药品名称TASIGNA
申请号022068产品号001
活性成分NILOTINIB HYDROCHLORIDE MONOHYDRATE市场状态处方药
剂型或给药途径CAPSULE;ORAL规格EQ 200MG BASE
治疗等效代码参比药物
批准日期2007/10/29申请机构NOVARTIS PHARMACEUTICALS CORP
化学类型New molecular entity (NME)审评分类Standard 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
71697912023/07/04YYU-836PDF格式
83895372026/07/18YYU-1374PDF格式
84153632026/07/18YYU-1407PDF格式
82937562027/09/25YPDF格式
81639042028/08/23YYPDF格式
85017602026/07/18YYPDF格式
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
历史市场独占权保护信息
NCE2012/10/29
ODE2014/10/29
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
022068023APLetter2016/09/28下载
022068023APLabel2016/09/29下载
022068021APLetter2015/10/16下载
022068021APLabel2015/10/22下载
022068020APLetter2015/01/28下载
022068020APLabel2015/01/30下载
022068019APLetter2014/09/29下载
022068019APLabel2014/09/30下载
022068018APLetter2013/10/01下载
022068018APLabel2013/10/01下载
022068017APLetter2014/01/23下载
022068017APLabel2014/01/23下载
022068016APLetter2013/05/28下载
022068014APLetter2013/06/13下载
022068014APLabel2013/06/18下载
022068013APLetter2013/05/22下载
022068012APLabel2012/05/02下载
022068012APMedication Guide2012/05/02下载
022068012APLetter2012/05/03下载
022068011APLabel2012/12/21下载
022068011APLetter2012/12/26下载
022068011APMedication Guide2013/02/26下载
022068009APLetter2011/11/22下载
022068009APLabel2011/11/25下载
022068009APMedication Guide2011/11/25下载
022068008APMedication Guide2011/11/25下载
022068008APLetter2011/11/22下载
022068008APLabel2011/11/25下载
022068007APLabel2011/11/01下载
022068007APLetter2011/11/01下载
022068006APLabel2011/01/14下载
022068006APLetter2011/01/20下载
022068005APLabel2010/06/17下载
022068005APLetter2010/06/22下载
022068004APLabel2010/06/17下载
022068004APLetter2010/06/22下载
022068002APLabel2009/09/16下载
022068002APLetter2010/01/21下载
022068001APLabel2010/03/17下载
022068001APLetter2010/03/18下载
022068000APMedication Guide2009/11/18下载
022068000APLabel2007/10/29下载
022068000APLetter2007/11/08下载
022068000APReview2008/03/14下载
022068000APSummary Review2008/07/22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
022068023AP2016/09/27Labeling Revision
022068021AP2015/10/15Labeling Revision
022068020AP2015/01/27Efficacy Supplement with Clinical Data to Support
022068019AP2014/09/25Labeling Revision
022068018AP2013/09/27Labeling Revision
022068017AP2014/01/22Efficacy Supplement with Clinical Data to Support
022068016AP2013/05/22Labeling Revision
022068015AP2013/08/14Manufacturing Change or Addition
022068014AP2013/06/12Labeling Revision
022068013AP2013/05/17Labeling Revision
022068012AP2012/05/01Labeling Revision
022068011AP2012/12/20Efficacy Supplement with Clinical Data to Support
022068009AP2011/11/18Labeling Revision
022068008AP2011/11/18Efficacy Supplement with Clinical Data to Support
022068007AP2011/10/26Labeling Revision
022068006AP2011/01/14Accelerated Approval
022068005AP2010/06/17New or Modified Indication
022068004AP2010/06/17Labeling Revision
022068002AP2009/08/21Labeling Revision
022068001AP2010/03/15Labeling Revision
022068000AP2007/10/29Approval