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OPUVIZ (Samsung Bioepis AU Pty Ltd)
Product name
OPUVIZ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
213 (255 working days)
Active ingredients
Aflibercept
Registration type
New biosimilar medicine
Indication
The approved indications for these therapeutic goods are:
- OPUVIZ 2 mg (aflibercept) is indicated in adults for the treatment of:
- neovascular (wet) age-related macular degeneration (wet AMD)
- visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO)
- visual impairment due to macular oedema secondary to branch retinal vein occlusion (BRVO)
- diabetic macular oedema (DME)