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Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1662892
Name of medicinal product: OMNITROPE
Active substances:
Somatropin
Estonian, English, Latin
ATC code: H01AC01
Dosage form: solution for injection
Route of administration: subcutaneous use
Strengh: 10mg 1ml
Amount in package: 1.5ml 10TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
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 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: September 3, 2014
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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