Vabomere

RSS

meropenem / vaborbactam

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

Overview

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.

Vabomere contains the active substances meropenem and vaborbactam.

This EPAR was last updated on 14/03/2019

Authorisation details

Product details
Name
Vabomere
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
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Menarini International Operations Luxembourg S.A.
Revision
1
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

20/02/2019 Vabomere - EMEA/H/C/004669 - T/0001

Contents

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Pharmacotherapeutic group

Antibacterials for systemic use

Therapeutic indication

Vabomere 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.

Vabomere 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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