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ZOLGENSMA (Novartis Pharmaceuticals Australia Pty Ltd)

Product name
ZOLGENSMA
Date registered
Evaluation commenced
Decision date
Approval time
230 (255 working days)
Active ingredients
onasemnogene abeparvovec
Registration type
EOI
Indication

ZOLGENSMA (onasemnogene abeparvovec) is indicated for the treatment of paediatric patients with 5q spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene with 3 or fewer copies of the SMN2 gene. (Refer to Dosage and Method of Administration, section 4.2, Special Populations, paediatric patients and section 5.1 Clinical Trials).