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Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: GENOTROPIN
Active substances:
Somatropin
Estonian, English, Latin
ATC code: H01AC01
Dosage form: powder and solvent for solution for injection
Strength: 5,3mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated June 5, 2024)
Package information leaflet (PIL): EST  (last updated June 5, 2024)
Labelling:  (last updated July 6, 2018)
Indication: Children. Growth disturbance due to insufficient secretion of growth hormone and growth disturbance associated with Turner syndrome or chronic renal insufficiency. Growth disturbance (current height SDS < -2.5 and parental adjusted height SDS <-1) in short children born small for gestational age (SGA), with a birth weight and/or length below -2SD, who failed to show catch-up growth (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. 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 IGF-I concentrations (< 2 SDS) who may be considered for one test. The cut off point of the dynamic test should be strict.
Safety features: Yes
Marketing authorization holder: Pfizer Europe MA EEIG 
Marketing authorization number: 128596 
Marketing authorization issued on: March 20, 1996 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: National 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1022072  GENOTROPIN  powder and solvent for solution for injection  5,3mg 1TK  Prescription  100% 50%  83,36  28.05.2024     
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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