RHOLISTIQ (Kadmon Oceania Pty Ltd)
Product name
RHOLISTIQ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
160 (255 working days)
Active ingredients
belumosudil mesilate
Registration type
NCE/NBE
Indication
RHOLISTIQ (film-coated tablet) is indicated for the treatment of patients with chronic graft-versus-host disease (chronic GVHD) aged 12 years and older who have an inadequate response to corticosteroids.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.