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  药店国别: 美国药房
产地国家: 美国
所属类别: 抗过敏药物->抗过敏药物
处方药:处方药
包装规格: 0.09 毫克/毫升 118毫升
计价单位:
   
生产厂家中文参考译名:
Nextwave Pharmaceuticals
生产厂家英文名:
Nextwave Pharmaceuticals
原产地英文商品名:
NEXICLON XR extended release oral suspension 0.09 mg/ml 118ml
原产地英文药品名:
CLONIDINE
中文参考商品译名:
NEXICLON XR缓释口服混悬液 0.09 毫克/毫升 118毫升
中文参考药品译名:
可乐定
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Children's allergy symptoms
临床试验期:

中文适应病症参考翻译1:
儿童过敏症状
药品信息:
Tris Pharma,开发创新药物传递技术的专业制药公司,今天宣布美国食品药品监督管理局 (FDA)接受了其过敏的处理的延长的版本 Carbinoxamine 口头暂挂 NDA 在孩子的二年和更老。 如果审批, Tris Pharma 的被扩大的版本暂挂将提供替代给现在可以得到的立即版本公式化。 Carbinoxamine 是与几年的温和地沉着的抗组胺证明的安全性和效力。 在 2006年之前 carbinoxamine 是用途广泛,当超过 100 被销售的 Carbinoxamine 包含产品包括延长的版本固定的剂量和组合产品。 然而,接近所有这些是未审阅粮食与药物管理局的严谨审批流程的更旧的产品。 在 2006 个 DESI 复核之后,粮食与药物管理局去除了根据的所有 carbinoxamine 产品除被复核了的二种立即版本公式化外,创建重视福利与一种延长的版本公式化相关的患者和医生的无效。 一位主导的纽约的儿科医生,劳拉 Garabedian,博士经常建议 Carbinoxamine 说, “我总是发现 Carbinoxamine 十分有效在对待过敏症状对于儿童,但是不典型地建议它首先排行疗法,因为现有的立即版本公式化需要被药量每天的多个时期包括剂量,当子项在因而做标准贫寒时的学校。 我盼望该一种真的 1/2 小时时数的公式化好口味。 新产品配置文件应该转换为被改进的标准和更好的结果”。 Ketan Mehta, Tris 总裁兼 CEO 被添加, “这是在 Tris 的 OralXR+ 技术平台基础上的第四 NDA 提交包括 Nexiclon™ XR,最近被生成的第一 24 小时液体被扩大的版本暂挂。 Tris 的传递途径包括为这个呼吸市场瞄准的几个另外的产品,即咳嗽,感冒,过敏疗法和指定为提交以后二年。 Tris 计划生成 Carbinoxamine 在 2012 季节的被扩大的版本暂挂和当前评估其选项包括成为伙伴与其他专业 Pharma 公司。 ” Tris Pharma, the development of innovative drug delivery technology specialty pharmaceutical company, today announced that the US Food and Drug Administration (FDA) accepted its allergy treatment extended version Carbinoxamine oral pending NDA in children two years and older. If approval is expanded version pending Tris Pharma will provide an alternative to the currently available immediate release formulation. Carbinoxamine with years of gentle calm antihistamine prove safety and efficacy. In the year 2006 carbinoxamine was widely used, when more than 100 Carbinoxamine marketed products include extended version contains a fixed dose and combination products. However, close to all of these are not rigorous approval process to review the Food and Drug Administration's older products. After 2006 DESI review, the FDA removed all carbinoxamine based products in addition to being a review of the two immediate release formulation, the creation of a great importance to the welfare and extended version of formulaic related patients and physicians is invalid. A leading New York pediatrician Laura Garabedian, Dr. often recommended Carbinoxamine said, "I've always found Carbinoxamine very effective in treating allergy symptoms in children, but does not typically recommend therapy ranking it first, because the existing immediate release dose formulation needs to be multiple times a day, including dose, and therefore do when a child in school when the standard was poor. I am really looking forward to this one 1/2 hour hours formulaic good taste. The new product configuration file should be converted to improved standards and better results. " Ketan Mehta, Tris President and CEO added, "This is the fourth NDA OralXR in Tris + technology platform based on the submissions include Nexiclon ™ XR, recently produced the first 24 hours the liquid is expanded version pending. Tris transfer channels, including several for the respiratory market targeting additional products, namely cough, cold, allergy treatments and designated for the submission of the next two years. Tris plans to generate Carbinoxamine being expanded version of the 2012 season and is currently pending assess their options become Pharma companies partner with other professionals. "
更新日期: 2015-02-12
附件:
201532322231732.pdf    

 
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