适应症
口腔溃疡
用法与用量
通常，成人每天有一次上颚牙密窝(50毫克)。
临床成绩
国内临床成绩
以口腔咽咽干头症患者为对象，以检查使用1次1次，每天使用14天1次的复用性和安全性为目的，进行了把米克纳索尔剂作为对照的随机化非盲检查并行组比较测试。对于开始使用试验药物的第15天的病变得分和症状分数为基础的临床效果，治愈率为本药剂群46.8%(29/62例子)，橘子油凝胶剂群47.5%(29/61例子)。
包装
14粒:[含干剂的塑料瓶子]
制造商
Soken Co.Ltd.
销售
久光制药株式会社 注：以上中文资料不够完整，使用者以原处方资料为准。 完整说明附件： http://www.info.pmda.go.jp/go/pack/62907A1D1026_1_01/
Approval of domestic manufacturing sales approval of oral oropharyngeal candidiasis drug "orabi tablet oral cavity"
SOH group, a 100% subsidiary of soken group, has received approval for manufacturing sales of "orabi tablets oral 50 mg."
SOH group, a 100 percent subsidiary of soken group, has received approval for the sale of the product of "orabi tablets oral 50 mg" (hereinafter, "orrabi") on September 21 in Japan.
"Orrabi" (development code so-1105) is a new drug type medicinal product of the daily mucosa miconazole which is an antifungicide of the oral mucosa attachment type once administered once a day to treat oropharyngeal candidiasis which contracting the immune function in patients who lowered the immune function. The technology used for the development of "orabi" was called lauriad, and was developed to provide high concentration of active components directly to the local site.
Regarding the domestic sale of "orrabi", we have granted exclusive sales right to the group company of Fuji Film Co., Ltd. The company has received 200 million yen as milestone at the time of the approval acquisition, and after the sales start, it has the right to receive milestone separately at the time of the loyalty and a predetermined decision of the sales target.
"Orrabi" was developed by the French pharmaceutical company bioalliance Pharma, and was first approved in France in October 2006. Since then, it has been sold in two European and US registered trademarks of oravir /loramycrr.
In the end of May 2011, we have obtained the exclusive development right of orobi from bioalliance pharma. The efficacy and safety of "orabi" were confirmed using the data of the randomized phase III clinical trial which carried out the clinical clinical trial and the addition of mikonazole containing pharmaceutical as a control drug in Japan, and the medicine in Japan Approval of product manufacturing sales approval was obtained.
Tadayoshi Yasui, President of the president, said:
I am glad that Obama will be able to obtain the sales approval in Japan and the way to start sales in the coming months. We would like to express our gratitude to the clinical researchers, hospital staff and patients to participate in our clinical development program and to make our approval possible. The sales partner of this drug is scheduled for the Fuji film Toyama Chemical Co., Ltd., established on October 1, and is convinced that "orrabi" will be a useful treatment for the patient. "
In addition, we expect that the impact of this issue on our earnings forecast is slight.
Reference
Outline of orabi r tablet oral 50mg
Approval date
Production supplier Co.Ltd.
Orrabi r tablets 50mg oral cavity
Containing 50 mg of niconazole
Oral oropharyngeal candidiasis
Oral oropharyngeal candidiasis is a fungal infection mainly caused by Candida albicans (Candida albicans). It is often seen in patients suffering from immunodeficiency such as HIV and malignant tumors, and there are types such as pseudophakic candidiasis and erythema (atrophic) candidiasis. Symptoms include tongue pain, caution, taste abnormality, swallowing difficulty, and white mossy, erythema lesion, and stomatitis. With aging and medical technology advances, candidiasis is increasing.
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