Designation of Denosumab (XGEVA) as an Orphan Drug - Amgen Australia Pty Ltd

Administered by Department of Health, Disability and Ageing

Legislation au C2012G00075 In force Gazette

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DESIGNATION OF denosumab (XGEVA) 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 denosumab (XGEVA) as an orphan drug on the 3rd October 2012 for the treatment of patients with giant cell tumours of the bone.

 

The dose form of denosumab (XGEVA) for this indication is solution for injection.

 

The sponsor of denosumab (XGEVA) is Amgen Australia Pty Ltd.

 

 

 

 

 

 

(signed by)

 

Dr Anthony Gill

Delegate of the Secretary

 

3rd October 2012

 

 

 

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.