Designation of (ASFOTASE ALFA) as an Orphan Drug - Alexion Pharmaceuticals Australasia Pty Ltd

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Legislation au C2012G00120 In force Gazette

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DESIGNATION OF (Asfotase Alfa) 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 Asfotase Alfa as an orphan drug on the 15 October 2012 for the treatment of hypophosphatasia (HPP).

 

The dose form of Asfotase Alfa for this indication is subcutaneous injection.

 

The sponsor of Asfotase Alfa is Alexion Pharmaceuticals Australasia Pty Ltd.

 

 

 

 

 

(Signed by)

 

 

Dr Anthony Gill

Delegate of the Secretary

 

15 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.