Revised SPC: Lucentis (ranibizumab) 10 mg/ml solution for injection

SPC has been updated to advise that long-term safety in preterm infants with retinopathy of prematurity has been studied for 2 years in the RAINBOW extension trial and showed no new safety signals. The safety profile in preterm infants has not been established beyond 2 years

Source:

electronic Medicines compendium