| 药品名称 | TIVICAY | | 申请号 | 204790 | 产品号 | 001 | | 活性成分 | DOLUTEGRAVIR SODIUM | 市场状态 | 处方药 | | 剂型或给药途径 | TABLET;ORAL | 规格 | EQ 50MG BASE | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 2013/08/12 | 申请机构 | VIIV HEALTHCARE CO
| | 化学类型 | New molecular entity (NME) | 审评分类 | Priority review drug |
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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 | 2018/08/12 | | M-166 | 2018/07/30 | | 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 | | 204790 | 008 | AP | Letter | 2016/06/10 | 下载 | | 204790 | 008 | AP | Label | 2016/06/10 | 下载 | | 204790 | 007 | AP | Letter | 2016/04/26 | 下载 | | 204790 | 007 | AP | Label | 2016/04/29 | 下载 | | 204790 | 005 | AP | Label | 2015/08/07 | 下载 | | 204790 | 005 | AP | Letter | 2015/08/10 | 下载 | | 204790 | 002 | AP | Letter | 2014/12/24 | 下载 | | 204790 | 002 | AP | Label | 2015/01/08 | 下载 | | 204790 | 001 | AP | Label | 2014/05/13 | 下载 | | 204790 | 001 | AP | Letter | 2014/05/13 | 下载 | | 204790 | 000 | AP | Label | 2013/08/19 | 下载 | | 204790 | 000 | AP | Letter | 2013/08/20 | 下载 | | 204790 | 000 | AP | Review | 2013/09/13 | 下载 | | 204790 | 000 | AP | Summary Review | 2013/09/13 | 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 | | 204790 | 009 | AP | 2016/09/19 | Manufacturing Change or Addition | | 204790 | 008 | AP | 2016/06/09 | Efficacy Supplement with Clinical Data to Support | | 204790 | 007 | AP | 2016/04/22 | Efficacy Supplement with Clinical Data to Support | | 204790 | 006 | AP | 2015/11/05 | Manufacturing Change or Addition | | 204790 | 005 | AP | 2015/08/05 | Labeling Revision | | 204790 | 003 | AP | 2014/08/29 | Manufacturing Change or Addition | | 204790 | 002 | AP | 2014/12/19 | Labeling Revision | | 204790 | 001 | AP | 2014/05/12 | Labeling Revision | | 204790 | 000 | AP | 2013/08/12 | Approval |
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