| 商品名称 | Revinty Ellipta |
|---|
| 适用类别 | Human |
|---|
| 治疗领域 | Asthma |
|---|
| 通用名/非专利名称 | fluticasone furoate;vilanterol |
|---|
| 活性成分 | fluticasone furoate;vilanterol trifenatate |
|---|
| 产品号 | EMEA/H/C/002745 |
|---|
| 患者安全信息 | No |
|---|
| 许可状态 | Authorised |
|---|
| ATC编码 | R03AK10 |
|---|
| 是否额外监管 | No |
|---|
| 是否仿制药或hybrid药物 | No |
|---|
| 是否生物类似药 | No |
|---|
| 是否附条件批准 | No |
|---|
| 是否特殊情形 | No |
|---|
| 是否加速审评 | No |
|---|
| 是否罕用药 | No |
|---|
| 上市许可日期 | 2014/05/02 |
|---|
| 上市许可开发者/申请人/持有人 | GlaxoSmithKline Trading Services Limited |
|---|
| 人用药物治疗学分组 | Adrenergics and other drugs for obstructive airway diseases |
|---|
| 兽用药物治疗学分组 | |
|---|
| 审评意见日期 | 2014/03/20 |
|---|
| 欧盟委员会决定日期 | 2025/03/12 |
|---|
| 修订号 | 25 |
|---|
| 治疗适应症 | Asthma Indication Revinty Ellipta is indicated in the regular treatment of asthma in adults and adolescents aged 12 years and older, where use of a combination product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate: patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short acting beta2-agonists. COPD Indication Revinty Ellipta is indicated for the symptomatic treatment of adults with COPD with a FEV1 <70% predicted normal (post-bronchodilator) in patients with an exacerbation history despite bronchodilator therapy. |
|---|
| 适用物种 | |
|---|
| 兽用药物ATC编码 | |
|---|
| 首次发布日期 | 2018/08/21 |
|---|
| 最后更新日期 | 2025/03/14 |
|---|
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/revinty-ellipta-epar-product-information_en.pdf |
|---|
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/revinty-ellipta |
|---|