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The Expert Committee, after evaluation, declines to list the medicine proposed in the application.
The Model List of Essential Medicines reports reasons that Committee Members have identified for denying listing.
Rejected
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Rejected
ATC codes: J01DH56
EMLc
Indication
Other specified other antibiotic resistant Enterobacterales ICD11 code: MG50.CY
INN
Imipenem + cilastatin + relebactam
Medicine type
Chemical agent
Antibiotic groups
List type
Complementary (EML)
(EMLc)
Formulations
Parenteral > General injections > IV: 500 mg + 500 mg + 250 mg powder for injection
EML status history
Application rejected 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 Committee did not recommend inclusion of imipenem + cilastatin + relebactam (IMR) as a Reserve group antibiotic on the complementary list of the EML and EMLc for the treatment of infections caused by multidrug-resistant organisms. The Committee noted that IMR lacks in vitro activity against the carbapenemase genotypes most commonly associated globally with carbapenem resistance in Enterobacterales and that other antibiotics with similar spectrum of activity (e.g. cefiderocol, ceftazidime + avibactam, meropenem + vaborbactam) are already included as Reserve antibiotics on the Model Lists.