OPDIVO (Bristol-Myers Squibb Australia Pty Ltd)
Product name
OPDIVO
Date registered
Evaluation commenced
Decision date
Approval time
140 working days (255)
Active ingredients
nivolumab
Registration type
EOI
Indication
OPDIVO, in combination YERVOY (ipilimumab), is now also indicated for the treatment of patients with intermediate/poor-risk, previously untreated advanced renal cell carcinoma.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available