Designation of Sorafenib (NEXAVAR) as an Orphan Drug - Bayer Australia Limited

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Legislation au C2013G00385 In force Gazette

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DESIGNATION OF sorafenib (NEXAVAR) 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 sorafenib (NEXAVAR) as an orphan drug on the 4 March 2013 for the treatment of patients with radioactive iodine treatment (RAI) refractory, locally advanced or metastatic differentiated thyroid cancer (DTC).

 

 

The dose form of sorafenib (NEXAVAR) for this indication is tablet.

 

The sponsor of sorafenib (NEXAVAR) is Bayer Australia Limited.

 

 

 

 

 

(Signed by)

 

 

Dr Anthony Gill

Delegate of the Secretary

 

4 March 2013

 

 

 

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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.