内容提示: HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use REXULTI safely and effectively. See full prescribing information for REXULTI. REXULTI® (brexpiprazole) tablets, for oral use Initial U.S. Approval: 2015 WARNING: INCREASED MORTALITY IN ...
美国FDA 依匹哌唑(Rexulti,brexpiprazole)FDA官方说明书 英文原版.pdf,HIGHLIGHTS OF PRESCRIBING INFORMATION WARNINGS AND PRECAUTIONS These highlights do not include all the information needed to use • Cerebrovascular Adverse Reactions in Elderly Patients
Otsuka and Lundbeck announce the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) of REXULTI® (brexpiprazole) for the treatment of schizophrenia in pediatric patients 13 to 17 years of age. The FDA prev
Inc.(Otsuka) and H. Lundbeck A/S (Lundbeck) announce the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) of REXULTI®(brexpiprazole) for the treatment of schizo...
17Rexulti brexpiprazole7/10/2015Otsuka Pharm Co Ltd精神分裂与重度抑郁 16Entresto sacubitril/valsartan7/7/2015Novartis Pharms Corp抗心衰 15Orkambi lumacaftor 200 mg/ivacaftor 125 mg 7/2/2015Vertex Pharms Inc囊性纤维化 14Kengreal canegrelor6/22/2015Chiesi Usa Inc凝血致冠状动脉堵塞 13Viberzi eluxa...
for adults with previously untreated DLBCL,not otherwise specified,or high-grade B-cell lym-phoma that 106、 is considered low-intermediate risk or higher.Rexulti(brexpiprazole)tablets were initially approved in 2015 as an add-on therapy for major depressive disorder and as a treatment for ...
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) report that the U.S. Food and Drug Administration (FDA) has accepted a Supplemental New Drug Application (sNDA) for the treatment of schizophrenia in ad...
丙肝巨头吉利德(Gilead)丙肝鸡尾酒Harvoni近日在美国监管方面再传喜讯,FDA已批准扩大Harvoni(ledipasvir/sofosbuvir)的适用人群,用于伴有晚期肝脏疾病的丙肝患者。具体而言,FDA已批准Harvoni联合利巴韦林(RBV)的12周治疗方案,用于:(1)无肝硬化或伴有代偿性肝硬化(Child-Pugh A)的基因型1或基因型4慢性丙型肝炎病毒(HCV ...
INDICATIONS REXULTI is indicated for: Use as an adjunctive therapy to antidepressants in adults with major depressive disorder Treatment of schizophrenia in adults IMPORTANT SAFETY INFORMATION WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS ...