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ATC codes: Pending
EMLc
Indication
Acute malnutrition in infants, children or adolescents ICD11 code: 5B52
Medicine type
Plant-derived medicine
List type
Core (EML)
(EMLc)
Formulations
Biscuit or paste of nutritional composition as determined by the UN joint statement on the community-based management of severe acute malnutrition and Codex alimentarius guidelines.
EML status history
Application rejected in 2017 (TRS 1006)
Application rejected in 2019 (TRS 1021)
Added in 2023 (TRS 1049)
Sex
All
Age
Children (1 month - 12 years)
Therapeutic alternatives
The recommendation is for this specific medicine
Patent information
Patents have expired in most jurisdictions
Summary of evidence and Expert Committee recommendations
The Expert Committee recommended the inclusion of ready-to-use therapeutic food (RUTF) on the core list of the EMLc for the treatment of severe acute malnutrition (SAM) in children aged 6 months to 5 years based on evidence from systematic reviews that demonstrated that the use of RUTF is associated with important benefits in terms of nutritional recovery and weight gain compared to standard care. The Committee was satisfied with the information provided by the applicants addressing the specific concerns highlighted by the 2019 Expert Committee regarding potential consequences of including RUTF on the Model List and associated risk-mitigation measures. The Committee was also reassured by the publication of Codex Alimentarius guidelines which define the nutritional composition, production and labelling standards for RUTF as a food for special medical purposes.