UVADEX (Terumo BCT Australia Pty Ltd)
Product name
UVADEX
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
198 working days (255)
Active ingredients
methoxsalen
Registration type
NCE/NBE
Indication
UVADEX (concentrated solution for injection) is indicated for extracorporeal administration with the THERAKOS CELLEX Photopheresis System for the treatment of steroid-refractory and steroid-intolerant chronic graft versus host disease (cGvHD) in adults following allogeneic HSC transplantation.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.