DESIGNATION OF recombinant human coagulation factor VIII Fc fusion protein 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 recombinant human coagulation factor VIII Fc fusion protein as an orphan drug on 22 February 2013 for the treatment of control and prevention (including routine prophylaxis) of bleeding episodes in adults and children with haemophilia A.
The dose form of recombinant human coagulation factor VIII Fc fusion protein for this indication is lyophilized powder for reconstitution IV injection.
The sponsor of recombinant human coagulation factor VIII Fc fusion protein is Biogen Idec Australia Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
22 February 2013