COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF dichlorphenamide (Keveyis) 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 dichlorphenamide (Keveyis) as an orphan drug on 2 August 2016 for the treatment of primary periodic paralysis.
The dose form of dichlorphenamide (Keveyis) for this indication is tablet.
The sponsor of dichlorphenamide (Keveyis) is Ranbaxy Australia Pty Ltd
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
2 August 2016