Vaborem

RSS

meropenem / vaborbactam

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 26/07/2023

Authorisation details

Product details
Name
Vaborem
Agency product number
EMEA/H/C/004669
Active substance
  • meropenem trihydrate
  • vaborbactam
International non-proprietary name (INN) or common name
  • meropenem
  • vaborbactam
Therapeutic area (MeSH)
  • Urinary Tract Infections
  • Bacteremia
  • Bacterial Infections
  • Respiratory Tract Infections
  • Pneumonia
  • Pneumonia, Ventilator-Associated
Anatomical therapeutic chemical (ATC) code
J01DH
Publication details
Marketing-authorisation holder
Menarini International Operations Luxembourg S.A.
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
20/11/2018
Contact address

1, Avenue de la Gare
L-1611 Luxembourg
Luxembourg

Product information

24/07/2023 Vaborem - EMEA/H/C/004669 - R/0019

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Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antibacterials for systemic use

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.

Assessment history

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