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  药店国别: 美国药房
产地国家: 美国
所属类别: 糖尿病->2型糖尿病
处方药:处方药
包装规格: 25毫克/片 30片/盒
计价单位:
   
生产厂家中文参考译名:
勃林格殷格翰
生产厂家英文名:
BOEHRINGER INGELHEIM
该药品相关信息网址1:
http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/23_may_2014_empagliflozin.html
该药品相关信息网址2:
http://www.healthline.com/health-news/FDA-approves-jardiance-type-2-diabetes-080414
该药品相关信息网址3:
https://www.jardiance.com/
原产地英文商品名:
JARDIANCE 25mg 30tabs
原产地英文药品名:
EMPAGLIFLOZIN
中文参考商品译名:
JARDIANCE 25毫克/片 30片/盒
中文参考药品译名:
EMPAGLIFLOZIN
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
type 2 diabetes
临床试验期:
完成
中文适应病症参考翻译1:
2型糖尿病
药品信息:
糖尿病新药—依帕列净片Jardiance(empagliflozin)tab 勃林格殷格翰-礼来糖尿病联盟5月23日联合宣布,糖尿病新药Jardiance(empagliflozin)获欧盟委员会(EC)批准,用于饮食结合运动未能取得充分血糖控制的2型糖尿病成人患者的治疗,以改善血糖控制。 Jardiance的获批,也标志着勃林格殷格翰-礼来糖尿病联盟获批的第3个糖尿病产品。 Jardiance为每日一次的片剂,获批剂量为10mg和25mg。Jardiance可单独用药,也可与其他降糖药联合用药,包括胰岛素,二甲双胍。 Jardiance的获批,是基于一项涵括超过10个跨国III期试验的大型临床项目的数据,涉及超过1.3万例2型糖尿病患者。该项目数据表明,Jardiance 10mg和25mg剂量作为单药疗法或与广泛的背景疗法(包括二甲双胍,磺酰脲,胰岛素,pioglitazone等)联合用药,均显著降低了患者的糖化血红蛋白(HA1c)水平,同时也显著降低了体重、血压。 Jardiance属于钠-葡萄糖协同转运蛋白-2(SGLT-2)抑制剂类药物。新兴的SGLT-2抑制剂类药物,已被证实能够阻断肾脏中葡萄糖的再吸收作用,将过多的葡萄糖排泄到体外,从而达到降低血糖水平的效果,而且该降糖效果不依赖于β细胞功能和胰岛素抵抗. empagliflozin On 20 March 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Jardiance, 10 mg and 25 mg film-coated tablets, intended for the treatment of type 2 diabetes mellitus. The applicant for this medicinal product is Boehringer Ingelheim International GmbH. They may request a re-examination of any CHMP opinion, provided they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion. The active substance of Jardiance is empagliflozin, a blood glucose lowering agent, ATC code: A10BX12. Empagliflozin works by blocking a protein in the kidney called the human sodium-glucose co-transporter-2 (SGLT2). This reduces glucose re-absorption in the kidney leading to glucose excretion in the urine, thereby lowering levels of glucose in the blood of patients with type 2 diabetes. The benefits with Jardiance are its ability to improve glycaemic control. The most common side effects are hypoglycaemia (when used with sulphonylurea or insulin), genital and urinary tract infections, pruritus and increased urination. A pharmacovigilance plan for Jardiance will be implemented as part of the marketing authorisation. The approved indication is: “Treatment of type 2 diabetes mellitus to improve glycaemic control in adults as: Monotherapy When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance. 1 Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion. Jardiance EMA/CHMP/157961/2014 Page 2/2 Add-on combination therapy In combination with other glucose–lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations)." Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission. The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit-to-risk balance for Jardiance and therefore recommends the granting of the marketing authorisation. (*) The correction concerns the deletion of the following sentence “It is proposed that Jardiance be prescribed by physicians experienced in the treatment of type 2 diabetes”.
更新日期: 2014-08-11
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