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Afiveg (aflibercept)

BiosimilarAdditional monitoring
Region
🇪🇺 EU
Active substance
aflibercept
Company
STADA Arzneimittel AG
Status
Authorised
Therapeutic area
Wet Macular Degeneration; Macular Edema; Diabetes Complications; Retinal Vein Occlusion; Choroidal Neovascularization
CHMP opinion
Thu 19 Jun 2025
EU approval
Mon 18 Aug 2025
Designations
Biosimilar, Additional monitoring
Application
EMEA/H/C/006761
ATC
S01LA05
Official record
www.ema.europa.eu

Indication

Afiveg is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) (see section 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 section1), visual impairment due to myopic choroidal neovascularisation (myopic CNV) (see section 5.1).

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

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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.