药品通用名 依匹哌唑片 英文名称 Brexpiprazole Tablets 商品名 Rexulti 规格 2mg 剂型 片剂 持证商 Otsuka Pharmaceutical Co Ltd 备注1 未进口原研药品 备注2 美国橙皮书 来源分类 暂无权限 来源批次 暂无权限 VIP试用医疗器械查询APP下载客服中心常见问题数据可视化数据分析挖掘系统网站地图业务介绍友情...
8月18日,大冢制药还公布了brexpiprazole治疗边缘性人格障碍(borderline personality disorder,BPD)2期临床试验(NCT04100096)的顶线结果。这是一项随机、双盲、安慰剂对照2期试验,于2019年启动,与灵北联合开展。该试验旨在评估灵活剂量的brexpiprazole(2至3mg)作为单药疗法治疗BPD成人患者的疗效、安全性和耐受性。该试验包...
0.5 mg oral tablets 1 mg oral tablets 2 mg oral tablets 3 mg oral tablets 4 mg oral tablets How should I store Rexulti? Rexulti should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 ...
大冢制药(Otsuka)近日宣布,其抗精神病药物Rexulti(brexpiprazole,依匹哌唑)口腔崩解(OD)片剂已获得日本监管部门的批准。除了现有的常规片剂(Rexulti 1mg、2mg),Rexulti OD(0.5mg、1mg、2mg)片剂的上市将提供一种新的选择。Rexulti OD片剂是一种在口腔内迅速崩解的剂型,因此,对于因吞咽困难而无法服用片剂的患者,很容...
根据第3周时的YMRS评分结果,这2项研究中,brexpiprazole与安慰剂未能表现出统计学意义的显著差异,没有达到主要终点。在这2项研究中,安慰剂对评分量表的影响显著高于预期。(生物谷Bioon.com) 原文出处:Otsuka Obtains Approval in Japan for Orally-Disintegrating-Dose Form of REXULTI Tablets...
3 DOSAGE FORMS AND STRENGTHS REXULTI tablets are available in 6 strengths (see Table 2). Table 2: REXULTI Tablet Strengths and Identifying Features Tablet Strength 0.25 mg 0.5 mg 1 mg 2 mg 3 mg 4 mg Tablet Color/Shape Light brown; Round; shallow convex; bevel-edged Light orange Round;...
Store Rexulti tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep out of the reach of children.Rexulti ingredientsActive ingredient: brexpiprazoleInactive ingredients: lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, low-substituted ...
询价记录( 2 ) 依匹哌唑片Rexulti参比制剂信息 通用名: 依匹哌唑片 商品名: Rexulti 英文名: Brexpiprazole Tablets 剂型: 片剂 规格: 4mg 单位: --- 持证商: Otsuka Pharmaceutical Co Ltd 上市国家: 美国橙皮书 什么是参比制剂?参比制剂用于仿制药的开发以证明仿制产品与原研产品的质量是否一致,是仿制药开发...
Availability (generic available) Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg Assessment Assessment Assessment Assess mental status (orientation, mood, behavior) before and periodically during therapy. Assess for suicidal tendencies, especially during early therapy for depression. Restrict amo...
(brexpiprazole) tablets, for oral use attack) (5.3) Initial U.S. Approval: 2015 • Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring. (5.4) WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS • Tardive Dyskinesia: Discontinue if clinically appropriate. (5.5) ...