欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Eylea
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/002392
患者安全信息No
许可状态Authorised
ATC编码S01LA05
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2012/11/21
上市许可开发者/申请人/持有人Bayer 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2012/09/20
欧盟委员会决定日期2026/01/15
修订号39
治疗适应症Eylea 114.3 mg/ml solution for injection and Eylea 114.3 mg/ml solution for injection in pre-filled syringe Eylea is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) visual impairment due to diabetic macular oedema (DME) visual impairment due to macular oedema secondary to retinal vein occlusion (branch, central and hemiretinal RVO) Eylea 40 mg/mL solution for injection in pre-filled syringe Eylea is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) visual impairment due to diabetic macular oedema (DME) visual impairment due to myopic choroidal neovascularisation (myopic CNV) Eylea is indicated in preterm infants for the treatment of retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 2+ or 3+) or AP-ROP (aggressive posterior ROP) disease Eylea 40 mg/mL solution for injection in a vial Eylea is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) visual impairment due to diabetic macular oedema (DME) visual impairment due to myopic choroidal neovascularisation (myopic CNV)
适用物种
兽用药物ATC编码
首次发布日期2018/07/30
最后更新日期2026/03/04
产品说明书https://www.ema.europa.eu/en/documents/product-information/eylea-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/eylea
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