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New medicine carglumic acid approved to treat rare disorders

Te Arai BioFarma has received Medsafe registration for the Prescription Medicine Carglumic Acid Waymade for the treatment of hyperammonaemia caused by a variety of rare genetic metabolic disorders:

N-acetylglutamate synthase (NAGS) primary deficiency

Organic acidaemias:

isovaleric acidaemia.

methymalonic acidaemia.

propionic acidaemia.

Hyperammonaemia is characterised by an excess ammonia in the blood which can lead to brain injury and death.

"Carglumic Acid Waymade joins our growing portfolio of orphan medicines for the treatment of rare disorders. Te Arai BioFarma believes it is important that medicines for rare disorders are registered by Medsafe in order to assure our community of appropriate quality and control of medicines." Julia Reese, Director of Regulatory Affairs.

For more information:

Carglumic Acid Waymade Data Sheet

Metabolic Service https://www.starship.org.nz/directory-of-services/metabolic-service/

https://raredisorders.org.nz/

Te Arai BioFarma Ltd 0800 TE ARAI.

Carglumic Acid Waymade is a Prescription Medicine. For full information please consult the Medsafe website and product data sheet at www.medsafe.govt.nz.

Te Arai BioFarma is a New Zealand owned family company created to improve access to Medicines for New Zealanders.

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