药品名称MIRAPEX
申请号020667产品号002
活性成分PRAMIPEXOLE DIHYDROCHLORIDE市场状态处方药
剂型或给药途径TABLET;ORAL规格0.25MG
治疗等效代码AB参比药物
批准日期1997/07/01申请机构BOEHRINGER INGELHEIM
化学类型New molecular entity (NME)审评分类Standard review drug
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
60018612018/01/16U-784PDF格式
61944452018/01/16U-784PDF格式
历史专利信息
48868122010/10/08YYPDF格式
48868122011/03/25PDF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
历史市场独占权保护信息
I-5172009/11/07
M-1042014/05/13
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
020667034APLetter2016/08/01下载
020667034APLabel2016/08/02下载
020667033APLetter2016/01/15下载
020667033APLabel2016/01/25下载
020667030APLetter2015/03/31下载
020667030APLabel2015/04/02下载
020667030APLabel2015/04/02下载
020667030APLetter2015/04/03下载
020667029APLetter2013/03/04下载
020667029APLabel2013/03/05下载
020667027APLetter2012/09/05下载
020667027APLabel2012/09/06下载
020667025APLetter2011/05/16下载
020667025APLabel2011/05/16下载
020667024APLetter2012/07/18下载
020667024APLabel2012/07/19下载
020667023APLetter2012/07/18下载
020667023APLabel2012/07/19下载
020667022APLabel2012/07/19下载
020667022APLetter2012/07/18下载
020667021APLetter2012/07/18下载
020667021APLabel2012/07/19下载
020667019APLabel2012/07/30下载
020667019APLetter2012/07/18下载
020667018APLabel2009/01/06下载
020667018APLetter2009/01/06下载
020667017APLetter2009/01/06下载
020667017APLabel2009/01/06下载
020667014APLetter2009/01/06下载
020667014APLabel2009/01/06下载
020667013APLabel2006/11/09下载
020667013APLetter2006/11/14下载
020667011APLetter2006/11/14下载
020667011APLabel2006/11/09下载
020667008APLetter2003/05/30下载
020667008APReview2007/06/12下载
020667000APReview1997/07/01下载
020667000APLetter1997/07/01下载
020667000APOther Important Information from FDA2012/09/19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
020667034AP2016/07/28Labeling Revision
020667033AP2016/01/14Labeling Revision
020667032AP2015/11/20Manufacturing Change or Addition
020667031AP2015/05/11Manufacturing Change or Addition
020667030AP2015/03/27Labeling Revision
020667030AP2015/04/01Labeling Revision
020667029AP2013/03/01Labeling Revision
020667027AP2012/08/31Efficacy Supplement with Clinical Data to Support
020667025AP2011/05/13Efficacy Supplement with Clinical Data to Support
020667024AP2012/07/17Labeling Revision
020667023AP2012/07/17Labeling Revision
020667022AP2012/07/17Labeling Revision
020667021AP2012/07/17Labeling Revision
020667019AP2012/07/17Labeling Revision
020667018AP2008/12/31Labeling Revision
020667017AP2008/12/31Labeling Revision
020667014AP2008/12/31Labeling Revision
020667013AP2006/11/07New or Modified Indication
020667011AP2006/11/07New or Modified Indication
020667009AP2002/12/04Expiration Date Change
020667008AP2003/05/06Labeling Revision
020667007AP1999/09/03Labeling Revision
020667006AP1999/11/18Package Change
020667005AP1999/12/13Control Supplement
020667004AP1997/11/26Manufacturing Change or Addition
020667002AP1998/02/12Manufacturing Change or Addition
020667001AP1998/02/19Labeling Revision
020667000AP1997/07/01Approval