| 药品名称 | XALKORI | | 申请号 | 202570 | 产品号 | 001 | | 活性成分 | CRIZOTINIB | 市场状态 | 处方药 | | 剂型或给药途径 | CAPSULE;ORAL | 规格 | 200MG | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 2011/08/26 | 申请机构 | PF PRISM CV
| | 化学类型 | New molecular entity (NME) | 审评分类 | Priority review drug | | 罕用药/孤儿药 | 是 | | |
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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 | | NCE | 2016/08/26 | | ODE | 2018/08/26 | | M-163 | 2018/09/14 | | ODE | 2023/03/11 | | 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 | | 202570 | 018 | AP | Label | 2016/04/29 | 下载 | | 202570 | 018 | AP | Letter | 2016/05/02 | 下载 | | 202570 | 017 | AP | Label | 2016/05/03 | 下载 | | 202570 | 017 | AP | Letter | 2016/05/04 | 下载 | | 202570 | 016 | AP | Letter | 2016/10/28 | 下载 | | 202570 | 016 | AP | Label | 2016/03/11 | 下载 | | 202570 | 014 | AP | Letter | 2015/09/16 | 下载 | | 202570 | 014 | AP | Label | 2015/09/23 | 下载 | | 202570 | 013 | AP | Letter | 2015/03/24 | 下载 | | 202570 | 013 | AP | Label | 2015/03/24 | 下载 | | 202570 | 011 | AP | Label | 2014/05/30 | 下载 | | 202570 | 011 | AP | Letter | 2014/06/02 | 下载 | | 202570 | 009 | AP | Letter | 2013/10/08 | 下载 | | 202570 | 009 | AP | Label | 2013/10/07 | 下载 | | 202570 | 007 | AP | Letter | 2013/10/08 | 下载 | | 202570 | 007 | AP | Label | 2013/10/08 | 下载 | | 202570 | 006 | AP | Label | 2013/11/22 | 下载 | | 202570 | 006 | AP | Letter | 2013/11/25 | 下载 | | 202570 | 004 | AP | Letter | 2013/03/01 | 下载 | | 202570 | 004 | AP | Label | 2013/03/15 | 下载 | | 202570 | 003 | AP | Label | 2012/02/28 | 下载 | | 202570 | 003 | AP | Letter | 2012/02/29 | 下载 | | 202570 | 002 | AP | Letter | 2012/02/29 | 下载 | | 202570 | 002 | AP | Label | 2012/03/15 | 下载 | | 202570 | 000 | AP | Label | 2011/08/26 | 下载 | | 202570 | 000 | AP | Letter | 2011/08/30 | 下载 | | 202570 | 000 | AP | Review | 2011/09/27 | 下载 | | 202570 | 000 | AP | Summary Review | 2011/09/27 | 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 | | 202570 | 018 | AP | 2016/04/28 | Labeling Revision | | 202570 | 017 | AP | 2016/04/29 | Labeling Revision | | 202570 | 016 | AP | 2016/03/11 | Efficacy Supplement with Clinical Data to Support | | 202570 | 015 | AP | 2015/12/07 | Manufacturing Change or Addition | | 202570 | 014 | AP | 2015/09/14 | Efficacy Supplement with Clinical Data to Support | | 202570 | 013 | AP | 2015/03/20 | Labeling Revision | | 202570 | 012 | AP | 2014/08/26 | Manufacturing Change or Addition | | 202570 | 011 | AP | 2014/05/28 | Labeling Revision | | 202570 | 010 | AP | 2014/02/14 | Manufacturing Change or Addition | | 202570 | 009 | AP | 2013/10/07 | Labeling Revision | | 202570 | 008 | AP | 2013/09/13 | Manufacturing Change or Addition | | 202570 | 007 | AP | 2013/10/07 | Labeling Revision | | 202570 | 006 | AP | 2013/11/20 | Efficacy Supplement with Clinical Data to Support | | 202570 | 005 | AP | 2013/03/12 | Manufacturing Change or Addition | | 202570 | 004 | AP | 2013/02/28 | Labeling Revision | | 202570 | 003 | AP | 2012/02/24 | Labeling Revision | | 202570 | 002 | AP | 2012/02/17 | Labeling Revision | | 202570 | 000 | AP | 2011/08/26 | Approval |
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