Regulatory PathRegulatory requirements compared

Active substance

Ertapenem

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Eranza1000 mgPowder for concentrate for solution for infusion · Intravenous use10 VialSAR 1191.85Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
INVANZ 1 gm Powder for Concentrate for Solution for Infusion1 gPowder for concentrate for solution for infusion · Intravenous use1 VialSAR 133.65NCE · PrescriptionMERCK SHARP & DOHME LIMITEDValid
Indications — CHI Daman Drug Formulary

Pyogenic Arthritis

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

ProductStrengthForm · routeApplicantStatusFirst approved
INVANZEQ 1GM BASE/VIALinjectable · intramuscular, intravenousMSD SUB MERCKPrescription21 Nov 2001
ERTAPENEM SODIUMEQ 1GM BASE/VIALinjectable · intramuscular, intravenousACS DOBFAR SPAPrescription16 Apr 2018
ERTAPENEM SODIUMEQ 1GM BASE/VIALinjectable · intramuscular, intravenousEUGIA PHARMAPrescription25 Jun 2018
ERTAPENEM SODIUMEQ 1GM BASE/VIALinjectable · intramuscular, intravenousSAVIOR LIFETEC CORPPrescription19 Mar 2019
ERTAPENEM SODIUMEQ 1GM BASE/VIALinjectable · intramuscular, intravenousGLANDPrescription26 Mar 2021
ERTAPENEM SODIUMEQ 1GM BASE/VIALinjectable · intramuscular, intravenousQILU ANTIBIOTICSPrescription31 Oct 2024
ERTAPENEM SODIUMEQ 1GM BASE/VIALinjectable · intramuscular, intravenousSUN PHARMDiscontinued2 May 2023

EMA European Union — centrally authorised medicines

Invanz Merck Sharp & Dohme B.V. · Authorised · authorised 18 Apr 2002 · ATC J01DH03

Therapeutic indication (EMA)

Treatment Treatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required: intra-abdominal infections; community-acquired pneumonia; acute gynaecological infections; diabetic foot infections of the skin and soft tissue. Prevention Invanz is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Ertapenem SUN SUN Pharmaceutical Industries (Europe) B.V. · Authorised · authorised 15 Jul 2022

Therapeutic indication (EMA)

Treatment Ertapenem SUN is indicated in paediatric patients (3 months to 17 years of age) and in adults for the treatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required (see sections 4.4 and 5.1): Intra-abdominal infections Community acquired pneumonia Acute gynaecological infections Diabetic foot infections of the skin and soft tissue (see section 4.4) Prevention Ertapenem SUN is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery (see section 4.4). Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Ertapenem Hospira Hospira UK Limited · Application withdrawn · ATC J01DH03

Therapeutic indication (EMA)

Treatment of bacterial infections and prophylaxis of surgical site infection following elective colorectal surgery.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ERTAPENEM FOR INJECTION024907731 G / VIALPOWDER FOR SOLUTION · INTRAMUSCULAR; INTRAVENOUSJUNO PHARMA CANADA INC.
ERTAPENEM FOR INJECTION024921481 G / VIALPOWDER FOR SOLUTION · INTRAMUSCULAR; INTRAVENOUSAURO PHARMA INC
ERTAPENEM FOR INJECTION024961271 G / VIALPOWDER FOR SOLUTION · INTRAVENOUS; INTRAMUSCULARFRESENIUS KABI CANADA LTD
ERTAPENEM FOR INJECTION025111501 G / VIALPOWDER FOR SOLUTION · INTRAVENOUS; INTRAMUSCULARDR REDDY'S LABORATORIES LTD
ERTAPENEM FOR INJECTION025371761 G / VIALPOWDER FOR SOLUTION · INTRAVENOUS; INTRAMUSCULAREUGIA PHARMA INC.
INVANZ022474371 G / VIALPOWDER FOR SOLUTION · INTRAVENOUS; INTRAMUSCULARMERCK CANADA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACERTAPENEM 1 GRAM VIAL$26.62948per EA23 Sep 2026
US NADACERTAPENEM 1 GRAM VIAL$47.2056per EA23 Sep 2026
NHS Drug TariffErtapenem 1g powder for solution for infusion vials£31.651 vial1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

All safety entries for ertapenem →

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.