Australia - English - Department of Health (Therapeutic Goods Administration)

merck healthcare pty ltd - cetuximab, quantity: 5 mg/ml - injection, intravenous infusion - excipient ingredients: citric acid monohydrate; water for injections; sodium chloride; sodium hydroxide; glycine; polysorbate 80 - erbitux is indicated for the treatment of patients with epidermal growth factor receptor (egfr)-expressing, ras wild-type metastatic colorectal cancer. in combination with infusional 5-fluorouracil/folinic acid plus irinotecan. in combination with irinotecan in patients who are refractory to first-line chemotherapy. in first-line in combination with folfox. as a single agent in patients who have failed or are intolerant to oxaliplatin-based therapy and irinotecan-based therapy. (see clinical trials) erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck. in combination with radiation therapy for locally advanced disease. in combination with platinum-based chemotherapy for recurrent and/or metastatic disease.

Australia - English - Department of Health (Therapeutic Goods Administration)

merck healthcare pty ltd - cetuximab, quantity: 5 mg/ml - injection, intravenous infusion - excipient ingredients: water for injections; citric acid monohydrate; polysorbate 80; sodium chloride; sodium hydroxide; glycine - erbitux is indicated for the treatment of patients with epidermal growth factor receptor (egfr)-expressing, ras wild-type metastatic colorectal cancer. in combination with infusional 5-fluorouracil/folinic acid plus irinotecan. in combination with irinotecan in patients who are refractory to first-line chemotherapy. in first-line in combination with folfox. as a single agent in patients who have failed or are intolerant to oxaliplatin-based therapy and irinotecan-based therapy. (see clinical trials) erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck. in combination with radiation therapy for locally advanced disease. in combination with platinum-based chemotherapy for recurrent and/or metastatic disease.

United States - English - NLM (National Library of Medicine)

imclone llc - cetuximab (unii: pqx0d8j21j) (cetuximab - unii:pqx0d8j21j) - cetuximab 2 mg in 1 ml - erbitux® is indicated: - in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (scchn). - in combination with platinum-based therapy with fluorouracil for the first-line treatment of patients with recurrent locoregional disease or metastatic scchn. - as a single-agent for the treatment of patients with recurrent or metastatic scchn for whom prior platinum-based therapy has failed. erbitux is indicated for the treatment of k-ras wild-type, epidermal growth factor receptor (egfr)-expressing, metastatic colorectal cancer (mcrc) as determined by an fda-approved test [see dosage and administration (2.2)] : - in combination with folfiri (irinotecan, fluorouracil, leucovorin) for first-line treatment, - in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, - as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan.

Israel - English - Ministry of Health

merck serono ltd - cetuximab - solution for infusion - cetuximab 5 mg/ml - cetuximab - cetuximab - erbitux® is indicated for the treatment of patients with epidermal growth factor receptor (egfr) - expressing, ras wild-type metastatic colorectal cancer• in combination with irinotecan-based chemotherapy• in first-line in combination with folfox• as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecanerbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck (scchn)• in combination with radiation therapy for locally advanced disease• in combination with platinum-based chemotherapy for recurrent and/or metastatic disease• as a single agent after failure of platinum-based chemotherapy for recurrent and/or metastatic disease

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - cetuximab 2 mg/ml;   - solution for infusion - 2 mg/ml - active: cetuximab 2 mg/ml   excipient: dibasic sodium phosphate dihydrate monobasic sodium phosphate dihydrate sodium chloride water for injection

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - cetuximab 5 mg/ml;  ;   - solution for infusion - 5 mg/ml - active: cetuximab 5 mg/ml     excipient: citric acid monohydrate glycine polysorbate 80 sodium chloride sodium hydroxide water for injection - erbitux is indicated for the treatment of patients with epidermal growth factor receptor (egfr)-expressing, ras wild-type metastatic colorectal cancer · in combination with infusional 5-fluorouracil/folinic acid plus irinotecan · in combination with irinotecan in patients who are refractory to first-line chemotherapy · in first-line in combination with folfox · as a single agent in patients who have failed or are intolerant to oxaliplatin-based therapy and irinotecan-based therapy. (see clinical trials)

Singapore - English - HSA (Health Sciences Authority)

merck pte. ltd. - cetuximab, chimeric antibody - infusion, solution - 5mg/ml - cetuximab, chimeric antibody 5mg/ml

European Union - English - EMA (European Medicines Agency)

merck europe b.v.  - cetuximab - head and neck neoplasms; colorectal neoplasms - antineoplastic agents - erbitux is indicated for the treatment of patients with epidermal growth factor receptor (egfr)-expressing, ras wild-type metastatic colorectal cancer:in combination with irinotecan-based chemotherapy;in first-line in combination with folfox;as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.for details, see section 5.1.erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck:in combination with radiation therapy for locally advanced disease;in combination with platinum-based chemotherapy for recurrent and/or metastatic disease.

Canada - English - Health Canada

imclone, llc - cetuximab - solution - 2mg - cetuximab 2mg - antineoplastic agents

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

merck serono ltd - cetuximab - solution for infusion - 5mg/1ml