| 商品名称 | Temybric Ellipta |
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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 | fluticasone furoate;umeclidinium;vilanterol |
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| 活性成分 | fluticasone furoate;umeclidinium bromide;vilanterol trifenatate |
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| 产品号 | EMEA/H/C/005254 |
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| 患者安全信息 | No |
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| 许可状态 | Lapsed |
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| ATC编码 | R03AL08 |
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| 是否额外监管 | Já |
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| 是否仿制药或hybrid药物 | Nei |
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| 是否生物类似药 | Nei |
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| 是否附条件批准 | Nei |
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| 是否特殊情形 | Nei |
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| 是否加速审评 | Nei |
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| 是否罕用药 | Nei |
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| 上市许可日期 | 2019/06/12 |
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| 上市许可开发者/申请人/持有人 | GlaxoSmithKline Trading Services Limited |
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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 | 2021/12/11 |
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| 修订号 | 4 |
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| 治疗适应症 | Temybric Ellipta is indicated as a maintenance 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 ?2-agonist or a combination of a long-acting ?2-agonist and a long-acting muscarinic antagonist (for effects on symptom control and prevention of exacerbations see section 5.1). |
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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 | 2019/09/23 |
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| 最后更新日期 | 2022/11/24 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/temybric-ellipta-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/temybric-ellipta |
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