COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Methoxsalen (UVADEX) AS AN ORPHAN DRUG
I, Dr Anthony Gill, Delegate of the Secretary for the purposes of 16J of the Therapeutic Goods Regulations 1990 (“the Regulations”), acting under subregulation 16J(2) of the Regulations, designate Methoxsalen (UVADEX) as an orphan drug on 1 October 2015 for the treatment of Graft-versus-host disease (GVHD) following allogeneic HSC transplantation.
The dose form of Methoxsalen (UVADEX), for this indication is injection solution.
The sponsor of Methoxsalen (UVADEX) is Terumo BCT Australia Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
1 October 2015