Is Cilastatin + Imipenem + Relebactam 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 Cilastatin + Imipenem + Relebactam, including Recarbrio (500,500,250 mg,mg,mg, Powder for solution for infusion, SAR 15509.40).

Is Cilastatin + Imipenem + Relebactam approved by the US FDA?

Drugs@FDA lists 1 application product line for Cilastatin + Imipenem + Relebactam, including RECARBRIO (Discontinued).

Is Cilastatin + Imipenem + Relebactam authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Cilastatin + Imipenem + Relebactam: Recarbrio.

Active substances

Cilastatin + Imipenem + Relebactam

SFDA 1
US FDA 1
EMA 1
Health Canada 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Recarbrio	500,500,250 mg,mg,mg	Powder for solution for infusion · Intravenous use	25 Vial	SAR 15509.40	NCE · Prescription	Merck Sharp & Dohme B.V	Valid

Indications — CHI Daman Drug Formulary

HOSPITAL AND VENTILATER ACQUIRED PNEUMONIA; RECURRENT URINARY TRACT INFECTIONS (UTI)

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

Product	Strength	Form · route	Applicant	Status	First approved
RECARBRIO	EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL	powder · intravenous	MSD MERCK CO	Discontinued	16 Jul 2019

EMA European Union — centrally authorised medicines

Recarbrio Merck Sharp & Dohme B.V. · Authorised · authorised 13 Feb 2020 · ATC J01DH56

Therapeutic indication (EMA)

Recarbrio is indicated for:- Treatment of hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP), in adults (see sections 4.4 and 5.1).- Treatment of bacteraemia that occurs in association with, or is suspected to be associated with HAP or VAP, in adults.- Treatment of infections due to aerobic Gram-negative organisms in adults 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.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
RECARBRIO	02565323	500 MG / VIAL; 250 MG / VIAL; 500 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	MERCK CANADA INC

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.