COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Lenalidomide (REVLIMID) 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 Lenalidomide (REVLIMID) as an orphan drug on 28 January 2015 for the treatment of patients with mantle cell lymphoma.
The dose form of Lenalidomide (REVLIMID) for this indication is capsule.
The sponsor of Lenalidomide (REVLIMID) is Celgene Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
28 January 2015