COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Bevacizumab (AVASTIN) 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 Bevacizumab (AVASTIN) as an orphan drug on 21 March 2014 for the treatment of persistent, recurrent or Stage IV carcinoma of the cervix.
The dose form of Bevacizumab (AVASTIN) for this indication is injection, concentrated.
The sponsor of Bevacizumab (AVASTIN) is Roche Products Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
25 March 2014