Byooviz (ranibizumab)
- Region
- 🇪🇺 EU
- Active substance
- ranibizumab
- Company
- Samsung Bioepis NL B.V.
- Status
- Authorised
- Therapeutic area
- Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Myopia, Degenerative
- CHMP opinion
- Thu 24 Jun 2021
- EU approval
- Wed 18 Aug 2021
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/005545
- ATC
- S01LA04
- Official record
- www.ema.europa.eu
Indication
Byooviz is indicated in adults for: The treatment of neovascular (wet) age-related macular degeneration (AMD) The treatment of visual impairment due to diabetic macular oedema (DME) The treatment of proliferative diabetic retinopathy (PDR) The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) The treatment of visual impairment due to choroidal neovascularisation (CNV)
Regulatory milestones
No milestones recorded in the last year.
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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.