药品名称EPIVIR
申请号020564产品号003
活性成分LAMIVUDINE市场状态处方药
剂型或给药途径TABLET;ORAL规格300MG
治疗等效代码AB参比药物
批准日期2002/06/24申请机构VIIV HEALTHCARE CO
化学类型New molecular entity (NME)审评分类
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
59050822016/05/18YYPDF格式
5905082*PED2016/11/18PDF格式
历史专利信息
50474072009/11/17PDF格式
5047407*PED2010/05/17PDF格式
59050822016/05/18PDF格式
71192022009/02/08YPDF格式
7119202*PED2009/08/08PDF格式
与本品相关的市场独占权保护信息
独占权代码失效日期
D-1472018/03/23
历史市场独占权保护信息
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
020564036APLabel2016/07/21下载
020564036APLetter2016/07/22下载
020564035APLetter2015/10/02下载
020564035APLabel2015/10/07下载
020564034APLabel2015/02/20下载
020564034APLetter2015/02/24下载
020564033APLetter2015/03/26下载
020564033APLabel2015/04/14下载
020564031APLetter2011/11/22下载
020564031APLabel2011/12/02下载
020564028APLetter2008/02/07下载
020564028APLabel2008/02/14下载
020564026APLabel2006/10/26下载
020564026APLetter2006/10/31下载
020564024APReview2007/09/26下载
020564024APLabel2006/06/14下载
020564024APLetter2006/06/20下载
020564021APLetter2004/10/04下载
020564021APLabel2004/10/04下载
020564020APLetter2004/12/02下载
020564020APLabel2004/12/03下载
020564020APReview2007/09/26下载
020564019APLetter2003/11/25下载
020564019APLabel2003/12/02下载
020564017APReview2007/09/26下载
020564016APLetter2002/03/01下载
020564015APLetter2002/06/24下载
020564015APLabel2002/06/24下载
020564014APLetter2002/10/08下载
020564014APLabel2002/10/08下载
020564012APReview2005/01/06下载
020564012APLetter2001/03/06下载
020564007APReview2007/09/26下载
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
020564036AP2016/07/20Efficacy Supplement with Clinical Data to Support
020564035AP2015/09/30Labeling Revision
020564034AP2015/02/19Labeling Revision
020564033AP2015/03/23Efficacy Supplement with Clinical Data to Support
020564032AP2012/12/18Manufacturing Change or Addition
020564031AP2011/11/18Labeling Revision
020564028AP2008/02/01Patient Population Altered
020564026AP2006/10/25Labeling Revision
020564024AP2006/06/13Labeling Revision
020564021AP2004/09/29Labeling Revision
020564020AP2004/11/22Approval
020564019AP2003/11/13Labeling Revision
020564017AP2002/09/13Manufacturing Change or Addition
020564016AP2002/03/01Labeling Revision
020564015AP2002/06/24New Dosage Regimen
020564014AP2002/10/08Labeling Revision
020564013AP2001/06/19Labeling Revision
020564012AP2001/03/06Labeling Revision
020564011AP2001/01/05Labeling Revision
020564010AP1999/03/08Labeling Revision
020564009AP1999/03/08Labeling Revision
020564008AP1998/11/05Control Supplement
020564007AP1999/03/23Efficacy Supplement with Clinical Data to Support
020564006AP1997/12/15Labeling Revision
020564005AP1998/02/03Manufacturing Change or Addition
020564004AP1997/12/15Labeling Revision
020564003AP1997/10/31Manufacturing Change or Addition
020564002AP1997/04/11New or Modified Indication
020564001AP1996/07/31Labeling Revision
020564000AP1995/11/17Approval