COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Romiplostim (Nplate) 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 Romiplostim (Nplate)as an orphan drug on 20 June 2017 for the treatment of chronic immune (idiopathic) thrombocytopenic purpura (ITP).
The dose form of Romiplostim (Nplate) for this indication is powder for Injection.
The sponsor of Romiplostim (Nplate) is Amgen Australia Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
20 June 2017