COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Ruxolitinib JAKAVI 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 Ruxolitinib JAKAVI as an orphan drug on 16 October 2014 for the treatment of patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea
The dose form of Ruxolitinib JAKAVI for this indication is tablet.
The sponsor of Ruxolitinib JAKAVI is Novartis Pharmaceuticals Australia Pty Ltd
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
24 October 2014