Drug guidance
Ursodeoxycholic acid for treating primary biliary cirrhosis
Condition
Liver
1 September 2020
Published on 02 May 2019
Last Updated on 01 Sep 2020
Guidance Recommendations
The Ministry of Health's Drug Advisory Committee has recommended:
Ursodeoxycholic acid 250 mg capsule, 500 mg tablet and 50 mg/ml suspension for treating primary biliary cirrhosis in patients without decompensated hepatic cirrhosis.
Subsidy status
Ursodeoxycholic acid 250 mg capsule, 500 mg tablet and 50 mg/ml suspension are recommended for inclusion on the MOH Standard Drug List (SDL).
Ursodeoxycholic acid 50 mg/ml suspension does not have regulatory approval with the Health Sciences Authority (HSA). The responsibility of prescribing an unregistered product to patients lies with the treating clinician. Before treatment is started, it is important to consider the availability of other suitable registered alternatives and inform the patient or their carer that the product is unregistered.
Ursodeoxycholic acid for treating primary biliary cirrhosis (updated 1 Sept 2020) [PDF, 162 KB]
Ursodeoxycholic acid for treating primary biliary cirrhosis PES (updated 1 Sept 2020) [PDF, 109 KB]