药品名称 | AFINITOR DISPERZ | 申请号 | 203985 | 产品号 | 003 | 活性成分 | EVEROLIMUS | 市场状态 | 处方药 | 剂型或给药途径 | TABLET, FOR SUSPENSION;ORAL | 规格 | 5MG | 治疗等效代码 | | 参比药物 | 是 | 批准日期 | 2012/08/29 | 申请机构 | NOVARTIS PHARMACEUTICAL CORP
| 化学类型 | New dosage form | 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 | ODE | 2017/10/29 | PED | 2018/04/29 | 历史市场独占权保护信息 | I-630 | 2013/10/29 | NCE | 2014/03/30 | PED | 2014/04/29 | PED | 2014/09/30 |
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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 | 203985 | 010 | AP | Letter | 2016/02/01 | 下载 | 203985 | 010 | AP | Label | 2016/02/02 | 下载 | 203985 | 008 | AP | Letter | 2015/01/26 | 下载 | 203985 | 008 | AP | Label | 2015/01/29 | 下载 | 203985 | 007 | AP | Label | 2014/07/02 | 下载 | 203985 | 007 | AP | Letter | 2014/07/03 | 下载 | 203985 | 005 | AP | Label | 2014/02/21 | 下载 | 203985 | 005 | AP | Letter | 2014/02/21 | 下载 | 203985 | 004 | AP | Letter | 2014/02/21 | 下载 | 203985 | 004 | AP | Label | 2014/02/21 | 下载 | 203985 | 003 | AP | Letter | 2013/11/07 | 下载 | 203985 | 003 | AP | Label | 2013/11/08 | 下载 | 203985 | 002 | AP | Label | 2014/02/21 | 下载 | 203985 | 002 | AP | Letter | 2014/02/21 | 下载 | 203985 | 000 | AP | Label | 2012/08/29 | 下载 | 203985 | 000 | AP | Letter | 2012/08/31 | 下载 | 203985 | 000 | AP | Review | 2013/11/12 | 下载 | 203985 | 000 | AP | Summary Review | 2013/11/12 | 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 | 203985 | 010 | AP | 2016/01/29 | Efficacy Supplement with Clinical Data to Support | 203985 | 009 | AP | 2015/08/24 | Manufacturing Change or Addition | 203985 | 008 | AP | 2015/01/23 | Labeling Revision | 203985 | 007 | AP | 2014/07/01 | Labeling Revision | 203985 | 006 | AP | 2015/07/01 | Manufacturing Change or Addition | 203985 | 005 | AP | 2014/02/20 | Labeling Revision | 203985 | 004 | AP | 2014/02/20 | Labeling Revision | 203985 | 003 | AP | 2013/11/06 | Efficacy Supplement with Clinical Data to Support | 203985 | 002 | AP | 2014/02/20 | Labeling Revision | 203985 | 001 | AP | 2013/03/26 | Manufacturing Change or Addition | 203985 | 000 | AP | 2012/08/29 | Approval |
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