RANIVIZ (Actor Pharmaceuticals Pty Ltd)
Product name
RANIVIZ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
134 (175 working days)
Active ingredients
Ranibizumab
Registration type
New biosimilar medicine
Indication
Raniviz (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,
- 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).
Not recommended for use in preterm infants.