COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Andepatuzumab mafodotin (TBA) 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 Andepatuzumab mafodotin (TBA) as an orphan drug on 15 September 2016 for the treatment of glioblastoma multiforme.
The dose form of Andepatuzumab mafodotin (TBA) for this indication is Lyophylised powder for injection.
The sponsor of Andepatuzumab mafodotin (TBA) is AbbVie Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
15 September 2016