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  药店国别: 法国药房
产地国家: 法国
所属类别: 影响血液及造血系统药物->溶栓抗凝药物
处方药:处方药
包装规格: 3.75毫克/毫升 120毫升/瓶
计价单位:
   
生产厂家英文名:
Pierre Fabre Dermatologie
该药品相关信息网址1:
http://www.hemangeol.com/hcp/
原产地英文商品名:
Hemangiol oral solution 3.75mg/ml 120ml 1 bottle
原产地英文药品名:
PROPRANOLOL HCL
中文参考商品译名:
Hemangeol口服液 3.75毫克/毫升 120毫升/瓶
中文参考药品译名:
盐酸普萘洛尔
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Infantile hemangioma
临床试验期:
完成
中文适应病症参考翻译1:
婴幼儿血管瘤
药品信息:
2014年3月17日(美国时间),法国医药公司Pierre Fabre对外宣布,公司旗下的儿科药Hemangeol(盐酸普萘洛尔)获FDA批准。Hemangeol是第一个也是唯一一个用于获批治疗婴幼儿血管瘤(Infantile hemangioma )增生的药物。 Hemangeol是专门开发的用于儿童安全有效的口服液,预期2014年 6月在美国上市销售。该药于2013年5月向FDA提交新药申请,同时也在欧洲提交了上市申请,已经得到CHMP的积极意见,预计2014年4月28日在欧洲获批。 关于婴幼儿血管瘤 婴幼儿血管瘤(Infantile hemangioma)是一种常见的良性血管瘤,在新生儿中发病率为3%-10%。这种良性的血管瘤表现为内皮组织的异常增生。在新生儿出生后的4-6周内很难被检测到,大多数的婴幼儿血管瘤不需要接受治疗,仅有大概12%的患者需要治疗。 关于Hemangeol Hemangeol是在FDA指导原则下开发的,专门用于婴幼儿的普萘洛尔新剂型。在出生后5周至5周岁的婴儿进行的随机、多中心、双盲对照临床研究实验发现,接受Hemangeol治疗的婴儿和使用空白对照的婴儿达到临床主要终点(完全获几乎完全抑制血管瘤)分别为60.4%和3.6%(P<0.0001)。 Pierre Fabre gains EU approval for Hemangiol, for proliferating infantile hemangioma French drugmaker Pierre Fabre Dermatologie Laboratories has obtained European Commission authorization to market Hemangiol (propranolol), the first and only drug to be approved for the treatment of proliferating infantile hemangioma requiring systemic treatment, the company said. Hemangiol is an oral solution specially developed for pediatric use. It will be launched firstly in France and Germany, and gradually throughout other European markets. This European agreement follows the US Food and Drug Administration approval obtained for the same product but under the Hemangeol brand name (The Pharma Letter March 18); a launch in the USA is set for June. This PUMA (Pediatric Use Marketing Authorization) is only the second of its type, for all pathologies, that the European Medicines Agency has issued since the system was established in 2007. The efficacy of propranolol for the treatment of infantile hemangioma was first discovered in 2007 by Christine Leaute-Labreze, a dermatologist at Bordeaux University Hospital Center. In 2009, Pierre Fabre Dermatologie and the University of Bordeaux formed a partnership to make this discovery available to infants with infantile hemangioma (IT) under conditions specifically adapted to pediatric use. Within this framework, Pierre Fabre Dermatologie took charge of the pharmaceutical, toxicological, clinical and industrial development aspects.
更新日期: 2015-09-16
附件:
20147819021316.pdf    

 
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