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奥氮平(晶型1)

奥氮平(晶型1) API

奥氮平(晶型1)-API

CAS Number: 132539-06-1

治疗类别
双相情感障碍
抗精神分裂症
中枢神经系统 (CNS)
API技术
合成
剂型
口服固体制剂
注射剂
瑞迪博士研发状态
可得到
注册备案情况
USA
Canada
CEP
Europe
Australia
New Zealand
创新品牌(美国)
ZYPREXA

作用机制

The mechanism of action of olanzapine, as with other drugs having efficacy in schizophrenia, is unknown.

However, it has been proposed that this drug’s efficacy in schizophrenia is mediated through a combination of dopamine and serotonin type 2 (5HT2) antagonism. The mechanism of action of olanzapine in the treatment of acute manic or mixed episodes associated with bipolar I disorder is unknown.

适应症

ZYPREXA® (olanzapine) is an atypical antipsychotic indicated:

As oral formulation for the:

  • Treatment of schizophrenia.
  • Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial.
  • Adolescents (ages 13-17): Efficacy was established in one 6- week trial in patients with schizophrenia. The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. 
  • Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder.
  • Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial
  • Adolescents (ages 13-17): Efficacy was established in one 3- week trial in patients with manic or mixed episodes associated with bipolar I disorder. The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents.
  • Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks.
  • Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder.
  • Efficacy was established in two 6-week clinical trials in adults. Maintenance efficacy has not been systematically evaluated.

As ZYPREXA IntraMuscular for the:

  • Treatment of acute agitation associated with schizophrenia and bipolar I mania.
  • Efficacy was established in three 1-day trials in adults.

As ZYPREXA and Fluoxetine in Combination for the:

  • Treatment of depressive episodes associated with bipolar I disorder.
  • Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax.
  • Treatment of treatment resistant depression.
  • Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.

Dr. Reddy's的专长

Dr. Reddy's总部位于印度海得拉巴,是全球领先的活性药物成分(API)供应商之一。 Dr. Reddy's的API业务是美国、欧洲、巴西、拉丁美洲、日本、中国、韩国和新兴市场的制药公司的首选合作伙伴。

Dr. Reddy's博士的API业务在过去30多年来在开发和制造复杂API(如类固醇,多肽,复杂长链分子和高效API(HPAPI /肿瘤药物))方面所建立的深厚技术优势中茁壮成长。 我们在知识产权和法规事务方面的实力可以帮助我们始终如一地达到并超越监管标准,从而为这一专业知识提供补充。 Dr. Reddy's博士 奥氮平(晶型1) API是研发,知识产权和监管方面广泛专业知识的结果。

帮助我们的客户率先进入市场的关键组成部分是响应式供应链。 我们通过确保所有设施都高效运行并达到最新的质量,安全和生产率标准来实现这一目标。 业务和工厂之间的强大互联可以快速响应动态的市场变化,从而避免短缺并满足需求的突然激增。

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免责声明

本目錄中的任何信息(包括對任何產品或服務的任何引用)均不構成銷售要約,或被解釋為代表銷售要約。受有效專利保護的產品不提供或供應用於商業用途。但是,只要存在此類監管豁免,就可以出於監管提交的目的提供此類產品的研究數量。買方應對各自市場的專利方案進行獨立評估,並承擔所有與專利相關的責任。在印度受有效專利保護的產品不可用於商業用途,但可用於第 107A 節。