Is Ceftaroline fosamil 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 Ceftaroline fosamil, including ZINFORO 600 MG I.V. VIAL (600 mg, Powder for concentrate for solution for infusion, SAR 1897.60).

Is Ceftaroline fosamil approved by the US FDA?

Drugs@FDA lists 2 application product lines for Ceftaroline fosamil, including TEFLARO (Prescription); CEFTAROLINE FOSAMIL (Prescription).

Is Ceftaroline fosamil authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Ceftaroline fosamil: Zinforo.

Are there safety signals or safety updates for Ceftaroline fosamil?

US FDA: 1 entry (latest 2020-11-27).

Active substance

Ceftaroline fosamil

SFDA 1
US FDA 2
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
ZINFORO 600 MG I.V. VIAL	600 mg	Powder for concentrate for solution for infusion · Intravenous use	10 Vial	SAR 1897.60	NCE · Prescription	PFIZER	Valid

Indications — CHI Daman Drug Formulary

BACTERIAL SKIN INFECTIONS - PURULENT SKIN AND SOFT TISSUE INFECTIONS (CUTANEOUS ABSCESSES, FURUNCLES, CARBUNCLES); BACTERIAL SKIN INFECTIONS - SURGICAL SITE INFECTIONS; COMMUNITY ACQUIRED PNEUMONEA; HOSPITAL AND VENTILATER ACQUIRED PNEUMONIA; OSTEOMYELITIS

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

Product	Strength	Form · route	Applicant	Status	First approved
TEFLARO	400MG/VIAL; 600MG/VIAL	powder · intravenous	ABBVIE	Prescription	29 Oct 2010
CEFTAROLINE FOSAMIL	400MG/VIAL; 600MG/VIAL	powder · intravenous	APOTEX	Prescription	21 Sep 2021

EMA European Union — centrally authorised medicines

Zinforo Pfizer Ireland Pharmaceuticals · Authorised · authorised 22 Aug 2012 · ATC J01DI02

Therapeutic indication (EMA)

Zinforo is indicated for the treatment of the following infections in neonates, infants, children, adolescents and adults: Complicated skin and soft tissue infections (cSSTI) Community-acquired pneumonia (CAP) Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Safety signals and safety-related labeling changes

US FDA 27 Nov 2020 TEFLARO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for ceftaroline fosamil →

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.