骨质疏松症治疗药物——艾尔骨化醇
日本厚生省于2011年1月21日批准骨质疏松症治疗药物——艾尔骨化醇上市，其有效物质艾尔骨化醇是继阿法骨化醇后又一新的用于治疗骨质疏松症的活性维生素D3衍生物。一项由1054例骨质疏松症患者参加的历时3年的Ⅲ期临床数据显示，艾尔骨化醇疗效优于阿法骨化醇，且安全性与阿法骨化醇相似，具有较好的应用前景。
商品名:Edirol(エディロールカプセル)
通用名:艾尔骨化醇(eldecalcitol)
原研公司:日本中外制药株式会社、日本正大制药株式会社
类别:骨质疏松症治疗药(活性维生素D3制剂)

分子式:C30H50O5
相对分子质量:490.71
化学名:(1R,2R,3R,5Z,7E)-2-(3hydroxiypropyloxy)-9,10-secocholesta-5,7,10(19)triene-1,3,25-triol
CAS号:104121-92-8
适应症:骨质疏松症
用法与用量:成人1日1次,每次0.75μg口服。视症状可减少服药剂量。
获批单位:日本中外制药株式会社
批准日期:2011年1月21日
剂型规格:(1)软胶囊,0.5μg;(2)软胶囊,0.75μg
颜色:(1)茶白色不透明;(2)茶褐色透明包装:(1)100片(PTP)、140片(PTP)

完整处方附件：http://www.info.pmda.go.jp/go/pack/3112006M1022_1_05/

Launch of the Osteoporosis Agent “Edirol® Capsule”April 8, 2011 (Tokyo) - Chugai Pharmaceutical Co., Ltd.[Head Office: Chuo-ku, Tokyo; President: Osamu Nagayama (hereafter, “Chugai”)] and Taisho Toyama Pharmaceutical Co., Ltd.[Head Office: Toshima-ku, Tokyo; President: Akira Ohira (hereafter, “Taisho Toyama”)] announced today that eldecalcitol, an active vitamin D3 agent [brand name: Edirol® Capsule 0.5mg and 0.75mg
(hereafter, “Edirol®”)], which obtained approval on January 21, 2011 for the treatment of osteoporosis, has been listed on National Health Insurance drug reimbursement price list on March 11 and will be launched on April 11.
It is estimated that 12 million people have osteoporosis in Japan. It is important to increase bone density and thus reduce the incidence of fractures since osteoporosis-related fractures reduce quality of life, rendering patients bedridden and increase the risk of death. Edirol® is an activated vitamin D3 agent which was discovered by Chugai and co-developed with Taisho Pharmaceutical Co., Ltd. [Head Office: Toshima-ku, Tokyo; Chairman and CEO: Akira Uehara].
As an active vitamin D3 agent with an indication of osteoporosis, Edirol® comes to the market as a new treatment after many years since the launch of alfacalcidol (Chugai brand name: Alfarol®, launch: 1981, additional indication of osteoporosis: 1983) and calcitriol (Chugai brand name: Rocaltrol®, launch: 1986, additional indication of osteoporosis: 1989).
“Edirol®,” as a new active vitamin D3 derivative that enhances effect to bone, will contribute to significant improvement of the quality of life of the patients.
Through the provision of the new treatment options, Chugai and Taisho Toyama will continue its effort to contribute to osteoporosis treatment and to make efforts for promoting the
proper use.
Note) “Alfarol Capsule 3mg” and “Rocaltrol® Injection” is not indicated for osteoporosis.
Product name:
Edirol® Capsule 0.5mg
Edirol® Capsule 0.75mg
Generic name:Eldecalcitol
Indication:Osteoporosis
Dosage and administration: Usually, for adults, 0.75mg of eldecalcitol should be orally administered once daily.
However, the dosage may be reduced to 0.5mg once daily according to the symptoms.
Date of approval:January 21, 2011
Date of drug price listing:March 11, 2011
Date of launch:April 11, 2011
Shelf life:2 years 6 months
Edirol® is a registered trademark of Chugai Pharmaceutical Co., Ltd.
附件：
20125222535611.PDF   

 
20125222532417.PDF

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产地国家: 日本
原产地英文商品名:
EDIROL(エディロールカプセル) 0.75mcg/cap 100caps/box
原产地英文药品名:
ELDECALCITOL
原产地英文化合物名称:
(1R,2R,3R,5Z,7E)-2-(3hydroxiypropyloxy)-9,10-secocholesta-5,7,10(19)triene-1,3,25-triol
中文参考商品译名:
EDIROL(エディロールカプセル) 0.75微克/胶囊 100胶囊/盒
中文参考药品译名:
艾尔骨化醇
生产厂家中文参考译名:
中外制药株式会社
生产厂家英文名:
Chugai Pharmaceutical Co Ltd
产地国家: 日本

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产地国家: 日本
原产地英文商品名:
EDIROL(エディロールカプセル) 0.5mcg/cap 100caps/box
原产地英文药品名:
ELDECALCITOL
原产地英文化合物名称:
(1R,2R,3R,5Z,7E)-2-(3hydroxiypropyloxy)-9,10-secocholesta-5,7,10(19)triene-1,3,25-triol
中文参考商品译名:
EDIROL(エディロールカプセル) 0.5微克/胶囊 100胶囊/盒
中文参考药品译名:
艾尔骨化醇
生产厂家中文参考译名:
中外制药株式会社
生产厂家英文名:
Chugai Pharmaceutical Co Ltd