Is Cefepime + Enmetazobactam 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 Cefepime + Enmetazobactam, including Exblifep (2,0.5 g,g, Powder for concentrate for solution for infusion, SAR 6190.60).

Is Cefepime + Enmetazobactam approved by the US FDA?

Drugs@FDA lists 1 application product line for Cefepime + Enmetazobactam, including EXBLIFEP (Discontinued).

Is Cefepime + Enmetazobactam authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Cefepime + Enmetazobactam: Exblifep.

Active substances

Cefepime + Enmetazobactam

SFDA 1
US FDA 1
EMA 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Exblifep	2,0.5 g,g	Powder for concentrate for solution for infusion · Intravenous use	10 Vial	SAR 6190.60	NCE · Prescription	Acino AG	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
EXBLIFEP	EQ 2GM BASE/VIAL;0.5GM/VIAL	powder · intravenous	ORCHID PHARMA	Discontinued	22 Feb 2024

EMA European Union — centrally authorised medicines

Exblifep Advanz Pharma Limited · Authorised · authorised 21 Mar 2024 · ATC J01DE51

Therapeutic indication (EMA)

Exblifep is indicated for the treatment of the following infections in adults (see sections 4.4 and 5.1): - Complicated urinary tract infections (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. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Components

Cefepime

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.