Malta - English - Medicines Authority

pfizer hellas s.a. 243 messoghion ave., neo psychiko 15451, athens, greece - somatropin - powder and solvent for solution for injection - somatropin 5.3 mg/ml - pituitary and hypothalamic hormones and analogues

Malta - English - Medicines Authority

eli lilly & co. limited - somatropin - powder and solvent for solution for injection - somatropin 6 mg - pituitary and hypothalamic hormones and analogues

Malta - English - Medicines Authority

eli lilly & co. limited - somatropin - powder and solvent for solution for injection - somatropin 12 mg - pituitary and hypothalamic hormones and analogues

Malta - English - Medicines Authority

eli lilly & co. limited - somatropin - powder and solvent for solution for injection - somatropin 24 mg - pituitary and hypothalamic hormones and analogues

Malta - English - Medicines Authority

cherubino limited - somatropin 8 mg - powder and solvent for solution for injection

European Union - English - EMA (European Medicines Agency)

ipsen pharma - somatropin - turner syndrome; dwarfism, pituitary - pituitary and hypothalamic hormones and analogues - 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.replacement of endogenous growth hormone in adults with growth hormone deficiency of either childhood or adult-onset etiology. growth hormone deficiency should be confirmed appropriately prior to treatment.

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.

Canada - English - Health Canada

eli lilly canada inc - somatropin - powder for solution - 5mg - somatropin 5mg - pituitary

Canada - English - Health Canada

emd serono, a division of emd inc., canada - somatropin; sodium chloride - powder for solution - 3.3mg; 5ml - somatropin 3.3mg; sodium chloride 5ml - pituitary

Canada - English - Health Canada

hoffmann-la roche limited - somatropin; water - kit - 5mg; 10ml - somatropin 5mg; water 10ml - pituitary