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TEVIMBRA (Beigene Aus Pty Ltd)
Product name
TEVIMBRA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
204 (255 working days)
Active ingredients
tislelizumab
Registration type
EOI
Indication
TEVIMBRA in combination with gemcitabine and cisplatin is indicated for the first-line treatment of adult patients with recurrent or metastatic nasopharyngeal carcinoma (NPC).
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.