药品名称 | ZORTRESS | 申请号 | 021560 | 产品号 | 002 | 活性成分 | EVEROLIMUS | 市场状态 | 处方药 | 剂型或给药途径 | TABLET;ORAL | 规格 | 0.5MG | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | 2010/04/20 | 申请机构 | NOVARTIS PHARMACEUTICALS CORP
| 化学类型 | New formulation or new manufacturer | 审评分类 | Standard 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 | I-668 | 2016/02/15 | 历史市场独占权保护信息 | NCE | 2014/03/30 | PED | 2013/10/20 | 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 | 021560 | 019 | AP | Letter | 2016/10/14 | 下载 | 021560 | 019 | AP | Label | 2016/10/17 | 下载 | 021560 | 018 | AP | Letter | 2015/11/09 | 下载 | 021560 | 018 | AP | Label | 2015/11/12 | 下载 | 021560 | 011 | AP | Letter | 2015/01/28 | 下载 | 021560 | 011 | AP | Label | 2015/01/30 | 下载 | 021560 | 009 | AP | Letter | 2012/05/04 | 下载 | 021560 | 008 | AP | Letter | 2012/10/04 | 下载 | 021560 | 008 | AP | Label | 2012/10/04 | 下载 | 021560 | 008 | AP | Medication Guide | 2012/10/04 | 下载 | 021560 | 007 | AP | Letter | 2012/04/27 | 下载 | 021560 | 007 | AP | Label | 2012/05/01 | 下载 | 021560 | 006 | AP | Label | 2013/02/20 | 下载 | 021560 | 006 | AP | Letter | 2013/02/20 | 下载 | 021560 | 004 | AP | Letter | 2011/11/28 | 下载 | 021560 | 000 | AP | Letter | 2010/04/29 | 下载 | 021560 | 000 | AP | Medication Guide | 2010/04/30 | 下载 | 021560 | 000 | AP | Label | 2010/05/03 | 下载 | 021560 | 000 | AP | Review | 2010/06/16 | 下载 | 021560 | 000 | AP | Summary Review | 2010/06/16 | 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 | 021560 | 019 | AP | 2016/10/12 | Efficacy Supplement with Clinical Data to Support | 021560 | 018 | AP | 2015/11/05 | Labeling Revision | 021560 | 017 | AP | 2016/03/01 | Manufacturing Change or Addition | 021560 | 014 | AP | 2015/06/24 | Manufacturing Change or Addition | 021560 | 013 | AP | 2013/11/14 | Manufacturing Change or Addition | 021560 | 012 | AP | 2013/12/05 | Manufacturing Change or Addition | 021560 | 011 | AP | 2015/01/27 | Labeling Revision | 021560 | 010 | AP | 2013/03/26 | Manufacturing Change or Addition | 021560 | 009 | AP | 2012/05/02 | Labeling Revision | 021560 | 008 | AP | 2012/10/02 | Labeling Revision | 021560 | 007 | AP | 2012/04/26 | Labeling Revision | 021560 | 006 | AP | 2013/02/15 | New or Modified Indication | 021560 | 004 | AP | 2011/11/21 | Labeling Revision | 021560 | 000 | AP | 2010/04/20 | Approval |
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