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Posted 17-Oct-2018

OCALIVA obeticholic acid tablets (5 mg and 10 mg) are now TGA Registered Products


On the 21 September 2018, OCALIVA was granted approval by the Therapeutic Good Administration (TGA) as a Schedule 4 Prescription Medicine. 

OCALIVA is indicated for the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.

OCALIVA has been developed by our partners INTERCEPT PHARMA and is approved within the European Union and United States. The addition of the Australian approval strengthens physicians’ ability to effectively treat this rare liver disease.

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

It is expected that TGA-approved Australian stock in Emerge Health livery will become available in Q1 2019.

All orders, medical and product enquiries and adverse event reports concerning OCALIVA should be directed to Emerge Health on:

Direct: (03) 9077 4486
Fax: (03) 8672 0792 
E-mail: customerservice@emergehealth.com.au
Mail: Emerge Health
Suite 3, 22 Gillman Street
Hawthorn East VIC 3123 Australia

Feel free to contact us if you require any further information regarding OCALIVA.