ERBITUX

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

Active ingredients

The drug ERBITUX contains one active pharmaceutical ingredient (API):

1 Cetuximab UNII PQX0D8J21J - CETUXIMAB

Cetuximab is a chimeric monoclonal IgG1 antibody that is specifically directed against the epidermal growth factor receptor (EGFR). EGFR signalling pathways are involved in the control of cell survival, cell cycle progression, angiogenesis, cell migration and cellular invasion/metastasis. Cetuximab blocks binding of endogenous EGFR ligands resulting in inhibition of the function of the receptor. Read about Cetuximab

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
ERBITUX Solution for infusion	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
L01FE01	Cetuximab	L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01F Monoclonal antibodies and antibody drug conjugates → L01FE EGFR (Epidermal Growth Factor Receptor) inhibitors
Discover more medicines within L01FE01

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 10262D, 10265G, 4312Y, 4435K, 4436L, 4731B, 7223E, 7240C, 7242E, 7273T
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 525419504130316, 525419505137314
Country: CA	Health Products and Food Branch	Identifier(s): 02271249
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 28991-08-09
Country: EE	Ravimiamet	Identifier(s): 1293128, 1293140
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 04281003
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 090232, 090242
Country: FR	Base de données publique des médicaments	Identifier(s): 66843357
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 114952, 114955
Country: HK	Department of Health Drug Office	Identifier(s): 57484
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 6540, 6541
Country: JP	医薬品医療機器総合機構	Identifier(s): 4291415A1021
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1028046, 1028048
Country: NL	Z-Index G-Standaard	Identifier(s): 14969475
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 83267, 83275
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 13176
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100038502
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W65944002, W65944004
Country: SG	Health Sciences Authority	Identifier(s): 13629P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 1333011H, 1333012H
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699808770110, 8699808770127
Country: US	FDA, National Drug Code	Identifier(s): 66733-948, 66733-958
Country: ZA	Health Products Regulatory Authority	Identifier(s): 41/30.2/0883