DESIGNATION OF normal immunoglobulin (human) (KIOVIG) 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 normal immunoglobulin (human) (KIOVIG) as an orphan drug on the 29 November 2012 for the treatment of Immunomodulatory therapy in multifocal motor neuropathy (MMN).
The dose form of normal immunoglobulin (human) (KIOVIG) for this indication is intravenous use injection.
The sponsor of normal immunoglobulin (human) (KIOVIG) is Baxter Healthcare Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
29 November 2012