Reviewer No. 1
Checklist for application of: Pancreatic enzymes (inclusion)
In the WHO Essential Medicines List for Children
(1) Have all important studies that you are aware of been included? Yes √ (2) Is there adequate evidence of efficacy for the proposed use? Yes √ (3) Is there evidence of efficacy in diverse settings and/or populations? Yes √ (4) Are there adverse effects of concern? Yes √ (5) Are there special requirements or training needed for safe/effective use? No √ (6) Is this product needed to meet the majority health needs of the population? Yes √ (important therapy for patients suffering from exocrine pancreatic insufficiency) (7) Is the proposed dosage form registered by a stringent regulatory authority? Yes √ (8) What action do you propose for the Committee to take? Inclusion in the WHO Essential Medicines List for Children. (9) Additional comment, if any. The dose requirements for infants, especially those below 6 months of age need to be specified because their diet is predominantly milk based (ideally for infants below 6 months of age, exclusive breast‐feeding is recommended). Special instructions are required for the type of foods and liquids that can be consumed with the product. About a quarter of the reported ADRs may be serious.