DESIGNATION OF eculizumab (SOLIRIS) 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 eculizumab (SOLIRIS) as an orphan drug on the 26 October 2012 for the treatment of infection – associated haemolytic uraemic syndrome.
The dose form of eculizumab (SOLIRIS) for this indication is concentrated solution for IV infusion Vial.
The sponsor of eculizumab (SOLIRIS) is Alexion Pharmaceuticals Australasia Pty Ltd.
(signed by)
Dr Anthony Gill
Delegate of the Secretary
26 October 2012