Is Meropenem + Vaborbactam 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 Meropenem + Vaborbactam, including Vabomere (1,1 g,g, Powder for concentrate for solution for infusion, SAR 1881.30).

Is Meropenem + Vaborbactam approved by the US FDA?

Drugs@FDA lists 1 application product line for Meropenem + Vaborbactam, including VABOMERE (Prescription).

Is Meropenem + Vaborbactam authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Meropenem + Vaborbactam: Vaborem.

Is Meropenem + Vaborbactam on the WHO Model List of Essential Medicines?

Yes — 6.2.3. Reserve group antibiotics (complementary list): Carbapenem-resistant Pseudomonas aeruginosa; Carbapenem resistant Acinetobacter baumannii; Other carbapenem resistant Enterobacterales; Carbapenem resistant Klebsiella pneumoniae; Carbapenem resistant Escherichia coli.

Active substances

Meropenem + Vaborbactam

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
Vabomere	1,1 g,g	Powder for concentrate for solution for infusion · Intravenous use	6 Vial	SAR 1881.30	NCE · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid

Indications — CHI Daman Drug Formulary

HOSPITAL AND VENTILATER ACQUIRED PNEUMONIA

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

Product	Strength	Form · route	Applicant	Status	First approved
VABOMERE	1GM/VIAL;1GM/VIAL	powder · intravenous	REMPEX	Prescription	29 Aug 2017

EMA European Union — centrally authorised medicines

Vaborem Menarini International Operations Luxembourg S.A. · Authorised · authorised 20 Nov 2018 · ATC J01DH

Therapeutic indication (EMA)

Vaborem is indicated for the treatment of the following infections in adults: Complicated urinary tract infection (cUTI), including pyelonephritis Complicated intra-abdominal infection (cIAI) 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. Vaborem is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options. 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
VABOMERE	02554151	1 G / VIAL; 1 G / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	XEDITON PHARMACEUTICALS INC

WHO WHO Model List of Essential Medicines (2025)

6.2.3. Reserve group antibiotics · complementary
Carbapenem-resistant Pseudomonas aeruginosa; Carbapenem resistant Acinetobacter baumannii; Other carbapenem resistant Enterobacterales; Carbapenem resistant Klebsiella pneumoniae; Carbapenem resistant Escherichia coli
Parenteral > General injections > IV: 1 g in vial + 1 g in vial 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.