Yesafili (aflibercept)
- Region
- 🇪🇺 EU
- Active substance
- aflibercept
- Company
- Biosimilar Collaborations Ireland Limited
- Status
- Authorised
- Therapeutic area
- Macular Edema; Retinal Vein Occlusion; Diabetic Retinopathy; Myopia, Degenerative; Diabetes Complications
- CHMP opinion
- Thu 20 Jul 2023
- EU approval
- Fri 15 Sep 2023
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/006022
- ATC
- S01LA05
- Official record
- www.ema.europa.eu
Indication
Yesafili 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.