Valtropin

somatropin

The marketing authorisation for Valtropin has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 14/08/2012 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

10/05/2012  Valtropin -EMEA/H/C/000602 -A20/08

Contents

• 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

Please note that the size of the above document can exceed 50 pages.

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Pharmacotherapeutic group

Pituitary and hypothalamic hormones and analogues

Therapeutic indication

Paediatric poulation

• 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.

Adult patients

• 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.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents