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ATC codes: J01DI54
EMLc
Indication
Carbapenem-resistant Pseudomonas aeruginosa ICD11 code: MG50.80
INN
Ceftolozane + tazobactam
Medicine type
Chemical agent
Antibiotic groups
List type
Complementary
Formulations
Parenteral > General injections > IV: 1 g + 0.5 g powder for injection
EML status history
Application rejected in 2019 (TRS 1021)
Added in 2023 (TRS 1049)
Sex
All
Age
Also recommended for children
Therapeutic alternatives
The recommendation is for this specific medicine
Patent information
Main patent is active in several jurisdictions. For more information on specific patents and license status for developing countries visit www.MedsPal.org
Summary of evidence and Expert Committee recommendations
The Expert Committee recommended the inclusion of ceftolozane + tazobactam as Reserve group antibiotic on the complementary list of the EML and EMLc for the treatment of infections caused or suspected to be caused by carbapenem-resistant Pseudomonas aeruginosa, a “Critical” priority pathogen on the 2017 WHO Priority Pathogens List. The Committee acknowledged that the clinical evidence for efficacy of ceftolozane + tazobactam against this specific pathogen is limited but considered that the availability of carbapenem-sparing alternatives for treatment of drug-resistant Pseudomonas aeruginosa was important as part of the strategy to limit/prevent further emergence and spread of carbapenem-resistant organisms.