| 商品名称 | Ranivisio |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Wet Macular Degeneration;Macular Edema;Diabetic Retinopathy;Diabetes Complications |
| 通用名/非专利名称 | ranibizumab |
| 活性成分 | ranibizumab |
| 产品号 | EMEA/H/C/005019 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | S01LA04 |
| 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 | 2022/08/25 |
| 上市许可开发者/申请人/持有人 | Midas Pharma GmbH |
| 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 | 2022/06/23 |
| 欧盟委员会决定日期 | 2025/11/13 |
| 修订号 | 7 |
| 治疗适应症 | Ranivisio is indicated in adults for: • The treatment of neovascular (wet) age-related macular degeneration (AMD) • The treatment of visual impairment due to diabetic macular oedema (DME) • The treatment of proliferative diabetic retinopathy (PDR) • The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) • The treatment of visual impairment due to choroidal neovascularisation (CNV) |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2022/06/20 |
| 最后更新日期 | 2025/11/14 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/ranivisio-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/ranivisio |