Codes ATC: J04AM06
Tuberculosis Code ICD11: 1B4Z
Ethambutol + isoniazid + pyrazinamide + rifampicin
Type de médicament
Chemical agent
Type de liste
Liste de base
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 > Solid: 275 mg + 75 mg + 400 mg + 150 mg tablet
Historique des statuts LME
Ajouté pour la première fois en 1999 (TRS 895)
Modifié en 2007 (TRS 950)
Adolescents et adultes
Équivalence thérapeutique
La recommandation concerne ce médicament spécifique
Renseignements sur le brevet
Patents have expired in most jurisdictions
Lire la suite sur les brevets.
Résumé des preuves et recommandation du comité d'experts
The EMLc Subcommittee did not endorse the inclusion of this fixed-dose combination for the treatment of tuberculosis on the EMLc. The various fixed-dose combinations were considered as a group, as there is no clinical evidence for any of these combinations in children. However, it is difficult to determine the necessary appropriate combinations and what the strengths of the components should be in FDCs for use in children without examining further data (including pharmacokinetic data, stratified by weight and age). The Subcommittee therefore decided to endorse the lower strength rifampicin + isoniazid combinations (60 mg + 30 mg and 60 mg + 60 mg) and rifampicin + isoniazid + pyrazinamide (60 mg + 30 mg + 150 mg) as probably useful for many children, but requested an urgent review of all clinical evidence to support these and other potential combinations.