COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Equine Antithymocyte Immunoglobulin (ATGAM) 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 Equine Antithymocyte Immunoglobulin (ATGAM) as an orphan drug on 8 October 2015 for the treatment of aplastic anaemia.
The dose form of Equine Antithymocyte Immunoglobulin (ATGAM) for this indication is injection, solution.
The sponsor of Equine Antithymocyte Immunoglobulin (ATGAM) is Pfizer Australia Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
8 October 2015