COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Lonoctocog alfa Afstyla 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 Lonoctocog alfa (AFSTYLA) as an orphan drug on 26 November 2015 for the treatment in adults and children with haemophilia A (congenital FVIII deficiency) for:
• Control and prevention of bleeding episodes
• Routine prophylaxis to prevent or reduce the frequency of bleeding episodes
• Perioperative prophylaxis (surgical prophylaxis)
The dose form of Lonoctocog alfa (AFSTYLA) for this indication is powder for reconstitution and injection.
The sponsor of Lonoctocog alfa (AFSTYLA) CSL Behring Australia Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
26 November 2015