This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Nigeria, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.
The drug ERBITUX contains one active pharmaceutical ingredient (API):
1
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UNII
PQX0D8J21J - CETUXIMAB
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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. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| ERBITUX Solution for infusion | MPI, EU: SmPC | European Medicines Agency (EU) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | 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 |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| AU | Pharmaceutical Benefits Scheme | 10262D, 10265G, 4312Y, 4435K, 4436L, 4731B, 7223E, 7240C, 7242E, 7273T |
| BR | Câmara de Regulação do Mercado de Medicamentos | 525419504130316, 525419505137314 |
| CA | Health Products and Food Branch | 02271249 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 28991-08-09 |
| EE | Ravimiamet | 1293128, 1293140 |
| ES | Centro de información online de medicamentos de la AEMPS | 04281003 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 090232, 090242 |
| FR | Base de données publique des médicaments | 66843357 |
| GB | Medicines & Healthcare Products Regulatory Agency | 114952, 114955 |
| HK | Department of Health Drug Office | 57484 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 6540, 6541 |
| JP | 医薬品医療機器総合機構 | 4291415A1021 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1028046, 1028048 |
| NG | Registered Drug Product Database | A6-0438 |
| NL | Z-Index G-Standaard | 14969475 |
| NL | Z-Index G-Standaard, PRK | 83267, 83275 |
| NZ | Medicines and Medical Devices Safety Authority | 13176 |
| PL | Rejestru Produktów Leczniczych | 100038502 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W65944002, W65944004 |
| SG | Health Sciences Authority | 13629P |
| TN | Direction de la Pharmacie et du Médicament | 1333011H, 1333012H |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699808770110, 8699808770127 |
| US | FDA, National Drug Code | 66733-948, 66733-958 |
| ZA | Health Products Regulatory Authority | 41/30.2/0883 |
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