COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF THIOTEPA (TEPADINA) 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 Thiotepa (TEPADINA) as an orphan drug on 23 February 2016 for the conditioning treatment prior to haematopoietic progenitor cell transplantation.
The dose form of Thiotepa (TEPADINA) for this indication is powder for injection.
The sponsor of Thiotepa (TEPADINA) is Helex-A Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
23 February 2016