| 商品名称 | Aerivio 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;fluticasone propionate |
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| 活性成分 | salmeterol xinafoate;fluticasone propionate |
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| 产品号 | EMEA/H/C/002752 |
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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| 许可状态 | Withdrawn |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 | 2019/10/04 |
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| 修订号 | 2 |
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| 治疗适应症 | Aerivio Spiromax is indicated for use in adults aged 18 years and older only. Asthma Aerivio 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) Aerivio 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 | 2017/06/09 |
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| 最后更新日期 | 2020/01/15 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/aerivio-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/aerivio-spiromax |
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