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UVADEX (Terumo BCT Australia Pty Ltd)
Product name
UVADEX
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
175 working days (255)
Active ingredients
methoxsalen
Registration type
EOI
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.
- palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) that is unresponsive to other forms of treatment.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.