COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF avelumab 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 avelumab as an orphan drug on 27 July 2016 for the treatment of Merkel Cell Carcinoma.
The dose form of avelumab for this indication is concentrated solution for intravenous infusion.
The sponsor of avelumab is Merck Serono Australia Pty Ltd
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
27 July 2016