Canada - English - Health Canada

kyowa kirin, inc. - burosumab - solution - 30mg - burosumab 30mg - electrolytic, caloric and water balance agents, miscellanous

Canada - English - Health Canada

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

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

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

kyowa kirin, inc. - granisetron (unii: wzg3j2mcol) (granisetron - unii:wzg3j2mcol) - granisetron 3.1 mg in 24 h - sancuso® is indicated for the prevention of nausea and vomiting in adults receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days duration. sancuso is contraindicated in patients with known hypersensitivity to granisetron or to any of the components of the transdermal system [see description (10)] . risk summary available published data and postmarketing reports with granisetron use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in a published ex vivo human placental perfusion model, no transplacental passage of granisetron was detected at a concentration (5 ng/ml) that mimics the plasma concentration achieved following transdermal application of sancuso. in animal reproduction studies, no adverse developmental effects were observed in pregnant rats and rabbits administered granisetron hydrochloride during organogenesis at intravenous doses up to 24 times and 16 times, respective

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

kyowa kirin, inc. - burosumab (unii: g9wjt6rd29) (burosumab - unii:g9wjt6rd29) - crysvita is indicated for the treatment of x-linked hypophosphatemia (xlh) in adult and pediatric patients 6 months of age and older. crysvita is indicated for the treatment of fgf23-related hypophosphatemia in tumor-induced osteomalacia (tio) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adult and pediatric patients 2 years of age and older. crysvita is contraindicated: - in concomitant use with oral phosphate and/or active vitamin d analogs (e.g. calcitriol, paricalcitol, doxercalciferol, calcifediol) due to the risk of hyperphosphatemia [see warnings and precautions (5.2) and drug interactions (7.1)] . - when serum phosphorus is within or above the normal range for age [see warnings and precautions (5.2)] . - in patients with severe renal impairment or end stage renal disease because these conditions are associated with abnormal mineral metabolism [see use in specific population (8.6)] . risk summary there are no available data on crysvita use in pregnan

European Union - English - EMA (European Medicines Agency)

kyowa kirin holdings b.v. - burosumab - hypophosphatemia, familial; hypophosphatemic rickets, x-linked dominant; osteomalacia - drugs for treatment of bone diseases - crysvita is indicated for the treatment of x-linked hypophosphataemia, in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease, and in adults.crysvita is indicated for the treatment of fgf23-related hypophosphataemia in tumour-induced osteomalacia associated with phosphaturic mesenchymal tumours that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults.

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

kyowa kirin international uk newco ltd - glyceryl trinitrate - rectal ointment - 4mg/1gram

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

kyowa kirin international uk newco ltd - calcium carbonate; colecalciferol - chewable tablet - 1.5gram ; 400unit

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.

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

kyowa kirin malaysia sdn. bhd. - darbepoetin alfa; darbepoetin alfa -