药品名称GLEEVEC
申请号021588产品号002
活性成分IMATINIB MESYLATE市场状态处方药
剂型或给药途径TABLET;ORAL规格EQ 400MG BASE
治疗等效代码AB参比药物
批准日期2003/04/18申请机构NOVARTIS PHARMACEUTICALS CORP
化学类型New dosage form审评分类
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
68940512019/05/23YYU-649PDF格式
69583352021/12/19U-791PDF格式
69583352021/12/19U-1883PDF格式
RE439322018/07/16YYPDF格式
75447992018/07/16YYPDF格式
5521184*PED2015/07/04PDF格式
6894051*PED2019/11/23PDF格式
6958335*PED2022/06/19PDF格式
7544799*PED2019/01/16PDF格式
RE43932*PED2019/01/16PDF格式
历史专利信息
55211842015/01/04PDF格式
与本品相关的市场独占权保护信息
独占权代码失效日期
I-6662016/01/25
ODE2020/01/25
ODE2015/12/19
历史市场独占权保护信息
I-5102009/10/19
I-5112009/10/19
I-5122009/10/19
I-5132009/10/19
I-5142009/10/19
I-5832011/12/19
ODE2008/05/10
ODE2009/02/01
ODE2013/10/19
PED2006/11/10
PED2006/11/20
PED2008/11/10
PED2009/08/01
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
021588047APLabel2016/09/29下载
021588047APLetter2016/10/04下载
021588046APLetter2016/08/29下载
021588046APLabel2016/08/29下载
021588045APLabel2016/08/29下载
021588045APLetter2016/08/29下载
021588042APLetter2015/02/02下载
021588042APLabel2015/02/03下载
021588040APLetter2014/05/22下载
021588040APLabel2014/05/28下载
021588039APLetter2013/10/31下载
021588039APLabel2013/10/31下载
021588038APLetter2013/02/25下载
021588038APLabel2013/02/26下载
021588037APLetter2013/01/30下载
021588037APLabel2013/01/30下载
021588035APLabel2012/01/31下载
021588035APLetter2012/02/03下载
021588031APLabel2011/04/01下载
021588031APLetter2011/04/06下载
021588030APLetter2011/04/06下载
021588030APLabel2011/04/01下载
021588028APLetter2009/06/02下载
021588028APLabel2009/06/05下载
021588027APLabel2009/02/12下载
021588027APLetter2009/02/13下载
021588026APLetter2009/06/02下载
021588025APLetter2008/12/29下载
021588024APLabel2008/09/26下载
021588024APLetter2008/10/01下载
021588023APLetter2008/05/05下载
021588022APLetter2008/10/01下载
021588022APLabel2008/09/26下载
021588021APLabel2008/09/26下载
021588021APLetter2008/10/01下载
021588020APLabel2007/09/19下载
021588020APLetter2007/09/25下载
021588017APLetter2006/10/23下载
021588017APLabel2006/10/23下载
021588017APReview2006/10/19下载
021588016APLabel2006/09/28下载
021588016APLetter2006/10/02下载
021588014APLabel2006/10/23下载
021588014APLetter2006/10/23下载
021588014APReview2006/10/19下载
021588013APReview2006/10/19下载
021588013APLetter2006/10/23下载
021588013APLabel2006/10/23下载
021588012APLabel2006/10/23下载
021588012APLetter2006/10/23下载
021588012APReview2006/10/19下载
021588011APReview2006/10/19下载
021588011APLabel2006/10/23下载
021588011APLetter2006/10/23下载
021588010APLabel2006/06/01下载
021588010APLetter2006/06/02下载
021588009APLabel2006/11/06下载
021588009APLetter2006/11/06下载
021588008APLabel2005/10/25下载
021588008APLetter2005/10/25下载
021588007APLetter2005/05/20下载
021588006APLetter2005/05/20下载
021588005APLetter2005/03/18下载
021588005APLabel2005/03/18下载
021588005APReview2015/05/26下载
021588003APLetter2004/06/25下载
021588003APLabel2004/06/25下载
021588002APLabel2003/12/08下载
021588002APReview2005/04/08下载
021588002APLetter2003/12/22下载
021588001APReview2004/08/09下载
021588001APLabel2003/05/20下载
021588001APLetter2003/06/08下载
021588000APLabel2003/04/28下载
021588000APLetter2003/05/29下载
021588000APOther Important Information from FDA2003/12/09下载
021588000APReview2006/06/07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
021588047AP2016/09/27Labeling Revision
021588046AP2016/08/25Labeling Revision
021588045AP2016/08/25Efficacy Supplement with Clinical Data to Support
021588042AP2015/01/30Efficacy Supplement with Clinical Data to Support
021588040AP2014/05/22Labeling Revision
021588039AP2013/10/30Labeling Revision
021588038AP2013/02/21Labeling Revision
021588037AP2013/01/25New or Modified Indication
021588035AP2012/01/31Accelerated Approval
021588031AP2011/04/01Labeling Revision
021588030AP2011/04/01Accelerated Approval
021588028AP2009/05/27Labeling Revision
021588027AP2009/02/10Labeling Revision
021588026AP2009/05/27Accelerated Approval
021588025AP2008/12/19Labeling Revision
021588024AP2008/09/26Accelerated Approval
021588023AP2008/04/30Package Change
021588022AP2008/09/26Labeling Revision
021588021AP2008/09/26Labeling Revision
021588020AP2007/09/13Efficacy Supplement with Clinical Data to Support
021588017AP2006/10/19New or Modified Indication
021588016AP2006/09/27New or Modified Indication
021588014AP2006/10/19New or Modified Indication
021588013AP2006/10/19New or Modified Indication
021588012AP2006/10/19New or Modified Indication
021588011AP2006/10/19New or Modified Indication
021588010AP2006/05/31Labeling Revision
021588009AP2006/10/30Labeling Revision
021588008AP2005/10/20Efficacy Supplement with Clinical Data to Support
021588007AP2005/05/18Labeling Revision
021588006AP2005/05/19Control Supplement
021588005AP2005/03/14Efficacy Supplement with Clinical Data to Support
021588003AP2004/06/23Labeling Revision
021588002AP2003/12/08Accelerated Approval
021588001AP2003/05/20Patient Population Altered
021588000AP2003/04/18Approval