DESIGNATION OF Propranolol Hydrochloride 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 Propranolol Hydrochloride as an orphan drug on the 3rd October 2012 for the treatment of proliferating infantile hemangiomas requiring systemic therapy.
The dose form of Propranolol Hydrochloride for this indication is oral solution.
The sponsor of Propranolol Hydrochloride is Pierre Fabre Medicament Australia Pty Limited.
(signed by)
Dr Anthony Gill
Delegate of the Secretary
3rd October 2012