Defined Organism Substance - Pancrelipase
NHPID name:
Pancrelipase
Reference:
Proper name(s):
Common name(s):
Category:
Approved Biological Substance Name
Monograph(s):
Schedule 1:
Source material(s):
- Bos taurus ( Parts: Pancreas )
- Sus scrofa ( Parts: Pancreas )
Preparations:
Additional details:
Detail:
The only acceptable pharmaceutical dosage forms are delayed-release capsules, tablets, or granules (e.g. enteric-coated tablets, capsules containing enteric-coated granules/(mini)microspheres). The dosage form must be qualified with an additional term to describe the delayed release (e.g. enteric-coated capsules, gastro-resistant tablets, microencapsulated pancreatic enzymes) (WHO 2011).
Roles
Medicinal
Rationale:
Classified as an NHP under Schedule 1, item 2 (an extract) of the Natural Health Products Regulations.
Reference: NNHPDRestrictions:
General:
Upper limit:
20000.0
Units:
Detail:
The maximum dose of pancrelipase, in terms of lipase activity, is 20 000 USP units per dosage unit.
Reference:
Non-NHP
Rationale:
A non-NHP when the product is captured by the Prescription Drug List: When sold in a dosage form that provides more than 20 000 USP units of lipase activity per dosage unit or indicated for the treatment of pancreatic exocrine insufficiency.
Reference: NNHPD