Valtropin : EPAR - Summary for the public (PDF/293.37 KB)
First published: 31/05/2007
Last updated: 14/08/2012
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|Date of issue of marketing authorisation valid throughout the European Union||
10/05/2012 Valtropin - EMEA/H/C/000602 - A20/08
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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- Long-term treatment of children (2 to 11 years old) and adolescents (12 to 18 years old) with growth failure due to an inadequate secretion of normal endogenous growth hormone.
- Treatment of short stature in children with Turner syndrome, confirmed by chromosome analysis.
- Treatment of growth retardation in pre-pubertal children with chronic renal insufficiency.
- Replacement therapy in adults with pronounced growth hormone deficiency of either childhood- or adult-onset aetiology.
Patients with severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional 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 growth hormone deficiency (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be recommended, except for those having low insulin-like growth factor-1 (IGF-1) concentrations (< 2 standard deviation score (SDS)), who may be considered for one test. The cut-off point of the dynamic test should be strict.