COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF siltuximab (sylvant) 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 siltuximab (SYLVANT) as an orphan drug on 14 August 2014 for the treatment of adults with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpes virus-8 (HHV-8) negative.
The dose form of siltuximab (SYLVANT) for this indication is powder for infusion.
The sponsor of siltuximab (SYLVANT) is Janssen-Cilag Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
14 August 2014