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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1197851
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Name of medicinal product:
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NUTROPINAQ
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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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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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10mg 2ml
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Amount in package:
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2ml 3TK
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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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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.
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Safety features:
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Yes
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Summary of product characteristics (SPC):
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Package information leaflet (PIL):
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EST
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Labelling:
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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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Ipsen Pharma
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Marketing authorization number:
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EU/1/00/164
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Marketing authorization issued on:
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19 March 2004
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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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Centralised
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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:
10 June 2014
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription