COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Brentuximab vedotin (ADCETRIS) 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 Brentuximab vedotin (ADCETRIS) as an orphan drug on 6 December 2016 for the treatment of cutaneous T-Cell lymphoma.
The dose form of Brentuximab vedotin (ADCETRIS) for this indication is powder for injection.
The sponsor of Brentuximab vedotin (ADCETRIS) is Takeda Pharmaceuticals Australia Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
6 December 2016