WELIREG (Merck Sharp & Dohme (Australia) Pty Ltd)
Product name
WELIREG
Date registered
Evaluation commenced
Decision date
Approval time
247 (255 working days)
Active ingredients
belzutifan
Registration type
NCE/NBE
Indication
WELIREG (belzutifan) is indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) haemangioblastomas, or pancreatic neuroendocrine tumours (pNET), not requiring immediate surgery.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.