European Union - English - EMA (European Medicines Agency)

sandoz gmbh - somatropin - turner syndrome; prader-willi syndrome; dwarfism, pituitary - pituitary and hypothalamic hormones and analogues - infants, children and adolescentsgrowth disturbance due to insufficient secretion of growth hormone (gh).growth disturbance associated with turner syndrome.growth disturbance associated with chronic renal insufficiency.growth disturbance (current height standard-deviation score (sds) < -2.5 and parental adjusted sds < -1) in short children / adolescents born small for gestational age (sga), with a birth weight and / or length below -2 standard deviations (sds), who failed to show catch-up growth (height velocity (hv) sds < 0 during the last year) by four years of age or later.prader-willi syndrome (pws), for improvement of growth and body composition. the diagnosis of pws should be confirmed by appropriate genetic testing.adultsreplacement therapy in adults with pronounced growth hormone deficiency. patients with severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic pituitary pathology and at least one known deficiency of a pituitary hormone not being prolactin. these patients should undergo a single dynamic test in order to diagnose or exclude a growth hormone deficiency. in patients with childhood-onset isolated gh deficiency (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be recommended, except for those having low insulin-like-growth-factor-i (igf-i) concentrations (sds < -2) who may be considered for one test. the cut-off point of the dynamic test should be strict.

Singapore - English - HSA (Health Sciences Authority)

siemens healthcare pte. ltd. - clinical chemistry - for the quantitative measurement of insulin-like growth factor binding protein 3 (igfbp-3) in serum or heparinized plasma, as an aid in the evaluation of growth disorders.

European Union - English - EMA (European Medicines Agency)

ipsen pharma - mecasermin - laron syndrome - pituitary and hypothalamic hormones and analogues - for the long-term treatment of growth failure in children and adolescents with severe primary insulin-like-growth-factor-1 deficiency (primary igfd).severe primary igfd is defined by:height standard deviation score ≤ -3.0 and;basal insulin-like growth factor-1 (igf-1) levels below the 2.5th percentile for age and gender and;growth hormone (gh) sufficiency;exclusion of secondary forms of igf-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.severe primary igfd includes patients with mutations in the gh receptor (ghr), post-ghr signalling pathway, and igf-1 gene defects; they are not gh deficient, and therefore, they cannot be expected to respond adequately to exogenous gh treatment. it is recommended to confirm the diagnosis by conducting an igf-1 generation test.

Singapore - English - HSA (Health Sciences Authority)

merck pte. ltd. - somatropin - injection, solution - 6.0mg/ml - somatropin 6 mg/1.03 ml

Singapore - English - HSA (Health Sciences Authority)

merck pte. ltd. - somatropin - injection, solution - 12mg/ml - somatropin 12 mg/1.50 ml

Singapore - English - HSA (Health Sciences Authority)

merck pte. ltd. - somatropin - injection, solution - 20mg/ml - somatropin 20 mg/2.5 ml

Ireland - English - HPRA (Health Products Regulatory Authority)

merck serono (ireland) limited - somatropin, recombinant human growth hormone - powder and solvent for solution for injection - 8 milligram(s) - somatropin and somatropin agonists; somatropin

European Union - English - EMA (European Medicines Agency)

ipsen pharma - mecasermin - laron syndrome - pituitary and hypothalamic hormones and analogues - for the long-term treatment of growth failure in children and adolescents with severe primary insulin-like-growth-factor-1 deficiency (primary igfd).severe primary igfd is defined by:height standard deviation score ≤ -3.0 and;basal insulin-like growth factor-1 (igf-1) levels below the 2.5th percentile for age and gender and;growth hormone (gh) sufficiency;exclusion of secondary forms of igf-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.severe primary igfd includes patients with mutations in the gh receptor (ghr), post-ghr signalling pathway, and igf-1 gene defects; they are not gh deficient, and therefore, they cannot be expected to respond adequately to exogenous gh treatment. it is recommended to confirm the diagnosis by conducting an igf-1 generation test.

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

novo nordisk pharmaceuticals pty ltd - somatropin, quantity: 10 mg/ml - injection, solution - excipient ingredients: histidine; phenol; poloxamer; mannitol; water for injections - children:treatment of growth failure in children due to pituitary growth hormone deficiency. treatment of growth failure in girls due to gonadal dysgenesis (turner's syndrome). treatment of growth failure in children due to chronic renal insufficiency whose height is on or less than the twenty-fifth percentile and whose growth velocity is on or less than the twenty-fifth percentile for bone age. chronic renal insufficiency is defined as glomerular filtration rate of less than 30 ml/min/1.73 m2. treatment of severe growth failure due to intrauterine growth retardation (i.e., children born small for gestational age (birth weight and/or length < -2 sd) without spontaneous catch up growth by 2 years of age). adults: treatment of adults with severe growth hormone deficiency as diagnosed in the insulin tolerance test for growth hormone deficiency and defined by peak growth hormone concentrations of less than 2.5 nanogram/ml. in order to establish childhood onset [co] growth hormone insufficiency, reconfirmation by

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

novo nordisk pharmaceuticals pty ltd - somatropin, quantity: 6.67 mg/ml - injection, solution - excipient ingredients: poloxamer; mannitol; histidine; water for injections; phenol - children:treatment of growth failure in children due to pituitary growth hormone deficiency. treatment of growth failure in girls due to gonadal dysgenesis (turner's syndrome). treatment of growth failure in children due to chronic renal insufficiency whose height is on or less than the twenty-fifth percentile and whose growth velocity is on or less than the twenty-fifth percentile for bone age. chronic renal insufficiency is defined as glomerular filtration rate of less than 30 ml/min/1.73 m2. treatment of severe growth failure due to intrauterine growth retardation (i.e., children born small for gestational age (birth weight and/or length < -2 sd) without spontaneous catch up growth by 2 years of age). adults: treatment of adults with severe growth hormone deficiency as diagnosed in the insulin tolerance test for growth hormone deficiency and defined by peak growth hormone concentrations of less than 2.5 nanogram/ml. in order to establish childhood onset [co] growth hormone insufficiency, reconfirmation by