药品名称FAMVIR
申请号020363产品号003
活性成分FAMCICLOVIR市场状态处方药
剂型或给药途径TABLET;ORAL规格125MG
治疗等效代码AB参比药物
批准日期1995/12/11申请机构NOVARTIS PHARMACEUTICALS CORP
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
58407632015/09/01U-96PDF格式
59168932015/09/01U-96PDF格式
5840763*PED2016/03/01PDF格式
5916893*PED2016/03/01PDF格式
历史专利信息
52469372010/09/21U-96PDF格式
58665812014/10/04U-96PDF格式
5866581*PED2015/04/04PDF格式
61243042014/10/04U-96PDF格式
6124304*PED2015/04/04PDF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
D-1032009/07/28
I-5012009/07/28
M-1122015/02/09
M-982014/01/31
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
020363047APLetter2016/09/20下载
020363047APLabel2016/09/20下载
020363042APLetter2013/04/25下载
020363042APLabel2013/04/30下载
020363040APLabel2012/02/10下载
020363040APLetter2012/02/13下载
020363038APLetter2012/02/13下载
020363038APLabel2012/02/10下载
020363037APLabel2011/01/31下载
020363037APLetter2011/02/04下载
020363036APLetter2009/12/31下载
020363036APLabel2010/01/12下载
020363034APLetter2008/12/24下载
020363034APLabel2009/01/02下载
020363028APLabel2006/08/04下载
020363028APLetter2006/08/04下载
020363027APLetter2006/08/04下载
020363027APLabel2006/08/04下载
020363026APLabel2006/02/28下载
020363026APLetter2006/03/01下载
020363019APLetter2001/03/29下载
020363019APLabel2001/03/29下载
020363019APReview2004/04/14下载
020363016APLetter1998/06/12下载
020363014APLetter1998/06/12下载
020363010APLetter1998/06/12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
020363047AP2016/09/16Labeling Revision
020363046AP2015/09/10Manufacturing Change or Addition
020363045AP2015/10/19Manufacturing Change or Addition
020363044AP2015/05/14Manufacturing Change or Addition
020363042AP2013/04/24Labeling Revision
020363041AP2014/06/25Manufacturing Change or Addition
020363040AP2012/02/09Labeling Revision
020363038AP2012/02/09Efficacy Supplement with Clinical Data to Support
020363037AP2011/01/31Efficacy Supplement with Clinical Data to Support
020363036AP2009/12/24Efficacy Supplement with Clinical Data to Support
020363034AP2008/12/22Labeling Revision
020363028AP2006/07/28New or Modified Indication
020363027AP2006/07/28New Dosage Regimen
020363026AP2006/02/22Labeling Revision
020363020AP2002/08/06Manufacturing Change or Addition
020363019AP2001/03/29Labeling Revision
020363017AP1999/02/02Control Supplement
020363016AP1998/06/12Labeling Revision
020363015AP1998/03/26Control Supplement
020363014AP1998/06/12New or Modified Indication
020363013AP1997/07/15Labeling Revision
020363012AP1997/09/17New or Modified Indication
020363011AP1997/01/31Manufacturing Change or Addition
020363010AP1998/06/12Labeling Revision
020363009AP1997/01/13Labeling Revision
020363008AP1996/04/26Labeling Revision
020363007AP1996/07/29Labeling Revision
020363006AP1995/09/08Manufacturing Change or Addition
020363005AP1996/07/29Labeling Revision
020363004AP1995/12/11New or Modified Indication
020363001AP1994/12/27Manufacturing Change or Addition
020363000AP1994/06/29Approval