| 药品名称 | POMALYST | | 申请号 | 204026 | 产品号 | 003 | | 活性成分 | POMALIDOMIDE | 市场状态 | 处方药 | | 剂型或给药途径 | CAPSULE;ORAL | 规格 | 3MG | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 2013/02/08 | 申请机构 | CELGENE CORP
| | 化学类型 | New molecular entity (NME) | 审评分类 | Standard 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 | 2018/02/08 | | ODE | 2020/02/08 | | I-707 | 2018/04/23 | | 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 | | 204026 | 014 | AP | Letter | 2016/07/01 | 下载 | | 204026 | 014 | AP | Label | 2016/07/05 | 下载 | | 204026 | 013 | AP | Letter | 2016/04/25 | 下载 | | 204026 | 012 | AP | Letter | 2016/07/01 | 下载 | | 204026 | 012 | AP | Label | 2016/07/05 | 下载 | | 204026 | 011 | AP | Letter | 2015/12/02 | 下载 | | 204026 | 010 | AP | Letter | 2015/10/28 | 下载 | | 204026 | 009 | AP | Letter | 2015/09/16 | 下载 | | 204026 | 008 | AP | Label | 2015/04/28 | 下载 | | 204026 | 008 | AP | Letter | 2015/04/24 | 下载 | | 204026 | 006 | AP | Letter | 2015/04/24 | 下载 | | 204026 | 006 | AP | Label | 2015/04/28 | 下载 | | 204026 | 005 | AP | Letter | 2015/04/24 | 下载 | | 204026 | 005 | AP | Label | 2015/04/28 | 下载 | | 204026 | 004 | AP | Letter | 2014/09/16 | 下载 | | 204026 | 003 | AP | Letter | 2014/03/19 | 下载 | | 204026 | 003 | AP | Label | 2014/03/19 | 下载 | | 204026 | 002 | AP | Letter | 2013/11/18 | 下载 | | 204026 | 000 | AP | Label | 2013/02/08 | 下载 | | 204026 | 000 | AP | Medication Guide | 2013/02/08 | 下载 | | 204026 | 000 | AP | Letter | 2013/02/11 | 下载 | | 204026 | 000 | AP | Other | 2013/02/12 | 下载 | | 204026 | 000 | AP | Review | 2013/03/20 | 下载 | | 204026 | 000 | AP | Summary Review | 2013/03/20 | 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 | | 204026 | 014 | AP | 2016/06/30 | Labeling Revision | | 204026 | 013 | AP | 2016/04/22 | Supplement | | 204026 | 012 | AP | 2016/06/30 | Labeling Revision | | 204026 | 012 | AP | 2016/06/30 | Labeling Revision | | 204026 | 011 | AP | 2015/12/01 | Supplement | | 204026 | 010 | AP | 2015/10/27 | Efficacy Supplement with Clinical Data to Support | | 204026 | 009 | AP | 2015/09/14 | Labeling Revision | | 204026 | 008 | AP | 2015/04/23 | Labeling Revision | | 204026 | 006 | AP | 2015/04/23 | Efficacy Supplement with Clinical Data to Support | | 204026 | 005 | AP | 2015/04/23 | Labeling Revision | | 204026 | 004 | AP | 2014/09/12 | Labeling Revision | | 204026 | 003 | AP | 2014/03/13 | Labeling Revision | | 204026 | 002 | AP | 2013/11/15 | Efficacy Supplement with Clinical Data to Support | | 204026 | 001 | AP | 2013/10/03 | Manufacturing Change or Addition | | 204026 | 000 | AP | 2013/02/08 | Approval |
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