Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Merck KGaA, 64271, Darmstadt, Germany
Erbitux 5 mg/mL solution for infusion.
| Pharmaceutical Form |
|---|
|
Solution for infusion. Colourless solution. |
Each mL of solution for infusion contains 5 mg cetuximab.
Each vial of 20 mL contains 100 mg cetuximab. Each vial of 100 mL contains 500 mg cetuximab.
Cetuximab is a chimeric monoclonal IgG1 antibody produced in a mammalian cell line (Sp2/0) by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| 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. |
| List of Excipients |
|---|
|
Sodium chloride |
20 mL or 100 mL of solution in a vial (Type I glass) with a stopper (halobutyl rubber) and a seal (aluminium/polypropylen).
Pack size of 1 vial.
Not all vial sizes may be marketed.
Merck KGaA, 64271, Darmstadt, Germany
EU/1/04/281/003
EU/1/04/281/005
Date of first authorisation: 29/06/2004
Date of latest renewal: 29/06/2009
| Drug | Countries | |
|---|---|---|
| ERBITUX | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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