药品注册申请号:103948
申请类型:BLA (生物制品许可申请)
申请人:GENZYME
申请人全名:--
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 CAMPATH ALEMTUZUMAB VIAL; INTRAVENOUS 10MG/ML No No None 2001/05/07 -- Prescription
002 CAMPATH ALEMTUZUMAB VIAL; INTRAVENOUS 30MG/ML No No None -- Prescription
003 LEMTRADA ALEMTUZUMAB INJECTABLE;INJECTION 12MG/1.2ML (10MG/ML) No No None -- Prescription
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2024/05/20 SUPPL-5193(补充) Approval Labeling STANDARD
2024/03/04 SUPPL-5191(补充) Approval REMS N/A
2024/02/08 SUPPL-5192(补充) Approval Labeling STANDARD
2023/04/26 SUPPL-5188(补充) Approval Labeling STANDARD
2022/09/27 SUPPL-5187(补充) Approval Labeling STANDARD
2022/05/26 SUPPL-5185(补充) Approval Labeling STANDARD Letter for LEMTRADA
2022/01/13 SUPPL-5184(补充) Approval Labeling STANDARD Label and Medication Guide for LEMTRADA
2021/08/18 SUPPL-5183(补充) Approval Labeling STANDARD Label for LEMTRADA
2021/04/28 SUPPL-5182(补充) Approval Labeling STANDARD
2021/03/12 SUPPL-5180(补充) Approval REMS N/A
2020/10/22 SUPPL-5181(补充) Approval Labeling STANDARD
2020/09/25 SUPPL-5179(补充) Approval Labeling STANDARD
2020/09/25 SUPPL-5177(补充) Approval Labeling STANDARD
2020/06/29 SUPPL-5176(补充) Approval Labeling STANDARD
2020/05/27 SUPPL-5173(补充) Approval Labeling STANDARD
2019/11/26 SUPPL-5171(补充) Approval Labeling STANDARD
2019/10/29 SUPPL-5170(补充) Approval Labeling STANDARD
2019/10/29 SUPPL-5169(补充) Approval Labeling STANDARD
2019/07/31 SUPPL-5172(补充) Approval Labeling 901 REQUIRED
2019/04/23 SUPPL-5168(补充) Approval REMS N/A
2019/01/16 SUPPL-5164(补充) Approval Labeling STANDARD Label for LEMTRADA
2019/01/16 SUPPL-5163(补充) Approval Labeling STANDARD Label for LEMTRADA
2018/11/29 SUPPL-5167(补充) Approval Labeling STANDARD Label for CAMPATH
2018/11/28 SUPPL-5165(补充) Approval Labeling STANDARD Label for LEMTRADA
2018/11/28 SUPPL-5160(补充) Approval Efficacy STANDARD Label for LEMTRADA
2017/12/13 SUPPL-5159(补充) Approval Labeling STANDARD Label for LEMTRADA
2017/10/05 SUPPL-5158(补充) Approval Labeling STANDARD
2017/10/05 SUPPL-5157(补充) Approval Labeling 901 REQUIRED Label for CAMPATH
2016/04/05 SUPPL-5153(补充) Approval REMS N/A
2015/09/18 SUPPL-5151(补充) Approval REMS N/A
2014/11/14 SUPPL-5139(补充) Approval Efficacy STANDARD
2014/09/05 SUPPL-5150(补充) Approval Labeling STANDARD
2009/03/30 SUPPL-5092(补充) Approval Labeling STANDARD
2007/09/19 SUPPL-5070(补充) Approval Efficacy PRIORITY ;Orphan
2004/05/19 SUPPL-5035(补充) Approval Labeling STANDARD
2001/05/07 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity PRIORITY ;Orphan
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
与本品治疗等效的药品
本品无治疗等效药品
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