COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Migalastat hydrochloride (GALAFOLD) 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 Migalastat hydrochloride (GALAFOLD) as an orphan drug on 2 February 2016 for the long-term treatment of adult and adolescent patients with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency) who have an amendable mutation.
The dose form of Migalastat hydrochloride (GALAFOLD) for this indication is capsules for oral administration.
The sponsor of Migalastat hydrochloride (GALAFOLD) is ERA Consulting Australia Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
2 February 2016