| 商品名称 | Trimbow |
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| 适用类别 | Human |
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| 治疗领域 | Pulmonary Disease, Chronic Obstructive |
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| 通用名/非专利名称 | beclometasone;formoterol;glycopyrronium bromide |
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| 活性成分 | beclometasone dipropionate;formoterol fumarate dihydrate;glycopyrronium bromide |
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| 产品号 | EMEA/H/C/004257 |
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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 | R03AL09 |
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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 | 2017/07/17 |
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| 上市许可开发者/申请人/持有人 | Chiesi Farmaceutici S.p.A. |
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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 | 2017/05/18 |
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| 欧盟委员会决定日期 | 2025/02/13 |
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| 修订号 | 9 |
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| 治疗适应症 | Maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and high dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year. COPDMaintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5.1). AsthmaMaintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year. |
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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 | 2017/07/17 |
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| 最后更新日期 | 2025/02/17 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/trimbow-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/trimbow |
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