ATC codes: J04AK01
Tuberculosis ICD11 code: 1B4Z
Medicine type
Chemical agent
List type
Core WHO recommends and endorses the use of fixed-dose combinations and the development of appropriate new fixed-dose combinations, including modified dosage forms, non-refrigerated products and paediatric dosage forms of assured pharmaceutical quality.
Oral > Liquid: 30 mg per mL (EMLc)
Oral > Solid: 400 mg tablet ; 150 mg tablet (dispersible) ; 150 mg tablet (scored)
EML status history
First added in 1982 (TRS 685)
Changed in 1997 (TRS 882)
Changed in 2007 (TRS 946)
Changed in 2007 (TRS 950)
Also recommended for children
Therapeutic alternatives
The recommendation is for this specific medicine
Patent information
Patents have expired in most jurisdictions
Summary of evidence and Expert Committee recommendations
There are no international data publicly available that describe the prevalence and incidence of TB in children under 15 years of age, and few clinical trials of treatment on children. However, TB is accepted as a public health priority and therefore treatment of it fulfi ls the criteria for essential medicines. All four medicines used in standard treatment are licensed for use in children. The EMLc Subcommittee endorsed all four and noted that an oral liquid form of all of them was available. The Subcommittee recommended that all of these single agents be added to the List (ethambutol 25 mg/ml, isoniazid 50 mg/5 ml, pyrazinamide 30 mg/ml, rifampicin 20 mg/ml).