Australian Approved Name (AAN): Tilactase
Common name/s and synonyms: Tilactase derived from Aspergillus oryzae; Beta-Galactosidase; Lactase; Beta-D-Galactosidase; Beta-D-Galactoside
Warnings and Restrictions: Must be derived from Aspergillus oryzae and comply with the relevant USP monograph.
When the dosage form is undivided, the units ‘acid lactase units per gram’ and ‘Thousand acid lactase units per gram’ are permitted. When the dosage form is divided, the units ‘acid lactase units’ and ‘thousand acid lactase units’ are permitted.
Allowable purpose of the ingredient: Active
TGA reference: International Non-Proprietary Name