Friday, 4 December 2009
欧洲杯微信买球阿斯利康今天宣布，美国食品药品监督管理局（FDA）批准了Seroquel（Quetiapine fumarate）片剂，用于治疗青少年（13-17岁）的精神分裂症，作为单一疗法，以及与双极性I I I型躁狂事件相关的急性治疗儿童和青少年（10-17岁）的疾病，无论是单一疗法还是锂或脱甲状腺的辅助手段。
The SEROQUEL paediatric clinical programme was undertaken to provide important clinical information for healthcare providers who treat paediatric patients with the serious diseases schizophrenia and bipolar mania. The paediatric studies for SEROQUEL were designed and initiated in consultation with FDA in accordance with a formal Written Request, pursuant to Section 505A of the Federal Food, Drug, and Cosmetic Act, for paediatric information on SEROQUEL.
“儿童和青少年的双极性躁狂症和精神分裂症虽然很少见，却是严重的疾病，因此必须批准在该患者人群中使用治疗。”欧洲杯微信买球“由于个人对药物的反应不同，因此患者和从业人员需要经过验证的治疗选择，使他们能够在个人情况下权衡安全性和功效。这些新的Seroquel指示为治疗患有这些严重精神疾病的小儿患者提供了另一种选择的选择。”
The SEROQUEL paediatric approval is based on data from four studies. Three of the studies (Study 112, Study 149, and Study 150) evaluated the efficacy and safety of SEROQUEL in the treatment of adolescents with schizophrenia (13-17 years of age) or children and adolescents with bipolar I disorder (10-17 years of age). The fourth study (Study 28) assessed the pharmacokinetic profile of SEROQUEL in children and adolescents. Doses of 400 mg to 800 mg of SEROQUEL were specifically studied in the paediatric program.
The FDA has required that AstraZeneca implement a Risk Evaluation and Mitigation Strategy (REMS). The REMS for SEROQUEL requires a Medication Guide and periodic assessments that will include a survey of patients' understanding of the potential risks of SEROQUEL. The REMS applies to all approved indications.
给编辑的注释：
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit:www.vivelima.com
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