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Valtropin (somatropin)

Biosimilar
Region
🇪🇺 EU
Active substance
somatropin
Company
BioPartners GmbH
Status
Withdrawn
Therapeutic area
Turner Syndrome; Dwarfism, Pituitary
EU approval
Mon 24 Apr 2006
Designations
Biosimilar
Application
EMEA/H/C/000602
ATC
H01AC01
Official record
www.ema.europa.eu

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.

Regulatory milestones

No milestones recorded in the last year.

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