BYOOVIZ (Samsung Bioepis AU Pty Ltd)
Product name
BYOOVIZ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
152 (255 working days)
Active ingredients
Ranibizumab
Registration type
NCE/NBE
Indication
BYOOVIZ (ranibizumab) 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),
- treatment of proliferative diabetic retinopathy (PDR),
- the treatment of visual impairment due to choroidal neovascularisation (CNV),
- the treatment of visual impairment due to choroidal neovascularisation (CNV) secondary to pathologic myopia (PM),
- the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (RVO).