COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Tremelimumab 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 Tremelimumab as an orphan drug on 26 November 2015 for the treatment of malignant mesothelioma.
The dose form of Tremelimumab for this indication is solution for infusion.
The sponsor of Tremelimumab is AstraZeneca.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
26 November 2015