COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Factor XI Concentrate (human coagulation factor XI) 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 Factor XI Concentrate (human coagulation factor XI) as an orphan drug on 31 October 2014 for the treatment and prevention of bleeding in patients with either congenital factor XI deficiency or acquired factor XI inhibitors.
The dose form of Factor XI Concentrate (human coagulation factor XI) for this indication is powder for injection.
The sponsor of Factor XI Concentrate (human coagulation factor XI) is CSL Behring (Australia) Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
12 December 2014