| 药品名称 | XGEVA | | 申请号 | 125320 | 产品号 | 002 | | 活性成分 | DENOSUMAB | 市场状态 | 处方药 | | 剂型或给药途径 | INJECTABLE; SUBCUTANEOUS | 规格 | 70MG/ML | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | | 申请机构 | AMGEN | | 化学类型 | | 审评分类 | |
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| 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 | | 无 | | 历史专利信息 | | 无 |
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| 与本品相关的市场独占权保护信息 | | 独占权代码 | 失效日期 | | 无 | | 历史市场独占权保护信息 | | 无 |
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| 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 | | 125320 | 178 | AP | Letter | 2016/08/09 | 下载 | | 125320 | 178 | AP | Label | 2016/08/09 | 下载 | | 125320 | 177 | AP | Letter | 2016/03/04 | 下载 | | 125320 | 177 | AP | Label | 2016/03/04 | 下载 | | 125320 | 174 | AP | Label | 2015/04/10 | 下载 | | 125320 | 174 | AP | Letter | 2015/04/13 | 下载 | | 125320 | 170 | AP | Letter | 2015/03/02 | 下载 | | 125320 | 170 | AP | Label | 2015/03/02 | 下载 | | 125320 | 168 | AP | Letter | 2015/06/10 | 下载 | | 125320 | 168 | AP | Label | 2015/06/10 | 下载 | | 125320 | 162 | AP | Letter | 2015/05/26 | 下载 | | 125320 | 160 | AP | Letter | 2014/12/09 | 下载 | | 125320 | 160 | AP | Label | 2014/12/10 | 下载 | | 125320 | 155 | AP | Label | 2014/06/04 | 下载 | | 125320 | 155 | AP | Letter | 2014/06/05 | 下载 | | 125320 | 150 | AP | Label | 2014/06/17 | 下载 | | 125320 | 150 | AP | Letter | 2014/06/18 | 下载 | | 125320 | 124 | AP | Label | 2013/08/27 | 下载 | | 125320 | 124 | AP | Letter | 2013/08/27 | 下载 | | 125320 | 114 | AP | Label | 2013/08/27 | 下载 | | 125320 | 114 | AP | Letter | 2013/08/27 | 下载 | | 125320 | 113 | AP | Label | 2013/07/05 | 下载 | | 125320 | 113 | AP | Letter | 2013/07/08 | 下载 | | 125320 | 094 | AP | Label | 2013/06/13 | 下载 | | 125320 | 094 | AP | Letter | 2013/06/13 | 下载 | | 125320 | 080 | AP | Label | 2013/02/20 | 下载 | | 125320 | 080 | AP | Letter | 2013/02/20 | 下载 | | 125320 | 0085 | AP | Letter | 2012/09/18 | 下载 | | 125320 | 0085 | AP | Label | 2012/09/18 | 下载 | | 125320 | 0078 | AP | Label | 2012/06/11 | 下载 | | 125320 | 0078 | AP | Letter | 2012/06/11 | 下载 | | 125320 | 007 | AP | Label | 2010/11/19 | 下载 | | 125320 | 007 | AP | Letter | 2010/11/22 | 下载 | | 125320 | 007 | AP | Review | 2015/11/09 | 下载 | | 125320 | 006 | AP | Label | 2011/09/20 | 下载 | | 125320 | 006 | AP | Letter | 2011/09/20 | 下载 | | 125320 | 0054 | AP | Label | 2012/05/01 | 下载 | | 125320 | 0054 | AP | Letter | 2012/05/02 | 下载 | | 125320 | 0053 | AP | Letter | 2012/05/14 | 下载 | | 125320 | 0053 | AP | Label | 2012/05/16 | 下载 | | 125320 | 0051 | AP | Letter | 2012/09/24 | 下载 | | 125320 | 0051 | AP | Medication Guide | 2012/09/25 | 下载 | | 125320 | 0051 | AP | Label | 2012/09/25 | 下载 | | 125320 | 005 | AP | Letter | 2011/09/20 | 下载 | | 125320 | 005 | AP | Label | 2011/09/20 | 下载 | | 125320 | 0000 | AP | Label | 2010/06/02 | 下载 | | 125320 | 0000 | AP | Medication Guide | 2010/06/03 | 下载 | | 125320 | 0000 | AP | Letter | 2010/06/04 | 下载 | | 125320 | 0000 | AP | Review | 2010/08/18 | 下载 | | 125320 | 0000 | AP | Summary Review | 2010/08/18 | 下载 | | 125320 | 0000 | AP | Other | 2011/10/07 | 下载 |
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| 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 | | 125320 | 178 | AP | 2016/08/05 | Labeling Revision | | 125320 | 177 | AP | 2016/03/02 | Labeling Revision | | 125320 | 174 | AP | 2015/04/08 | Labeling Revision | | 125320 | 170 | AP | 2015/02/26 | Labeling Revision | | 125320 | 168 | AP | 2015/06/08 | Labeling Revision | | 125320 | 162 | AP | 2015/05/21 | Labeling Revision | | 125320 | 160 | AP | 2014/12/05 | Efficacy Supplement with Clinical Data to Support | | 125320 | 155 | AP | 2014/06/04 | Labeling Revision | | 125320 | 150 | AP | 2014/06/16 | Supplement | | 125320 | 124 | AP | 2013/08/23 | Labeling Revision | | 125320 | 114 | AP | 2013/08/23 | Labeling Revision | | 125320 | 113 | AP | 2013/07/03 | Labeling Revision | | 125320 | 094 | AP | 2013/06/13 | Efficacy Supplement with Clinical Data to Support | | 125320 | 080 | AP | 2013/02/15 | Labeling Revision | | 125320 | 0085 | AP | 2012/09/14 | Labeling Revision | | 125320 | 0078 | AP | 2012/06/07 | Labeling Revision | | 125320 | 007 | AP | 2010/11/18 | Supplement | | 125320 | 006 | AP | 2011/09/16 | Supplement | | 125320 | 0054 | AP | 2012/04/27 | Supplement | | 125320 | 0053 | AP | 2012/05/10 | Labeling Revision | | 125320 | 0051 | AP | 2012/09/20 | Patient Population Altered | | 125320 | 005 | AP | 2011/09/16 | Supplement | | 125320 | 0000 | AP | 2010/06/01 | Approval |
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