COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF nitisinone (Nitisinone Tablets) 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 (Nitisinone Tablets) as an orphan drug on 28 November 2016 for the treatment of patients with hereditary tyrosinaemia type 1 in combination with dietary restriction of tyrosine and phenylalanine.
The dose form of nitisinone (Nitisinone Tablets) for this indication is tablet.
The sponsor of nitisinone (Nitisinone Tablets) is Orpharma Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
28 November 2016