COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF C1 esterase inhibitor, HUMAN (berinert), 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 C1 esterase inhibitor, human (Berinert), as an orphan drug on 10 April 2017 for subcutaneous administration for prophylaxis (routine prevention) of hereditary angioedema (HAE) attacks.
The dose form of C1 esterase inhibitor, human (Berinert), for this indication is powder for injection, subcutaneous.
The sponsor of C1 esterase inhibitor, human (Berinert), is CSL Behring Australia Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
10 April 2017