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)

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.

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.

Ireland - English - HPRA (Health Products Regulatory Authority)

merck serono limited - somatropin - solution for injection - 5.83 mg/ml - somatropin and somatropin agonists

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

Ireland - English - HPRA (Health Products Regulatory Authority)

merck serono limited - somatropin - solution for injection - 8 mg/ml - somatropin and somatropin agonists

Singapore - English - HSA (Health Sciences Authority)

scigen pte. ltd. - recombinant somatropin - injection, solution - 10 mg/1.5ml - recombinant somatropin 10 mg/1.5ml

Singapore - English - HSA (Health Sciences Authority)

scigen pte. ltd. - recombinant somatropin - injection, solution - 5mg/1.5ml - recombinant somatropin 5mg/1.5ml

Singapore - English - HSA (Health Sciences Authority)

novo nordisk pharma (singapore) pte ltd - somatropin - injection - 10 mg/1.5 ml - somatropin 10 mg/1.5 ml