英文药名：NovoEight(turoctocog alfa)   中文药名：重组凝血因子VIII冻干粉注射剂 日文药名：ノボエイト静注用 生产厂家：诺和诺德日本公司 药品介绍 2013年11月20日，重组凝血因子VIII产品NovoEight(turoctocog alpha)已通过日本药事食品卫生审议会药品委员会(Committee on Drugs of Japan's Pharmaceutical Affairs and Sanitation Council)的审查，审查程序中接下来的步骤是日本卫生劳动福利部(MHLW)的正式批准。 药品委员会(Committee of Drugs)担任MHLW的顾问机构，处理包括新药申请在内的相关事宜。在日本的审查程序中，在获得MHLW授予的上市批准前，通过药品委员会的审查是一个重要的里程碑。 NovoEight是turoctocog alpha的商品名，该药是诺德诺德第三代重组凝血因子VIII，利用了最新的基因重组及蛋白纯化技术，用于A型血友病患者出血事件的预防和治疗。 NovoEight已在III期Guardian项目中进行了评价，这是迄今为止在A型血友病患者中开展的最大的临床预注册试验项目，涉及超过200例A型血友病患者。这些III期临床试验包括既往接受过治疗的重度A型血友病成人及儿童患者，研究结果证明了turoctocog-alpha对出血事件的预防及治疗疗效，同时患者体内未产生抑制剂。 NovoEight分别于今年10月和11月获FDA和欧盟委员会(EC)批准，同时，诺和诺德已向其他一些国家的监管机构提交了该药的监管申请文件。 批准上市时间：2014年 药品形状：冻干粉（付溶解液） 包装规格：250/500 /1000/1500/2000/3000国际单位 原处方资料附件： http://www.info.pmda.go.jp/go/pack/6343440D1023_1_04/ Novo Nordisk Pharma, "Novoate IV for Prolongation" Extends Room Storage Period Novo Nordisk Pharma Co.Ltd. (President: Klaus Iracen, headquarters: Chiyoda-ku, Tokyo) announced that it has approved 250, 500, 1,000, 1,500 for intravenous injection of recombinant blood coagulation factor VIII 2000, and 3000 (generic name: Troctokog alpha ((genetical recombination)), below, Novoight (R)), we will inform you that we were approved on 14th October. For Novoight (R), the period that can be stored at room temperature (below 30 ° C) at home has been extended to twelve months twice the past six months. Also, the validity period of the formulation has been 24 months since the manufacture so far, but this time the extension to 30 months was accepted. Regarding the preservation and stability of blood coagulation factor VIII preparation, there are surveys asking patients and parents about what kind of preservation condition is desired for pharmaceuticals currently on the market in the United States and Canada. (1) As a result, I prefer an improvement over the extension of the storage period (12 months) at room temperature rather than prolonging the shelf life under refrigerated condition, the reason is that traveling can be made more securely, It was able to hold or to be able to treat immediately as needed. Novo Nordisk continues to develop and improve products that are more effective, safer and more convenient for patients while listening to the voices of patients with haemophilia and their families. By extending the room temperature preservation period of this time, many patients who use Novaite (R) around the world, including haemophilia patients in Japan, will further realize the benefits of Novoight (R) hoping. About Novoate (R) Novoate (R) has been approved in January 2014, and was released in May, with the indication "suppression of bleeding tendency in patients with blood coagulation factor VIII deficiency". B domain cleavage type recombinant blood coagulation factor VIII preparation developed by pursuing improvement of reliability, safety, convenience of formulation by using the latest protein drug discovery / purification technology. In the manufacture of Novoite (R), we do not use proteins derived from animals and humans that are at risk of developing infectious diseases. Based on the results of Phase 3 international joint clinical trial participating in Japan, the usage and dosage for regular replacement therapy for adults and children was specified. 6 standards vials are available, it is possible to set a wide and detailed dose setting, according to the growing stage of the patient, and according to the situation of weight, lifestyle and bleeding, appropriate You can choose the vial size. Currently, Novoight (R) is approved in 37 countries and is on sale in 13 countries.