Designation of Tafenoquine (TBA) as an orphan drug - GlaxoSmithKline Australia

Administered by Department of Health, Disability and Ageing

Legislation au C2017G00502 In force Gazette

Legislation content

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

 

DESIGNATION OF tafenoquine (TBA) 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 tafenoquine (TBA) as an orphan drug on 21 April 2017 for the radical cure (prevention of relapse) of Plasmodium vivax malaria.

The dose form of tafenoquine (TBA) for this indication is tablet.

The sponsor of tafenoquine (TBA) is GlaxoSmithKline Australia Pty Ltd.

 

 

(Signed by)

 

Dr Anthony Gill

Delegate of the Secretary

21 April 2017

 

 

Interactions

Authorises

All Versions

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.