COMMONWEALTH OF AUSTRALIA
Department of Health and Ageing
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Ramucirumab (Cyramza) 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 Ramucirumab (Cyramza) as an orphan drug on 17 September 2013 is for the treatment of patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma after prior chemotherapy.
The dose form of Ramucirumab (Cyramza) for this indication is solution for infusion.
The sponsor of Ramucirumab (Cyramza) is Eli Lilly.
(Signed by)
Dr Anthony Gill
Office of Scientific Evaluation
Delegate of the Secretary
17 September 2013