| 商品名称 | Yesafili |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Macular Edema; Retinal Vein Occlusion; Diabetic Retinopathy; Myopia, Degenerative; Diabetes Complications |
| 通用名/非专利名称 | aflibercept |
| 活性成分 | aflibercept |
| 产品号 | EMEA/H/C/006022 |
| 患者安全信息 | no |
| 授权状态 | Authorised |
| ATC编码 | S01LA05 |
| 是否额外监管 | yes |
| 是否仿制药 | no |
| 是否生物类似药 | yes |
| 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 |
| 批准上市日期 | 2023/09/15 |
| 上市许可持有人/公司名称 | Viatris Limited |
| 人用药物治疗分组 | Ophthalmologicals |
| 审评意见发布日期 | 2023/07/20 |
| 决定日期 | 2023/11/29 |
| 修订号 | 1 |
| 适应症 | Yesafili is indicated for adults for the treatment ofneovascular (wet) age-related macular degeneration (AMD) (see section 5.1),visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1),visual impairment due to diabetic macular oedema (DME) (see section 5.1),visual impairment due to myopic choroidal neovascularisation (myopic CNV) (see section 5.1). |
| 首次发布日期 | 2023/07/17 |
| 修订日期 | 2023/12/04 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/yesafili-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/yesafili |