药品注册申请号:125147
申请类型:BLA (生物制品许可申请)
申请人:AMGEN
申请人全名:--
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 VECTIBIX PANITUMUMAB INJECTABLE; IV (INFUSION) 5ML/100MG No None 2006/09/27 -- Prescription
002 VECTIBIX PANITUMUMAB INJECTABLE; IV (INFUSION) 10ML/200MG No None -- Prescription
003 VECTIBIX PANITUMUMAB INJECTABLE; IV (INFUSION) 20ML/400MG No None -- Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2017/06/29 SUPPL 207 Approval Efficacy STANDARD
2015/03/11 SUPPL 200 Approval Labeling STANDARD
2014/08/30 SUPPL 194 Approval Labeling STANDARD
2014/05/23 SUPPL 186 Approval Efficacy STANDARD
2014/05/23 SUPPL 108 Approval Efficacy STANDARD
2013/03/28 SUPPL 169 Approval Labeling STANDARD
2012/08/17 SUPPL 152 Approval Labeling STANDARD
2012/08/17 SUPPL 148 Approval Labeling STANDARD
2011/12/12 SUPPL 137 Approval Labeling STANDARD
2011/03/15 SUPPL 123 Approval Labeling STANDARD
2010/05/26 SUPPL 103 Approval Labeling STANDARD
2009/07/17 SUPPL 80 Approval Labeling STANDARD
2009/07/17 SUPPL 78 Approval Labeling STANDARD
2009/04/27 SUPPL 67 Approval Labeling STANDARD
2008/06/23 SUPPL 26 Approval Efficacy STANDARD
2007/11/06 SUPPL 18 Approval Labeling STANDARD
2006/09/27 ORIG 1 Approval Type 1 - New Molecular Entity STANDARD
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
与本品治疗等效的药品
本品无治疗等效药品
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药品NDC数据与药品包装、标签说明书
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