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ERBITUX Solution for infusion (2019)

Active ingredients: Cetuximab

Product Name and Form

Erbitux 5 mg/mL solution for infusion.

Pharmaceutical form

Solution for infusion.

Colourless solution.

Qualitative and Quantitative Composition

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.

Chemical substance
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
Glycine
Polysorbate 80
Citric acid monohydrate
Sodium hydroxide
Water for injections

Pack sizes and Marketing

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.

Marketing authorization holder
Authorization dates

Merck KGaA, 64271, Darmstadt, Germany

Date of first authorisation: 29/06/2004

Date of latest renewal: 29/06/2009

Marketing authorization number:

EU/1/04/281/003

EU/1/04/281/005