| 药品名称 | AVASTIN | | 申请号 | 125085 | 产品号 | 002 | | 活性成分 | BEVACIZUMAB | 市场状态 | 处方药 | | 剂型或给药途径 | VIAL; INTRAVENOUS | 规格 | 400MG | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | | 申请机构 | GENENTECH | | 化学类型 | | 审评分类 | |
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| 与本品相关的专利信息（来自橙皮书Orange Book） | | 专利号 | 专利过期日 | 是否化合物专利 | 是否产品专利 | 专利用途代码 | 专利下载 | | 无 | | 历史专利信息 | | 无 |
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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 | | 无 | | 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 | | 125085 | 312 | AP | Letter | 2015/12/02 | 下载 | | 125085 | 312 | AP | Label | 2015/12/02 | 下载 | | 125085 | 310 | AP | Letter | 2015/10/01 | 下载 | | 125085 | 310 | AP | Label | 2015/10/07 | 下载 | | 125085 | 308 | AP | Label | 2015/05/08 | 下载 | | 125085 | 308 | AP | Letter | 2015/05/11 | 下载 | | 125085 | 305 | AP | Label | 2014/11/14 | 下载 | | 125085 | 305 | AP | Letter | 2014/11/17 | 下载 | | 125085 | 301 | AP | Label | 2014/08/14 | 下载 | | 125085 | 301 | AP | Letter | 2014/08/15 | 下载 | | 125085 | 301 | AP | Summary Review | 2014/08/19 | 下载 | | 125085 | 297 | AP | Letter | 2014/09/03 | 下载 | | 125085 | 297 | AP | Label | 2014/09/03 | 下载 | | 125085 | 285 | AP | Letter | 2013/12/17 | 下载 | | 125085 | 285 | AP | Label | 2013/12/17 | 下载 | | 125085 | 267 | AP | Letter | 2013/03/28 | 下载 | | 125085 | 267 | AP | Label | 2013/04/01 | 下载 | | 125085 | 265 | AP | Letter | 2012/11/23 | 下载 | | 125085 | 265 | AP | Label | 2012/11/28 | 下载 | | 125085 | 263 | AP | Label | 2013/01/24 | 下载 | | 125085 | 263 | AP | Letter | 2013/01/25 | 下载 | | 125085 | 239 | AP | Label | 2012/10/26 | 下载 | | 125085 | 239 | AP | Letter | 2012/10/29 | 下载 | | 125085 | 225 | AP | Label | 2011/09/30 | 下载 | | 125085 | 225 | AP | Letter | 2011/10/04 | 下载 | | 125085 | 208 | AP | Letter | 2011/02/15 | 下载 | | 125085 | 204 | AP | Letter | 2011/01/10 | 下载 | | 125085 | 0241 | AP | Letter | 2011/12/27 | 下载 | | 125085 | 0238 | AP | Label | 2012/05/07 | 下载 | | 125085 | 0238 | AP | Letter | 2012/05/08 | 下载 | | 125085 | 0169 | AP | Label | 2009/05/05 | 下载 | | 125085 | 0169 | AP | Letter | 2009/05/13 | 下载 | | 125085 | 0168 | AP | Label | 2009/08/04 | 下载 | | 125085 | 0168 | AP | Letter | 2009/08/06 | 下载 | | 125085 | 0145 | AP | Label | 2008/03/27 | 下载 | | 125085 | 0145 | AP | Letter | 2008/03/28 | 下载 | | 125085 | 0131 | AP | Label | 2007/09/26 | 下载 | | 125085 | 0091 | AP | Letter | 2008/02/27 | 下载 | | 125085 | 0091 | AP | Review | 2011/02/15 | 下载 | | 125085 | 0085 | AP | Review | 2006/10/11 | 下载 | | 125085 | 0085 | AP | Label | 2006/10/23 | 下载 | | 125085 | 0085 | AP | Letter | 2006/10/23 | 下载 | | 125085 | 0082 | AP | Letter | 2006/09/25 | 下载 | | 125085 | 0082 | AP | Label | 2006/09/25 | 下载 | | 125085 | 0074 | AP | Label | 2006/06/21 | 下载 | | 125085 | 0074 | AP | Letter | 2006/06/27 | 下载 | | 125085 | 0074 | AP | Review | 2006/06/20 | 下载 | | 125085 | 0067 | AP | Letter | 2006/04/21 | 下载 | | 125085 | 0067 | AP | Label | 2006/04/21 | 下载 | | 125085 | 0045 | AP | Label | 2005/09/30 | 下载 | | 125085 | 0045 | AP | Letter | 2005/10/20 | 下载 | | 125085 | 000 | AP | Other Important Information from FDA | 2009/12/11 | 下载 | | 125085 | 000 | AP | Label | 2004/02/27 | 下载 | | 125085 | 000 | AP | Letter | 2004/02/27 | 下载 | | 125085 | 000 | AP | Review | 2005/01/28 | 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 | | 125085 | 312 | AP | 2015/12/01 | Labeling Revision | | 125085 | 310 | AP | 2015/09/29 | Labeling Revision | | 125085 | 308 | AP | 2015/05/07 | Labeling Revision | | 125085 | 308 | AP | 2015/05/07 | Labeling Revision | | 125085 | 305 | AP | 2014/11/14 | Efficacy Supplement with Clinical Data to Support | | 125085 | 301 | AP | 2014/08/14 | Efficacy Supplement with Clinical Data to Support | | 125085 | 297 | AP | 2014/08/30 | Labeling Revision | | 125085 | 285 | AP | 2013/12/16 | Labeling Revision | | 125085 | 267 | AP | 2013/03/26 | Labeling Revision | | 125085 | 265 | AP | 2012/11/20 | Labeling Revision | | 125085 | 263 | AP | 2013/01/23 | New or Modified Indication | | 125085 | 239 | AP | 2012/10/26 | Efficacy Supplement with Clinical Data to Support | | 125085 | 225 | AP | 2011/09/30 | Supplement | | 125085 | 208 | AP | 2011/02/08 | Supplement | | 125085 | 204 | AP | 2010/12/28 | Supplement | | 125085 | 0241 | AP | 2011/12/20 | Supplement | | 125085 | 0238 | AP | 2012/05/03 | Supplement | | 125085 | 0169 | AP | 2009/05/05 | Supplement | | 125085 | 0168 | AP | 2009/07/31 | Supplement | | 125085 | 0145 | AP | 2008/03/10 | Supplement | | 125085 | 0131 | AP | 2007/09/20 | Supplement | | 125085 | 0091 | AP | 2008/02/22 | Supplement | | 125085 | 0085 | AP | 2006/10/11 | Supplement | | 125085 | 0082 | AP | 2006/09/21 | Supplement | | 125085 | 0074 | AP | 2006/06/20 | Supplement | | 125085 | 0067 | AP | 2006/04/18 | Supplement | | 125085 | 0045 | AP | 2005/09/30 | Supplement | | 125085 | 000 | AP | 2004/02/26 | Approval |
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