COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF DEFIBROTIDE 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 Defibrotide as an orphan drug on 12 November 2013 for the treatment of hepatic veno-occlusive disease (VOD).
The dose form of Defibrotide for this indication is concentrate for solution for infusion.
The sponsor of Defibrotide is Link Healthcare.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
12 November 2013