COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Chlormethine VALCHLOR 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 Chlormethine VALCHLOR as an orphan drug on 25 March 2015 for the treatment of cutaneous T cell lymphoma.
The dose form of Chlormethine VALCHLOR for this indication is topical gel.
The sponsor of Chlormethine VALCHLOR is Actelion Pharmaceuticals Australia Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
25 March 2015