Approval status and evidence for WHO essential medicines for children in the United States, United Kingdom, and Japan: a cross-sectional study

Table 8 Essential medicines for children unapproved in the US, UK, and Japan without supporting evidence either in adults or children

Name	ATC^a	Therapeutic use	Adult efficacy^b	Paediatric efficacy^b	Dosage Form^c
Paromomycin	A	Leishmaniasis	No evidence	No evidence	NA
Linezolid	J	Tuberculosis	No evidence	No evidence	A
Morphine	N	Sedation^d	No evidence	No evidence	A
Amodiaquine	P	Malaria	No evidence	No evidence	NA
Artemether	P	Malaria	Inconclusive	Inconclusive	NA
Nifurtimox	P	African trypanosomiasis	Inconclusive	No evidence	NA
Nifurtimox	P	American trypanosomiasis	Inconclusive	No evidence	NA
Levamisole	P	Helminth infection	Inconclusive	No evidence	NA
Benzyl benzoate	P	Scabies	No evidence	No evidence	NA

^aAnatomical Therapeutic Chemical (ATC) classification code: A, alimentary tract and metabolism; J, general anti-infectives for systemic use; N, nervous system; P, antiparasitic products
^bAdult or paediatric efficacy: Inconclusive, evidence is inconclusive
^cDosage Form: A, available; NA, not available
^dMorphine is listed in the EMLc as the drug of choice for the treatment of severe acute or chronic pain, which was acknowledged as approved in the three countries. However, efficacy of morphine for sedation has not been established or approved in any of the three countries. That is why the listing of morphine indicated to sedation as unapproved

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