COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Lenvatinib (Not stated) AS AN ORPHAN DRUG
I, Dr Tim Greenaway, 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 (Not stated) as an orphan drug on 14 July 2017 for the treatment of hepatocellular carcinoma.
The dose form of Lenvatinib (Not stated) for this indication is hard capsules.
The sponsor of Lenvatinib (Not stated) is Eisai Australia Pty Ltd.
(Signed by)
Dr Tim Greenaway
Delegate of the Secretary
14 July 2017