DESIGNATION OF leuprorelin acetate (LUCRIN) 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 leuprorelin acetate (LUCRIN) as an orphan drug on the 19 December 2012 for the treatment of Central Precocious Puberty (CPP.)
The dose form of leuprorelin acetate (LUCRIN) for this indication is Injection.
The sponsor of leuprorelin acetate (LUCRIN) is AbbVie Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
19 December 2012