Vaborem
meropenem / vaborbactam
Table of contents
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.
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List item
Vabomere : EPAR - Medicine overview (PDF/75.82 KB)
First published: 18/12/2018
EMA/657766/2018 -
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List item
Vabomere : EPAR - Risk-management-plan summary (PDF/70.58 KB)
First published: 18/12/2018
Authorisation details
Product details | |
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Name |
Vaborem
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Agency product number |
EMEA/H/C/004669
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Active substance |
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International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
J01DH
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Publication details | |
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Marketing-authorisation holder |
Menarini International Operations Luxembourg S.A.
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Revision |
7
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Date of issue of marketing authorisation valid throughout the European Union |
20/11/2018
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Contact address |
1, Avenue de la Gare |
Product information
24/07/2023 Vaborem - EMEA/H/C/004669 - R/0019
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.