COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Anti-H5N1 equine immunoglobulin F(ab’)2 fragments (FABENFLU) 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 Anti-H5N1 equine immunoglobulin F(ab’)2 fragments (FABENFLU) as an orphan drug on 12 February 2014 for the treatment of passive immunotherapy in case of post-exposure or suspected post-exposure to H5N1 avian influenza virus.
The dose form of Anti-H5N1 equine immunoglobulin F(ab’)2 fragments (FABENFLU) for this indication is solution for infusion.
The sponsor of Anti-H5N1 equine immunoglobulin F(ab’)2 fragments (FABENFLU) is Fab’entech.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
12 February 2014