Is Doripenem registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Doripenem.

Is Doripenem approved by the US FDA?

Drugs@FDA lists 1 application product line for Doripenem, including DORIBAX (Discontinued).

Is Doripenem authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Doripenem.

Are there safety signals or safety updates for Doripenem?

MHRA: 1 entry (latest 2014-12-11).

Active substance

Doripenem

SFDA 1
US FDA 1
EMA 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
DORIBAX 500MG/VIAL POWDER FOR INFUSION	500 mg	Powder for solution for infusion · Intravenous use	10 Vial	SAR 968.30	NCE · Prescription	JANSSEN-CILAG	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
DORIBAX	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · intravenous	SHIONOGI	Discontinued	12 Oct 2007

EMA European Union — centrally authorised medicines

Doribax Janssen-Cilag International NV · Withdrawn · authorised 25 Jul 2008 · ATC J01DH04

Therapeutic indication (EMA)

Doribax is indicated for the treatment of the following infections in adults: nosocomial pneumonia (including ventilator-associated pneumonia); complicated intra-abdominal infections; complicated urinary tract infections. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Safety signals and safety-related labeling changes

MHRA 11 Dec 2014 Doripenem (Doribax▼): updated dosing recommendations
Previous dosing regimens for doripenem in such patients found to be insufficient.

All safety entries for doripenem →

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.