USA - engelsk - NLM (National Library of Medicine)

ultragenyx pharmaceutical inc. - burosumab (unii: g9wjt6rd29) (burosumab - unii:g9wjt6rd29) - burosumab 10 mg in 1 ml - 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

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

kyowa kirin australia pty ltd - burosumab, quantity: 30 mg - injection, solution - excipient ingredients: sorbitol; histidine; methionine; polysorbate 80; water for injections; hydrochloric acid - crysvita (burosumab) is indicated for the treatment of x-linked hypophosphataemia (xlh) in adults, adolescents and children 1 year of age or older.

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

kyowa kirin australia pty ltd - burosumab, quantity: 20 mg - injection, solution - excipient ingredients: sorbitol; histidine; methionine; polysorbate 80; water for injections; hydrochloric acid - crysvita (burosumab) is indicated for the treatment of x-linked hypophosphataemia (xlh) in adults, adolescents and children 1 year of age or older.

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

kyowa kirin australia pty ltd - burosumab, quantity: 10 mg - injection, solution - excipient ingredients: sorbitol; histidine; methionine; polysorbate 80; water for injections; hydrochloric acid - crysvita (burosumab) is indicated for the treatment of x-linked hypophosphataemia (xlh) in adults, adolescents and children 1 year of age or older.

Israel - engelsk - Ministry of Health

medison pharma ltd - burosumab - solution for injection - burosumab 10 mg / 1 ml - burosumab - crysvita is indicated for the treatment of x-linked hypophosphatemia (xlh) in adult and paediatric patients 6 months of age and oldertumor-induced osteomalaciacrysvita 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.

Israel - engelsk - Ministry of Health

medison pharma ltd - burosumab - solution for injection - burosumab 20 mg / 1 ml - burosumab - crysvita is indicated for the treatment of x-linked hypophosphatemia (xlh) in adult and paediatric patients 6 months of age and oldertumor-induced osteomalaciacrysvita 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.

Israel - engelsk - Ministry of Health

medison pharma ltd - burosumab - solution for injection - burosumab 30 mg / 1 ml - burosumab - crysvita is indicated for the treatment of x-linked hypophosphatemia (xlh) in adult and paediatric patients 6 months of age and oldertumor-induced osteomalaciacrysvita 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.

Den europeiske union - tsjekkisk - EMA (European Medicines Agency)

kyowa kirin holdings b.v. - burosumab - hypophosphatemia, familial; hypophosphatemic rickets, x-linked dominant; osteomalacia - léky na léčbu nemocí kostí - 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.

Den europeiske union - rumensk - EMA (European Medicines Agency)

kyowa kirin holdings b.v. - burosumab - hypophosphatemia, familial; hypophosphatemic rickets, x-linked dominant; osteomalacia - medicamente pentru tratamentul bolilor osoase - 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.

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

kyowa kirin malaysia sdn. bhd. - burosumab -