| 商品名称 | Airexar Spiromax |
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| 适用类别 | Human |
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| 治疗领域 | Pulmonary Disease, Chronic Obstructive;Asthma |
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| 通用名/非专利名称 | salmeterol xinafoate;fluticasone propionate |
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| 活性成分 | salmeterol;fluticasone propionate |
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| 产品号 | EMEA/H/C/004267 |
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| 患者安全信息 | No |
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| 许可状态 | Withdrawn |
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| ATC编码 | R03AK06 |
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| 是否额外监管 | No |
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| 是否仿制药或hybrid药物 | No |
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| 是否生物类似药 | No |
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| 是否附条件批准 | No |
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| 是否特殊情形 | No |
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| 是否加速审评 | No |
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| 是否罕用药 | No |
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| 上市许可日期 | 2016/08/18 |
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| 上市许可开发者/申请人/持有人 | Teva B.V. |
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| 人用药物治疗学分组 | Drugs for obstructive airway diseases |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2016/06/23 |
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| 欧盟委员会决定日期 | 2018/02/19 |
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| 修订号 | 2 |
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| 治疗适应症 | Airexar Spiromax is indicated for use in adults aged 18 years and older only. AsthmaAirexar Spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting ?2 agonist) is appropriate: - patients not adequately controlled on a lower strength corticosteroid combination product or - patients already controlled on a high dose inhaled corticosteroid and long-acting ?2 agonist. Chronic Obstructive Pulmonary Disease (COPD)Airexar Spiromax is indicated for the symptomatic treatment of patients with COPD, with a FEV1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy. |
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| 适用物种 | |
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| 兽用药物ATC编码 | |
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| 首次发布日期 | 2017/03/09 |
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| 最后更新日期 | 2019/07/02 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/airexar-spiromax-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/airexar-spiromax |
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