Therapeutic Goods Act 1989
Therapeutic Goods Regulations 1990
DESIGNATION OF Elosulfase-alpha 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 Elosulfase-alpha as an orphan drug on 3rd July, 2013 for the treatment of mucopolysaccharidosis IV type A (Morquio A syndrome, MPS IVA).
The dose form of Elosulfase-alpha for this indication is solution for infusion, 5 mL/vial with 1 mg/mL concentrate.
The sponsor of Elosulfase-alpha is BioMarin Pharmaceutical Australia Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
3rd July, 2013