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Vaborem (meropenem;vaborbactam)

Region

🇪🇺 EU

Active substance

meropenem;vaborbactam

Company

Menarini International Operations Luxembourg S.A.

Status

Authorised

Therapeutic area

Urinary Tract Infections; Bacteremia; Bacterial Infections; Respiratory Tract Infections; Pneumonia; Pneumonia, Ventilator-Associated

CHMP opinion

Thu 20 Sep 2018

EU approval

Tue 20 Nov 2018

Application

EMEA/H/C/004669

ATC

J01DH

Official record

www.ema.europa.eu

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.

Regulatory milestones

No milestones recorded in the last year.

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.