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ATC codes: J04AA01
EMLc
Indication
Multi-drug resistant Mycobacterium tuberculosis ICD11 code: ML32.00
Medicine type
Chemical agent
List type
Complementary (EML)
(EMLc)
Additional notes
Medicines for the treatment of multidrug-resistant tuberculosis (MDR-TB) should be used in specialized centres adhering to WHO standards for TB contol.
Formulations
Oral > Solid: 4 g granules in sachet
EML status history
First added in 1999 (TRS 895)
Changed in 2007 (TRS 950)
Changed in 2019 (TRS 1021)
Changed in 2021 (TRS 1035)
Removed in 2023 (TRS 1049)
Sex
All
Age
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
The Committee recommended deletion from the EML and/or EMLc of various formulations and strengths of amikacin (injection: 100 mg/2 mL (as sulfate) in 2 mL vial), ethambutol (Oral liquid: 25 mg/mL), ethionamide (tablet: 125 mg), isoniazid (oral liquid: 50 mg/5 mL), linezolid (powder for oral liquid: 100 mg/5 mL), p-aminosalicylic acid (granules: 4 g in sachet) and pyrazinamide (oral liquid: 30 mg/mL), noting that they are not optimal formulations and strengths for tuberculosis treatment. A new formulation of p-aminosalicylic acid (as p-aminosalicylate sodium) was recommended for inclusion to replace the previously listed one which has been discontinued by the only manufacturer.