Is Ceftolozane + Tazobactam registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Ceftolozane + Tazobactam, including ZERBAXA Powder For Injection Vial (0.5,1 g,g, Powder for injection, SAR 3282.10).

Is Ceftolozane + Tazobactam approved by the US FDA?

Drugs@FDA lists 1 application product line for Ceftolozane + Tazobactam, including ZERBAXA (Prescription).

Is Ceftolozane + Tazobactam authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Ceftolozane + Tazobactam: Zerbaxa.

Is Ceftolozane + Tazobactam on the WHO Model List of Essential Medicines?

Yes — 6.2.3. Reserve group antibiotics (complementary list): Carbapenem-resistant Pseudomonas aeruginosa.

Active substances

Ceftolozane + Tazobactam

SFDA 1
US FDA 1
EMA 1
Health Canada 1
WHO EML 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ZERBAXA Powder For Injection Vial	0.5,1 g,g	Powder for injection · Intravenous use	10 Vial	SAR 3282.10	NCE · Prescription	MERCK SHARP & DOHME	Valid

Indications — CHI Daman Drug Formulary

ACUTE PYELONEPHRITIS; HOSPITAL AND VENTILATER ACQUIRED PNEUMONIA; INTRA-ABDOMINAL INFECTIONS

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	powder · intravenous	CUBIST PHARMS LLC	Prescription	19 Dec 2014

EMA European Union — centrally authorised medicines

Zerbaxa Merck Sharp & Dohme B.V. · Authorised · authorised 18 Sep 2015 · ATC J01DI54

Therapeutic indication (EMA)

Zerbaxa is indicated for the treatment of the following infections in adults: Complicated intra abdominal infections; Acute pyelonephritis; Complicated urinary tract infections; Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP). Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ZERBAXA	02446901	0.5 G / VIAL; 1 G / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	MERCK CANADA INC

WHO WHO Model List of Essential Medicines (2025)

6.2.3. Reserve group antibiotics · complementary
Carbapenem-resistant Pseudomonas aeruginosa
Parenteral > General injections > IV: 1 g + 0.5 g powder for injection

Components

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.