COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Pasireotide (as Embonate) (SIGNIFOR LAR) 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 Pasireotide (SIGNIFOR LAR) as an orphan drug on 29 October 2013 for the treatment of patients with Acromegaly for whom medical therapy is appropriate.
The dose form of Pasireotide (SIGNIFOR LAR) for this indication is modified release injection.
The sponsor of Pasireotide (SIGNIFOR LAR) is Novartis Pharmaceuticals Australia Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
29 October 2013