| 商品名称 | GoResp Digihaler (previously Budesonide/Formoterol Teva Pharma B.V.) |
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| 适用类别 | Human |
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| 治疗领域 | Asthma;Pulmonary Disease, Chronic Obstructive |
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| 通用名/非专利名称 | budesonide;formoterol fumarate dihydrate |
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| 活性成分 | Budesonide;formoterol fumarate dihydrate |
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| 产品号 | EMEA/H/C/004882 |
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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 | 2020/04/03 |
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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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| 审评意见日期 | 2020/01/30 |
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| 欧盟委员会决定日期 | 2025/02/10 |
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| 修订号 | 6 |
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| 治疗适应症 | Budesonide/Formoterol Teva Pharma B.V. is indicated in adults 18 years of age and older only. Asthma Budesonide/Formoterol Teva Pharma B.V. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: -in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists. or -in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists. COPD Symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV1) < 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 | 2020/04/07 |
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| 最后更新日期 | 2025/02/18 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/goresp-digihaler-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/goresp-digihaler |
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