Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: NUTROPINAQ
Active substances:
Somatropin
Estonian, English, Latin
ATC code: H01AC01
Dosage form: solution for injection
Strength: 10mg 2ml
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Indication: Paediatric population - Long-term treatment of children with growth failure due to inadequate endogenous growth hormone secretion. - Long-term treatment of girls from 2 years old with growth failure associated with Turner syndrome. - Treatment of prepubertal children with growth failure associated with chronic renal insufficiency up to the time of renal transplantation. Adult population - Replacement of endogenous growth hormone in adults with growth hormone deficiency of either childhood or adult-onset etiology. Growth hormone deficiency should be confirmed appropriately prior to treatment. In adults with growth hormone deficiency the diagnosis should be established depending on the etiology: Adult-onset: The patient must have growth hormone deficiency as a result of hypothalamic or pituitary disease, and at least one other hormone deficiency diagnosed (except for prolactin). Test for growth hormone deficiency should not be performed until adequate replacement therapy for other hormone deficiencies have been instituted. Childhood-onset: Patients who have had growth hormone deficiency as a child should be retested to confirm growth hormone deficiency in adulthood before replacement therapy with NutropinAq is started.
Safety features: Yes
Marketing authorization holder: Ipsen Pharma 
Marketing authorization number: EU/1/00/164 
Marketing authorization issued on: March 19, 2004 
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
1197840  NUTROPINAQ  solution for injection  10mg 2ml 2ml 1TK  Prescription           
1197851  NUTROPINAQ  solution for injection  10mg 2ml 2ml 3TK  Prescription           
1197862  NUTROPINAQ  solution for injection  10mg 2ml 2ml 6TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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