药品名称ACTEMRA
申请号125276产品号002
活性成分TOCILIZUMAB市场状态处方药
剂型或给药途径INJECTABLE; INJECTION规格200MG/10ML
治疗等效代码参比药物
批准日期申请机构GENENTECH
化学类型审评分类
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
历史专利信息
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
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
125276107APLetter2016/09/26下载
125276107APLabel2016/09/27下载
125276106APLetter2015/08/21下载
125276105APLetter2014/11/14下载
125276092APLabel2013/10/21下载
125276092APLetter2013/10/22下载
125276075APLetter2013/07/05下载
125276064APLetter2013/05/01下载
125276064APLabel2013/05/01下载
125276011APLetter2011/01/07下载
125276011APLabel2011/01/11下载
125276010APLetter2011/01/07下载
125276010APLabel2011/01/11下载
125276007APLabel2011/01/11下载
1252760049APLetter2012/10/15下载
1252760049APLabel2012/10/15下载
1252760049APReview2012/12/28下载
1252760048APLetter2012/06/22下载
1252760046APLetter2012/08/15下载
1252760046APLabel2012/08/15下载
1252760023APLabel2011/04/18下载
1252760023APLetter2011/05/26下载
1252760022APLetter2011/05/26下载
1252760022APLabel2011/04/18下载
1252760000APLabel2010/01/12下载
1252760000APMedication Guide2010/01/13下载
1252760000APLetter2010/01/26下载
1252760000APReview2010/03/09下载
1252760000APSummary Review2010/03/09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
125276107AP2016/09/23Efficacy Supplement with Clinical Data to Support
125276106AP2015/08/18Efficacy Supplement with Clinical Data to Support
125276105AP2014/11/13Labeling Revision
125276092AP2013/10/21Labeling Revision
125276075AP2013/07/02Labeling Revision
125276064AP2013/04/29Efficacy Supplement with Clinical Data to Support
125276011AP2011/01/04Supplement
125276010AP2011/01/04Supplement
125276007AP2011/01/04Supplement
1252760049AP2012/10/11Patient Population Altered
1252760048AP2012/06/20Supplement
1252760046AP2012/08/13Supplement
1252760023AP2011/04/15Supplement
1252760022AP2011/04/15Supplement
1252760000AP2010/01/08Approval