SOGROYA- somapacitan-beco injection, solution USA - engelsk - NLM (National Library of Medicine)

sogroya- somapacitan-beco injection, solution

novo nordisk - somapacitan (unii: 8foj430u94) (somapacitan - unii:8foj430u94) -  sogroya is indicated for the: sogroya is contraindicated in patients with:   risk summary there are no available data on the use of sogroya during pregnancy; however, published studies describing the use of short-acting recombinant growth hormone (rhgh) during pregnancy over several decades have not identified any drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, subcutaneously administered somapacitan-beco was not teratogenic in rats or rabbits during organogenesis at doses approximately 12 times the clinical exposure at the maximum recommended human dose (mrhd) of 8 mg/week. no adverse developmental outcomes were observed in a pre- and post-natal development study with administration of somapacitan-beco to pregnant rats from organogenesis through lactation at approximately 275 times the clinical exposure at the mrhd (see data) . the background risk of birth defects and miscarriage for the indicated population is unknown. in the

Sogroya Den europeiske union - bulgarsk - EMA (European Medicines Agency)

sogroya

novo nordisk a/s - somapacitan - Растеж - Хипофизни и хипоталамични хормони и аналози - sogroya is indicated for the replacement of endogenous growth hormone (gh) in children  aged 3  years and above, and adolescents with growth failure due to growth hormone deficiency (paediatric ghd), and in adults with growth hormone deficiency (adult ghd).

Sogroya Den europeiske union - latvisk - EMA (European Medicines Agency)

sogroya

novo nordisk a/s - somapacitan - izaugsme - hipofīzes un hipotalāma hormoni un analogi - sogroya is indicated for the replacement of endogenous growth hormone (gh) in children  aged 3  years and above, and adolescents with growth failure due to growth hormone deficiency (paediatric ghd), and in adults with growth hormone deficiency (adult ghd).

Sogroya Den europeiske union - maltesisk - EMA (European Medicines Agency)

sogroya

novo nordisk a/s - somapacitan - tkabbir - ormoni u analogi pitwitarji u ipotalamiċi - sogroya is indicated for the replacement of endogenous growth hormone (gh) in children  aged 3  years and above, and adolescents with growth failure due to growth hormone deficiency (paediatric ghd), and in adults with growth hormone deficiency (adult ghd).

Sogroya Den europeiske union - litauisk - EMA (European Medicines Agency)

sogroya

novo nordisk a/s - somapacitan - augimas - hipofizės ir hipotalaminiai hormonai ir analogai - sogroya is indicated for the replacement of endogenous growth hormone (gh) in children  aged 3  years and above, and adolescents with growth failure due to growth hormone deficiency (paediatric ghd), and in adults with growth hormone deficiency (adult ghd).

Sogroya Den europeiske union - kroatisk - EMA (European Medicines Agency)

sogroya

novo nordisk a/s - somapacitan - rast - hipofiza i hipotalamusni hormoni i analozi - sogroya is indicated for the replacement of endogenous growth hormone (gh) in children  aged 3  years and above, and adolescents with growth failure due to growth hormone deficiency (paediatric ghd), and in adults with growth hormone deficiency (adult ghd).