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EMA Product

Vaborem

Product approved by European Medicines Agency (EU)

Basic Information

Vaborem

Regulatory Information

EMEA/H/C/004669

Authorised

November 20, 2018

September 20, 2018

8

July 25, 2024

Company Information

Luxembourg

1, Avenue de la Gare L-1611 Luxembourg

MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.

Active Substances Detail

meropenem trihydratevaborbactam

meropenem trihydrate

Detailed Information

Therapeutic Indication

### Therapeutic indication Vaborem is indicated for the treatment of the following infections in adults: - Complicated urinary tract infection (cUTI), including pyelonephritis - Complicated intra-abdominal infection (cIAI) - Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP). Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Vaborem is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Overview Summary

Vaborem (previosly Vabomere) is an antibiotic used in adults to treat the following infections, including when they have spread into the blood (bacteraemia): - complicated (difficult-to-treat) infections of the urinary tract, including kidneys; - complicated abdominal infections of the tissues and organs in the belly (intra-abdominal infections); - lung infections caught in hospital (hospital-acquired pneumonia), including ventilator-associated pneumonia (pneumonia caught from a ventilator, which is a machine that helps a patient to breathe). It can also be used for infections caused by Gram-negative bacteria when other treatments might not work. Vaborem contains the active substances meropenem and vaborbactam.

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