Pfizer Inc. (PFE) Monday announced that the European Commission has granted marketing authorization for Emblaveo for the treatment of adult patients impacted by serious infectious diseases.
The authorization is for complicated intra-abdominal infections, hospital-acquired pneumonia, and complicated urinary tract infections, including pyelonephritis. This approval is based on results from the previously reported Phase 3 program comprising the REVISIT and ASSEMBLE studies.
The company said Emblaveo is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options.
The marketing authorization of Emblaveo is valid in all 27 European Union member states, as well as in Iceland, Liechtenstein, and Norway.
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