Singapur - Englisch - HSA (Health Sciences Authority)

novo nordisk pharma (singapore) pte ltd - somatropin - injection - 5 mg/1.5 ml - somatropin 5 mg/1.5 ml

Malta - Englisch - Malta Medicines Authority

novonordisk a/s novo alle, dk – 2880 bagsvaerd, denmark - somatropin - solution for injection - somatropin 5 mg - pituitary and hypothalamic hormones and analogues

Malta - Englisch - Malta Medicines Authority

novonordisk a/s novo alle, dk – 2880 bagsvaerd, denmark - somatropin - solution for injection - somatropin 10 mg - pituitary and hypothalamic hormones and analogues

Malta - Englisch - Malta Medicines Authority

novonordisk a/s novo alle, dk – 2880 bagsvaerd, denmark - somatropin - solution for injection - somatropin 3.3 mg/ml - pituitary and hypothalamic hormones and analogues

Malta - Englisch - Malta Medicines Authority

novonordisk a/s novo alle, dk – 2880 bagsvaerd, denmark - somatropin - solution for injection - somatropin 6.7 mg/ml - pituitary and hypothalamic hormones and analogues

Europäische Union - Englisch - EMA (European Medicines Agency)

biopartners gmbh - somatropin - turner syndrome; dwarfism, pituitary - pituitary and hypothalamic hormones and analogues - paediatric poulationlong-term treatment of children (2 to 11 years old) and adolescents (12 to 18 years old) with growth failure due to an inadequate secretion of normal endogenous growth hormone.treatment of short stature in children with turner syndrome, confirmed by chromosome analysis.treatment of growth retardation in pre-pubertal children with chronic renal insufficiency.adult patientsreplacement therapy in adults with pronounced growth hormone deficiency of either childhood- or adult-onset aetiology.patients with severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional 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 growth hormone 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-1 (igf-1) concentrations (< 2 standard deviation score (sds)), who may be considered for one test. the cut-off point of the dynamic test should be strict.

Vereinigtes Königreich - Englisch - MHRA (Medicines & Healthcare Products Regulatory Agency)

novo nordisk ltd - somatropin (epr) - solution for injection - 3.3mg/1ml

Vereinigtes Königreich - Englisch - MHRA (Medicines & Healthcare Products Regulatory Agency)

novo nordisk ltd - somatropin (epr) - solution for injection - 6.7mg/1ml

Vereinigtes Königreich - Englisch - MHRA (Medicines & Healthcare Products Regulatory Agency)

novo nordisk ltd - somatropin (epr) - solution for injection - 10mg/1ml

Vereinigtes Königreich - Englisch - MHRA (Medicines & Healthcare Products Regulatory Agency)

merck serono ltd - somatropin (rmc) - powder and solvent for solution for injection - 8mg