COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF stiripentol (DIACOMIT) 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 stiripentol (DIACOMIT) as an orphan drug on 23 June 2016 for the treatment of severe myoclonic epilepsy in infancy (SMEI also known as Dravet syndrome).
The dose forms of stiripentol (DIACOMIT) for this indication are capsule and oral powder.
The sponsor of stiripentol (DIACOMIT) is Emerge Health Pty Ltd
(signed by)
Dr Anthony Gill
Delegate of the Secretary
23 June 2016