*Extended the indication to pediatric patients from bith at age 37 weeks gestation up to 2 years of age, based on two adequate and well controlled studies in 44 ages 0 to less than 2 years and extrapolation from of adult CNS efficacy data *The frequency, type, and severity of adverse reactions in pediatric patients were similar to those in adults. *Dosing established [0.1 mL/kg body weight (0.1 mmol/kg)] *PK studies suggest that clearance of Gadavist is similar in pediatric patients and adults, including pediatric patients age younger than 2 years *Juvenile toxicity studies in rats did not reveal findings suggestive of a specific risk for use in pediatric patients including term neonates and infants
|