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Posted 17-Feb-2015

Carbaglu® (carglumic acid 200mg dispersible tablets) is now a TGA Registered Product

EMERGE HEALTH PTY LTD the exclusive distributor of Carbaglu® (carglumic acid 200mg dispersible tablets) in Australia is pleased to announce approval has been granted by the Therapeutic Good Administration (TGA) for the following indications:

Hyperammonaemia due to N-acetylglutamate synthase primary deficiency

Hyperammonaemia due to Organic Acidaemias such as:

  • Hyperammonaemia due to isovaleric acidaemia
  • Hyperammonaemia due to methymalonic acidaemia
  • Hyperammonaemia due to propionic acidaemia

Carbaglu has been developed by our partners Orphan Europe and is approved within the European Union and United States. The addition of the Australian approval strengthens physicians’ ability to effectively treat hyperammonaemia.

The registration of Carbaglu® further demonstrates Emerge Health’s focus and commitment to improving the availability of medicines to treat rare diseases in Australasia.

For all medical and product enquiries or adverse event reports concerning Carbaglu® should be directed to Emerge Health on:

Fax: 03 8672 0792

E-mail: medicalaffairs@emergehealth.com.au

Mail: Emerge Health Suite 3, Level 1, 2 Theatre Place Canterbury VIC 3126 Australia

Should you have any questions regarding this change, please contact Emerge Health on (03) 9077 4486. In case of emergency please call – 0417 112 590.