Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: OMNITROPE
Active substances:
Estonian, English, Latin
ATC code: H01AC01
Dosage form: solution for injection
Strength: 10mg 1ml
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
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 3, 2014 
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
1662870  OMNITROPE  solution for injection  10mg 1ml 1.5ml 1TK  Prescription           
1662881  OMNITROPE  solution for injection  10mg 1ml 1.5ml 5TK  Prescription           
1662892  OMNITROPE  solution for injection  10mg 1ml 1.5ml 10TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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