DESIGNATION OF riociguat 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 Riociguat as an orphan drug on the 16 October 2012 for the treatment of Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH).
The dose form of Riociguat for this indication is Immediate – release tablets.
The sponsor of Riociguat is Bayer Australia Limited.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
16 October 2012