LUCENTIS (Novartis Pharmaceuticals Australia Pty Ltd)
Product name
LUCENTIS
Date registered
Evaluation commenced
Decision date
Approval time
198 (255 working days)
Active ingredients
ranibizumab (rbe)
Registration type
EOI
Indication
LUCENTIS (solution for injection) is now also indicated in preterm infants for: the treatment of retinopathy of prematurity (ROP) with zone I (stage 1 +, 2 +, 3 or 3 +), zone II (stage 3 +) or AP-ROP (aggressive posterior ROP) disease.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.