PREVYMIS (Merck Sharp & Dohme (Australia) Pty Ltd)
Product name
PREVYMIS
Date registered
Evaluation commenced
Decision date
Approval time
180 working days (255)
Active ingredients
letermovir
Registration type
NCE/NBE
Indication
PREVYMIS (film-coated tablets; concentrated injection for infusion) is indicated for the prophylaxis of cytomegalovirus (CMV) infection or disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.