European Union - English - EMA (European Medicines Agency)

biopartners gmbh - somatropin - growth - pituitary and hypothalamic hormones and analogues, somatropin and somatropin agonists - somatropin biopartners is indicated for the replacement therapy of endogenous growth hormone in adults with childhood- or adult-onset growth-hormone deficiency (ghd).adult-onset: patients with ghd in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone excluding prolactin. these patients should undergo a single dynamic test in order to diagnose or exclude a ghd.childhood-onset: in patients with childhood-onset isolated ghd (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be performed after completion of growth, except for those having low insulin-like-growth-factor-i (igf-i) concentrations (< -2 standard-deviation score (sds)), who may be considered for one test. the cut-off point of the dynamic test should be strict.

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

ipsen pty ltd - somatropin, quantity: 5 mg/ml - injection, solution - excipient ingredients: water for injections; phenol; polysorbate 20; sodium citrate dihydrate; citric acid; sodium chloride - long-term treatment of children with growth failure due to inadequate endogenous growth hormone secretion. long-term treatment of growth failure associated with turner syndrome. treatment of prepubertal children with growth failure associated with chronic renal insufficiency up to the time of renal transplantation. treatment of adults with severe growth hormone deficiency as diagnosed in the insulin tolerance test for growth hormone deficiency and defined by peak gh concentrations of less than 2.5 ng/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

Ireland - English - HPRA (Health Products Regulatory Authority)

merck serono limited - somatropin, recombinant human growth hormone - pdr+solv for soln for inj - 8 milligram - somatropin and somatropin agonists

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

eli lilly australia pty ltd - somatropin, quantity: 12 mg (equivalent: somatropin, qty 36 iu) - injection, solution - excipient ingredients: hydrochloric acid; metacresol; sodium hydroxide; glycerol; water for injections - humatrope is indicated for the long-term treatment of children who have growth failure due to inadequate secretion of normal endogenous growth hormone.,humatrope is also indicated for the treatment of growth disturbances associated with gonadal dysgenesis (turner syndrome).,humatrope is also indicated for the treatment of adults with severe growth hormone deficiency 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 deficiency. in patients with childhood onset isolated gh deficiency (no evidence of hypothalamic-pituitary disease or cranal irradiation), two dynamic tests should be recommended, except for those having low igf-i concentrations less than or equal to 2 sds who may be considered for one test. the cut-off point of the dynamic test should be strict.,humatrope is also indicated for the treatment of growth retardation in prepubertal children with 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.,humatrope is also indicated for the treatment of growth failure in children born small for gestational age (sga) who fail to demonstrate catch-up growth by age two to four years (see clinical trials). humatrope is also indicated for the treatment of growth failure in children born small for gestational age (sga) who fail to demonstrate catch-up growth by age two to four years. (see clinical trials)

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

eli lilly australia pty ltd - somatropin, quantity: 6 mg (equivalent: somatropin, qty 18 iu) - injection, solution - excipient ingredients: water for injections; sodium hydroxide; glycerol; hydrochloric acid; metacresol - humatrope is indicated for the long-term treatment of children who have growth failure due to inadequate secretion of normal endogenous growth hormone.,humatrope is also indicated for the treatment of growth disturbances associated with gonadal dysgenesis (turner syndrome).,humatrope is also indicated for the treatment of adults with severe growth hormone deficiency 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 deficiency. in patients with childhood onset isolated gh deficiency (no evidence of hypothalamic-pituitary disease or cranal irradiation), two dynamic tests should be recommended, except for those having low igf-i concentrations less than or equal to 2 sds who may be considered for one test. the cut-off point of the dynamic test should be strict.,humatrope is also indicated for the treatment of growth retardation in prepubertal children with 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.,humatrope is also indicated for the treatment of growth failure in children born small for gestational age (sga) who fail to demonstrate catch-up growth by age two to four years (see clinical trials). humatrope is also indicated for the treatment of growth failure in children born small for gestational age (sga) who fail to demonstrate catch-up growth by age two to four years. (see clinical trials)

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

eli lilly australia pty ltd - somatropin, quantity: 24 mg (equivalent: somatropin, qty 72 iu) - injection, solution - excipient ingredients: water for injections; hydrochloric acid; glycerol; sodium hydroxide; metacresol - humatrope is indicated for the long-term treatment of children who have growth failure due to inadequate secretion of normal endogenous growth hormone.,humatrope is also indicated for the treatment of growth disturbances associated with gonadal dysgenesis (turner syndrome).,humatrope is also indicated for the treatment of adults with severe growth hormone deficiency 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 deficiency. in patients with childhood onset isolated gh deficiency (no evidence of hypothalamic-pituitary disease or cranal irradiation), two dynamic tests should be recommended, except for those having low igf-i concentrations less than or equal to 2 sds who may be considered for one test. the cut-off point of the dynamic test should be strict.,humatrope is also indicated for the treatment of growth retardation in prepubertal children with 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.,humatrope is also indicated for the treatment of growth failure in children born small for gestational age (sga) who fail to demonstrate catch-up growth by age two to four years (see clinical trials). humatrope is also indicated for the treatment of growth failure in children born small for gestational age (sga) who fail to demonstrate catch-up growth by age two to four years. (see clinical trials)

Israel - English - Ministry of Health

novo nordisk ltd., israel - somatropin - solution for injection - somatropin 10 mg / 1 ml - somatropin - somatropin - children: * short stature due to inadequate or failed secretion of pituitary growth hormone or turner`s syndrome. * short stature in children with renal insufficiency. * growth disturbance (current height sds < - 2.5 and parental adjusted height sds < - 1) in short children born small for gestational age (sga) with a birth weight and/or length below - 2 sd who failed to show catch-up growth (hv sds < during the last year) by 4 years of age or later.* children with short stature associated with noonan syndrome.adults: treatment of adults with hypothalamic-pituitary disease resulting from organic disease or pituitary tumors treated medically surgically or radiotherapy or patients with childhood onset of g.h. deficiency.

Israel - English - Ministry of Health

novo nordisk ltd., israel - somatropin - solution for injection - somatropin 10 mg / 1.5 ml - somatropin - somatropin - children: * short stature due to inadequate or failed secretion of pituitary growth hormone or turner`s syndrome. * short stature in children with renal insufficiency. * growth disturbance (current height sds < - 2.5 and parental adjusted height sds < - 1) in short children born small for gestational age (sga) with a birth weight and/or length below - 2 sd who failed to show catch-up growth (hv sds < during the last year) by 4 years of age or later.* children with short stature associated with noonan syndrome.adults: treatment of adults with hypothalamic-pituitary disease resulting from organic disease or pituitary tumors treated medically surgically or radiotherapy or patients with childhood onset of g.h. deficiency.

Israel - English - Ministry of Health

ferring pharmaceuticals ltd - somatropin - powder and solvent for solution for injection - somatropin 10 mg - somatropin - somatropin - children :short stature due to inadequate or failed secretion of pituitary growth hormone or turner's syndrome. short stature in children with renal insufficiency.