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Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: OMNITROPE
Active substances:
Somatropin
Estonian, English, Latin
ATC code: H01AC01
Dosage form: solution for injection
Strength: 6,7mg 1ml
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Indication: Infants, children and adolescents - Growth disturbance due to insufficient secretion of growth hormone (growth hormone deficiency, GHD). - 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 height SDS < -1) in short children/adolescents born small for gestational age (SGA), with a birth weight and/or length below -2 standard deviation (SD), who failed to show catch-up growth (height velocity (HV) SDS < 0 during the last year) by 4 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. - Adult onset: Patients who have severe growth hormone deficiency associated with multiple hormone deficiencies as a result of known hypothalamic or pituitary pathology, and who have at least one known deficiency of a pituitary hormone not being prolactin. These patients should undergo an appropriate dynamic test in order to diagnose or exclude a growth hormone deficiency. - Childhood onset: Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes. Patients with childhood onset GHD should be re-evaluated for growth hormone secretory capacity after completion of longitudinal growth. In patients with a high likelihood for persistent GHD, i.e. a congenital cause or GHD secondary to a hypothalamic-pituitary disease or insult, an insulin-like growth factor-I (IGF-I) SDS < -2 off growth hormone treatment for at least 4 weeks should be considered sufficient evidence of profound GHD. All other patients will require IGF-I assay and one growth hormone stimulation test.
Safety features: Yes
Marketing authorization holder: Sandoz GmbH 
Marketing authorization number: EU/1/06/332 
Marketing authorization issued on: September 19, 2007 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1369032  OMNITROPE  solution for injection  6,7mg 1ml 1.5ml 1TK  Prescription  100% 50%  156,30  12.06.2024     
1369043  OMNITROPE  solution for injection  6,7mg 1ml 1.5ml 5TK  Prescription           
1369054  OMNITROPE  solution for injection  6,7mg 1ml 1.5ml 10TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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