药品名称RAPAMUNE
申请号021083产品号001
活性成分SIROLIMUS市场状态处方药
剂型或给药途径SOLUTION;ORAL规格1MG/ML
治疗等效代码参比药物
批准日期1999/09/15申请机构PF PRISM CV
化学类型New molecular entity (NME)审评分类Priority 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
历史专利信息
51008992013/07/07U-290PDF格式
5100899*PED2014/01/07PDF格式
52121552010/05/18U-291PDF格式
5212155*PED2010/11/18PDF格式
53088472011/05/03U-292PDF格式
5308847*PED2011/11/03PDF格式
54038332012/04/04U-293PDF格式
5403833*PED2012/10/04PDF格式
55367292013/09/30YPDF格式
5536729*PED2014/03/30PDF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
ODE2022/05/28
历史市场独占权保护信息
D-1142010/01/30
NPP2008/03/11
PED2006/10/11
PED2008/09/11
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
021083058APLetter2015/11/09下载
021083058APLabel2015/11/12下载
021083056APLabel2015/03/09下载
021083056APLetter2015/03/10下载
021083055APLetter2015/05/29下载
021083055APLabel2015/06/01下载
021083054APLetter2013/09/17下载
021083053APLetter2013/03/08下载
021083053APLabel2013/03/08下载
021083051APLetter2012/12/11下载
021083051APLabel2012/12/14下载
021083050APLetter2011/06/09下载
021083049APLetter2011/07/13下载
021083048APLetter2010/11/08下载
021083048APLabel2010/11/04下载
021083047APLabel2010/12/01下载
021083047APLetter2010/12/07下载
021083046APLetter2010/07/08下载
021083046APLabel2010/08/27下载
021083045APLetter2010/02/01下载
021083045APLabel2010/02/04下载
021083044APLabel2010/12/01下载
021083044APLetter2010/12/07下载
021083043APLabel2010/05/03下载
021083043APLetter2010/04/28下载
021083042APLabel2010/05/03下载
021083042APLetter2010/04/28下载
021083041APLabel2009/10/14下载
021083041APLetter2009/11/10下载
021083040APLetter2009/11/10下载
021083040APLabel2009/10/01下载
021083038APLabel2009/02/04下载
021083037APLabel2008/03/07下载
021083037APLetter2008/03/10下载
021083036APLetter2008/03/07下载
021083036APLabel2008/03/07下载
021083034APLabel2007/10/22下载
021083034APLetter2007/10/22下载
021083033APLabel2008/01/18下载
021083033APLetter2008/01/18下载
021083031APLabel2007/05/07下载
021083031APLetter2007/05/09下载
021083030APLetter2007/01/25下载
021083030APLabel2007/01/16下载
021083029APLetter2007/02/12下载
021083028APLabel2006/10/23下载
021083026APLabel2007/01/16下载
021083026APLetter2007/01/16下载
021083025APLetter2006/06/06下载
021083025APLabel2006/06/06下载
021083024APLetter2006/06/06下载
021083024APLabel2006/06/06下载
021083023APLabel2005/10/14下载
021083023APLetter2005/10/14下载
021083022APLabel2005/10/14下载
021083022APLetter2005/10/14下载
021083021APLetter2005/07/08下载
021083021APLabel2005/07/07下载
021083020APLetter2005/07/08下载
021083020APLabel2005/07/07下载
021083019APLetter2005/03/14下载
021083019APLabel2005/03/14下载
021083017APLetter2004/07/21下载
021083017APLabel2004/07/21下载
021083015APLetter2003/10/09下载
021083015APLabel2003/10/10下载
021083014APLetter2004/06/14下载
021083014APLabel2003/03/26下载
021083010APLetter2003/01/23下载
021083010APLabel2003/01/23下载
021083009APLabel2003/01/23下载
021083009APLetter2003/01/23下载
021083008APLetter2003/01/23下载
021083008APLabel2003/01/23下载
021083007APLabel2003/01/23下载
021083007APLetter2003/01/23下载
021083006APLabel2003/04/11下载
021083006APLetter2003/04/18下载
021083006APReview2009/09/14下载
021083005APLetter2003/01/23下载
021083005APLabel2003/01/23下载
021083000APLetter1999/09/15下载
021083000APReview1999/09/15下载
021083000APMedication Guide2010/12/07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
021083058AP2015/11/05Labeling Revision
021083057AP2015/07/31Manufacturing Change or Addition
021083056AP2015/03/06Labeling Revision
021083055AP2015/05/28Efficacy Supplement with Clinical Data to Support
021083054AP2013/05/30Labeling Revision
021083053AP2013/03/07Labeling Revision
021083051AP2012/12/10Labeling Revision
021083050AP2011/06/06Labeling Revision
021083049AP2011/07/11Labeling Revision
021083048AP2010/11/08Labeling Revision
021083047AP2010/11/23Labeling Revision
021083046AP2010/07/02Labeling Revision
021083045AP2010/01/25Labeling Revision
021083044AP2010/11/23Labeling Revision
021083043AP2010/04/22Labeling Revision
021083042AP2010/04/22Labeling Revision
021083041AP2009/10/08Labeling Revision
021083040AP2009/09/24Labeling Revision
021083038AP2009/01/29Labeling Revision
021083037AP2008/03/05Labeling Revision
021083036AP2008/03/05Labeling Revision
021083034AP2007/10/17Labeling Revision
021083033AP2008/01/14Efficacy Supplement with Clinical Data to Support
021083031AP2007/05/02Labeling Revision
021083030AP2007/01/12Labeling Revision
021083029AP2007/01/30Patient Population Altered
021083028AP2006/10/19Labeling Revision
021083026AP2007/01/09Labeling Revision
021083025AP2006/06/02Labeling Revision
021083024AP2006/06/02Efficacy Supplement with Clinical Data to Support
021083023AP2005/10/07Labeling Revision
021083022AP2005/10/07Labeling Revision
021083021AP2005/06/30Labeling Revision
021083020AP2005/06/30Labeling Revision
021083019AP2005/03/11Patient Population Altered
021083017AP2004/07/20Labeling Revision
021083015AP2003/10/02Labeling Revision
021083014AP2003/03/26Labeling Revision
021083010AP2003/01/23Labeling Revision
021083009AP2003/01/23Labeling Revision
021083008AP2003/01/23Labeling Revision
021083007AP2003/01/23Labeling Revision
021083006AP2003/04/11New or Modified Indication
021083005AP2003/01/23Labeling Revision
021083004AP2000/08/25Labeling Revision
021083002AP2000/05/03Labeling Revision
021083001AP2000/03/17Expiration Date Change
021083000AP1999/09/15Approval