COMMONWEALTH OF AUSTRALIA
Department of Health and Ageing
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF eliglustat (TBA) 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 eliglustat (TBA) as an orphan drug on 2 August 2013 for the treatment of long term treatment of adult patients with Gaucher disease type 1 (GD1).
The dose form of eliglustat (TBA) for this indication is capsules.
The sponsor of eliglustat (TBA) is Sanofi-Aventis Australia Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
2 August 2013