AFINITOR (Novartis Pharmaceuticals Australia Pty Ltd)
Product name
AFINITOR
Date registered
Evaluation commenced
Decision date
Approval time
182 working days (255)
Active ingredients
everolimus
Registration type
EOI
Indication
AFINITOR (tablets) is now also indicated for the adjunctive treatment of patients aged 2 years and older with Tuberous Sclerosis Complex (TSC) and associated refractory seizures.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.