Summary of evidence and Expert Committee recommendations
The Committee considered whether to list on the EMLc enalapril or captopril as an indicative angiotensin-converting enzyme inhibitor, with a square box. There is slightly more evidence for efficacy and safety for enalapril and it is licensed by at least one stringent regulatory authority for use in children.
The Committee noted that the European Medicines Agency (EMEA) may have further information available about this topic in the future and suggested that WHO continue to collaborate with the Agency as data become available.
On balance, noting that a flexible oral solid dosage form would be desirable, the Committee recommended the inclusion of enalapril in the EMLc for the treatment of hypertension in children, with the addition of the square box symbol.
A 5mg strength formulation was added to the EML and EMLc for enalapril.