US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| EMBLAVEO | EQ 0.5GM BASE/VIAL;1.5GM/VIAL | powder · intravenous | ABBVIE | Prescription | 7 Feb 2025 |
EMA European Union — centrally authorised medicines
Emblaveo Pfizer Europe MA EEIG · Authorised · authorised 22 Apr 2024 · ATC J01DF51
Therapeutic indication (EMA)
Emblaveo is indicated for the treatment of the following infections in adult patients (see sections 4.4 and 5.1):• Complicated intra-abdominal infection (cIAI)• Hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP) • Complicated urinary tract infection (cUTI), including pyelonephritisEmblaveo is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options (see sections 4.2, 4.4, and 5.1).Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.