Reviewer No. 2
Checklist for application of: inclusion of pancreatic enzymes
In the WHO Essential Medicines List for Children
(1) Have all important studies that you are aware of been included? Yes √ No (2) Is there adequate evidence of efficacy for the proposed use? No Yes √ (3) Is there evidence of efficacy in diverse settings and/or populations? Yes √ No (4) Are there adverse effects of concern? No Yes √ *1 (5) Are there special requirements or training needed for safe/effective use? No √ *2 Yes (6) Is this product needed to meet the majority health needs of the population? Yes √ *3 No (7) Is the proposed dosage form registered by a stringent regulatory authority? No Yes √ *4 (8) What action do you propose for the Committee to take? Inclusion in the WHO Essential Medicines List for Children under section 17 (9) Additional comment, if any. *1. ADRs are considered serious in about 25% of reported ADRs (comparative evidence on safety) *2. Special recommendations are related to the type of food and liquids taken with the product *3. The product meets the needs of patients suffering from maldigestion because of Exocrine Pancreatic insufficiency *4. In the application is stated that there is not FDA approval, but the approval was issued later, on June 18‐th, 2008. The dose recommendation has to be specified for the infants less than 6 months old (including newborns) because of the specific food (only milk) they take.