| 药品名称 | OLYSIO | | 申请号 | 205123 | 产品号 | 001 | | 活性成分 | SIMEPREVIR SODIUM | 市场状态 | 处方药 | | 剂型或给药途径 | CAPSULE;ORAL | 规格 | EQ 150MG BASE | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 2013/11/22 | 申请机构 | JANSSEN PRODUCTS LP
| | 化学类型 | New molecular entity (NME) | 审评分类 | Priority review drug |
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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 | | 205123 | 011 | AP | Label | 2016/05/23 | 下载 | | 205123 | 011 | AP | Letter | 2016/05/24 | 下载 | | 205123 | 010 | AP | Letter | 2016/03/02 | 下载 | | 205123 | 010 | AP | Label | 2016/03/03 | 下载 | | 205123 | 009 | AP | Letter | 2015/04/13 | 下载 | | 205123 | 009 | AP | Label | 2015/04/14 | 下载 | | 205123 | 008 | AP | Label | 2015/04/16 | 下载 | | 205123 | 008 | AP | Letter | 2015/04/17 | 下载 | | 205123 | 008 | AP | Review | 2015/08/21 | 下载 | | 205123 | 006 | AP | Letter | 2015/10/06 | 下载 | | 205123 | 006 | AP | Label | 2015/12/10 | 下载 | | 205123 | 005 | AP | Label | 2015/10/08 | 下载 | | 205123 | 005 | AP | Letter | 2015/10/06 | 下载 | | 205123 | 003 | AP | Letter | 2014/09/08 | 下载 | | 205123 | 003 | AP | Label | 2014/09/09 | 下载 | | 205123 | 002 | AP | Letter | 2014/11/07 | 下载 | | 205123 | 002 | AP | Label | 2014/11/07 | 下载 | | 205123 | 001 | AP | Label | 2013/12/06 | 下载 | | 205123 | 001 | AP | Letter | 2013/12/09 | 下载 | | 205123 | 000 | AP | Review | 2013/12/24 | 下载 | | 205123 | 000 | AP | Summary Review | 2013/12/24 | 下载 | | 205123 | 000 | AP | Letter | 2013/11/25 | 下载 | | 205123 | 000 | AP | Label | 2013/11/26 | 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 | | 205123 | 011 | AP | 2016/05/20 | Efficacy Supplement with Clinical Data to Support | | 205123 | 010 | AP | 2016/02/26 | Efficacy Supplement with Clinical Data to Support | | 205123 | 009 | AP | 2015/04/10 | Labeling Revision | | 205123 | 008 | AP | 2015/04/15 | Labeling Revision | | 205123 | 007 | AP | 2015/06/19 | Manufacturing Change or Addition | | 205123 | 006 | AP | 2015/10/05 | Efficacy Supplement with Clinical Data to Support | | 205123 | 005 | AP | 2015/10/05 | Efficacy Supplement with Clinical Data to Support | | 205123 | 004 | AP | 2015/03/03 | Manufacturing Change or Addition | | 205123 | 003 | AP | 2014/09/05 | Labeling Revision | | 205123 | 002 | AP | 2014/11/05 | Efficacy Supplement with Clinical Data to Support | | 205123 | 001 | AP | 2013/12/05 | Labeling Revision | | 205123 | 000 | AP | 2013/11/22 | Approval |
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