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

kyowa kirin, inc. - mogamulizumab (unii: yi437801be) (mogamulizumab - unii:yi437801be) - poteligeo is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (mf) or sézary syndrome (ss) after at least one prior systemic therapy. none. risk summary there are no available data on poteligeo use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. in an animal reproduction study, administration of mogamulizumab-kpkc to pregnant cynomolgus monkeys from the start of organogenesis through delivery did not show a potential for adverse developmental outcomes at maternal systemic exposures 27 times the exposure in patients at the recommended dose, based on auc (see data ). in general, igg molecules are known to cross the placental barrier and in the monkey reproduction study mogamulizumab-kpkc was detected in fetal plasma. therefore, poteligeo has the potential to be transmitted from the mother to the developing fetus. poteligeo is not recommended during pregnancy or in women of childbearing potential not using contraception. the es

Israel - English - Ministry of Health

medison pharma ltd - mogamulizumab - concentrate for solution for infusion - mogamulizumab 4 mg / 1 ml - mogamulizumab - poteligeo is indicated for the treatment of adult patients with mycosis fungoides (mf) or sézary syndrome (ss) who have received at least one prior systemic therapy.

European Union - English - EMA (European Medicines Agency)

kyowa kirin holdings b.v. - mogamulizumab - sezary syndrome; mycosis fungoides - antineoplastic agents - poteligeo is indicated for the treatment of adult patients with mycosis fungoides (mf) or sézary syndrome (ss) who have received at least one prior systemic therapy.

Canada - English - Health Canada

kyowa kirin, inc. - mogamulizumab - solution - 4mg - mogamulizumab 4mg

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

kyowa kirin australia pty ltd - mogamulizumab, quantity: 20 mg - injection, intravenous infusion - excipient ingredients: citric acid monohydrate; glycine; polysorbate 80; sodium hydroxide; hydrochloric acid; water for injections - poteligeo is indicated for the treatment of adult patients (18 years of age and above) with mycosis fungoides (mf) or s?zary syndrome (ss) who have received at least one prior systemic therapy

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

kyowa kirin holdings b.v., netherlands - mogamulizumab - concentrate for solution for infusion - 4 mg/ml

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

kyowa kirin co.,ltd - mogamulizumab(genetical recombination) - injection

Israel - English - Ministry of Health

alexion pharma israel ltd - ravulizumab - concentrate for solution for infusion - ravulizumab 10 mg/ml - ravulizumab - ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with paroxysmal nocturnal haemoglobinuria (pnh): • in patients with haemolysis with clinical symptom(s) indicative of high disease activity. • in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.ultomiris is indicated in the treatment of adult patients with generalized myasthenia gravis (gmg) who are anti-acetylcholine receptor (achr) antibody-positive.

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

alexion pharmaceuticals australasia pty ltd - ravulizumab, quantity: 100 mg/ml - injection, concentrated - excipient ingredients: monobasic sodium phosphate; dibasic sodium phosphate; polysorbate 80; arginine; sucrose; water for injections - ultomiris is indicated:,? for the treatment of patients with paroxysmal nocturnal haemoglobinuria (pnh),? for the treatment of patients with atypical haemolytic uraemic syndrome (ahus),? as an add-on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gmg) who are anti-acetylcholine receptor (achr) antibody-positive.,? for the treatment of adult patients with neuromyelitis optica spectrum disorder (nmosd) who are anti-aquaporin 4 (aqp4) antibody-positive.,ultomiris is not intended for the acute treatment of a nmosd relapse.

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

alexion pharmaceuticals australasia pty ltd - ravulizumab, quantity: 100 mg/ml - injection, intravenous infusion - excipient ingredients: monobasic sodium phosphate; dibasic sodium phosphate; polysorbate 80; arginine; sucrose; water for injections - ultomiris is indicated:,? for the treatment of patients with paroxysmal nocturnal haemoglobinuria (pnh),? for the treatment of patients with atypical haemolytic uraemic syndrome (ahus),? as an add-on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gmg) who are anti-acetylcholine receptor (achr) antibody-positive.,? for the treatment of adult patients with neuromyelitis optica spectrum disorder (nmosd) who are anti-aquaporin 4 (aqp4) antibody-positive.,ultomiris is not intended for the acute treatment of a nmosd relapse.