COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF albutrepenonacog alfa 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 albutrepenonacog alfa as an orphan drug on 27 October 2014 for the treatment and prophylaxis of bleeding associated with congenital factor IX deficiency (haemophilia B).
The dose form of albutrepenonacog alfa for this indication is injection.
The sponsor albutrepenonacog alfa is CSL Behring Australia Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
27 October 2014