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OPDIVO (Bristol-Myers Squibb Australia Pty Ltd)
Product name
OPDIVO
Date registered
Evaluation commenced
Decision date
Approval time
207 (255 working days)
Active ingredients
nivolumab
Registration type
EOI
Indication
OPDIVO, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of patients with unresectable or metastatic urothelial carcinoma.