New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - cobimetinib hemifumarate 22.2mg equivalent to cobimetinib 20 mg - film coated tablet - 20 mg - active: cobimetinib hemifumarate 22.2mg equivalent to cobimetinib 20 mg excipient: croscarmellose sodium lactose monohydrate macrogol 3350 magnesium stearate microcrystalline cellulose polyvinyl alcohol purified talc purified water titanium dioxide - cotellic is indicated for use in combination with zelboraf (vemurafenib) for the treatment of patients with unresectable or metastatic melanoma with braf v600 mutation.

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

roche products pty ltd - cobimetinib fumarate, quantity: 22.2 mg (equivalent: cobimetinib, qty 20 mg) - tablet, film coated - excipient ingredients: titanium dioxide; macrogol 3350; magnesium stearate; microcrystalline cellulose; polyvinyl alcohol; purified talc; lactose monohydrate; croscarmellose sodium - cotellic is indicated for use in combination with zelboraf (vemurafenib) for the treatment of patients with unresectable or metastatic melanoma with braf v600 mutation

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

roche products ltd - cobimetinib hemifumarate - tablet - 20mg

European Union - English - EMA (European Medicines Agency)

roche registration gmbh - cobimetinib hemifumarate - melanoma - antineoplastic agents - cotellic is indicated for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

roche (malaysia) sdn. bhd. - cobimetinib hemifumarate -

Canada - English - Health Canada

hoffmann-la roche limited - cobimetinib (cobimetinib fumarate) - tablet - 20mg - cobimetinib (cobimetinib fumarate) 20mg - antineoplastic agents

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

genentech, inc. - cobimetinib fumarate (unii: 6exi96h8sv) (cobimetinib - unii:er29l26n1x) - cobimetinib 20 mg - cotellic® is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600e or v600k mutation, in combination with vemurafenib. cotellic®, as a single agent, is indicated for the treatment of adult patients with histiocytic neoplasms. none. risk summary based on findings from animal reproduction studies and its mechanism of action, cotellic can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)]. there are no available data on the use of cotellic during pregnancy. in animal reproduction studies, oral administration of cobimetinib in pregnant rats during organogenesis was teratogenic and embryotoxic at exposures (auc) that were 0.9 to 1.4-times those observed in humans at the recommended human dose of 60 mg [see data] . advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - cobimetinib as hemifumarate - film coated tablets - cobimetinib as hemifumarate 20 mg - cotellic is indicated for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation.cotellic as a single agent, is indicated for the treatment of adult patients with histiocytic neoplasms.

Singapore - English - HSA (Health Sciences Authority)

roche singapore pte. ltd. - cobimetinib hemifumarate 22.20mg eqv to cobimetinib - tablet, film coated - cobimetinib hemifumarate 22.20mg eqv to cobimetinib 20mg

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

f. hoffmann-la roche ltd - cobimetinib (como cobimetinib hemifumarato) - cobimetinib (como cobimetinib hemifumarato)....20.00 mg