COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF natalizumab (tysabri) 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 natalizumab (TYSABRI) as an orphan drug on 1 July 2014 for the treatment of relapsing-remitting multiple sclerosis in children aged 10-17 years.
The dose form of natalizumab (TYSABRI) for this indication is concentrated injection solution.
The sponsor of natalizumab (TYSABRI) is Biogen Idec Australia.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
1 July 2014