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ATC codes: J04AM05
EMLc
Indication
Tuberculosis ICD11 code: 1B4Z
INN
Isoniazid + pyrazinamide + rifampicin
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.
Formulations
Oral > Solid: 50 mg + 150 mg + 75 mg tablet (dispersible) (EMLc) ; 75 mg + 400 mg + 150 mg tablet (EML)
EML status history
First added in 1997 (TRS 882)
Changed in 2007 (TRS 950)
Changed in 2009 (TRS 958)
Changed in 2017 (TRS 1006)
Changed in 2019 (TRS 1021)
Sex
All
Age
Also recommended for children
Therapeutic equivalence
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 deletion of the 150 mg + 500 mg + 150 mg formulation of isoniazid + pyrazinamide + rifampicin for intermittent use three times weekly from the core list of the EML, noting the advice of the WHO Global TB Programme that its use is no longer recommended in current WHO guidelines based on evidence that patients who received three times weekly dosing had a higher risk of treatment failure, disease relapse and acquired drug resistance compared with patients who received daily dosing (1). References: 1. Guidelines for treatment of drug-susceptible tuberculosis and patient care, 2017 update. Geneva: World Health Organization; 2017.