EPARs human use - Valtropin//Somatropin

FICHA FARMACOLÓGICA de Somatropin. Contiene la Monografía en distintos idiomas (de la Comunidad Económica Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Se recuerda que todas las informaciones científico-clínicas, así como técnicas propias de la producción, sólo se publican en idioma inglés. Cerasale. JUNIO 17, 2009.-

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EPARs for authorised medicinal products for human use - Valtropin

International Nonproprietary Name or Common Name
Somatropin
Pharmaco-therapeutic Group
Somatropin
ATC Code
H01AC01

Therapeutic Indication:
Paediatric patients:- Long-term treatment of children 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.

Adults:- 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 I (IGF-I) concentrations (< 2 standard deviation score (SDS)), who may be considered for one test. The cut-off point of the dynamic test should be strict.

Date of issue of Marketing Authorisation valid throughout the European Union
24 April 2006

Orphan medicinal product designation date
Not applicable