHCARE PHARMACEUTICALS INC
化学类型New molecular entity (NME)审评分类Standard review drug
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
59808642016/11/09YYU-1119PDF格式
历史专利信息
无
与本品相关的市场独占权保护信息
独占权代码失效日期
NCE2016/03/14
I-6882017/06/11
历史市场独占权保护信息
无
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
201277011APLetter2016/04/28下载
201277011APLabel2016/05/05下载
201277010APLetter2015/08/03下载
201277010APLabel2015/09/21下载
201277008APLetter2014/12/31下载
201277008APLabel2015/01/05下载
201277007APLetter2014/06/12下载
201277003APLetter2013/10/18下载
201277003APLabel2013/10/21下载
201277001APLetter2012/03/26下载
201277000APLabel2011/03/15下载
201277000APLetter2011/03/16下载
201277000APReview2011/04/11下载
201277000APSummary Review2011/04/11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
201277012AP2015/11/25Manufacturing Change or Addition
201277011AP2016/04/27Efficacy Supplement with Clinical Data to Support
201277010AP2015/07/31Labeling Revision
201277009AP2015/06/01Manufacturing Change or Addition
201277008AP2014/12/29Efficacy Supplement with Clinical Data to Support
201277007AP2014/06/11Efficacy Supplement with Clinical Data to Support
201277004AP2013/12/18Manufacturing Change or Addition
201277003AP2013/10/17Labeling Revision
201277002AP2013/07/31Manufacturing Change or Addition
201277001AP2012/03/22Labeling Revision
201277000AP2011/03/14Approval