| 商品名称 | Ahzantive |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Wet Macular Degeneration;Macular Edema;Retinal Vein Occlusion;Choroidal Neovascularization;Diabetes Complications |
| 通用名/非专利名称 | aflibercept |
| 活性成分 | aflibercept |
| 产品号 | EMEA/H/C/006607 |
| 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 | 2025/01/13 |
| 上市许可开发者/申请人/持有人 | Formycon AG |
| 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 | 2024/11/14 |
| 欧盟委员会决定日期 | 2025/11/06 |
| 修订号 | 4 |
| 治疗适应症 | Ahzantive 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 | 2024/11/15 |
| 最后更新日期 | 2025/11/07 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/ahzantive-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/ahzantive |