药品名称COARTEM
申请号022268产品号001
活性成分ARTEMETHER; LUMEFANTRINE市场状态处方药
剂型或给药途径TABLET;ORAL规格20MG;120MG
治疗等效代码参比药物是
批准日期2009/04/07申请机构NOVARTIS PHARMACEUTICALS CORP
化学类型New molecular entity (NME)审评分类Priority review drug
罕用药/孤儿药是
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
56773312014/10/14YU-977PDF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
ODE2016/04/07
历史市场独占权保护信息
NCE2014/04/07
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
022268012APLetter2015/03/20下载
022268012APLabel2015/03/20下载
022268004APLetter2013/05/01下载
022268004APLabel2013/05/01下载
022268003APLabel2012/08/07下载
022268003APLetter2012/08/07下载
022268001APLetter2010/02/23下载
022268001APLabel2010/02/23下载
022268000APLetter2009/04/14下载
022268000APLabel2009/04/16下载
022268000APReview2009/07/08下载
022268000APSummary Review2009/07/08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
022268016AP2016/06/01Manufacturing Change or Addition
022268014AP2016/01/06Manufacturing Change or Addition
022268013AP2015/09/02Manufacturing Change or Addition
022268012AP2015/03/19Labeling Revision
022268011AP2015/01/20Manufacturing Change or Addition
022268010AP2014/08/12Manufacturing Change or Addition
022268009AP2014/05/06Manufacturing Change or Addition
022268008AP2014/04/17Manufacturing Change or Addition
022268007AP2013/11/18Manufacturing Change or Addition
022268006AP2013/04/05Manufacturing Change or Addition
022268005AP2013/04/03Manufacturing Change or Addition
022268004AP2013/04/29Labeling Revision
022268003AP2012/08/06Labeling Revision
022268001AP2010/02/17Labeling Revision
022268000AP2009/04/07Approval