European Union - English - EMA (European Medicines Agency)

pierre fabre medicament - encorafenib - melanoma; colorectal neoplasms - antineoplastic agents - encorafenib is indicated:in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutationin combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (crc) with a braf v600e mutation, who have received prior systemic therapy

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

pierre fabre australia pty ltd - encorafenib, quantity: 75 mg - capsule, hard - excipient ingredients: magnesium stearate; copovidone; iron oxide black; gelatin; iron oxide red; iron oxide yellow; poloxamer; titanium dioxide; crospovidone; colloidal anhydrous silica; microcrystalline cellulose; succinic acid - melanoma,encorafenib, in combination with binimetinib, is indicated for the treatment of adult patients who have unresectable or metastatic melanoma with a braf v600e or v600k mutation, as detected by a validated test.,colorectal cancer,encorafenib, in combination with cetuximab, is indicated for the treatment of adult patients who have metastatic colorectal cancer (mcrc) with a braf v600e mutation as detected by a validated test, and who have received prior systemic therapy.

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

pierre fabre australia pty ltd - encorafenib, quantity: 50 mg - capsule, hard - excipient ingredients: magnesium stearate; copovidone; iron oxide black; gelatin; iron oxide red; iron oxide yellow; poloxamer; titanium dioxide; crospovidone; colloidal anhydrous silica; microcrystalline cellulose; succinic acid - melanoma,encorafenib, in combination with binimetinib, is indicated for the treatment of adult patients who have unresectable or metastatic melanoma with a braf v600e or v600k mutation, as detected by a validated test.,colorectal cancer,encorafenib, in combination with cetuximab, is indicated for the treatment of adult patients who have metastatic colorectal cancer (mcrc) with a braf v600e mutation as detected by a validated test, and who have received prior systemic therapy.

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

array biopharma inc. - encorafenib (unii: 8l7891mrb6) (encorafenib - unii:8l7891mrb6) -

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

array biopharma inc. - encorafenib (unii: 8l7891mrb6) (encorafenib - unii:8l7891mrb6) - braftovi is indicated, in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a braf v600e or v600k mutation, as detected by an fda-approved test [see dosage and administration (2.1)] . braftovi is indicated, in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (crc) with a braf v600e mutation, as detected by an fda-approved test, after prior therapy [see dosage and administration (2.1)] . braftovi is indicated, in combination with binimetinib, for the treatment of adult patients with metastatic non-small cell lung cancer (nsclc) with a braf v600e mutation, as detected by an fda-approved test [see dosage and administration (2.1)] . braftovi is not indicated for treatment of patients with wild-type braf melanoma, wild-type braf crc, or wild-type braf nsclc [see warnings and precautions (5.2)] . none. risk summary based on its mechanism of action, braftovi can cause fetal harm when administered to a pregnant w

Israel - English - Ministry of Health

medison pharma ltd - encorafenib - hard gelatin capsules - encorafenib 75 mg - encorafenib - braf v600e or v600k mutation-positive unresectable or metastatic melanomaencorafenib is a kinase inhibitor indicated, in combination with binimetinib, for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600e or v600k mutation .braf v600e mutation-positive metastatic colorectal cancer (crc)encorafenib is indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (crc) with a braf v600e mutation, as detected by an approved test after prior therapy.

Canada - English - Health Canada

pfizer canada ulc - encorafenib - capsule - 75mg - encorafenib 75mg - antineoplastic agents

Singapore - English - HSA (Health Sciences Authority)

pierre fabre singapore pte ltd - encorafenib - capsule - encorafenib 50mg

Singapore - English - HSA (Health Sciences Authority)

pierre fabre singapore pte ltd - encorafenib - capsule - encorafenib 75mg

European Union - English - EMA (European Medicines Agency)

pierre fabre medicament - binimetinib - melanoma - antineoplastic agents - binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation.