Active-ingredient Dossier
Ursodeoxycholic Acid
Active-ingredient Dossier for Ursodeoxycholic Acid (bile acid). Australian brands, products, PBS listings, PBAC outcomes — compiled by arcimedes.
- Brand: URSODOX
- Brand: URSOFALK
- Brand: APO-URSODEOXYCHOLIC
- Brand: ARX-URSODEOXYCHOLIC
- Brand: URSO
- Brand: URSOSAN
- Therapeutic area: Hepatology
- Therapeutic area: Gastroenterology
What is
Ursodeoxycholic Acid Ursodeoxycholic Acid is a bile acid used in registered therapeutic products.
Australian brands containing
Ursodeoxycholic Acid — URSODOX — URSOFALK — APO-URSODEOXYCHOLIC — ARX-URSODEOXYCHOLIC — URSO — URSOSAN
Therapeutic areas
Ursodeoxycholic Acid is registered in gastroenterology, with 10 brands containing this ingredient on the ARTG.
Sponsor landscape
Seven sponsors market ursodeoxycholic acid in Australia: Arrotex Pharmaceuticals, Medreich, Dr Falk Pharma, Viatris, GM Pharma, Generic Health, and other manufacturers.
PBS and regulatory activity
Two brands containing ursodeoxycholic acid have PBS-listed items, with the latest PBS schedule date of 1 May 2026. The latest PBAC outcome was recorded on 1 March 2023, with one brand holding a PBAC outcome on record and no AusPARs issued.