ATC codes: J04AC01
Tuberculosis ICD11 code: 1B4Z
Medicine type
Chemical agent
List type
Additional notes
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: 50 mg per 5 mL (EMLc)
Oral > Solid: 100 mg tablet ; 100 mg tablet (dispersible) (EMLc) ; 300 mg tablet
EML status history
First added in 1977 (TRS 615)
Changed in 1979 (TRS 641)
Changed in 2007 (TRS 946)
Changed in 2007 (TRS 950)
Changed in 2019 (TRS 1021)
Changed in 2021
Also recommended for children
Therapeutic alternatives
The recommendation is for this specific medicine
Patent information
Patents have expired in most jurisdictions
Expert Committee recommendation
The Expert Committee recommended the deletion of isoniazid 50 mg tablet (scored) from the EML and EMLc as requested in the application, noting that it is not an optimal, appropriate formulation for the treatment of tuberculosis, in line with recommendations in the current WHO tuberculosis treatment guidelines. The Committee recognized that dispersible tablet formulations are the preferred child-friendly formulations and provide flexible dosing options. However, because of concerns about limited uptake and availability of dispersible-tablet formulations of isoniazid in some countries, the Committee did not recommend the deletion of the oral liquid formulation isoniazid at this time. To allow countries time to transition to the adoption of the preferred, listed dispersible-tablet formulations, the Committee advised that this formulations will be deleted from the Model Lists without further consideration in 2023, unless an application is received to support its retention.