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

amgen australia pty ltd - panitumumab, quantity: 400 mg - injection, concentrated - excipient ingredients: sodium acetate trihydrate; sodium chloride; water for injections - vectibix is indicated for the treatment of patients with wild-type ras metastatic colorectal cancer (mcrc) (see precautions laboratory tests): - as first line therapy in combination with folfox. efficacy may be influenced by patient performance status (see clinical trials; precautions). - as second line therapy in combination with folfiri for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan). efficacy may be influenced by patient performance status (see clinical trials). - as monotherapy in patients after the failure of standard chemotherapy.

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

amgen australia pty ltd - panitumumab, quantity: 100 mg - injection, concentrated - excipient ingredients: sodium chloride; sodium acetate trihydrate; water for injections - vectibix is indicated for the treatment of patients with wild-type ras metastatic colorectal cancer (mcrc) (see precautions laboratory tests): - as first line therapy in combination with folfox. efficacy may be influenced by patient performance status (see clinical trials; precautions). - as second line therapy in combination with folfiri for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan). efficacy may be influenced by patient performance status (see clinical trials). - as monotherapy in patients after the failure of standard chemotherapy.

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

amgen inc - panitumumab (unii: 6a901e312a) (panitumumab - unii:6a901e312a) - panitumumab 100 mg in 5 ml - vectibix is indicated for the treatment of patients with wild-type ras (defined as wild-type in both kras and nras  as determined by an fda-approved test for this use) metastatic colorectal cancer (mcrc) [see dos age and administration ( 2.1 )] : • as first-line therapy in combination with folfox [ see clinical studies ( 14.2 )] . • as monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy [see clinical studies ( 14.1 )] . limitation of use:  vectibix is not indicated for the treatment of patients with ras -mutant mcrc or for whom ras  mutation status is unknown [see dosage and administration ( 2.1 ) , warnings and precautions ( 5.2 ) , and clinical pharmacology ( 12.1 ) ]. none. risk summary based on data from animal studies and its mechanism of action, vectibix can cause fetal harm when administered to pregnant women [see clinical pharmacology ( 12.1 )] .   limited available data on the use of vectibix in pregnant

Israel - English - Ministry of Health

amgen europe b.v. - panitumumab - concentrate for solution for infusion - panitumumab 20 mg / 1 ml - panitumumab - in combination with chemotherapy for the treatment of unresectable, advanced or recurrent colorectal cancer (mcrc) with wild-type ras.monotherapy for the treatment of patients with metastatic colorectal carcinoma with wild-type ras after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

European Union - English - EMA (European Medicines Agency)

amgen europe b.v. - panitumumab - colorectal neoplasms - antineoplastic agents - vectibix is indicated for the treatment of adult patients with wild-type ras metastatic colorectal cancer (mcrc): , in first-line in combination with folfox or folfiri., in second-line in combination with folfiri for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan)., as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

Canada - English - Health Canada

amgen canada inc - panitumumab - solution - 100mg - panitumumab 100mg - antineoplastic agents

Canada - English - Health Canada

amgen canada inc - panitumumab - solution - 400mg - panitumumab 400mg - antineoplastic agents

Canada - English - Health Canada

amgen canada inc - panitumumab - solution - 200mg - panitumumab 200mg - antineoplastic agents

Singapore - English - HSA (Health Sciences Authority)

amgen biotechnology singapore pte ltd - panitumumab - infusion, solution concentrate - 100 mg/vial - panitumumab 100 mg/vial

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

amgen ltd - panitumumab - solution for infusion - 20mg/1ml