COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF nitisinone (Orfadin) 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 nitisinone (Orfadin) as an orphan drug on 31 August 2016 for the treatment of patients with hereditary tyrosinaemia type 1.
The dose form of nitisinone (Orfadin) for this indication is capsules and oral liquid suspension.
The sponsor of nitisinone (Orfadin) is A. Menarini Australia Pty Ltd
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
31 August 2016