DESIGNATION OF Canakinumab (ILARIS) 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 Canakinumab (ILARIS) as an orphan drug on 11 April 2013 for the treatment of active Systemic Juvenile Idiopathic Arthritis (sJIA) in patients aged 2 years and older.
The dose form of Canakinumab (ILARIS) for this indication is Powder for Injection.
The sponsor of Canakinumab (ILARIS) is Novartis Pharmaceuticals Australia Pty Limited.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
11 April 2013