Synagis: how long were the pivotal tox studies?

“Studies on repeated dose toxicity, effects on the reproduction, embryo-foetal & perinatal toxicity, mutagenic potential, oncogenic/carcinogenic potential and ecotoxicity/environmental risk assessment were not considered necessary by the applicant and were not performed.”

“A single dose toxicity study of palivizumab administered to Sprague Dawley rats via intravenous injection including assessment of clinical signs, body weight changes, food consumption, ophthalmoscopy, haematology, clinical and anatomic pathology until 14 days post injection gave no indication of toxicity”

“A single dose toxicity study of palivizumab administered to Sprague Dawley rats via intravenous injection”