OPDIVO (Bristol-Myers Squibb Australia Pty Ltd)
Product name
OPDIVO
Date registered
Evaluation commenced
Decision date
Approval time
142 (255 working days)
Active ingredients
nivolumab
Registration type
EOI
Indication
Malignant Pleural Mesothelioma (MPM)
OPDIVO (concentrate solution for infusion), in combination with ipilimumab, is now also indicated for the first-line treatment of patients with unresectable malignant pleural mesothelioma.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available