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Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1022072
Name of medicinal product: GENOTROPIN
Active substances:
Somatropin
Estonian, English, Latin
ATC code: H01AC01
Dosage form: powder and solvent for solution for injection
Route of administration: subcutaneous use
Strengh: 5,3mg
Amount in package: 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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
Summary of product characteristics (SPC):  (last updated February 28, 2022)
Package information leaflet (PIL): EST  (last updated February 28, 2022)
Labelling:  (last updated July 6, 2018)
Last imported to Estonia: February 1, 2023
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 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
50  12.01.2023     Yes      No      
100  12.01.2023     Yes      No  until 4 years   
100  12.01.2023     Yes  E89.3-E89.3; E23-E23; Q96-Q96; Q87.1-Q87.1; P05.1-P05.1; N18-N18  Endokrinoloog, Pediaater – endokrinoloog  No  until 4 years  kuni kasvutsoonide sulgumiseni 
100  12.01.2023     Yes  E89.3-E89.3; E23-E23; Q96-Q96; Q87.1-Q87.1; P05.1-P05.1; N18-N18  Endokrinoloog, Pediaater – endokrinoloog  No     kuni kasvutsoonide sulgumiseni 
Reference price: 83,36 EUR 
Under reference price: Yes 
Reference price of daily dose: 10,42 EUR 
Entry/Changing date: February 28, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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