| 商品名称 | DuoResp 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 | budesonide;formoterol |
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| 活性成分 | Budesonide;formoterol fumarate dihydrate |
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| 产品号 | EMEA/H/C/002348 |
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| 患者安全信息 | No |
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| 许可状态 | Authorised |
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| ATC编码 | R03AK07 |
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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 | 2014/04/28 |
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| 上市许可开发者/申请人/持有人 | Teva Pharma 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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| 欧盟委员会决定日期 | 2024/07/08 |
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| 修订号 | 13 |
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| 治疗适应症 | Asthma DuoResp Spiromax is indicated in adults and adolescents (12 years and older) for the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting ?? adrenoceptor agonist) is appropriate: in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting ?? adrenoceptor agonists. or in patients already adequately controlled on both inhaled corticosteroids and long-acting ?? adrenoceptor agonists. COPDDuoResp Spiromax is indicated in adults, aged 18 years and older for the symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV?) <70% predicted normal (post bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators. |
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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 | 2018/07/10 |
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| 最后更新日期 | 2024/07/24 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/duoresp-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/duoresp-spiromax |
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