COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Lenvatinib Mesilate 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 Lenvatinib as an orphan drug on 27 November 2014 for the treatment of patients with progressive, radioiodine - refractory differentiated thyroid cancer.
The dose form of Lenvatinib for this indication is capsule.
The sponsor of Lenvatinib is Eisai Australia Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
27 November 2014