| 商品名称 | Eydenzelt |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Wet Macular Degeneration;Macular Edema;Diabetes Complications;Retinal Vein Occlusion;Choroidal Neovascularization |
| 通用名/非专利名称 | aflibercept |
| 活性成分 | aflibercept |
| 产品号 | EMEA/H/C/005899 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | S01LA05 |
| 是否额外监管 | Yes |
| 是否仿制药或hybrid药物 | 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 |
| 上市许可日期 | 2025/02/12 |
| 上市许可开发者/申请人/持有人 | Celltrion Healthcare Hungary Kft. |
| 人用药物治疗学分组 | Ophthalmologicals |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2024/12/12 |
| 修订号 | |
| 治疗适应症 | Eydenzelt is indicated for adults for the treatment of: neovascular (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). |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2025/03/27 |
| 产品说明书 | |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/eydenzelt |