Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1197840
Name of medicinal product: NUTROPINAQ
Active substances:
Somatropin
Estonian, English, Latin
ATC code: H01AC01
Dosage form: solution for injection
Route of administration: subcutaneous use
Strengh: 10mg 2ml
Amount in package: 2ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
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 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: June 10, 2014
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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