EPARs human use - Increlex//mecasermin

FICHA FARMACOLÓGICA de mecasermin. 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. SEPTIEMBRE 02, 2009.

abrir aquí para acceder al documento EMEA completo:
EPARs for authorised medicinal products for human use - Increlex

Active Substance
mecasermin
International Nonproprietary Name or Common Name
mecasermin
Pharmaco-therapeutic Group
Somatropin and somatropin agonists
ATC Code
H01AC03

Therapeutic Indication:
For the long-term treatment of growth failure in children and adolescents with severe primary insulin-like growth factor 1 deficiency (Primary IGFD).

Severe Primary IGFD is defined by:
- height standard deviation score ≤-3.0 and
- basal IGF 1 levels below the 2.5th percentile for age and gender and
- GH sufficiency.
- Exclusion of secondary forms of IGF 1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.

Severe Primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signaling pathway, and IGF 1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment. It is recommended to confirm the diagnosis by conducting an IGF-1 generation test.

Date of issue of Marketing Authorisation valid throughout the European Union
3 August 2007

Orphan medicinal product designation date
26 August 2005

EPARs for authorised medicinal products for human use