tuximab. Erbitux can be associated with severe reactions during the infusion, so the patients must be monitored carefully while the medicine is being given.
Why has it been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Erbitux’s benefits are greater than its risks for the treatment of patients with EGFR-expressing, KRAS wild-type metastatic colorectal cancer, and patients with squamous cell cancer of the head and neck. The Committee recommended that Erbitux be given marketing authorisation.
Further information
The European Commission granted a marketing authorisation valid throughout the European Union for Erbitux to Merck KGaA on 29 June 2004. The marketing authorisation was renewed on 29 June 2009.
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Name
Erbitux 2 mg/ml solution for infusion
Composition
Each ml of solution for infusion contains 2 mg cetuximab.
Each vial of 50 ml contains 100 mg cetuximab.
Cetuximab is a chimeric monoclonal IgG antibody produced in a mammalian cell line (Sp2/0) byrecombinant DNA technology.
For a full list of excipients, see section 6.1.
Pharmaceutical Form
Solution for infusion.
Colourless solution that may contain product-related whitish and amorphous visible particles.
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