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BAVENCIO (Merck Healthcare Pty Ltd)
Product name
BAVENCIO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
120 (255 working days)
Active ingredients
avelumab
Registration type
EOI
Indication
BAVENCIO (concentrated solution for intravenous infusion) is indicated for the first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) whose disease has not progressed with first-line platinum-based induction chemotherapy.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available