COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Rovalpituzumab Tesirine (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 Rovalpituzumab Tesirine (TBA) as an orphan drug on 20 May 2017 for the treatment of small cell lung cancer.
The dose form of Rovalpituzumab Tesirine (TBA) for this indication is Lyophilised powder for injection.
The sponsor of Rovalpituzumab Tesirine (TBA) is Abbvie Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
20 May 2017