Designation of Idebenone (Raxone) as an orphan drug - TudorRose Consulting Pty Ltd

Administered by Department of Health, Disability and Ageing

Legislation au C2016G01159 In force Gazette

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COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

 

DESIGNATION OF idebenone (Raxone) 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 idebenone (Raxone) as an orphan drug on 24 August 2016 for the treatment of  Duchenne muscular dystrophy.

The dose form of idebenone (Raxone) for this indication is film coated tablet.

The sponsor of idebenone (Raxone) is TudorRose Consulting Pty Ltd.

 

 

(Signed by)

 

Dr Anthony Gill

Delegate of the Secretary

24 August 2016

 

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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.