COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF vinflunine ditartrate (JAVLOR) 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 vinflunine ditartrate (JAVLOR) as an orphan drug on 21 January 2015 for the treatment of adult patients with advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen.
The dose form of vinflunine ditartrate (JAVLOR) for this indication is injection.
The sponsor of vinflunine ditartrate (JAVLOR) is Pierre Fabre Australia.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
21 January 2015