Fig. 3
From: Clinical data required for the approval of pediatric pharmaceuticals in Japan
Characteristics of analyzed products. (a) Addition of new doses, dosage forms, and routes of administration for previously approved indications. (b) Two products were approved exclusively for children, not for adults (ranibizumab for retinopathy of prematurity, approved on November 22, 2019; valganciclovir hydrochloride for symptomatic congenital cytomegalovirus infection, approved on March 27, 2023)