COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF bortezomib (VELCADE) 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 bortezomib (VELCADE) as an orphan drug on 20 August 2014 for the treatment of patients with mantle cell lymphoma.
The dose form of bortezomib (VELCADE) for this indication is powder for injection.
The sponsor of bortezomib (VELCADE) is Janssen-Cilag Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
19 August 2014