英文药名：ultibro inhalation capsules（Glycopyrronium Bromide） 中文药名：格隆溴铵吸入用胶囊 生产厂家：瑞士诺华日本公司 药品介绍 薬效分类名 长时间作用性吸入気管支拡张配合剤 上市批准日期：2013年11月 适用症 缓解慢性支气管炎，肺气肿 剂量和用法 通常情况下，它被吸入与设备的辅助吸入此药每日一次只（110μg如茚达特罗和50μg的为格隆）一旦胶囊成人。 注意事项 这种药物可以用于治疗慢性阻塞性肺疾病的症状的长期管理。这种药物是不被用于急性治疗的目的在慢性阻塞性肺疾病的发作的药物。 包装规格 格隆溴铵吸入胶囊*14粒 格隆溴铵吸入胶囊*28粒 完整资料附件：http://www.info.pmda.go.jp/go/pack/2259805G1027_1_04/2259805G1027_1_04?view=body Once-daily Ultibro® Inhalation Capsules (QVA149) for COPD Launched in Japan Dual bronchodilation with Ultibro® is expected to set a new standard of care in COPD by combining the proven efficacy benefits and safety profiles of two established Novartis COPD treatments, the LABA*, Onbrez® Inhalation Capsules (indacaterol), and the LAMA**, Seebri® Inhalation Capsules (glycopyrronium bromide). All Novartis inhaled COPD portfolio products are developed for delivery via a single-dose dry powder inhaler (SDDPI) called the Breezhaler® inhalation device which has low air flow resistance, making it suitable for patients with airflow limitation1. The Breezhaler® device allows patients to hear, feel and see that they have taken the full dose correctly. Ultibro® was approved in Japan and EU (under the brand name Ultibro® Breezhaler®) in September, and has since been launched in Germany and Netherlands. US submission is anticipated in the second half of 2014. Ultibro®, Seebri®, Onbrez® and Breezhaler® are registered trademarks of Novartis AG. * a long-acting beta2-adrenergic agonist, ** a long-acting muscarinic antagonist About Seebri® Once-daily Seebri® Breezhaler® (EU)/ Seebri® Inhalation Capsules (Japan), (“Seebri”; glycopyrronium bromide), is a novel inhaled long-acting muscarinic antagonist (LAMA) indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. Seebri® was licensed to Novartis in April 2005 by Sosei and its co-development partner Vectura. Seebri® was first approved in the EU and Japan in September 2012 as a maintenance bronchodilator treatment for COPD, and has been approved in over 50 countries including Canada and Australia. Seebri® has been launched in Germany, the UK, Japan and other major markets. The US filing is expected in the first half of 2014. About COPD COPD is a chronic, progressive lung disease that is commonly caused by tobacco smoking, air pollution or occupational exposure, and results in airflow obstruction and debilitating bouts of breathlessness. Although the latest figures show only 220,000 people have been diagnosed with COPD in Japan. 诺华慢阻肺新药在欧盟及日本获批 Ultibro® Breezhaler® (QVA149)是首个获得欧盟委员会批准用于慢阻肺（COPD）成人患者维持治疗的双重支气管扩张剂，每日一次，用于缓解慢阻肺症状。 在日本，通过Breezhaler®装置给药的每日1次 Ultibro®吸入粉雾剂用胶囊(QVA149)获准用于缓解COPD气道阻塞引起的多种症状。 -ultibro inhalation capsules （Glycopyrronium Bromide)格隆溴铵/马来酸茚达特罗吸入用胶囊 -诺华（Novartis）和Vectura制药宣布，慢性阻塞性肺病（COPD）新药Ultibro（glycopyrronium/indacaterol，格隆/马来酸茚达特罗，50mcg/110mcg）获日本劳动卫生福利部（MHLW）批准，作为每日一次的吸入性胶囊，用于缓解COPD患者气道阻塞所致的各种症状。该药有望成为COPD临床护理的新标准，并有望使诺华取代葛兰素史克（GSK）在COPD市场中的领导地位。 Ultibro吸入性胶囊是实验性药物QVA149的商品名，通过Breezhaler单剂量干粉吸入器给药，是诺华公司在其Breezhaler吸入器中的第三个创新药物。 QVA149（格隆/马来酸茚达特罗，50mcg/110mcg）是一种具双重作用模式的支气管扩张剂，结合了诺华2种COPD药物的疗效和安全性：Onbrez吸入性胶囊（indacaterol，LABA）和Seebri吸入性胶囊（glycopyrronium，LAMA），这2种药物均通过Breezhaler单剂量干粉吸入器给药。目前，Onbrez和Seebri已在包括日本在内的多个国家广泛使用。 今年4月，诺华公布了有关QVA149在慢性阻塞性肺病（COPD）患者中的III期SPARK研究的详细结果。研究表明，与格隆（50mcg）及噻托溴铵（18mcg）相比，QVA149能够更有效地减少COPD急性发作。该项研究首次将固定剂量的长效β2-受体激动剂（LABA）和长效毒蕈碱受体拮抗剂（LAMA）组合与单一的LAMA疗法进行疗效比较