COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Teduglutide (REVESTIVE) 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 Teduglutide (REVESTIVE) as an orphan drug on 16 December 2015 for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support.
The dose form of Teduglutide (REVESTIVE) for this indication is powder for solution for injection.
The sponsor of Teduglutide (REVESTIVE) is Shire Australia Pty Limited.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
16 December 2015