COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF mepolizumab (Nucala) 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 mepolizumab (Nucala) as an orphan drug on 11 May 2017 for the treatment of patients with Eosinophilic Granulomatosis with Polyangiitis (EGPA).
The dose form of mepolizumab (Nucala) for this indication is powder for solution for injection.
The sponsor of mepolizumab (Nucala) is GlaxoSmithKline Australia Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
11 May 2017