COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF momelotinib dihydrochloride monohydrate 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 momelotinib dihydrochloride monohydrate as an orphan drug on 31 July 2017 for the treatment of primary myelofibrosis, post-polycythaemia vera myelofibrosis and post-essential thrombocythaemia myelofibrosis.
The dose form of momelotinib dihydrochloride monohydrate for this indication is film-coated tablets.
The sponsor of momelotinib dihydrochloride monohydrate is Gilead Sciences.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
31 July 2017