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. Cerasale. MAYO 21, 2009.-

abrir aquí:
EPARs for authorised medicinal products for human use - Increlex

Name of the Medicinal Product
Increlex

Marketing Authorisation Holder
Tercica Europe Ltd.
Riverside one
Sir John Rogerson's Quay
Dublin 2
Republic of Ireland

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