Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
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