Is Cetuximab registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Cetuximab, including Erbitux 100 mg per 20 ml (5 mg/ml, Solution for infusion, SAR 1089.00); Erbitux 500 mg per 100 ml (5 mg/ml, Solution for infusion, SAR 5445.00).

Is Cetuximab approved by the US FDA?

Drugs@FDA lists 1 application product line for Cetuximab, including ERBITUX (Prescription).

Is Cetuximab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Cetuximab: Erbitux.

Are there safety signals or safety updates for Cetuximab?

EMA PRAC: 4 entries; US FDA: 1 entry; MHRA: 1 entry (latest 2022-12-01).

Active substance

Cetuximab

SFDA 2
US FDA 1
EMA 1
Health Canada 1
Safety 6

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Erbitux 100 mg per 20 ml	5 mg/ml	Solution for infusion · Intravenous use	1 Bottle	SAR 1089.00	Biological · Prescription	Merck Europe BV	Valid
Erbitux 500 mg per 100 ml	5 mg/ml	Solution for infusion · Intravenous use	1 Bottle	SAR 5445.00	Biological · Prescription	Merck Europe BV	Valid

Indications — CHI Daman Drug Formulary

COLORECTAL CANCER-ADVANCED/ METASTATIC; HEAD AND NECK CANCER

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

Product	Strength	Form · route	Applicant	Status	First approved
ERBITUX	100mg/VIAL	vial · intravenous	IMCLONE	Prescription	12 Feb 2004

EMA European Union — centrally authorised medicines

Erbitux Merck Europe B.V. · Authorised · authorised 29 Jun 2004 · ATC L01FE01

Therapeutic indication (EMA)

Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer: in combination with irinotecan-based chemotherapy; in first-line in combination with FOLFOX; as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan. For details, see section 5.1. Erbitux is indicated for the treatment of adult patients with BRAF V600E mutant metastatic colorectal cancer: in combination with encorafenib and FOLFOX for the first line treatment; in combination with encorafenib in patients who have received prior systemic therapy. For details, see section 5.1, for biomarker-based patient selection, see section 4.2. Erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck: in combination with radiation therapy for locally advanced disease; in combination with platinum-based chemotherapy for recurrent and/or metastatic disease.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ERBITUX	02271249	2 MG / ML	SOLUTION · INTRAVENOUS	IMCLONE, LLC

Safety signals and safety-related labeling changes

EMA PRAC 1 Dec 2022 PRAC signal: Nephrotic syndrome
Action for MAH: update of the product information: No
EMA PRAC 7 Jul 2022 PRAC signal: Nephrotic syndrome
Action for MAH: update of the product information: No
US FDA 24 Sep 2021 ERBITUX — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
MHRA 11 Dec 2014 Cetuximab: new safety information available
importance of establishing wild type RAS (KRAS and NRAS) status before treatment of metastatic colorectal cancer
EMA PRAC 6 Feb 2014 PRAC signal: Increased fatal adverse events in patients with advanced solid tumours – publication from clinical trials
Action for MAH: update of the product information: No
EMA PRAC 31 Oct 2012 PRAC signal: Cytokine release syndrome
Action for MAH: update of the product information: No

All safety entries for cetuximab →

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.