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Omnitrope (somatropin)

Biosimilar
Region
🇪🇺 EU
Active substance
somatropin
Company
Sandoz GmbH
Status
Authorised
Therapeutic area
Turner Syndrome; Prader-Willi Syndrome; Dwarfism, Pituitary
CHMP opinion
Thu 26 Jun 2003
EU approval
Wed 12 Apr 2006
Designations
Biosimilar
Application
EMEA/H/C/000607
ATC
H01AC01
Official record
www.ema.europa.eu

Indication

Infants, children and adolescents Growth 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. Adults Replacement 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.

Regulatory milestones

No milestones recorded in the last year.

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.