COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Fingolimod (GILENYA, FILOSIR & FYNEFTA) 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 Fingolimod (GILENYA, FILOSIR & FYNEFTA) as an orphan drug on 24 November 2014 for the treatment of patients with Primary Progressive Multiple Sclerosis (PPMS) to delay the progression of physical disability.
The dose form of Fingolimod (GILENYA, FILOSIR & FYNEFTA) for this indication is capsule.
The sponsor of Fingolimod (GILENYA, FILOSIR & FYNEFTA) is Novartis Pharmaceuticals Australia Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
24 November 2014