Eylea (aflibercept)
- Region
- 🇪🇺 EU
- Active substance
- aflibercept
- Company
- Bayer AG
- Status
- Authorised
- Therapeutic area
- Wet Macular Degeneration; Macular Edema; Diabetes Complications; Retinal Vein Occlusion; Choroidal Neovascularization
- CHMP opinion
- Thu 20 Sep 2012
- EU approval
- Wed 21 Nov 2012
- Application
- EMEA/H/C/002392
- ATC
- S01LA05
- Official record
- www.ema.europa.eu
Indication
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)
Regulatory milestones
No milestones recorded in the last year.
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