Monograph: Lactase

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient. Notes: (i) Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion. (ii) The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant.
Date: 2019-04-29

NHPID name

Lactase ( Enzyme Nomenclature )

Proper name(s)

Common name(s)

Source material

Aspergillus flavus var. oryzae - Whole (CABI 2012, Bisby et al. 2010)

Route Of administration


Dosage form(s)

Use(s) or purpose(s)

Statement(s) to the effect of:




1 Day per day

Directions for use: Take with or immediately before a meal/food.

Duration of use

Digestive aid: Consult a health care practitioner/health care provider/health care professional/doctor/physician for prolonged use.

Risk information

Statement(s) to the effect of:

Caution(s) and Warning(s): Contraindication(s): No statement is required Known Adverse Reaction(s): Stop use if gastro-intestinal disturbance and/or hypersensitivity/allergy occur.  (Health Canada 2011)

Non-medicinal ingredients

Must be chosen from the current Natural health products ingredients database and must meet the limitations outlined in the database.


References cited