JAKAVI (Novartis Pharmaceuticals Australia Pty Ltd)
Product name
JAKAVI
Date registered
Evaluation commenced
Decision date
Approval time
144 (255 working days)
Active ingredients
ruxolitinib phosphate
Registration type
EOI
Indication
JAKAVI (tablet) is now also indicated for the treatment of patients aged 12 years and older with acute graft-versus-host disease who have inadequate response to corticosteroids.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.