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Active Substance: somatropin
Common Name: somatropin
ATC Code: H01AC01
Marketing Authorisation Holder: BioPartners GmbH
Active Substance: somatropin
Status: Withdrawn
Authorisation Date: 2006-04-24
Therapeutic Area: Dwarfism, Pituitary Turner Syndrome
Pharmacotherapeutic Group: Pituitary and hypothalamic hormones and analogues

Therapeutic Indication

Paediatric poulation

  • Long-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 patients

  • Replacement 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.

The marketing authorisation for Valtropin has been withdrawn at the request of the marketing-authorisation holder.

Source: European Medicines Agency

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