Is Avibactam + Ceftazidime pentahydrate authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Avibactam + Ceftazidime pentahydrate: Zavicefta.

Is Avibactam + Ceftazidime pentahydrate authorised in the United Kingdom?

The MHRA category lists of UK marketing authorisations include 1 product containing Avibactam + Ceftazidime pentahydrate, including ZAVICEFTA 2 G/0.5 G POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION.

Active substances

Avibactam + Ceftazidime pentahydrate

EMA 1
UK MHRA 1

Open in the medicines table

EMA European Union — centrally authorised medicines

Zavicefta Pfizer Ireland Pharmaceuticals Unlimited Company · Authorised · authorised 23 Jun 2016 · ATC J01DD52

Therapeutic indication (EMA)

Zavicefta is indicated in adults and paediatric patients aged 3 months and older for the treatment of the following infections: Complicated intra-abdominal infection (cIAI) Complicated urinary tract infection (cUTI), including pyelonephritis 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. Zavicefta is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults and paediatric patients aged 3 months and older with limited treatment options. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

UK MHRA United Kingdom — marketing authorisations

Product	Authorisation	Holder	Legal status
ZAVICEFTA 2 G/0.5 G POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION	PLGB 00057/1670	PFIZER LIMITED	POM

Components

Avibactam

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), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), 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.