Eydenzelt (aflibercept)
- Region
- 🇪🇺 EU
- Active substance
- aflibercept
- Company
- Celltrion Healthcare Hungary Kft.
- Status
- Authorised
- Therapeutic area
- Wet Macular Degeneration; Macular Edema; Diabetes Complications; Retinal Vein Occlusion; Choroidal Neovascularization
- CHMP opinion
- Thu 12 Dec 2024
- EU approval
- Wed 12 Feb 2025
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/005899
- ATC
- S01LA05
- Official record
- www.ema.europa.eu
Indication
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).
Regulatory milestones
No milestones recorded in the last year.
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- 🇪🇺 Vgenfli Authorised · Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A.
- 🇪🇺 Eiyzey Authorised · Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A.
- 🇪🇺 Eylea Authorised · Bayer AG
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.