COMMONWEALTH OF AUSTRALIA
Department of Health and Ageing
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Mifamurtide (Mepact) 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 Mifamurtide (Mepact) as an orphan drug on 2 September 2013 for the treatment of osteosarcoma.
The dose form of Mifamurtide (Mepact) for this indication is powder for infusion.
The sponsor of Mifamurtide (Mepact) is Nycomed Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
2 September 2013