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

genentech, inc. - faricimab (unii: qc4f7fkk7i) (faricimab - unii:qc4f7fkk7i) - vabysmo is a vascular endothelial growth factor (vegf) and angiopoietin 2 (ang-2) inhibitor indicated for the treatment of patients with: vabysmo is contraindicated in patients with ocular or periocular infections. vabysmo is contraindicated in patients with active intraocular inflammation. vabysmo is contraindicated in patients with known hypersensitivity to faricimab or any of the excipients in vabysmo. hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema, or severe intraocular inflammation. risk summary there are no adequate and well-controlled studies of vabysmo administration in pregnant women. administration of vabysmo to pregnant monkeys throughout the period of organogenesis resulted in an increased incidence of abortions at intravenous (iv) doses 158 times the human exposure (based on cmax ) of the maximum recommended human dose [see animal data] . based on the mechanism of action of vegf and ang-2 inhibitors, there is a potential risk to female reproductive capacity, and t

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

roche products pty ltd - faricimab, quantity: 120 mg/ml - injection, solution - excipient ingredients: histidine; acetic acid; methionine; sodium chloride; sucrose; polysorbate 20; water for injections - vabysmo is indicated for the treatment of:,- neovascular (wet) age-related macular degeneration (namd),- diabetic macular oedema (dmo).

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - faricimab - solution for injection - faricimab 120 mg/ml - faricimab - vabysmo is a vascular endothelial growth factor (vegf) and angiopoietin 2 (ang-2) inhibitor indicated for the treatment of patients with:• neovascular (wet) age-related macular degeneration (namd) • diabetic macular edema (dme)

European Union - English - EMA (European Medicines Agency)

roche registration gmbh - faricimab - wet macular degeneration; macular edema; diabetes complications - ophthalmologicals - vabysmo is indicated for the treatment of adult patients with:neovascular (wet) age-related macular degeneration (namd),visual impairment due to diabetic macular oedema (dme).

Canada - English - Health Canada

hoffmann-la roche limited - faricimab - solution - 6mg - faricimab 6mg

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - faricimab 120 mg/ml - solution for injection - 120 mg/ml - active: faricimab 120 mg/ml excipient: acetic acid histidine methionine polysorbate 20 sodium chloride sucrose water for injection - vabysmo is indicated for the treatment of: · neovascular (wet) age-related macular degeneration (namd)

Singapore - English - HSA (Health Sciences Authority)

roche singapore pte. ltd. - faricimab - injection, solution - faricimab 6.00mg/0.05ml

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

roche products ltd - faricimab - solution for injection - 120mg/1ml

Philippines - English - FDA (Food And Drug Administration)

f. hoffman-la roche ltd.; importer: roche (philippines), inc.; distributor: roche (philippines), inc. - faricimab - solution for intravitreal injection - 6 mg/0.05 ml (120 mg/ml)

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

f.hoffmann-la roche ltd., switzerland - faricimab - solution for injection - 120 mg/ml,