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Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1064281
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Name of medicinal product:
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GENOTROPIN
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Active substances:
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ATC code:
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H01AC01
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Dosage form:
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powder and solvent for solution for injection
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Route of administration:
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subcutaneous use
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Strengh:
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12mg
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Amount in package:
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5TK
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Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
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Additional information:
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Indication:
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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.
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Safety features:
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Yes
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Summary of product characteristics (SPC):
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 (last updated February 28, 2022)
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Package information leaflet (PIL):
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EST (last updated February 28, 2022)
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Labelling:
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(last updated July 6, 2018)
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Last imported to Estonia:
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Never imported to Estonia
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Marketing authorization holder:
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Pfizer Europe MA EEIG
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Marketing authorization number:
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292199
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Marketing authorization issued on:
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December 17, 1999
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Marketing authorization expires on:
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Unlimited
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Marketing authorization procedure type:
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National
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Reference price:
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Under reference price:
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Reference price of daily dose:
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Entry/Changing date:
April 25, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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